A Randomized, Single-Blind Clinical Study Assessing the Maximum Maxillary Bite Force When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
Phase: PHASE3
Conditions: Denture Retention
Sponsor: HALEON

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1  of 5 9  
C LI NI C A L P R O T O C O L  
A R a n d o mi z e d, Si n gl e -Bli n d Cli ni c al St u d y A s s e s si n g t h e M a xi m u m 
M a xill ar y Bit e F or c e W h e n U si n g T w o N o v el D e nt ur e A d h e si v e s 
C o m p ar e d t o U si n g N o -A d h e si v e  
Pr ot o c ol N u m b er:  
2 1 8 0 4 2  
C o m p o u n d/ Pr o d u ct N a m e:  
E x p eri m e nt al d e nt ur e a d h e si v e s  
U nit e d St at e s ( U S) I n v e sti g ati o n al 
N e w Dr u g (I N D) N u m b er:  
N/ A  
E ur o p e a n Cli ni c al Tri al s D at a b a s e 
( E u dr a C T) N u m b er: 
N/ A  
Ot h er R e g ul at or y A g e n c y I d e ntifi e d 
N u m b er:  
N/ A  
P h a s e:  
III 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
T his d oc u me nt c o ntai ns c o nfi de ntialit y state me nts t hat are n ot rele va nt f or t his p u blicl y 
a vaila ble versi o n 
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2  of 5 9  
 
I n v e sti g at or I nf or m ati o n 
 
Pri n ci p al I n v e sti g at or 
D et ail s  
 
  
 
 
 
 
 
  
 
 
 
I n v e sti g ati o n Sit e 
D et ail s  
 
 
 
 
 
S p o n s or I nf or m ati o n  
 
S p o n s or N a m e & L e g al 
R e gi st er e d A d dr e s s  
 
Gl a x o S mit h Kli n e C o n s u m er H e alt h c ar e 
( U K) Tr a di n g Li mit e d 
9 8 0 Gr e at W e st R o a d,  
Br e ntf or d,  
Mi d dl e s e x,  
T W 8 9 G S,  
U nit e d Ki n g d o m ( U K)  
S p o n s or C o nt a ct D et ail s  
 
Gl a x o S mit h Kli n e C o n s u m er H e alt h c ar e 
( G S K C H) 
1 8 4 Li b ert y C or n er R o a d, W arr e n, N J, 0 7 0 5 9, 
( U nit e d St at e s of A m eri c a) U S A  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3  of 5 9  
D o c u m e nt Hi st or y  
D o c u m e nt  
V er si o n  S u m m ar y of C h a n g e s  
Ori gi n al pr ot o c ol  
1. 0  
N ot a p pli c a bl e ( N/ A)  
A m e n d m e nt 1  
2. 0  
Ni n e  a d mi ni str ati v e c h a n g e s: - 
•  C h a n g e fr o m d at a q u eri e s b ei n g p erf or m e d fr o m 
m o nt hl y t o e v er y 8 w e e k s i n S e cti o n 1 1. 2. 1.  
•  D el eti o n of err o n e o u s e ntr y i n S e cti o n 8. 2. 1 w hi c h 
d e s cri b e d t a ki n g a b a s eli n e K O m e a s ur e.  T hi s 
pr o c e d ur e d o e s n ot n e e d t o b e p erf or m e d  a n d i s 
i n c o n si st e nt wit h t h e r e st of t h e pr ot o c ol. 
•  C orr e cti o n of r ef er e n c e t o s e cti o n s 1 5. 4 or 1 5. 5 t o 
c orr e ct r ef er e n c e of s e cti o n 1 5. 2.  T h e s e 
c orr e cti o n s ar e m a d e i n S e cti o n s 6. 1. 2, 6. 1. 3 a n d 
9. 1. 4  
•  I n s e cti o n s 9. 3. 1 a n d 9. 3. 2 a d diti o n  t h at a w at er 
ri n s e c o ul d b e p erf or m e d pri or t o O S T/ O H T 
e x a mi n ati o n s at e x a mi n er’ s di s cr eti o n.  
•  I n s e cti o n 4. 1 t ol er a n c e f or ti m e wi n d o w f or bit e 
f or c e r e a d s c h a n g e d fr o m ± 5 mi n s t o ± 5 mi n s at t h e 
0. 5 hr m e a s ur e m e nt a n d ± 1 0 mi n s f or all ot h er 
ti m e s.  T hi s ali g n s wit h r e st of t h e pr ot o c ol. 
•  Cl arifi c ati o n t o s e cti o n 1 2. 1 fr o m “ ( b) s u p eri orit y of 
eit h er or b ot h of E X P 1 a n d E X P 2  pr o d u ct s 
c o m p ar e d t o …” t o “ ( b) s u p eri orit y of eit h er or b ot h 
of t h e e x p eri m e nt al d e nt ur e a d h e si v e s pr o d u ct s 
c o m p ar e d t o …”.  
•  S e cti o n s 6. 1. 1 a n d 8. 1. 5 cl arifi e d t o all o w t h e 
d e nt ur e cl e a n si n g p a st e t o b e u s e d  t o cl e a n 
d e nt ur e s at t h e e n d of t h e t e st d a y.  
•  A d diti o n of i n str u cti o n s t o S e cti o n 6. 1. 3 t o di s c ar d 
fir st 1-2 i n c h e s of e xtr u d e d d e nt ur e a d h e si v e if 
s y n er e si s i s o b s er v e d.  
•  S e cti o n 9. 1. 4 m o difi e d t o all o w r e p e at e d bit e s t o b e 
p erf or m e d i n t h e e v e nt of a m et h o d ol o gi c al err or.  
 
 
 
 
 
 
A me n d me nts i nc or p orate all re visi o ns t o dat e, i ncl u di n g a me n d m e nts ma de at t he re q u est of 
c o u ntr y h ealt h a ut h orities, i nstit uti o nal re vie w b oar ds/et hics c o m mittees (I R Bs/ E Cs), etc.   
 
 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4  of 5 9  
Pri n ci p al I n v e sti g at or Pr ot o c ol A gr e e m e nt P a g e  
•  I c o nfir m a gree m e nt t o c o n d uct t he st u d y i n c o m plia nce wit h t he pr ot oc ol a n d a n y 
a me n d me nts acc or di n g t o t he c urre nt I nter n ati o nal C o nfere nce o n Har m o nisati o n G o o d 
Cli nical Practice (I C H G C P) g ui deli nes  a n d a p pli ca ble p orti o ns of E U M D R 2 0 1 7/ 7 4 5 a n d 
E ur o pea n N ati o n I nter n ati o nal Or ga nisati o n f or St a n dar disati o n (I S O) 1 4 1 5 5: 2 0 1 1 a n d 
I S O 1 4 1 5 5: 2 0 2 0. 
•  I ac k n o wle d ge t hat I a m res p o nsi ble f or o verall st u d y c o n d u ct. I a gree t o p ers o nall y 
c o n d uct or s u per vise t he descri be d st u d y.  
•  I a gree t o e ns ure t hat all associates, c ollea g ues a n d e m pl o yees assisti n g i n t he c o n d uct of 
t he st u d y are i nf or m e d a b o ut t heir o bli gati o ns. Mec ha nis ms are i n place t o e ns ure site staff 
recei v es all a p pr o priate i nf or mati o n t hr o u g h o ut t h e st u d y. 
•  I a gree t o c o n d uct t his st u d y i n f ull c o nfor ma nce wit h t he la ws a n d re g ul ati o ns of t he 
c o u ntr y i n w hic h t he researc h is c o n d u cte d a n d t he Declarati o n of Helsi n ki.  
 
I n v esti gat or Na me: 
 
I n v esti gat or Q ualificati o ns: 
 
I n v esti gat or Si g nat ure: 
 
Date of Si g nat ure/ A gree me nt:  
 
D D -M m m -Y Y Y Y  
 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5  of 5 9  
T a bl e of C o nt e nt s  
I n v esti gat or I nf or mati o n ...................................................................................................... 2  
S p o ns or I nf or mati o n  ............................................................................................................ 2  
D oc u me nt Hist or y  ............................................................................................................... 3  
Pri nci pal I n v esti gat or Pr ot oc ol A gree me nt Pa ge  ................................................................ 4  
Ta ble of C o nte nts  ................................................................................................................ 5  
1  
P R O T O C O L S U M M A R Y  ................................................................................................ 1 0  
1. 1  
S y n o psis  ................................................................................................................. 1 0  
1. 2  
Sc he d ule of A cti vities  ............................................................................................ 1 1  
2  
I N T R O D U C TI O N ............................................................................................................. 1 4  
2. 1  
St u d y R ati o nale  ...................................................................................................... 1 4  
2. 2  
Bac k gr o u n d  ............................................................................................................ 1 4  
2. 3  
Be nefit/ Ris k Assess me nt  ....................................................................................... 1 5  
2. 4  
Mec ha nis m of Acti o n/I n dicati o n  ........................................................................... 1 5  
3  
S T U D Y O BJ E C TI V E S A N D E N D P OI N T S  .................................................................... 1 5  
4  
S T U D Y D E SI G N  .............................................................................................................. 1 6  
4. 1  
O verall Desi g n  ....................................................................................................... 1 6  
4. 2  
Scie ntific Rati o nale f or St u d y Desi g n  ................................................................... 1 7  
4. 3  
J ustificati o n f or D ose ............................................................................................. 1 9  
4. 4  
E n d of St u d y Defi niti o n  ......................................................................................... 1 9  
5  
S T U D Y P O P U L A TI O N  .................................................................................................... 1 9  
5. 1  
T y pe a n d Pla n ne d N u m b er of S u bjects  ................................................................. 1 9  
5. 2  
I n cl usi o n Criteria ................................................................................................... 2 0  
5. 3  
E x cl usi o n Criteria  .................................................................................................. 2 0  
5. 4  
Ra n d o mizati o n Criteria  .......................................................................................... 2 1  
5. 5  
Lif est yle C o nsi derati o ns  ........................................................................................ 2 1  
5. 5. 1  
Meals/ Dietar y a n d Lifest yl e Re q uir e me nts a n d Restricti o ns  ................ 2 1  
5. 5. 2  
Alc o h ol a n d T o bacc o Restricti o ns  ........................................................ 2 2  
5. 5. 3  
Me dicati o n a n d Treat me nt Restricti o ns  ................................................ 2 2  
5. 6  
Scree n Fail ures ....................................................................................................... 2 2  
5. 7  
S p o ns or’s Q ualifie d Me dical Pers o n nel  ................................................................ 2 2  
5. 8  
Rater/ Cli nical Assess or Q ualificati o ns  .................................................................. 2 3  
6  
I N V E S TI G A TI O N A L/ S T U D Y P R O D U C T S................................................................... 2 3  
6. 1  
I n v esti gati o nal/ St u d y Pr o d uct S u p plies ................................................................. 2 3  
6. 1. 1  
Me dical De vices  .................................................................................... 2 4  
6. 1. 2  
D osa ge F or m a n d Pac k a gi n g  ................................................................. 2 5  
6. 1. 3  
Pre parati o n a n d Dis pe nsi n g ................................................................... 2 5  
6. 2  
A d mi nistrati o n  ....................................................................................................... 2 5  
6. 2. 1  
Me dicati o n/ D osi n g Err ors  ..................................................................... 2 6  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 6  of 5 9  
6. 2. 2  
O ver d ose  ............................................................................................... 2 6  
6. 3  
I n v esti gati o nal/ St u d y Pr o d uct St ora ge .................................................................. 2 6  
6. 4  
I n v esti gati o nal/ St u d y Pr o d uct Acc o u nta bilit y ....................................................... 2 7  
6. 4. 1  
Destr ucti o n of I n v esti gati o nal/ St u d y Pr o d uct S u p plies  ........................ 2 7  
6. 5  
Bli n di n g a n d All ocati o n/ Ra n d o mizati o n  ............................................................... 2 7  
6. 6  
Brea ki n g t he Bli n d  ................................................................................................. 2 8  
6. 7  
C o m plia nce  ............................................................................................................ 2 8  
6. 8  
C o nc o mita nt Me dicati o n/ Treat me nt(s)  .................................................................. 2 9  
7  
DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D S U BJ E C T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L  ......................................................................... 2 9  
7. 1  
S u bject Disc o nti n uati o n/ Wit h dra wal  ..................................................................... 2 9  
7. 2  
L ost t o F oll o w u p  ................................................................................................... 2 9  
8  
S T U D Y P R O C E D U R E S  ................................................................................................... 3 0  
8. 1  
Visit 1/ Scree ni n g  ................................................................................................... 3 0  
8. 1. 1  
I nf or me d C o nse nt .................................................................................. 3 1  
8. 1. 2  
De m o gra p hics  ....................................................................................... 3 2  
8. 1. 3  
I n cl usi o n/ E x cl usi o n Criteria ................................................................. 3 2  
8. 1. 4  
Me dical Hist or y a n d Pri or Me dicati o n/ Treat me nt  ................................ 3 1  
8. 1. 5  
De nt ure Clea ni n g  .................................................................................. 3 2  
8. 1. 6  
S u bject Eli gi bilit y  ................................................................................. 3 2  
8. 1. 7  
Ma n di b ular De nt ur e Sta bilizati o n  ......................................................... 3 2  
8. 2  
St u d y Peri o d  .......................................................................................................... 3 3  
8. 2. 1  
Visits 2 -5/ Treat me nt Peri o ds 1 -4  ......................................................... 3 3  
8. 3  
St u d y C o n cl usi o n  ................................................................................................... 3 4  
8. 4  
F oll o w -u p Visit/ P h o ne Call  ................................................................................... 3 4  
9  
S T U D Y A S S E S S M E N T S  ................................................................................................. 3 4  
9. 1  
Scree ni n g Assess me nts  .......................................................................................... 3 4  
9. 1. 1  
De nt ure Beari n g Tiss ue Sc ore  ............................................................... 3 4  
9. 1. 2  
Ka p ur -Ols h a n I n de x ( Well Fitti n g Assess me nt)  ................................... 3 5  
9. 1. 3  
Well Ma de assess me nt  .......................................................................... 3 5  
9. 1. 4  
Ma xillar y Bite F orce Ass ess me nt ( Trai ni n g a n d Q ualif yi n g Bites) ...... 3 6  
9. 2  
Efficac y Assess me nts  ............................................................................................ 3 6  
9. 2. 1  
Treat me nt D a y ( Visits 2 -5) Ma xillar y Bite F orce Assess me nts 
( Practice, Bas eli ne a n d T est Bites)........................................................ 3 6  
9. 3  
Safet y a n d Ot her Assess me nts  ............................................................................... 3 7  
9. 3. 1  
Oral S oft Tiss ue E x a mi nati o n  ............................................................... 3 7  
9. 3. 2  
Oral Har d Tiss ue E x a mi nati o n  .............................................................. 3 8  
1 0  A D V E R S E E V E N T A N D S E RI O U S A D V E R S E E V E N T S  ........................................... 3 8  
1 0. 1  
Defi niti o n of a n A d verse E ve nt ( A E)  .................................................................... 3 8  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 7  of 5 9  
1 0. 2  
Defi niti o n of a Seri o us A d verse E ve nt ( S A E)  ....................................................... 3 9  
1 0. 3  
Ti me Peri o d a n d Fre q ue n c y f or C ollecti n g A E a n d S A E I nf or mati o n  .................. 4 0  
1 0. 4  
Re p orti n g Pr oce d ures ............................................................................................. 4 1  
1 0. 4. 1  
Re p orti n g of a n A d verse E ve nt  ............................................................. 4 1  
1 0. 4. 2  
Re p orti n g of a Seri o us A d verse E ve nt  .................................................. 4 2  
1 0. 5  
E val uati n g A d v erse E ve nts  .................................................................................... 4 2  
1 0. 5. 1  
Assess me nt of I nte nsit y  ........................................................................ 4 2  
1 0. 5. 2  
Assess me nt of Ca usalit y  ....................................................................... 4 3  
1 0. 6  
F oll o w -u p of A Es a n d S A Es .................................................................................. 4 3  
1 0. 7  
Wit h dra wal D ue t o a n A d verse E ve nt  ................................................................... 4 4  
1 0. 8  
Re g ulat or y Re p orti n g Re q uire me nts f or S A Es ...................................................... 4 4  
1 0. 9  
Pre g n a nc y  .............................................................................................................. 4 5  
1 0. 9. 1  
Ti me Peri o d f or C ollecti n g Pre g n a nc y I nf or mati o n .............................. 4 5  
1 0. 9. 2  
Acti o n t o be Ta ke n if Pre g na n c y Occ urs  .............................................. 4 5  
1 0. 1 0  Me dical De vic e I n ci de nts  ...................................................................................... 4 5  
1 0. 1 0. 1  
Defi niti o n of a n I nci d e n t ....................................................................... 4 5  
1 0. 1 1  Re p orti n g of I nci de nts a n d Malf u ncti o ns  .............................................................. 4 6  
1 0. 1 2  F oll o w -u p of Me di cal De vice I nci de nts  ................................................................ 4 7  
1 0. 1 3  Re g ulat or y Re p orti n g Re q uire me nts f or Me dical De vice I n ci de nts ...................... 4 7  
1 1  D A T A M A N A G E M E N T  .................................................................................................. 4 7  
1 1. 1  
Case Re p ort F or m  .................................................................................................. 4 8  
1 1. 2  
Data Ha n dli n g  ........................................................................................................ 4 8  
1 1. 2. 1  
Data Q ueries  .......................................................................................... 4 8  
1 2  S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A A N A L Y S E S  .................................. 4 9  
1 2. 1  
Sa m ple Siz e Deter mi nati o n  ................................................................................... 4 9  
1 2. 2  
P o p ulati o ns f or A nal ys es  ....................................................................................... 4 9  
1 2. 3  
Statistical A nal yses  ................................................................................................ 5 0  
1 2. 3. 1  
Pri mar y A n al ysis  ................................................................................... 5 0  
1 2. 3. 2  
Sec o n dar y A nal ys es  .............................................................................. 5 0  
1 2. 3. 3  
Safet y A nal ysis  ..................................................................................... 5 1  
1 2. 3. 4  
E x cl usi o n of Data fr o m A nal ysis  .......................................................... 5 1  
1 2. 3. 5  
De m o gra p hic a n d Baseli ne C haracteristics  ........................................... 5 1  
1 2. 3. 6  
St u d y Pr o d uct C o m plia nce  .................................................................... 5 1  
1 2. 3. 7  
Ha n dli n g of Dr o p o uts a n d Missi n g Data  .............................................. 5 1  
1 2. 3. 8  
I nteri m A nal ysis .................................................................................... 5 2  
1 3  S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S .............................................................. 5 2  
1 3. 1  
Q ualit y C o ntr ol  ...................................................................................................... 5 2  
1 3. 2  
Q ualit y Ass ura nce  .................................................................................................. 5 2  
1 3. 3  
Re g ulat or y a n d Et hical C o nsi derati o ns  ................................................................. 5 3  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 8  of 5 9  
1 3. 3. 1  
I nstit uti o nal Re vie w B oar d/ Et hics C o m mittee..................................... 5 3  
1 3. 3. 2  
Et hical C o n d uct of t he St u d y  ................................................................ 5 3  
1 3. 3. 3  
S u bject I nf or mati o n a n d C o nse nt  .......................................................... 5 3  
1 3. 3. 4  
S u bject Recr uit me nt  .............................................................................. 5 4  
1 3. 3. 5  
Re p orti n g of Safet y Iss ues a n d Seri o us Breac hes of t he Pr ot oc ol  or 
I C H G C P ............................................................................................... 5 4  
1 3. 4  
P osti n g of I nf or m ati o n o n P u blicl y A vaila ble Cli nical Trial Re gisters  ................. 5 4  
1 3. 5  
Pr o visi o n of St u d y Res ults t o I n vesti gat ors  ........................................................... 5 4  
1 3. 6  
Rec or ds Rete nti o n  .................................................................................................. 5 5  
1 3. 7  
C o n diti o ns f or Ter mi nati n g t he St u d y  ................................................................... 5 5  
1 4  R E F E R E N C E S  .................................................................................................................. 5 6  
1 5  A P P E N DI CI E S .................................................................................................................. 5 7  
1 5. 1  
A B B R E VI A TI O N S  ............................................................................................... 5 7  
1 5. 2  
A p plicati o n I nstr u cti o ns ......................................................................................... 5 8  
1 5. 2. 1  
Ma xillar y De nt ure A d hesi ve A p plicati o n I nstr ucti o ns f or 
E x peri me ntal A d hesi ves ........................................................................ 5 8  
1 5. 2. 2  
Ma xil lar y De nt ure A d hesi ve A p plicati o n I nstr ucti o ns f or C o ntr ol 
A d hesi ve  ................................................................................................ 5 9  
1 5. 2. 3  
Ma n di b ular De nt ur e A d hesi ve A p plicati o n I nstr ucti o ns –  t o 
sta bilize t he ma n di b ular de nture o nl y (if re q uire d)  ............................... 5 9  
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C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 9  of 5 9  
Li st of i n t e xt t a bl e s  
Ta ble 1 -1  
Sc he d ule of Acti vities  ........................................................................... 1 1  
Ta ble 4 -1  
I n cisal Bite F orce Descri pti o ns ............................................................. 1 6  
Ta ble 6 -1  
I n v esti gati o nal/ St u d y Pr o d uct S u p plies ................................................ 2 3  
Ta ble 6 -2  
S u n dr y Ite ms  ......................................................................................... 2 4  
Ta ble 9 -1  
T he de nt ure b eari n g tiss u e sc ore ( Ka p ur,  1 9 6 7 ) ................................... 3 4  
Ta ble 1 5 -1  
A b bre viati o ns  ........................................................................................ 5 7  
 
 
 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 0  of 5 9  
1  
P R O T O C O L S U M M A R Y  
1. 1  
S y n o p si s  
S h ort Titl e:  
A Ra n d o mize d, Si n gle -Bli n d  (t o t he e x a mi ner perf or mi n g t h e bite f orce assess me nt) Cli nical 
St u d y Assessi n g t he 
M a xi m u m 
Ma xillar y Bite F orce 
W he n Usi n g T w o N o vel De nt ur e 
A d hesi ves C o m pare d t o Usi n g N o -A d hesi ve . 
B a c k gr o u n d a n d R ati o n al e : 
T he t w o e x peri me ntal de nt ure a d hesi ves bei n g teste d i n t his st u d y re q uir e cli nical e vi de nce of 
effic ac y i n deli veri n g d e nt ure h ol d t o s u p p ort i nte n de d clai ms.  Meas ure m e nt of t he ma xi m u m 
i ncisal Bite f orce ( B F) ac hie va ble pri or t o de nt ure disl o d g me nt is a c o m m o nl y us e d meas ure of 
de nt ure h ol d a n d will, t heref ore, be us e d i n t his st u d y.  
O bj e cti v e s a n d E n d p oi nt s : 
O bj e cti v e s  
E n d p oi nt s  
Pri m ar y  
T o c o m p ar e t h e m a xi m u m i n ci s al bit e f or c e u ntil 
m a xill ar y d e nt ur e di sl o d g e m e nt of t w o 
e x p eri m e nt al  d e nt ur e a d h e si v e s t o n o a d h e si v e 
o v er 1 2 h o ur s  
A r e a o v er b a s eli n e i n bit e f or c e o v er 1 2 h o ur s  
S e c o n d ar y  
T o c o m p ar e t h e m a xi m u m i n ci s al bit e f or c e u ntil 
m a xill ar y d e nt ur e di sl o d g e m e nt of t w o 
e x p eri m e nt al d e nt ur e a d h e si v e s t o n o a d h e si v e 
f or ti m e p eri o d s u p t o 9 h o ur s. 
Ar e a  o v er b a s eli n e u p t o 0. 5, 1, 3, 6 a n d 9 h o ur s  
S af et y  
T o a s s e s s t h e  l o c al t ol er a bilit y of t w o 
e x p eri m e nt al  d e nt ur e a d h e si v e s   
Tr e at m e nt e m er g e nt a d v er s e e v e nt s a n d 
i n ci d e nt s 
St u d y D e si g n : 
T his will be a si n gle -ce ntre, c o ntr olle d, ra n d o mize d, si n gle -bli n d ( wit h res p ect t o t he e x a mi ner 
perf or mi n g t he i ncisal bite f orce ( B F) meas ure me nts), 4 -treat me nt, 4- peri o d, cr oss -o ver st u d y 
t o e val uate t h e ma xi m u m ma xillar y B F i n a p o p ul ati o n of f ull ma xillar y d e nt ure wearers.  T h e 
ai ms of t his st u d y are t o i n vesti gate t he h ol d pr o perties of t w o e x peri me ntal de nt ure a d hesi ves 
usi n g esta blis he d ma xi m u m i ncisal B F met h o d ol o g y.  A c urre ntl y mar ket e d de nt ure a d h esi ve 
will be use d as a p ositi ve c o ntr ol, w hilst  use of n o a d hesi ve will be e m pl o ye d as a ne gati ve 
c o ntr ol.  T his st u d y d esi g n is si milar t o t hat e m pl o ye d i n pre vi o us st u dies (A xe et al., 2 0 1 8 , J ose 
et al., 2 0 1 8, Var g h ese et al., 2 0 1 9 ). 
St u d y Pr o d u ct s : 
T he t w o e x peri me ntal a d hesi ves bei n g i n ve sti gate d i n t his st u d y ha v e b ee n f or m ulate d t o 
pr o vi de de nt ure h ol d t hr o u g h o ut t he da y.  
I n t his st u d y t he e x peri me ntal de nt ure a d hesi ves will be c o m pare d t o n o a d hesi ve f or all B F 
assess me nts.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 1  of 5 9  
A mar kete d de nt ur e a d hesi ve wit h e xte nsi ve cli nical e vi de nce of  effi cac y, S u per P oli gri p Free 
( S P F), will be use d as a p ositi ve c o ntr ol t o assess st u d y vali dit y.  All a d hesi ve a p plicati o ns will 
be a p plie d b y cli nical site dis pe nsi n g staff a n d will be c o ntr olle d b y wei g ht f or t he ma xillar y 
de nt ure o nl y ( 1. 0 0 g ± 0. 0 5 gra ms ( g)).  If s u bjects als o wear a ma n di b ular de nt ure (eit her f ull or 
partial), t he n S P F  will  be use d t o sta bilize t he ma n di b ular de nt ure .  
T y p e a n d Pl a n n e d N u m b er of S u bj e ct s : 
A s ufficie nt n u m ber of healt h y s u bjects wit h f ull ma xillar y d e nt ures will be scr ee ne d t o 
ra n d o mize at least 4 5, t o e ns ure at least 4 2 e val ua ble s u bjects c o m plete t he e ntire st u d y.  
S u bjects will be male or fe male, a ge d 1 8 -8 5  years . 
T he pri mar y effic ac y e n d p oi nt is t he area-o ver -b aseli ne ( A O B ) o ver 1 2 h o urs f or t he i ncisal 
bite f orce ( i n p o u n ds [l bs]) ( de n ote d b y A O B0 -1 2). T he pri mar y o bjecti ve is t o c o m pare i ncisal 
bite f orce of t he t w o test a d hesi ves , i n de pe n de ntl y, vers us n o a d hesi v e o ver 1 2 h o urs, A O B 0 -1 2. 
T he st u d y vali dit y will first be e val uate d b y c o m pari n g S u per P oli gri p Free vs n o a d hesi ve f or 
A O B 0 -1 2. De m o nstrati n g st u d y vali dit y ( p < 0. 0 5 f or S u per P oli gri p Free vs n o a d hesi ve) is a 
prere q uisite t o perf or mi n g all ot her treat me nt c o m paris o ns. N o f urt her si g nifica nce testi n g will 
be perf or me d if t he i nitial vali dati o n ste p is n o t ac hie ve d.  
A n a nal ysis of c o vari a nce ( A N C O V A ) m o del will be use d t o a nal y ze A O B 0 -1 2, wit h treat me nt 
a n d peri o d as fi x e d effects; t he c o variates i n t his m o del are t h e s u bject le vel baseli ne a n d p eri o d 
le vel baseli ne mi n us s u bject le vel baseli ne. S u bject will be i ncl u de d as a ra n d o m effect. Pair wise 
treat me nt c o m paris o ns will be o btai ne d as a differe nce i n a dj uste d mea ns a n d prese nt e d wit h 
9 5 % c o nfi de n ce i nter vals ( CI) a n d ass o ciate d p -v al ues.  
T he sec o n dar y e n d p oi nts A O B 0 -0. 5, A O B0 -1, A O B0 -3, A O B0 -6, A O B0 -9 will be defi ne d a n d 
a nal yz e d i n a si milar ma n ner as A O B 0 -1 2.  
N o a dj ust me nts f or m ulti plicit y will be carrie d o ut f or h y p ot h esis testi n g of  pri mar y a n d  
sec o n dar y e n d p oi nts.  T he a nal ys es will be re p eate d f or eac h e x peri me ntal a d hesi ve wit h n o 
s plitti n g of al p ha or hierarc hical or der  b et wee n t he t w o  j oi nt pri mar y e n d p oi nts  of  A O B 0 -1 2, f or 
eac h test a d h esi ve.  
1. 2  
S c h e d ul e of A cti viti e s  
T he sc he d ule of acti vities ta ble pr o vi des a n o ver vie w of t he s u bject visits a n d st u d y pr oce d ures.   
T he i n vesti gat or ma y s c he d ul e visits ( u n pla n ne d visits) i n a d diti o n t o t h ose liste d o n t he 
sc he d ule of acti vities, t o c o n d uct e val uati o ns or assess me nts re q uire d t o pr otect t he well -bei n g 
of t he s u bject.  
T a bl e 1 -1  
S c h e d ul e of A cti viti e s  
Pr o c e d ur e/ A s s e s s m e nt  
S cr e e ni n g  
St u d y P eri o d  
Vi sit 1  
 
Vi sit 2  
Tr e at m e
nt 
P eri o d 1  
 
Vi sit 3  
Tr e at m e
nt P eri o d 
2  
 
Vi sit 4  
Tr e at m e
nt P eri o d 
3  
 
Vi sit 5  
Tr e at m e
nt P eri o d 
4  
I nf or m e d c o n s e nt 
X  
B et w e e n 1  a n d 2 8 
d a y s  
 
B et w e e n 1  a n d 2 8 
d a y s  
 
B et w e e n 1  a n d 2 8 
d a y s  
 
B et w e e n 1  a n d 2 8 
d a y s  
 
M e di c al hi st or y  
X  
 
 
 
 
D e nt al hi st or y  
X  
 
 
 
 
D e m o gr a p hi c s  
X  
 
 
 
 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 2  of 5 9  
Pr o c e d ur e/ A s s e s s m e nt  
S cr e e ni n g  
St u d y P eri o d  
Vi sit 1  
 
Vi sit 2  
Tr e at m e
nt 
P eri o d 1  
 
Vi sit 3  
Tr e at m e
nt P eri o d 
2  
 
Vi sit 4  
Tr e at m e
nt P eri o d 
3  
 
Vi sit 5  
Tr e at m e
nt P eri o d 
4  
C urr e nt/ pri or/ c o n c o mit a nt 
m e di c ati o n r e vi e w  
X  
X  
X  
X  
X  
D e nt ur e  cl e a ni n g 6  
X  
X  
X  
X  
X  
D e nt ur e B e ari n g Ti s s u e 
A s s e s s m e nt  
X  
 
 
 
 
Crit eri a f or w ell -m a d e a n d 
fitti n g d e nt ur e s 
X  
 
 
 
 
K a p ur -Ol s h a n I n d e x 
a s s e s s m e nt t o d et er mi n e 
eli gi bilit y  
X  
 
 
 
 
I n cl u si o n/ e x cl u si o n Crit eri a 
X  
X  
X  
X  
X  
O S T  E x a mi n ati o n 1  
X  
X  
X  
X  
X  
O H T E x a mi n ati o n 2  
X  
 
 
 
X  
M a n di b ul ar d e nt ur e 
st a bili z ati o n 3  
X  
X  
X  
X  
X  
Tr ai ni n g bit e s ( 3 i n ci s al B F 
m e a s ur e m e nt s wit h n o 
a d h e si v e)  
X  
 
 
 
 
Q u alif yi n g bit e s ( 4 I n ci s al 
B F m e a s ur e m e nt s wit h n o 
a d h e si v e)  
X  
 
 
 
 
S u bj e ct eli gi bilit y  
X  
 
 
 
 
Pr a cti c e bit e s ( 3 I n ci s al B F 
m e a s ur e m e nt s wit h n o 
a d h e si v e)  
 
X  
X  
X  
X  
B a s eli n e ( pr e -tr e at m e nt) 
i n ci s al B F m e a s ur e m e nt s 
 
X  
X  
X  
X  
S u bj e ct c o nti n u a n c e  
 
X  
X  
X  
X  
R a n d o mi z ati o n  
 
X  
 
 
 
P r o d u ct a p pli c ati o n t o 
m a xill ar y d e nt ur e b y sit e 
st aff  
 
X  
X  
X  
X  
I n ci s al B F m e a s ur e m e nt s 
( 0. 5, 1, 3, 6, 9, 1 2 hr) 
 
X  
X  
X  
X  
D e nt ur e cl e a ni n g at e n d of 
st u d y vi sit d a y  wit h r e m o v al 
of e x c e s s a d h e si v e fr o m 
m o ut h
4  
X  
X  
X  
X  
X  
A d v er s e e v e nt s a n d 
i n ci d e nt s r e vi e w5  
X  
X  
X  
X  
X  
St u d y c o n cl u si o n/ s u bj e ct 
e xit fr o m st u d y  
 
 
 
 
X  
A b bre viati o ns: O S T: Oral S oft Tiss ue, O H T: Oral Har d Tiss ue, B F: Bite f orce  
F o ot n otes:  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 3  of 5 9  
1.  O S T e xa m perf or me d bef ore de nt ure sta bilizati o n (if re q uir e d) a n d/ or c o m me nce me nt of B F assess me nts; 
a n d a gai n after de nt ure a n d resi d ual a d hesi ve re m o val at e n d of eac h st u d y visit.  
2.  O H T e xa m perf or me d at Scree ni n g ( Visit 1) f oll o wi n g t he first O S T e xa m; a n d at t he e n d of Treat me nt 
P eri o d 4 ( Visit 5), f oll o wi n g t he last O S T e xa m.  
3.  Ma n di b ular de nt ure ca n be st a bilize d, if prese nt, a n d re -sta bilize d usi n g a d hesi ve u p t o 2 ti mes ( ma x 3 
a d hesi ve a p plicati o ns per da y) at e xa mi ner’s discreti o n.  
4.  St u d y site staff w h o c o nfir m a bse nce of de nt ure a d hesi ve i n t he m o ut h at Visits 2 -5 will n ot be t he sa me 
pers o n as perf or mi n g a n y bli n de d assess me nts.  
5.  A d verse E ve nts ( A Es), Seri o us A d verse E ve nts ( S A Es), me dical de vice i nci de nts c oll ecte d i m me diatel y 
after s u bj ect pr o vi des c o nse nt t o partici pate i n t he st u d y a n d t hr o u g h o ut t he st u d y . 
6.  De nt ure clea ni n g t o be perf or me d pri or t o well -ma de assess me nt at Scree ni n g or pr o d uct a p plicati o n ( or 
de nt ure i nserti o n f or s u bj ects ra n d o mize d t o n o a d hesi ve treat me nt) at V 2 -5.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 4  of 5 9  
2  
I N T R O D U C TI O N 
De nt ure a d hesi ves ( or fi x ati ves) ha ve bee n use d b y e de nt ul o us s u bjects t o i m pr o ve t he rete nti o n 
a n d sta bilit y of t heir de nt ures f or ma n y years. T he pri mar y b e nefits of usi n g a de nt ure a d hesi v e 
crea m are t o e n ha nce ret e nti o n a n d sta bilit y of t h e pr ost hesis, a n d t o re d u ce f o o d e ntr a p me nt 
(Zar b et al., 2 0 1 3 ). A d h esi ves c o ntai n materials t hat bec o me h y drate d w he n t he y c o me i nt o 
c o ntact wit h sali va, all o wi n g t he a d hesi ve t o stic k rea dil y t o b ot h t he m uc osal s urface a n d t he 
fit s urface of t he de nt ure (S ha y , 1 9 9 7). 
T here are a n u m ber of rec o g niz e d met h o ds w hic h ha ve bee n use d t o de m o nstrate t he efficac y 
of a de nt ur e a d h esi ve. T hese i ncl u de t he Ka p ur I n de x (Ka p ur, 1 9 6 7 ) a n d bite f orce ( B F) u ntil 
de nt ure disl o d ge me nt (H o well a n d Ma nl y, 1 9 4 8 )  t o meas ure de nt ure rete nti o n a n d sta bilit y; 
de nt ure disl o d ge me nt (T ar bet et al., 1 9 8 0 ) t o m eas ure de nt ur e m o ve me nt i n f u ncti o n; a n d 
masticat or y p erf or m a nce (Ka p ur, 1 9 6 7 ) as a n i n dicat or of c he wi n g efficie n c y. T he B F cli nical 
m o del has bee n use d s uccessf ull y t o de m o nstrate t he efficac y of crea m de nt ure a d hesi ves t o 
i m pr o ve de nt ur e h ol d f or u p t o 1 2 h o urs a n d as earl y as 3 0 mi n utes  after t he a d hesi v e 
a p plicati o n, 
w hile als o  de m o nstrati n g differe n ces i n stre n gt h a m o n g vari o us a d hesi ve 
f or m ulati o ns (Grass o, 2 0 0 4 , C he w et al., 1 9 8 5 , C he w et al., 1 9 8 4 ).  T his st u d y i n vesti gates B F 
as a meas ur e me nt of rete nti o n of t he ma xillar y d e nt ure.  
I n t his st u d y, a B F  tra ns d ucer s yste m will be use d t o meas ure i ncisal bite f orce u ntil de nt ure 
disl o d ge me nt of ma xillar y c o m plete d e nt ures. S u bjects i n t his st u d y will ha ve de nt u res j u d ge d 
t o be cli nicall y acce pt a b le a n d m o derat el y well-fitti n g usi n g t he Ka p ur i n de x t hat was m o difie d 
b y Ols h a n et al. (Ols ha n et al., 1 9 9 2 ). De nt ur es will als o be j u d ge d t o b e well-ma de a n d usi n g 
t he desi g n a n d c o nstr ucti o n criteria t o e ns ure t he y are cli nicall y acce pta ble f or t he st u d y. 
T his cli nical st u d y is desi g ne d t o s u p p ort t he efficac y of t w o e x peri me ntal de nt ure a d h esi ve  
crea ms.   T he a d h esi ve h ol d pr o perties of t he e x peri me ntal pr o d uct s c o m pare d t o t he use of n o 
a d hesi ve will b e ass esse d t hr o u g h e v al uati o n of t he ma xi mal i ncisal bitef orce t hat ca n be 
ac hie ve d b ef ore de nt ur e disl o d ge me nt.   
2. 1  
St u d y R ati o n al e  
T he t w o e x peri me ntal de nt ure a d hesi v es re q uire a cli nical trial t o esta blis h cli nical efficac y 
t hr o u g h t he meas ur e me nt of de nt ur e ret e nti o n i n or der t o s u p p ort i nte n d e d clai ms f or eit her of 
t hese a d hesi ves. 
T he ma xi m u m ac hie va bl e i ncisal bi te f orce pri or t o de nt ure disl o d ge me nt is a c o m m o nl y use d 
meas ure of de nt ure h ol d f or de nt ure a d hesi ves a n d will t heref ore b e use d i n t his st u d y. 
T his is a P hase III st u d y t hat is pla n ne d t o be p erf or me d b y a cli nical site i n t he U nite d States 
of A meric a ( U S A ) wit h e x perie nce i n t he bite f orce met h o d ol o g y a n d e q ui p me nt.   
2. 2  
B a c k gr o u n d  
A B F tra ns d u cer will be use d t o meas ure t he ma xillar y i ncisal bite f orce o ver a 1 2 -h o ur ti me 
peri o d.  B F i n dicates de nt ure rete nti o n b y meas uri n g t he ma xi m u m f orce t hat ca n be a p plie d b y 
t he i ncis ors pri or t o disl o d ge m e nt of t he ma xillar y de nt ure (M u n oz et al., 2 0 1 2 ).  T his is li ne 
wit h pre vi o us G S K st u dies 
 
) w here t he B F cli nical m o del h as bee n 
s uccessf ull y use d t o de m o nstrate t he efficac y of d e nt ure  a d h esi ves t o  i m pr o ve de nt ure h ol d f or 
u p t o 1 2 h o urs a n d as earl y as 3 0 mi ns  after a d h esi ve a p plicati o n, w hilst als o de m o nstrati n g 
differe n ces i n stre n gt h a m o n g v ari o us a d hesi ve f or m ulati o ns.   
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 5  of 5 9  
Base d u p o n t heir c o m p ositi o ns a n d pre -cli nical i n vitr o testi n g 
met h o d ol o g y, t he t w o 
e x peri me ntal a d hesi ves are e x pecte d t o pr o vi d e s ufficie nt h ol d t o meet t h e o bjecti ves of t his 
st u d y.  B ot h s hare si milarities wit h t he p ositi ve c o ntr ol a d hesi ve w hi c h has pre vi o usl y b ee n 
s h o w n t o be effecti ve i n t his cli nical desi g n (
 
 
 
). 
2. 3  
B e n efit/ Ri s k A s s e s s m e nt  
T he pri mar y b e nefit of usa ge of a de nt ure a d hesi ve is t o pr o vi de greater h ol d a n d sta bilit y of 
t he de nt ure wit hi n t he oral ca vit y.  I n t his st u d y t he t w o e x peri me ntal de nt ure a d hesi ves are 
a ntici pate d t o pr o vi de a d e q uate de nt ur e h ol d.   
As detaile d i n t he Safet y State me nt f or t his st u d y, o n t he basis of t he t o xic ol o gical a n d safet y 
data a v aila ble f or t he i n gre die nts c o nt ai ne d i n t he e x peri me ntal de nt ure a d h esi ves ( 
 
a n d 
 a n d t he mar kete d pr o d uct S u per P oli gri p Free ( 
 A d hesi ve Crea m 
(
 a n d t he hist or y of use of  
 a n d si milar mar kete d pr o d ucts, t hese f or m ulati o ns 
are c o nsi dere d s uita ble f or use i n t he pr o p ose d cli nical st u d y. I n a d diti o n, t here are n o k n o w n 
safet y c o n cer ns re gar di n g t he use of Oral B De nt ure Br us h a n d P oli de n t De nt u Crè me De nt ure 
Clea nsi n g Paste d uri n g t his bite f orce e val uati o n st u d y.  All t hese pr o d ucts are c o nsi dere d 
s uita ble f or use u n der t h e c o n diti o ns of t his cli nical st u d y.  T he cli nical st u d y met h o d ol o g y is 
c o m m o nl y use d  as a n  effecti ve me a ns of e val ua ti n g t he h ol d perf or ma nce of a de nt ur e a d h esi ve.  
N o i nteracti o n 
wit h t he de nt ure a d h esi ves u n der e val uati o n a n d a n y c o nc o mita nt 
me dicati o ns/treat me nts is e x pecte d.  T he be n efit ris k pr ofile of t h is st u d y is t heref ore fa v ora bl e. 
2. 4  
M e c h a ni s m of A cti o n/I n di c at i o n 
De nt ure a d h esi ves f u ncti o n b y f or mi n g a n a d hesi v e la yer bet wee n t he de nt ure a n d g u m s urface 
t here b y re d u ci n g de nt ur e m o ve me nt a n d i m pr o vi n g h ol d.  T hese a d hesi ve pr o perties are dri ve n 
b y a c o m bi nati o n of differe nt a d h esi ve p ol y mers i n t he a d hesi ve crea ms, i ncl u di n g 
car b o x y met h yl cell ul ose ( C M C), car b o mer a n d p ol y vi n yl met h yl et her/ maleic a n h y dri de c o -
p ol y mer.  T h e p ol y mers are dis perse d i n a h y dr ocar b o n me di u m as a crea m .  I n t he oral ca vit y, 
t he crea m a bs or bs water a n d t he p ol y mers h y drate pr o vi di n g a d hesi ve n ess bet wee n t he de nt ure 
a n d t he de nt ure b eari n g tiss ues.  
3  
S T U D Y O B J E C TI V E S A N D E N D P OI N T S  
O bj e cti v e s  
E n d p oi nt s  
Pri m ar y  
T o c o m p ar e t h e m a xi m u m i n ci s al bit e f or c e u ntil 
m a xill ar y d e nt ur e di sl o d g e m e nt of t w o 
e x p eri m e nt al  d e nt ur e a d h e si v e s t o n o a d h e si v e 
o v er 1 2 h o ur s  
A r e a o v er b a s eli n e i n bit e f or c e o v er 1 2 h o ur s  
S e c o n d ar y  
T o c o m p ar e t h e m a xi m u m i n ci s al bit e f or c e u ntil 
m a xill ar y d e nt ur e di sl o d g e m e nt of t w o 
e x p eri m e nt al d e nt ur e a d h e si v e s t o n o a d h e si v e 
f or ti m e p eri o d s u p t o 9 h o ur s. 
Ar e a o v er b a s eli n e u p t o 0. 5, 1, 3, 6 a n d 9 h o ur s  
S af et y  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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C CI
C CI
C CI
C CI
C CI
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 6  of 5 9  
T o a s s e s s t h e  l o c al t ol er a bilit y of t w o 
e x p eri m e nt al  d e nt ur e a d h e si v e s   
Tr e at m e nt e m er g e nt a d v er s e e v e nt s a n d 
i n ci d e nt s 
T his st u d y will be c o nsi dere d s uccessf ul if eit her or b ot h of t he e x peri me ntal  de nt ure a d hesi ves 
are s h o w n t o ha ve a statisticall y si g nifica ntl y greater area o ver bas eli ne i n bite f orce o ver 1 2 
h o urs  ( A O B0 -1 2) c o m pare d t o n o a d hesi ve use.  I n a d diti o n, t o e ns ure assa y se nsiti vit y a n d f or 
t he st u d y t o be dee me d vali d, t he p ositi ve c o ntr ol de nt ure a d hesi ve will be re q uir e d t o 
de m o nstrate statisticall y si g nifica ntl y s u peri orit y t o n o  a d hesi ve usi n g t he s a me e n d p oi nt.  
4  
S T U D Y D E SI G N  
4. 1  
O v er all D e si g n  
T his will be a si n gle -ce nter, c o ntr olle d, ra n d o mize d, si n gle bli n d ( wit h res pect t o t he e x a mi ner 
perf or mi n g i ncisal bite f orce rea di n gs), 4 -tr eat m e nt, 4 treat me nt-peri o d, cr oss -o ver st u d y t o 
e val uate ma xi m u m ma xillar y bite f orce i n a p o p ul ati o n of f ull ma xillar y d e nt ure wearers.  
A s ufficie nt n u m ber of s u bjects will be s cree ne d, a ge d bet wee n 1 8 -8 5  years, wit h well -ma de 
a n d m o deratel y w ell -fitti n g c o m plete ma xillar y de nt ures.  A s uffici e nt n u m ber of healt h y 
s u bjects wit h f ull ma xillar y d e nt ures will be scree n e d t o ra n d o mize at least 4 5, t o e ns ure at least 
4 2 e val ua ble s u bjects c o m plete t he e ntire st u d y.   
T his st u d y c o nsists of 5 visits ( 1 scree ni n g visit a n d 4 treat me nt peri o ds).  At Visit 1, Scree ni n g, 
s u bjects will be assesse d f or eli gi bilit y bas e d o n t he i ncl usi o n/e xcl usi o n criteri a a n d will 
u n der g o a n Oral S oft Tiss ue ( O S T) e x a mi nati o n.  T he s u b ject’s ma xillar y de nt ur e will be 
assesse d f or rete nti o n a n d sta bilit y usi n g t he Ka p ur I n de x ( Ols ha n M o difi cati o n) a n d w het h er 
t he y are well ma de a n d will als o u n der g o a de nt ure beari n g tiss ue assess me nt.  F oll o wi n g t hese 
scree ni n g ass ess me nts, if a s u bject has a ma n di b ular de nt ure, t his will be sec ure d usi n g a 
mar kete d de nt ur e a d hesi ve.  S u bjects will t he n be i nstr ucte d o n t he use of t he B F e q ui p me nt 
a n d t he y will u n der g o 3 trai ni n g bites ( wit h o ut a d hesi ve) t o fa miliarize t he m wit h t he B F 
tra ns d ucer a n d h o w t o perf or m a vali d bite.  Aft er t he trai ni n g bites, s u bj ects will perf or m 4 
q ualif yi n g bites ( wit h o ut a d hesi ve).  All 4 of t he q ualif yi n g bites m ust be ≤ 9l bs ( p o u n ds) a n d 
at least 2 of t he 4 bites m ust be re pr o d uci ble ( ± 2l bs).  S u bjects t hat meet all i nc l usi o n criteria 
wit h n o e x cl usi o ns will ret ur n f or Visit 2 (treat me nt peri o d 1).  
O n eac h test da y ( Visit 2 t o Visit 5) s u bjects will ret ur n t o site wit h o ut de nt ure a d hesi ve bei n g 
use d, 
w here s u bject c o nti n ua nce 
will be assesse d a n d c o nfir me d, a n O S T -e de nt ul o us 
e x a mi nati o n perf or me d.  S u bject’s de nt ur es will t he n be clea n e d, t he ma n di b ular de nt ur e will 
be sta bilize d (as re q uire d) a n d t he s u bject will ri nse t heir m o ut h wit h p ota ble water pri or t o 
place me nt of t he de nt ures i n t he m o ut h.  S u bjects wil l t he n perf or m 3 practice bites t o re-
fa miliarize t he m wit h t he B F tr a ns d ucer a n d t he n t he y will u n der g o t he baseli ne i ncisal B F 
meas ure me nt (t he differe nt bites are s u m marize d i n Ta ble 4 -1).  F oll o wi n g ra n d o mizati o n, f or 
s u bjects ra n d o mize d t o use of a n ad hesi ve, 1. 0 g ( ± 0. 0 5 g) a d h esi ve pr o d uct will be a p plie d o nl y 
t o t he ma xillar y d e nt ure as per t he a p plicati o n i nstr ucti o ns ( A p pe n di x 1), a n d t he s u bject will 
refit t heir de nt ur e.  F or s u bjects ra n d o mize d t o n o a d hesi ve use, t he cl ea n a n d drie d de nt ure will 
be refitte d wit h o ut a d h esi ve.  
T a bl e 4 -1  
I n ci s al Bit e F or c e D e s cri pti o n s  
Bit e  
W h e n P erf or m e d  
P ur p o s e  
Tr ai ni n g  
S cr e e ni n g, Vi sit 1  
3 bit e s t o f a mili ari z e s u bj e ct s 
wit h B F e q ui p m e n t a n d 
p erf or mi n g a bit e.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 7  of 5 9  
Bit e  
W h e n P erf or m e d  
P ur p o s e  
Q u alif yi n g  
S cr e e ni n g, Vi sit 1  
4 bit e s t h at m u st e q u al ≤9l b s 
wit h 2 of t h e s e bit e s wit hi n 
( ± 2l b) a s p art of i n cl u si o n 
crit eri a.  
Pr a cti c e  
T e st d a y s ( Vi sit 2 -5) pr e 
b a s eli n e m e a s ur e m e nt s a n d 
a d h e si v e a p pli c ati o n  
3 bit e s t o r e-f a mili ari z e s u bj e ct s 
wit h p erf or mi n g v ali d bit e.  
B a s eli n e  
T e st d a y s ( Vi sit 2 -5) pr e 
a d h e si v e a p pli c ati o n  
A si n gl e bit e t o d et er mi n e 
B a s eli n e m e a s ur e m e nt wit h o ut 
a d h e si v e a p pli c ati o n. M u st b e 
≤9l b s  a n d wit hi n ± 2l b s  of o n e of 
t h e pr a cti c e bit e s p erf or m e d o n 
t h e s a m e d a y. 
T e st  
T e st d a y s ( Vi sit 2 -5) f oll o wi n g 
a d h e si v e a p pli c ati o n  
Si n gl e t e st bit e s t a k e n at 0. 5, 1, 
3, 6, 9 a n d 1 2 hr s.  
 
Test i ncisal B F me as ure me nts will be ta ke n at 0. 5, 1, 3, 6, 9 a n d 1 2 hrs ( ± 5 mi ns f or t he 0. 5 hr 
meas ure me nt, ± 1 0 mi ns f or all ot her ti me p oi nts ) after de nt ur e refitti n g.  F oll o wi n g t he 1 2 hr 
i ncisal B F meas ur e me nts, t he de nt ures, a n d a n y e x cess a d hesi ve will be re m o ve d, a n d t he 
de nt ures will be cle a ne d bef ore ret ur ni n g t o t he s u bject a fter a f urt her O S T- e x a mi nati o n.  
Safet y will be m o nit ore d t hr o u g h o ut t he st u d y t hr o u g h t he re p orti n g of A Es, i nci de nts a n d 
O S T/ O H T e x a mi nati o n.   T he e x a mi ner p erf or mi n g t he B F assess me nt s h o ul d re mai n bli n de d 
t o t he treat me nt. 
4. 2  
S ci e ntifi c R ati o n al e f or St u d y D e si g n  
De nt ures are u ni q ue t o eac h i n di vi d ual, a n d s o t h e m ost a p pr o priate met h o d t o e val uat e t heir 
perf or ma n ce wit h a n d wit h o ut a d hesi ve is a wit hi n s u bject c o m paris o n, a n d t heref ore a cr oss 
o ver desi g n will be use d f or t his st u d y.  
A mi ni m u m was h o ut pe ri o d bet wee n treat me nt visits is c o nsi dere d s ufficie nt t o mi ni mize a n y 
carr y o v er effects.  De nt ure a d hesi ve ac hie ves its f u ncti o n b y p h ysical mea ns a n d o nce 
c o m pletel y re m o ve d fr o m t he de nt ure, d o es n ot ha ve a n y resi d ual carr y -o v er effects.  T heref ore, 
t he mi ni m u m 1 -da y b et w ee n eac h treat me nt peri o d is c o nsi dere d a de q u ate rec o ver y fr o m test 
da y pr oce d ures.  T h ere will be a ma xi m u m of 2 8 d a ys bet wee n st u d y visits t o facilitate s u bj ect 
visit sc he d uli n g.  
I n cisal B F u ntil de nt ure disl o d g me nt is a meas ure of ma xillar y de nt ure rete nti o n a n d is a 
c o m m o nl y use d  o bjecti ve test met h o d t hat has bee n use d t o de m o nstrate t he efficac y of de nt ur e 
a d hesi ve 
 
).  T h e met h o d ol o g y will 
use a cali brate d ele ctr o ni c B F tra ns d u cer s yste m t o e ns ure acc urac y.  
S u bjects wit h c o m plete ma xillar y d e nt ures will b e recr uite d f or t his st u d y.  S u bjects  wit h p o orl y 
fitti n g de nt ures are ge nerall y a d vise d t o see k pr ost h o d o ntic a d vice t o im pr o ve t he fit (i.e. b y 
reli ni n g etc.), a n d t heref ore o nl y s u bjects wit h a well-ma de a n d m o deratel y -t o-well -fitti n g 
ma xillar y d e nt ure (as deter mi ne d usi n g t h e Ka p ur I n de x ( Ols ha n m o difi cati o n) f or de nt ur e 
rete nti o n a n d sta bilit y (K a p ur, 1 9 6 7 , Ols ha n et al., 1 9 9 2 ) will be c o nsi dere d f or e nr ollme nt . 
A sta ble l o wer de ntiti o n/ d e nt ure is re q uire d t o e na ble a n acc urate B F meas ure m e nt a n d 
t heref ore, if a partial or f ull ma n di b ular de nt ure is w or n, t his will be sec ure d (if dee me d 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 8  of 5 9  
necessar y b y t h e e x a mi ner) usi n g t he s u p plie d mar kete d de nt ur e a d hesi ve ( S u per P oli gri p Free), 
w hic h ma y  be rea p plie d, at t he e x a mi ner’s discreti o n, a ma xi m u m of 2 ti mes (t otal of 3
a p plicati o ns per da y) at e ac h visit peri o d.  
At Scree ni n g, Visit 1, trai ni n g B F meas ure me nts will be ta ke n t o all o w s u bjects t o fa miliarize 
t he msel ves wit h t he bitef orce me as ure me nt a n d t o u n dersta n d h o w t o bite i n a c o nsiste nt ma n ner 
f or B F te c h ni q ue a n d t o all o w t he e x a mi ner t o esta blis h w het her s u bjects u n dersta n d a n d are 
a ble t o c o n d uct t he n ecessar y bites.  If s u bjects are u na ble t o c o n d uct a vali d bite, t he y m a y be 
wit h dra w n  fr o m t he st u d y at t he e x a mi ner’s discreti o n.  Trai ni n g bites will be f oll o we d b y 4
q ualif yi n g bites  t hat will f or m part of t he i n cl usi o n criteria.  S u bjects will be re q uire d t o p erf or m 
practice bites o n eac h t est da y t o r e -fa miliarize t he msel ves wit h t he e q ui p me nt.  
W hilst bli n di n g is a n i m p orta nt c o nsi derati o n f or a n y cli nical st u d y, t he nat ure of t his st u d y 
pre ve nt s bli n di n g t o t he s u bject si nce t he y will be a ware of h a vi n g a d hesi ve or n o a d hesi v e 
prese nt.  A d diti o nall y, f or t he sa m e reas o n, t he site sta ff w h o a d mi nister t he pr o d ucts ca n n ot b e 
bli n de d.  T he le vel of bli n di n g is t heref ore restrict e d t o t he e x a mi ner w h o perf or ms t he bitef orce 
assess me nt, a n d he n ce t h e st u d y will be si n gle-bli n d  (t o t he e x a mi ner perf or mi n g t he bitef orce 
assess me nt). 
A p ositi ve c o ntr ol has bee n i ncl u de d i n t his st u d y as a m eas ure of assa y se nsiti vit y usi n g a 
c urre ntl y m ar kete d de nt ure a d h esi ve ( S u per P oli gri p Free) w hic h will be use d t o e ns ure st u d y 
vali dit y.  S P F  has b ee n c h ose n as a p ositi ve c o ntr ol f or t his st u d y as it is c urre ntl y m ar kete d a n d 
n u mer o us data e xists de m o nstrati n g its bite f orce efficac y vers us n o a d hesi ve (
 
 
 
 
.  A ‘n o a d h esi ve ’ c o ntr ol ar m is in cl u de d t o pr o vi de a 
c o nti n ual refere n ce p oi nt of n o a d hesi ve use o v er t he 1 2 -h o ur p eri o d.  N o a d hesi ve use is 
re pres e ntati ve of a si g nifi ca nt n u m ber of de nt ure wearers ( ~ 8 1 % of 7 5 0 milli o n de nt ure wearers, 
G S K data o n file).   I n a d diti o n, a n o a d h esi ve ar m will ai d i nter pretati o n of t he res ults of t his 
st u d y a n d all o w c o m paris o n  wit h pre vi o us st u dies . 
T he patter n of a p plicati o n of t he e x peri me ntal de nt u re a d h esi ves will be as per t he i nte n de d 
a p plicati o n i nstr ucti o ns f or t he pla n ne d  mar k ete d pr o d uct.  T he patter n of a p plicati o n of t he S P F 
de nt ure a d hesi v e (as t he p ositi ve c o ntr ol) o n t he ma xillar y de nt ure will be as per t he mar ket e d 
la bel i nstr ucti o n.  T he a p plicati o n of e x peri me ntal a n d c o ntr ol de nt ure a d hesi ves o n t he 
ma xillar y de nt ure will be c o ntr olle d b y wei g ht of 1. 0 0 g ( ± 0. 0 5 g) ( A p pe n di x 1 5. 2 ).  C o ntr olli n g 
a n d sta n dar dizi n g t he a p plicati o n of t he a d hesi ve b y wei g ht will li mit a n y variati o ns relate d t o 
t he a m o u nt of a d hesi ve a p plie d.  
T he a p plicati o n of t he S P F  t o sta bilize t he ma n di b ular de nt ur e will be per la bel i nstr ucti o n a n d 
will n ot be wei g h e d (see A p p e ndi x 1 5. 2 ). 
D ue t o l o n ge vit y of st u d y t est da ys ( 1 2 -1 4 hrs), s u bjects will be  pr o vi de d wit h 3 meals 
( brea kfast, l u nc h a n d di n ner) a n d s nac ks. T hes e meals a n d s nac ks will be sta n dar dize d a n d will 
be s peciall y c h ose n t o a v oi d partic ularl y t o u g h or c he w y f o o d s a n d will mai nl y c o nsist of f o o ds 
t hat are n ot li kel y t o mi grat e u n der d e nt ures a n d ca us e irritati o n (a v oi di n g e. g. fr uits a n d 
ve geta bles wit h see ds, s helle d/ u ns helle d n uts, brea ds wit h grai n/see ds etc). A d diti o nall y, 
s u bjects will be all o we d t o s nac k a d li b.   
S u bjects wit h te m p or o ma n di b ular j oi nt dis or ders are e x cl u de d s h o ul d t he i n vesti gat or belie v e 
t hat t his c o ul d affect t he s u bject’s partici pati o n, pri nci pall y re gar di n g t he a bilit y f or t h e s u bject 
t o a de q uatel y c h e w or bite.  S u bjects w h o use or ha ve e ver use d bis p h os p h o nate me dicati o ns 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 1 9  of 5 9  
are s pecificall y e x cl u de d fr o m t his st u d y o wi n g t o t he e n ha nce d ris k of bis p h os p h o nate -rel ate d 
oste o necr osis of t he ja w  ( B R O NJ) t hat is ass ociate d wit h re d uce d tiss ue t olera nce t o f u ncti o n 
wit h re m o va ble pr ost hes es (Sal da n ha et al., 2 0 1 2 ).  S u bjects w h o are x er ost o mic are e x cl u de d 
si nce t he pr o per f u ncti o n of de nt ure a d hesi ves re q uires a de q u ate h y drati o n fr o m sali va.  
As t he i n vesti gati o nal a d hesi ve s are me dical de vice s n o pre g n a nc y war ni n g o n la belli n g  is 
pla n ne d , an d s o  pre g na nc y test i n g will n ot be re q uire d.   S u bjects will , h o we ver, nee d t o pr o vi de 
ver bal c o n fir mati o n of ne gati ve pre g na n c y stat us a n d t his m ust be d oc u me nte d as part of t he 
e x cl usi o n criteria . 
De m o gra p h y i nf or mati o n will be rec or de d as part of t his st u d y, i ncl u di n g a ge, race a n d ge n der. 
I n acc or da nce wit h t he U nite d States F o o d a n d Dr u g A d mi nistrati o n ( U S F D A) g ui deli nes 
(F D A, 2 0 0 5 ) t he et h nicit y of s u bjects will als o be ca pt ure d. 
A n oral s oft tiss ue ( O S T) e x a m i nati o n will be c o n d ucte d at eac h treat me nt visit bef ore treat me nt 
is a p plie d t o e ns ure t he s u bject’s oral healt h is s ufficie nt t o all o w t he s u bject t o c o m plete t he 
assess me nts at t hat visit.  A f urt her O S T e x a m will be perf or me d at eac h treat me nt visit af ter 
t he c o m pleti o n of ass ess me nts t o assess f or p ossi ble A Es.  Si milarl y a n oral har d tiss ue ( O H T) 
e x a mi nati o n will be perf or me d at t he start ( visit 1) a n d e n d ( visit 5) of t h e st u d y t o assess f or 
p ote ntial A Es.  
4. 3  
J u stifi c ati o n f or D o s e  
A d hesi ve a p plicati o n will be wei g ht c o ntr olle d wit h 1. 0 0 g ( ± 0. 0 5 g) bei n g a p plie d t o t he 
ma xillar y de nt ur e.  T his d osi n g is i n li ne wit h pre vi o us G S K C H st u dies (
 
), is c o nsiste nt wit h sta n dar d usa ge of a 
de nt ure a d hesi ve a n d eli mi nates t he v aria bilit y ass ociate d wit h n ot c o ntr olli n g t he m ass of 
a d hesi ve.  
4. 4  
E n d of St u d y D efi niti o n  
A s u bject is c o nsi dere d t o ha ve c o m plete d t he st u d y if  he or s he has c o m plete d all p hases of t h e 
st u d y i ncl u di n g t he last visit or t he last sc he d ul e d pr oce d ure s h o w n i n t he Sc h e d ule of Acti vities.  
T he e n d of t his st u d y is d efi ne d as t he d ate of t he l ast visit of t he last s u bject i n t he st u d y.  
5  
S T U D Y P O P U L A TI O N  
5. 1  
T y p e a n d Pl a n n e d N u m b er of S u bj e ct s  
S ufficie nt s u bjects will be scree ne d t o ra n d o mize at least 4 5 t o e ns ure at least 4 2 e val ua ble 
s u bjects c o m plete t he e ntire st u d y.  
A n e nr olle d s u bject is o ne w h o has a gree d t o partici pate i n t he cli nical st u d y f oll o wi n g  
c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d s uccessf ull y met eli gi bilit y criteria t o pr ocee d 
be y o n d t h e scree ni n g visit . 
T his st u d y ca n f ulfill its o bjecti ves o nl y if a p pr o priate s u bjects are e nr oll e d.  T he f oll o wi n g 
eli gi bilit y criteria are d esi g ne d t o select s u bj ects f or w h o m partici pati o n i n t he st u d y is 
c o nsi dere d a p pr o priate.  All rele va nt me dical a n d n o n -me dical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n d eci di n g w het h er a s u bject is s uita ble f or t his pr ot oc ol.   
S u bject eli gi bilit y t o parti ci pate i n t he cli nical st u d y s h o ul d be re vie we d a n d d oc u me nte d b y a n 
a p pr o priate m e m ber of t h e i n vesti gat or’s st u d y t ea m bef ore s u bjects are i n cl u de d i n t he st u d y.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 0  of 5 9  
5. 2  
I n cl u si o n Crit eri a 
A n i n di vi d ual m ust meet all t he f oll o wi n g i ncl usi o n criteria t o be e li gi ble f or e nr oll me nt i nt o, 
a n d c o nti n ua nce i n t he st u d y: 
1.  S u bject pr o visi o n of a si g ne d a n d date d i nf or me d c o nse nt  d oc u me nt i n dicati n g t hat t he 
s u bject has bee n i nf or me d of all perti ne nt as pects of t he st u d y b ef ore a n y assess me nt is 
perf or me d . 
2.  A male or f e male su bject w h o , at t he ti me of scree ni n g, is bet wee n t he a ges of 1 8 -8 5 
years , i ncl usi ve. 
3.  A s u bject w h o is willi n g a n d a ble t o c o m pl y wit h sc he d ule d visits, a n d ot her st u d y 
pr oce d ures.  
4.  A s u bject  i n g o o d ge neral a n d me ntal healt h wit h, i n t he o pi ni o n of t he i n vesti gat or or 
me dicall y q u alifie d  desi g nee , n o cli nicall y si g nifica nt  or rele va nt a b n or malities i n me dical 
hist or y or u p o n oral  e x a mi nati o n, or c o n diti o n, t hat w o ul d i m pact t he s u bject’s safe t y, 
well bei n g or t he o utc o me of t he st u d y, if t he y were t o partici pate i n t he st u d y, or affect t he 
i n di vi d ual’s a bilit y t o u n dersta n d a n d f oll o w st u d y pr oce d ures a n d re q uire me nts. 
5.  A s u bject wit h a c o m pl etel y e de nt ul o us m a xill ar y arc h  rest ore d wit h a c o n ve nti o nal 
ma xillar y  f ull de nt ur e wit h a n  acr ylic bas e.  T he m a xillar y d e nt ure pr ost hesis m ust f ulfil all 
of t he f oll o wi n g:  
a. At least m o derat el y well -fitti n g ( Ka p ur I n d e x, Ols ha n M o dificati o n: ret e nti o n sc ore 
≥2, sta bilit y sc ore ≥2)  at t he Scree ni n g ( V 1) visit,  
b.  Is w ell ma de (acc or di n g t o t he well-ma de assess me nt).  
6.  A s u bject wit h B F meas ure me nts w hic h satisf y all t he f oll o wi n g criteria: 
a. T he q ualif yi n g B F meas ure me nts ( wit h o ut a d hesi v e) at V 1 ( Scree ni n g) m ust be 
≤9l bs.  
b.  At least 2 of t he 4 q ualif yi n g B F meas ure me nt s ( wit h o ut a d hesi ve) at V 1 
( Scree ni n g) m ust be re pr o d uci ble ( wit hi n ± 2l bs). 
c. T he Baseli n e B F me as ur e me nt ( wit h o ut a d hesi ve) at V 2 -5 m ust be ≤9l bs.  
d.  T he Baseli ne B F me as ur e me nt ( wit h o ut a d hesi ve) at V 2 -5 a n d at least 1 of t he 3 
practice B F meas ure me nts m ust b e wit hi n ± 2l bs  of eac h ot her.  
7.  A s u bject w h o is de nt ate i n t he ma n di b ular arc h or h as a partial or f ull de nt ure i n t he 
ma n di b ular arc h t hat is:  
a. s ufficie ntl y sta ble, i n t he o pi ni o n of t he i n vesti gat or, t o e na ble t he bite f orce 
deter mi nati o n t o be perf or me d.  
b.  well ma de (acc or di n g t o t he well -ma de assess me nt).  
5. 3  
E x cl u si o n Crit eri a  
A n i n di vi d ual w h o meets a n y of t he f oll o wi n g e x cl usi o n criteria will be  e x cl u de d fr o m t he 
st u d y: 
1.  A s u bject w h o is a n e m pl o yee of t he i n vesti gati o n al site, eit her directl y i n v ol ve d i n t he  
c o n d uct of t he st u d y or a me m ber of t heir i m me diate fa mil y; or a n e m pl o yee of t he 
i n vesti gati o nal site ot her wise s u per vise d b y t he i n vesti gat or; or, a G S K C H e m pl o yee 
directl y i n v ol ve d i n t he c o n d uct of t he st u d y or a me m ber of t heir i m me diate fa mil y.  
2.  A s u bject w h o has partici pate d i n ot her st u dies (i n cl u di n g n o n -me di ci nal st u dies) 
i n v ol vi n g i n vesti gati o nal pr o d uct(s) wit hi n 3 0 da ys  pri or t o Visit 1  a n d/ or d uri n g st u d y 
partici pati o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 1  of 5 9  
3.  A s u bject wit h , i n t he o pi ni o n of t he i n vesti gat or or me dicall y q ualif ie d desi g nee,  a n ac ute 
or c hr o nic me di cal or ps yc hiatric c o n diti o n or la b orat or y a b n or m alit y t hat ma y i ncreas e 
t he ris k ass ociate d wit h st u d y partici p ati o n or e x peri me ntal  pr o d uct a d mi nistrati o n or ma y 
i nterfere wit h t he i nter pretati o n of st u d y res ults a n d, i n t he j u d g me nt of t h e i n vesti gat or or 
me dicall y q u alifie d desi g nee, w o ul d ma ke t h e s u bject i na p pr o pri ate f or e ntr y i nt o t his 
st u d y. 
4.  A s u bject w h o is pre g n a nt  (self-re p orte d) or i nte n di n g t o bec o m e pre g n a nt o ver t he 
d urati o n of t he st u d y.  
5.  A s u bject w h o is breastfee di n g. 
6.  A s u bject wit h k n o w n or s us pecte d i nt olera n ce or h y perse nsiti vit y t o t he st u d y materials 
( or cl osel y relate d c o m p o u n ds) or a n y of t heir state d i n gre die nts.  
7.  A s u bject u n willi n g or u na ble t o c o m pl y wit h t he Lif est yle C o nsi derati o ns  descri be d i n 
t his pr ot oc ol.  
8.  A s u bject w h o is c urre ntl y ta ki n g or has ta ke n a bis p h os p h o nate dr u g (i.e., F osa ma x, 
Act o nel, B o ni va).  
9.  A s u bject w h o u ses a n y me dicati o n or h as a c o n diti o n (e. g. i ns uli n de pe n d e nt dia betes)  t hat, 
i n t he o pi ni o n of t he i n vesti gat or, w o ul d i nterfere wit h t he c o n d uct of t he st u d y. 
1 0.  A s u bject 
w h o has a n y cli nicall y si g nifica nt or rele va nt oral a b n or malit y (e. g. 
te m p or o ma n di b ular j oi nt [ T MJ] pr o ble ms or t o ot h a b n or malities ) t hat, i n t he o pi ni o n of t he 
i n vesti gat or, c o ul d affect t he B F meas ure me nts or s u bject safet y. 
1 1.  A s u bject w h o has a n y c o n diti o n or me dicati o n w hic h, i n t he o pi ni o n of t h e i n vesti gat or, is 
c urre ntl y ca usi n g x er ost o mia or w hic h co ul d i nterfere wit h t he c o n d u ct of t he st u d y.  
1 2.  A s u bjec t wit h a rece nt hist or y ( wit hi n t he last year) of alc o h ol or ot her s u bsta nce a b us e. 
1 3.  A s u bject wit h O S T e x a mi nati o n fi n di n gs (at V 1) s uc h as st o matitis, o pe n s ores, lesi o ns, 
ca vitie d cari es lesi o ns, re d ness or s welli n g w hic h i n t he o pi ni o n of t he i n vesti gat or, co ul d 
i nterfere wit h t he c o n d uct of t he st u d y. 
1 4.  A s u bject w h o has pr e vi o usl y bee n  e nr olle d i n t his st u d y.  
1 5.  A s u bject w h o is u na ble t o c o m pl y wit h st u d y re q uire me nts a n d/ or w h o is n ot a ble t o 
relia bl y p erf or m a vali d bite at t he e x a mi ner’s discreti o n. 
1 6.  A s u bject w h o, i n t he o pi ni o n of t he i n vesti gat or or me dicall y q ualifie d desi g nee, s h o ul d 
n ot partici pate i n t he st u d y.  
5. 4  
R a n d o mi z ati o n Crit eri a  
S u bjects will be ra n d o mize d i nt o t he st u d y pr o vi de d t he y h a ve satisfie d all s u bject selecti o n 
criteria.  
5. 5  
Lif e st yl e C o n si d er ati o n s  
5. 5. 1  
M e al s /Di et ar y  a n d Lif e st yl e R e q uir e m e nt s a n d R e stri cti o n s  
•  S u bjects wi ll be re q uire d t o re mai n o n site f or t he d urati o n of t he treat me nt visit da y.  
•  O n treat me nt visit da ys, s u bjects will o nl y b e per mitte d t o c o ns u me t he st a n dar dize d 
meals a n d s nac ks a n d c ol d dri n ks pr o vi de d.  
•  S u bjects are n ot per mitte d t o c he w g u m w hilst at t he st u d y site. 
T hr o u g h o ut t h e st u d y da y, s u bjects will be pr o vi de d wit h 3 sta n dar dize d meals ( brea kfast, l u n c h 
a n d di n ner) a n d s nac ks.  T hese meals a n d s nac ks will c o nsist of f o o ds t hat are n ot li kel y t o 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 2  of 5 9  
mi grate u n d er d e nt ures a n d ca us e irritati o n (a v oi di n g fr uits a n d v e geta bles wit h see ds, 
s helle d/ u ns helle d n uts, brea ds wit h grai n/see d etc.).  S u bjects will be all o we d t o s nac k a d  li b 
b ut will n ot be per mitte d t o eat a n y ot her f o o ds ot her t ha n t h ose pr o vi d e d.  
Brea kfast will be ser ve d wit hi n 1 hr after t he 1 hr B F meas ure me nt.  L u n c h will be pr o vi de d 
wit hi n 1 hr after t he 6 hr B F me as ure me nt.  Di n ner ( or s nac ks) will be pr o vi de d wit hi n 1 hr after 
t he 9 hr B F meas ure me nt. 
5. 5. 2  
Al c o h ol  a n d T o b a c c o  R e stri cti o n s  
•  S u bjects w ill n ot be per mitte d t o s m o ke, i ncl u di n g e-ci garettes a n d use c he wi n g t o bacc o 
or ot her t o bacc o pr o d ucts or c o ns u me alc o h ol f or t he d urati o n of t he scree ni n g visit a n d 
eac h tr eat me nt da y ( 1 2 -1 4 hrs) u ntil c o m pleti o n of all assess me nts.  
5. 5. 3  
M e di c ati o n a n d Tr e at m e nt R e stri cti o n s  
•  T he details of c urre nt a n d c o nc o mita nt me dicati o ns will be c ollecte d, a n d s u bjects 
will be all o we d t o partici pate if t hese me di cati o ns are j u d ge d t o be n o n -i nterferi n g b y 
t he i n vesti gat or as per i n cl usi o n a n d e x cl usi o n criteria. 
•  S u bjects wi ll n ot be per mitte d t o ha ve a n y r o uti ne de ntal/ de nt ure w or k perf or me d d uri n g 
t he ti me t hat t he y are i n t he st u d y, u nless it is f or e mer ge n c y treat me nt t hat s h o ul d n ot 
be dela ye d. T his is t o e ns ure t hat t he de nt ur e fit will n ot be altere d d uri n g t h e st u d y.   
•  If a s u bject uses d e nt ure a d hesi ve as part of t heir n or mal r o uti ne, t he n t he y ca n c o nti n ue 
usi n g t he a d h esi ve bet w ee n treat me nt visits, b ut t he y s h o ul d n ot c ha n ge t h e r o uti ne of 
a d hesi ve use d uri n g t he c o urse of t he st u d y.  
•  S u bjects will be i nstr ucte d t o r e p ort t o t he st u d y sit e o n treat me nt visit da ys ( Visits 2 -5) 
wit h o ut de nt ure a d h esi ve o n t heir ma xillar y de nt ure a n d ma n di b ular de nt ur e (if pres e nt).  
5. 6  
S cr e e n F ail ur e s  
Scree n fail ures are defi n e d as s u bjects w h o c o nse nt t o partici pate i n t he cli nical st u d y b ut are 
n ot s u bse q ue ntl y ra n d o mize d. T o e ns ure tra ns p are nt re p orti n g of s cree n fail ure s u bjects, a 
mi ni mal set of scree n fail ure i nf or mati o n will i ncl u de de m o gra p h y, scree n fail ure d etails (e. g. 
wit h dra wal of c o nse nt), eli gi bilit y criteria, a n y pr ot oc ol de v iati o ns a n d a n y a d v erse e v e nts or 
i nci de nts as a p plica ble.  
I n di vi d uals w h o d o n ot meet t he criteria f or parti ci pati o n i n t his st u d y (scree n fail ure) ma y n ot  
be re -s cree ne d. 
5. 7  
S p o n s or’ s Q u alifi e d M e di c al P er s o n n el  
C o ntact i nf or mati o n f or t he s p o ns or's a p pr o p ri atel y q ualifie d m e dical/ de nt al pers o n nel f or t he 
st u d y is d oc u me nt e d i n t he St u d y C o ntact List l ocate d i n t he i n vesti gat or st u d y master file h el d 
at t he st u d y site.  
T he c o ntact n u m ber is o nl y t o be use d b y i n vesti gati o nal staff see ki n g a d vice o n me dical/  de ntal 
q uesti o ns or pr o ble ms i n t he e v e nt t hat t he esta blis he d c o m m u nicati o n pat h wa ys bet w ee n t h e 
i n vesti gati o nal site a n d t he st u d y te a m are n ot a vaila ble. 
T he c o ntact n u m b er is n ot i nte n de d f or direct us e b y st u d y s u bjects.  T o facilitate access t o 
a p pro priatel y q ualifie d me dical/ de ntal pers o n nel o n st u d y -rel ate d me dical/ de ntal q uesti o ns or 
pr o ble ms, s u bjects will be pr o vi de d wit h a c o ntact car d.   T he c o ntact car d will pr o vi de, as a 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 3  of 5 9  
mi ni m u m, pr ot oc ol i de ntifiers, t he s u bject’s st u d y i de ntificati o n n u m ber , c o ntact i nf or mati o n 
f or t he i n vesti gati o nal site, a n d c o ntact details i n t he e ve nt t hat t he i n vesti gati o nal site ca n n ot 
be reac h e d t o pr o vi de a d vice o n a m e dical q u esti o n or pr o ble m i d e ntifie d b y a healt hcare 
pr ofessi o nal ot her t ha n t h e i n vesti gat or.  
5. 8  
R at er/ Cli ni c al A s s e s s or Q u alifi c ati o n s  
S uita bl y q ualifie d de nt al pr ofessi o nals wit h e x pertise i n pr ost h o d o ntics will be re q uire d t o 
perf or m t he O S T e x a mi nati o n, K O i n de x a n d t he scree ni n g ass ess me nts relati n g t o de nt ure fit 
a n d c o n diti o n f or t his st u d y.  A n e x a mi ner t hat is s uita bl y trai n e d i n carr yi n g o ut t he i n cisal B F 
meas ure me nts will als o be re q uire d t o perf or m t he B F assess me nts i n t his st u d y.  W here ver 
p ossi ble t he sa me e x a mi ners s h o ul d perf or m t he s a me assess me nts t hr o u g h o ut t he st u d y.  
6  
I N V E S TI G A TI O N A L/ S T U D Y P R O D U C T S 
F or t he p ur p oses of t his st u d y, p er I nt er nati o nal C o nfere n ce o n Har m o ni sati o n (I C H) g ui deli nes, 
a n d G S K p olic y, st u d y i nter ve nti o n is defi ne d as a n y i n vesti gati o nal i nter ve nti o n(s), mar kete d 
pr o d uct(s), pla ce b o, or me dical de vice(s) i nte n de d t o be a d mi nistere d t o a st u d y partici pa nt 
acc or di n g t o t he st u d y pr ot oc ol.  
T his i ncl u des a pr o d uct wit h a mar keti n g a ut h ori zati o n w he n use d or ass e m ble d (f or m ulate d or 
pac ka ge d) i n a wa y differe nt fr o m t he a p pr o ve d f or m, or w he n use d f or a n u na p pr o ve d 
i ndicati o n, or w he n use d t o gai n f urt her i nf or m ati o n a b o ut a n a p pr o ve d use.  
6. 1  
I n v e sti g ati o n al/ St u d y Pr o d u ct S u p pli e s 
T he f oll o wi n g st u d y pr o d ucts will be s u p plie d b y t he Cli nical S u p plies De part me nt, G S K C H:  
T a bl e 6 -1  
I n v e sti g ati o n al/ St u d y Pr o d u ct S u p pli e s 
 
Test Pr o d ucts  
Refere n ce Pr o d uct  
Pr o d uct N a me  
E x peri me ntal 
De nt ure A d hesi ve 1  
E x peri me ntal 
De nt ure A d hesi ve 2  
S u per P oli gri p Free  
( U S mar ket) 
P ac k D esi g n  
Si n gle T u bes  (fitte d wit h precisi o n n ozzle) 
Si n gle T u bes  (fitte d 
wit h flat ri b b o n 
n ozzle)  
Dis pe nsi n g Det ails  
O ne T u be per s u bject at treat me nt visit  
Pr o d uct M aster 
F or m ul ati o n C o de 
( M F C) 
 
 
 
M a n uf act urer  
 
 
 
D ose/ A p plic ati o n  
See Secti o n 1 5. 2  f or A d hesi ve a p plicati o n patter n.  A si n gle 
a p plicati o n per s u bject will be a d mi nistere d b y t he  st u d y site staff. 
R o ute of 
A d mi nistr ati o n  
Or al t o pic al - de nt ure a d hesive  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI
C CI
C CI
C CI
P P D
P P D

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 4  of 5 9  
T he t w o e x peri me ntal a d hesi ves are i nte n de d f or c o m mercializati o n a n d t he a p plicati o n 
i nstr ucti o ns here are c o nsiste nt wit h t he i nte n de d la bel i nstr ucti o ns.  T he test de nt ure a d hesi ves 
s hall be trac ked b y refere nce t o t heir u ni q ue b atc h n u m bers.  T h e test d e nt ur e a d h esi ves d o n ot 
c o ntai n a n y me dici n al or bi ol o gicall y acti ve s u bst a nces or materi als deri ve d fr o m h u ma ns or 
a ni mals.  
T he refere n ce a d hesi ve a n d t he a d hesi ve i nte n d e d f or use t o sta bilize t he  l o wer de nt ure, t h e 
de nt ure br us hes a n d t he de nt ure clea nsi n g p aste are all m ar kete d me dical de vices a n d will b e 
use d i n acc or da nce wit h t he la bel i nstr ucti o ns f or t hese pr o d ucts.  
Wit hi n t he U S A, t he e x peri me ntal a d h esi ves are cate g orize d as Class 1, 5 1 0( k ) e x e m pt me dical 
de vices a n d t heref ore a N o nsi g nifica nt Ris k ( N S R) a p plicati o n will be re q uire d as p art of t he 
I R B s u b missi o n t o c o n d uct t his st u d y i n t he U S A.  T hese pr o d ucts are c o nsi dere d t o be N S R 
de vices b ase d u p o n t h eir si milarit y wit h mar k ete d de nt u re a d hesi ves i n ter ms of t heir i nte n de d 
use, c o m p ositi o n, directi o ns f or use a n d tar get treate d p o p ulati o n.  
T a bl e 6 -2  
S u n dr y It e m s  
Ot her ite ms t o be s u p plie d b y t he Cli nical S u p pl ies De part me nt, G S K C H: 
N a me of Ite m  
P ur p ose  
S u per P oli gri p Free A d h esi ve Crea m 
( U S A mar ket place) 
T o sta bilize t he l o wer de nt ure (a p pl y 2 da bs 
t o t he l o wer de nt ur e [if re q uire d]; t o retai n 
l o wer de nt ur e) as p er t he pr o d uct la bel 
i nstr ucti o ns (Secti o n 1 5. 2. 3 ) 
Oral B De nt ur e br us hes  
Br us h  t o clea n de nt ur es  
P oli de nt De nt u Crè me De nt ure 
Clea nsi n g Paste ( U S A)  
Clea ni n g of de nt ures  
Nitrile Fi n ger C ots  
C o veri n g tr a ns d ucer pr o n gs  
Lar ge A nti -Static Wei g hi n g B oats  
Wei g hi n g a n d tra ns p orti n g de nt ur es  
All pr o d ucts will be s u p plie d i n t heir c o m mercial p ac ka gi n g.  Det aile d i nstr ucti o ns f or t he ret ur n 
of st u d y pr o d uct/st u d y s u p plies f or t he acc o u nta bilit y c hec ks a n d s u bse q ue nt destr ucti o n w hic h 
will be pr o vi de d b y G S K C H d uri n g t he st u d y i n ti me f or st u d y cl ose o ut visit.  
6. 1. 1  
M e di c al D e vi c e s  
T he defi niti o ns a n d pr oce d ures det aile d are i n acc or da nce wit h I S O 1 4 1 5 5 : 2 0 2 0.  T he G S K 
ma n ufact ur e d me dical d e vices pr o vi de d f or use i n t his st u d y are : 
•
T he e x peri me ntal  de nt ur e a d hesi ve crea m s f or e val uati o n.  I nstr u cti o ns f or use are
pr o vi de d i n  ( Secti o n 1 5. 2. 1 Ma xillar y De nt ure A d hesi ve A p plicati o n I nstr ucti o ns f or
E x peri me ntal A d hesi ves )
•
S u per P oli gri p Free ( use d as  p ositi ve c o ntr ol a n d ma n di b ular de nt ure sta bilizati o n).
I nstr u cti o ns f or use are pr o vi de d i n (Secti o ns 1 5. 2. 2 a n d 1 5. 2. 3 )
•
P oli de nt De nt u Crè me D e nt ure Clea ni n g Past e  f or clea ni n g of de nt ur es.  I nstr uctio ns f or
use pr o vi de d i n ( Secti o n 8 . 1.5 )
Ot her me dical d e vices ( n ot ma n ufact ur e d b y or f or G S K ) pr o vi de d f or use i n t his st u d y are : 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 5  of 5 9  
•
Oral B D e nt ure Br us h  f or clea ni n g of de nt ur es pri or t o testi n g.  I nstr ucti o ns f or use
pr o vi de d i n ( Secti o n 8 . 1.5 )
All de vice deficie nci es, ( i ncl u di n g malf u ncti o n, use err or a n d i na de q u ate la belli n g) s hall be 
d oc u me nte d, a n d re p orte d b y t he i n v esti gat or t hr o u g h o ut t he cli nical i n v esti ga ti o n (Secti o n  
1 0. 1 0 Me dical De vic e I n ci de nts ) a n d a p pr o priatel y ma na ge d b y t he s p o ns or. 
6. 1. 2  
D o s a g e F or m a n d P a c k a gi n g  
T he test pr o d ucts are i nte n de d f or oral use, a n d will be a d mi nistere d t o de nt ures e xter na ll y t o 
t he m o ut h, wit h t he de nt ures t he n re place d i n t he s u bject’s m o ut h as detaile d i n t he Pr o d uct 
A p plicati o n I nstr ucti o ns ( A p pe n di x 1 5. 2 ).  T he c o nte nt of t he pr o d uct la bels will be i n 
acc or da nce wit h all a p plica ble re g ulat or y re q uire m e nts a n d will be t he res p o nsi bilit y of t he G S K 
C H Gl o bal Cli nical S u p plies gr o u p.  Eac h st u d y la bel will c o ntai n, b ut n ot be li mite d t o, 
pr ot oc ol n u m ber, directi o ns f or use a n d st ora ge re q uire me nts.  
Care s h o ul d be t a ke n wit h t he s u p plie d pr o d ucts a n d t heir la bels s o t hat t h e y are m ai ntai ne d i n 
g o o d c o n diti o n.  It is i m p orta nt t hat all la bels re mai n i ntact a n d le gi ble f or t he d urati o n of t he 
st u d y. 
T he i n vesti gati o nal de nt ure a d hesi ves will be a p plie d fr o m t he i nte n de d fi nal pr o d uct pac ka gi n g 
a n d t he c o ntr ol de nt ur e a d hesi ve will be a p plie d fr o m t he pri mar y pr o d uct p ac ka gi n g.   
All pr o d ucts s u p plie d are f or use o nl y i n t his cli nical st u d y a n d s h o ul d n ot be use d f or a n y ot her 
p ur p ose.  
6. 1. 3  
Pr e p ar ati o n a n d Di s p e n si n g 
Test (i n vesti gati o nal a n d p ositi ve c o ntr ol) de nt ur e a d hesi ves will be a p plie d t o t he ma xillar y 
de nt ures b y q ualifie d u n bli n de d site pers o n nel acc or di n g t o t he Pr o d uct A p plicati o n I nstr ucti o ns 
i n A p pe n di x 1 5. 2 . 
S u bjects will be a ssi g ne d t o pr o d ucts i n acc or da nce wit h t he ra n d o mizati o n sc he d ule.  
St u d y 
pr o d uct 
will 
b e 
dis pe nse d 
b y 
q ualifie d 
u n bli n de d site 
p ers o n nel 
per t he 
d osa ge/a d mi nistrati o n i nstr ucti o ns.  T hes e staff me m bers will n ot b e i n v ol ve d i n a n y safet y, 
effic ac y ass ess me n ts or ot her as pects of t he st u d y t hat c o ul d be i nfl ue n ce d b y t he k n o wle d ge of 
pr o d uct a s u bject has b ee n assi g ne d t o use.  A n a d diti o nal me m ber of site staff s h o ul d e ns ure 
t he dis pe nsi n g pr oce d ures are c o m plet e d acc urat el y. 
S P F use d f or ma n di b ular de nt ure sta bilizati o n will als o be a p plie d b y sit e pers o n nel as per 
A p pe n di x 1 5. 2  
S y neresis is a c o m m o n occ urre nce wit h a n h y dr o us de nt ure a d h esi ves a n d prese nts n o safet y 
ris k t o t he s u bjects.  S h o ul d s y n eresis be o bser ve d wit h a n y de nt ur e a d hesi ve i n t his st u d y, t he 
first 1-2 i n c hes of t he e xtr u de d pr o d uct s h o ul d be discar de d t o a v oi d usi n g e x cessi vel y oil y 
pr o d uct.  
6. 2  
A d mi ni str ati o n  
S u bject’s de nt ures will first be cle a ne d t o re m o v e all traces of de nt ur e fi x ati ve, pl a q ue a n d 
partic ulates/ de bris t he n a n d drie d pri or t o a p plicati o n of ra n d o mize d a d hesi ve (Secti o n 8. 1. 5 ).  
F or s u bjects ra n d o mize d t o n o a d hesi ve, t he clea ni n g will still be perf or me d i n or der t o 
sta n dar dize t he clea nli ness of t he de nt ure pri or t o c o m me nce me nt of t he B F testi n g.  B ot h 
ma xillar y a n d ma n di b ular (if pres e nt) de nt ur es s h o ul d be clea n e d.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 6  of 5 9  
E x peri me ntal a n d p ositi ve c o ntr ol a d hesi ves will be a p plie d t o ma xillar y d e nt ure directl y fr o m 
t he pr o d uct p ac ka gin g o nt o t he de nt ures as per t he Pr o d uct A p plicati o n I nstr ucti o ns ( A p pe n di x  
1 5. 2 ).  T he de nt ures will t he n be ret ur ne d t o t he s u bject w h o s h o ul d re p ositi o n t he de nt ures i n 
t heir m o ut h a n d bite d o w n t o sec ure h ol d.  F or s u bjects ra n d o mize d t o n o a d hesi ve, t he de nt ures 
s h o ul d refitte d b y t h e s u bject f oll o wi n g clea ni n g a n d dr yi n g.  
O nl y s u bjects e nr olle d i n t he st u d y ma y recei ve st u d y pr o d ucts  a n d o nl y a ut h orize d site staff 
ma y s u p pl y or a d mi nister st u d y pr o d ucts .  Al l st u d y pr o d ucts  m ust be st ore d i n a sec ure, 
e n vir o n me ntall y c o ntr oll e d, a n d m o nit ore d ( ma n u al or a ut o mat e d) area i n acc or da nce wit h t he 
la bele d st ora ge c o n diti o ns wit h access li mite d t o t he a ut h orize d site staff o nl y . 
6. 2. 1  
M e di c ati o n/ D o si n g Err or s  
Me dicati o n/ d osi n g err ors ma y res ult, i n t his st u d y, fr o m t he a d mi nistrati o n or c o ns u m pti o n of: 
•
t he wr o n g pr o d uct,
•
b y t he wr o n g s u bject,
•
at t he wr o n g ti me,
•
or at t he wr o n g d os a ge.
S uc h me dicati o n/ d osi n g err ors occ urri n g t o a st u d y s u bject are t o be ca pt ur e d i n t he  case re p ort 
f or m (C R F ).  I n t he e ve nt of me dicati o n d osi n g err or, t he s p o ns or s h o ul d be n otifie d 
i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 h o urs. 
Me dicati o n/ d osi n g err ors are re p orta ble irres pecti ve of t he prese n ce of a n ass ociate d A E, 
i ncl u di n g:  
•
Me dicati o n/ d osi n g err ors i n v ol vi n g s u bject e x p os ure t o a n y of t he st u d y pr o d ucts;
•
P ote ntial me dicati o n/ d osi n g err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol
t hat d o or d o n ot i n v ol ve t he partici pati n g s u bject.
If a me dicati o n/ d osi n g err or is acc o m p a nie d b y a n A E, as deter mi ne d b y t he i n vesti gat or, t h e 
me dicati o n/ d osi n g err or a n d, a n y ass ociate d a d verse e ve nt(s) are t o be ca pt ure d i n t he C R F A E 
f or m.  
6. 2. 2  
O v er d o s e  
A n o ver d ose is a deli berate or i na d verte nt a d mi nistrati o n of a pr o d uct at a n a m o u nt hi g her t ha n 
s pecifie d i n t he pr ot oc ol. 
O ver d ose is n ot li kel y t o occ ur i n t his st u d y  si nce t he d ose will be acc uratel y dis pe nse d b y t he 
st u d y site staff. 
O ver d ose p er se is n ot a n A E. H o we v er, a n y cli nical se q uelae of a n o v er d ose s h o ul d  be re p ort e d 
as a n A E (a n d seri o us a d verse e ve nt ( S A E), if a p pr o priate). F or re p orti n g, f oll o w t he A E a n d 
S A E re p orti n g i nstr ucti o ns.  
6. 3  
I n v e sti g ati o n al/ St u d y Pr o d u ct St or a g e 
T he i n vesti gat or or desi g nee m ust c o nfir m a p pr o priate te m perat ur e c o n diti o ns ha ve bee n 
mai ntai ne d d uri n g tra nsit f or all st u d y pr o d ucts recei ve d a n d a n y discre p a ncies are re p orte d a n d 
res ol ve d bef ore us e acc or di n g t o t he s u p plie d s hi p pi n g d oc u me nt ati o n . 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 7  of 5 9  
T he i n vesti gat or, or d esi g nee, will e ns ure t hat all st u d y pr o d ucts are st ore d i n a s ec ure d area 
wi t h c o ntr olle d access u n der re q uire d st or a ge c o n diti o ns a n d i n acc or da n ce wit h a p plica ble 
re g ulat or y re q uire me nts a n d t he pr o d uct la b el.   
Site s yst e ms m ust be ca pa ble of meas uri n g a n d d oc u me nti n g (f or e x a m ple, via a l o g), at a 
mi ni m u m, dail y mi ni m u m a n d ma xi m u m te m perat ur es f or all site st ora ge l ocati o ns (as 
a p plica ble, i ncl u di n g fr o ze n, refri gerate d, a n d/ or r o o m -te m perat ure pr o d ucts).  T his s h o ul d be 
ca pt ure d fr o m t he ti me of first pr o d uct recei pt t hr o u g h o ut t he st u d y.  E ve n f or c o nti n u o us 
m o nit ori n g s yste ms, a l o g or site pr oce d ure t hat e ns ures acti ve dail y e val u ati o n f or e x c ursi o ns 
s h o ul d be a v aila ble.  T he o perati o n of t h e te m perat ure-m o nit ori n g de vice a n d st ora ge u nit (f or 
e x a m ple, refri gerat or), as a p plica ble, s h o ul d b e re g ularl y i ns pecte d t o e ns ure it  is mai ntai ne d i n 
w or ki n g or der.  
A n y e x c ursi o ns fr o m t he pr o d uct -la bel st ora ge c o n diti o ns s h o ul d be re p orte d t o a p pr o priate sit e 
staff u p o n disc o ver y a n d c o m m u nicate d t o s p o ns or as s o o n as p ossi ble.  T he site s h o ul d acti vel y 
p urs ue o pti o ns f or ret ur ni n g t he pr o d uct t o t he st ora ge c o n diti o ns as descri be d i n t he la beli n g, 
as s o o n as p ossi ble.  E x c ursi o ns fr o m t he st ora ge re q uir e me nts, i ncl u di n g a n y acti o ns ta ke n, 
m ust be d oc u me nte d as a pr ot oc ol de viati o n a n d re p orte d t o t he S p o ns or.   
O nce a n e x c ursi o n is i de ntifie d, t he affect e d pr o d uct ( or pr o d ucts) m ust be q uara nti ne d a n d n ot 
use d u ntil t he s p o ns or pr o vi des d oc u me ntati o n of per missi o n t o use. Use of a n y of t he affecte d 
pr o d uct(s) pri or t o s p o ns or a p pr o val will be c o nsi dere d a pr ot oc ol de viati o n.   
6. 4  
I n v e stig ati o n al/ St u d y Pr o d u ct A c c o u nt a bilit y  
All pr o d ucts s u p plie d are f or use o nl y i n t his cli nical st u d y a n d s h o ul d n ot be use d f or a n y ot her 
p ur p ose.  
All st u d y pr o d ucts m ust be recei ve d b y a desi g nate d pers o n at t he st u d y site, ha n dle d a n d st ore d 
safel y a n d pro perl y, a n d ke pt i n a sec ure d l ocati o n t o w hic h o nl y t he st aff ha ve access.  U p o n 
recei pt, all st u d y pr o d ucts s h o ul d be st or e d acc or di n g t o t he i nstr ucti o ns s p ecifie d o n t he pr o d uct 
la bels.  St u d y pr o d ucts are t o be dis pe nse d o nl y t o s u bjects e nr olle d i n t he st u d y i n acc or da nce 
wit h t he pr ot oc ol, b y a ut h orize d site staff.  
T he i n vesti gati ve site m ust mai ntai n a de q uate rec or ds d oc u me nti n g t he recei pt, use, l oss, or 
ot her dis p ositi o n of all t he pr o d uct s u p plies.  All st u d y pr o d ucts will be acc o u nte d f or usi n g t he 
i n vesti gati o nal/st u d y pr o d uct acc o u nta bilit y f or m/rec or d.  T he i n vesti gat or is res p o nsi ble f or 
st u d y pr o d uct acc o u nt a bilit y, rec o n ciliati o n, a n d rec or d mai nte n a nce.  
T he acc o u nt a bilit y rec or ds m ust be a vaila ble f or i ns pecti o n b y t h e st u d y m o nit or d uri n g t he 
st u d y.  M o nit ori n g of pr o d uct acc o u nta bilit y will be perf or me d b y t he m o nit or d uri n g site visits 
a n d at t he c o m pleti o n of t he st u d y.  
6. 4. 1  
D e str u cti o n of I n v e sti g ati o n al/ St u d y Pr o d u ct S u p pli e s  
At t he e n d of t he st u d y, a n i n ve nt or y of all use d a n d u n use d st u d y pr o d ucts a n d s u n dr y ite ms 
will be c o m pile d.  T h e i n vesti gati o nal/st u d y pr o d uct acc o u nta bilit y rec or d f or ret ur ne d st u d y 
pr o d ucts will t he n be c o m plete d.  Destr ucti o n of all t he st u d y pr o d ucts ( use d a n d u n use d) f or 
t his cli nical st u d y will be ma na ge d b y t he st u d y site staff i n acc or da nce wit h nati o nal, state a n d 
l ocal re g ulati o ns a n d pr o vi de G S K wit h a certificate of destr ucti o n. 
6. 5  
Bli n di n g a n d All o c ati o n/ R a n d o mi z ati o n  
Bli n di n g  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 8  of 5 9  
T his st u d y is descri b e d as si n gle bli n d or e x a mi ner -bli n d (t he e x a mi ner perf o r mi n g t he bite 
f orce e val uati o n will be bli n de d t o t he pr o d uct recei ve d).  Ot her staff fr o m t he st u d y site will 
n ot be bli n de d t o treat me nt recei ve d.  
T o e ns ure t he e x a mi ner perf or mi n g t he bite f orce e val uati o n re mai ns bli n de d t hr o u g h o ut t he 
st u d y, staff i nv ol ve d i n t h e pre p arati o n a n d dis pe nsi n g of st u d y pr o d ucts will w or k i n a s e parate 
area.  
T he i n vesti gat or’s k n o wle d ge of t he pr o d uct all o cati o n s h o ul d n ot i nfl ue nce t he decisi o n t o 
e nr oll a s u bject or affect t he or der i n w hic h s u bjects are e nr olle d.  
R a n d o m iz ati o n 
All s u bjects will be ra n d o mize d acc or di n g t o t he ra n d o mizati o n sc he d ule pr o vi de d b y t he st u d y 
bi ostatisticia n at 
. Bef ore t he st u d y is i nitiate d, trai ni n g, l o gi n 
i nf or mati o n a n d directi o ns f or St u d y pr o d ucts will be dis pe nse d acc or di n g t o t he ra n d o mizati o n 
sc he d ule at t he a p pr o priate st u d y visits. Ret ur ne d st u d y pr o d ucts s h o ul d n ot be re -dis pe nse d t o 
a n y s u bject.  
A u ni q ue scree ni n g n u m ber will i de ntif y eac h s u bject scree ne d f or st u d y partici pati o n. 
Scree ni n g n u m bers will be as si g ne d i n asce n di n g n u merical or der as eac h s u bject si g ns t heir 
c o nse nt f or m. S u bje cts w h o meet all i ncl usi o n a n d e x cl usi o n criteria will be ra n d o mize d 
acc or di n g t o t h e ra n d o mi zati o n sc he d ule. Ra n d o mizati o n n u m bers will be assi g ne d i n as ce n di n g 
n u merical o r der as eac h s u bject is deter mi ne d t o b e f ull y eli gi ble. T h e ra n d o mizati o n sc he d ule 
will i n dicate t he treat me nt or der se q u e nce; o ne of t he t hree tr eat me nts or n o a d hesi ve ( ne gati ve 
c o ntr ol) t o be use d f or eac h of t he f o ur st u d y peri o ds.  T he ra n d o mizati o n will use a Willia ms 
S q uare la y o ut a p pr o priate f or a 4 -peri o d cr oss o ver st u d y . T h e st u d y sit e will recei ve o ne 
ra n d o mizati o n sc he d ule wit h de-c o de d treat me nts. T his sc he d ule will be use d t o dis pe nse st u d y 
treat me nts t o t he s u bjects.  
6. 6  
Br e a ki n g t h e Bli n d  
I n case of a n e mer ge n c y, t he i n vesti gat or has t he s ole res p o nsi bilit y f or deter mi ni n g if 
u n bli n di n g of a s u bject’s pr o d uct assi g n me nt is warra nt e d. S u bject safet y m ust al wa ys be t h e 
first c o nsi derati o n i n ma ki n g s uc h a deter mi nati o n. If t he i n vesti gat or deci des t hat u n bli n di n g 
is warra nte d, t he i n vesti gat or s h o ul d ma ke e v er y eff ort t o c o ntact t he s p o ns or pri or t o u n bli n di n g 
a s u bject’s pr o d u ct assi g n me nt u nless t his c o ul d dela y e mer ge nc y tr eat me nt of t he s u bject.  
If a s u bject’s pr o d uct assi g n me nt is u n bli n de d, t he s p o ns or m ust be n otifie d wit hi n 2 4 h o urs 
after brea ki n g t he bli n d. T he date a n d reas o n t hat t he bli n d was br o ke n m ust be rec or de d i n t he 
s o urce d oc u m e ntati o n a n d case re p ort f or m, as a p plica ble. 
A n y A E ass o ciate d wit h brea ki n g t he bli n d m ust be rec or de d a n d re p orte d as s pecifie d i n t his 
pr ot oc ol. T he st u d y site ma y als o be re q uir e d t o i nf or m t he I R B/ E C if t he bli n d is br o ke n.  
T o brea k t he bli n d, t he st u d y c o or di n at or will use t he ra n d o mizati o n sc he d ule t o i nf or m t he 
i n vesti gat or of t h e treat me nt assi g nme nt f or t he s u bject f or t he a p pr o priat e st u d y visit.  
6. 7  
C o m pli a n c e  
St u d y pr o d ucts will be a d mi nistere d b y  i n vesti gat or site pers o n nel.  
T he n u m ber of a n y misse d or a d diti o nal a p plicati o n s will be ca pt ure d as pr ot oc ol de viati o ns 
i nt o t he C R F.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI
P P D

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 2 9  of 5 9  
6. 8  
C o n c o mit a nt M e di c ati o n/ Tr e at m e nt( s)  
A n y me dicati o ns, treat me nts or vacci ne (i ncl u di n g o ver -t he-c o u nt er or prescri pti o n me dici nes, 
vita mi ns, a n d/ or her bal s u p ple me nts) ta ke n d uri n g t he st u d y, fr o m si g ni n g t he i nf or me d c o nse nt, 
m ust be rec or de d i n t he C R F wit h i n dicati o n, reas o n f or use, u nit d ose, dail y d ose, a n d start a n d 
st o p dates of a d mi nistrati o n.  All s u bjects will be q uesti o ne d a b o ut me dicati o n s/treat me nts at 
eac h site visit.  
Details of a n y rele v a nt de ntal, me dical or s ur gi cal hist or y ( wit hi n t he last ye ar), i ncl u di n g 
aller gies of dr u g s e nsiti vit y, will be rec or de d i n t h e C R F.  T h e us e of c o nc o mita nt me dicati o ns 
is per mitte d i n t his st u d y e x ce pt f or t he use of bis p h os p h o nate dr u gs (e x cl usi o n criteri o n 9 ) a n d 
a n y m e dicati o ns t hat i n t he o pi ni o n of t he i n vesti gat or w o ul d i nterfere wit h t he c o n d uct of t his 
st u d y (e x cl usi o n criteri o n 1 0 ). 
Me dicati o n/treat me nts ta ke n wit hi n 
7  da ys of si g ni n g t he i nf or me d c o nse nt f or m will be 
d oc u me nte d as a pri or m e dicati o n/treat me nt.   Me dicati o ns/treat me nts ta ke n after a p plicati o n of 
first treat me nt (test a d hesi ves or n o a d hesi ve as per ra n d o mizati o n sc he d ule) will be 
d oc u me nte d as c o n c o mita nt me dicati o n/treat me nts.  
S u bjects will  be i nstr ucte d n ot t o ha ve a n y n o n -e mer ge n c y d e ntal/ de nt ure w or k perf or m e d 
d uri n g t he ti me t he y are i n t he st u d y, u nless disc usse d a n d per mitte d b y t he e x a mi ner. T his is 
t o ass ure t hat t he de nt ur e fit will n ot be altere d d uri n g t he st u d y. 
7  
DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D 
S U B J E C T DI S C O N TI N U A TI O N/ WI T H D R A W A L  
7. 1  
S u bj e ct Di s c o nti n u ati o n/ Wit h dr a w al  
A s u bject ma y wit h dr a w fr o m t he st u d y at a n y ti me at his or her o w n re q uest or ma y be 
wit h dra w n at a n y ti me at t he discreti o n of t he i n vesti gat or or s p o ns or f or  safet y, b e ha vi oral 
reas o ns, or t he i na bilit y of t he s u bject t o c o m pl y wit h t he pr ot oc ol re q uire d sc he d ule of st u d y 
visits or pr oce d ures.   
T he f oll o wi n g circ u msta nces re q uire disc o nti n uati o n of st u d y pr o d uct a n d/ or pre m at ure s u bject 
wit h dra wal:  
•  Pr ot oc ol v i olati o n t hat ma y i m pact t he s u bject’s s afet y 
•  Wit h dra wal of i nf or me d c o nse nt  
•  S u bject l ost t o f oll o w -u p  
•  Pre g n a nc y  
If a s u bj ect is disc o nti n ue d or pre mat urel y wit h dra ws fr o m t he st u d y, t he reas o n(s) f or 
disc o nti n uati o n or wit h dra wal a n d t h e ass ociate d date m ust be d oc u me nt e d i n t he rele va nt 
secti o n(s) of t he C R F.  
7. 2  
L o st t o F oll o w u p  
If a s u bject fails t o ret ur n t o t he site f or a re q uire d st u d y visit t he site m ust atte m pt t o c o ntact 
t he s u bject a n d resc he d ul e t he misse d visit as s o o n as p ossi ble a n d c o u nsel t he s u bject o n t he 
i m p orta nce of mai ntai ni n g t he assi g ne d visit sc he d ule a n d ascertai n w het her t he s u bject wis hes 
t o a n d/ or s h o ul d c o nti n ue i n t he st u d y. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 0  of 5 9  
A s u bject will be c o nsi dere d l ost t o f oll o w u p if he or s he re p eate dl y fails t o ret ur n f or sc h e d ule d 
vis its a n d is u na ble t o be c o ntacte d b y t he st u d y sit e. Bef ore a s u bject is dee me d l ost t o f oll o w 
u p, t he i n vesti gat or or desi g nee m ust ma ke e ver y eff ort t o re gai n c o nt act wit h t he s u bject ( w here 
p ossi ble, 3 tele p h o ne calls a n d, if necessar y, a certifie d lett er t o t he s u bject’s last k n o w n maili n g 
a d dress or l ocal e q ui val e nt met h o ds). T hese c o ntact atte m pts s h o ul d be d oc u me nte d. If c o ntact 
is ma de wit h t he s u bject, t he i n vesti gat or s h o ul d i n q uire a b o ut t he reas o n f or wit h dra wal, re q u est 
t hat t he s u bject ret ur n all pr o d ucts t h at t he y h a d b ee n dis pe ns e d a n d if a p pr o priate re q uest t h at 
t he s u bject ret ur n f or a fi nal visit a n d f oll o w-u p wit h t he s u bject re gar di n g a n y u nres ol ve d 
a d verse e ve nts ( A Es).  
Fi nal safet y assess me nts ma y be carrie d o ut w he n t he s u bject ret ur n s t o t he st u d y site, at t h e 
i n vesti gat or’s discreti o n, w hic h ma y i ncl u de a n O S T e x a mi nati o n.  
S h o ul d t he s u bject c o nti n ue t o be u nreac h a ble, h e/s he will be c o nsi dere d t o ha ve wit h dra w n 
fr o m t he st u d y a n d l ost t o f oll o w u p.  
Lac k of c o m pleti o n of all or a n y of t he earl y ter mi nati o n pr oce d ures will n ot be vie we d as 
pr ot oc ol de viati o ns s o l o n g as t he s u bj ect’s safet y was pres er ve d.  
If t he s u bject wit h dra ws fr o m t he st u d y a n d wit h dra ws c o ns e nt f or discl os ure of f ut ure 
i nf or mati o n, n o f urt her e val uati o ns s h o ul d be p erf or me d, a n d n o a d diti o nal data s h o ul d be 
c ollecte d e x ce pt f or a n y perti ne nt safet y i nf or mati o n.  T he s p o ns or ma y ret ai n a n d c o nti n ue t o 
use a n y data c ollecte d b ef ore s uc h wit h dra wal of c o nse nt.  
8  
S T U D Y P R O C E D U R E S  
T his secti o n lists t he pr oce d ures t o be c o m plete d at eac h pla n ne d st u d y visit.  T he ti mi n g of 
eac h pr oce d ure is liste d i n t he Sc he d ule of Acti vities secti o n.  
A d here n ce t o t he st u d y d esi g n re q uire m e nts, i ncl u di n g all pr oce d ures are esse ntial a n d re q uire d 
f or st u d y c o n d uct. 
8. 1  
Vi sit 1/ S cr e e ni n g  
Scree ni n g pr oce d ures will be c o n d ucte d b y t he I n v esti gat or, or s uita bl y q u alifie d desi g n ee.  
S u bjects will be scree ne d wit hi n 1 -2 8  da ys pri or t o a d mi nistrati o n of t he treat me nt (test a d hesi ve 
or n o a d hesi ve as per ra n d o mizati o n sc he d ule) t o c o nfir m t hat t he y meet t he s u bject selecti o n 
criteria f or t he st u d y.   
T he f oll o wi n g pr oce d ures will be c o m plete d  i n t he or der s p ecifie d w here p ossi ble a n d t h e 
o utc o mes rec or de d i n t he C R F : 
•  I nf or me d c o ns e nt 
•  Me dical hist or y a n d pri or a n d c urre nt me dicati o ns/treat me nts  
•  De ntal hist or y  
•  I n cl usi o n/e x cl usi o n criteria assess me nt  
•  De m o gra p hics  
•  C urre nt/ pri or/c o nc o mita nt me dicati o n re vie w  
•  Ma xillar y d e nt ure clea ni n g  
•  Ka p ur -Ols h a n I n de x ( well -fitti n g assess me nt) o nl y f or ma xillar y de nt ur es.  
•  Well -ma de assess me nt f or ma xillar y de nt ure s, a n d ma n di b ular de nt ures if prese nt. 
•  O S T e x a mi nati o n pri or t o de nt ure a d hesi ve a p plicati o n (if re q uire d f or ma n di b ular  
sta bilizati o n) a n d/ or c o m me nce me nt of B F meas ure me nts.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 1  of 5 9  
•  O H T e x a mi nati o n  
•  Ma n di b ular d e nt ure clea ni n g f oll o we d b y sta bilizati o n (if present)  
•  Perf or m B F tr ai ni n g bites a n d q ualif yi n g bite s 
•  S u bject eli gi bilit y assess e d  
•  Re m o val of de nt ure a n d e x cess a d hesi ve fr o m m o ut h  ( use d f or ma n di b ular sta bilizati o n) 
•  O S T e x a mi nati o n p ost ma n di b ular de nt ur e a n d de nt ure a d hesi ve re m o val  
•  P ost B F assess me nt  de nt ure clea ni n g  
•  A d verse e ve nts a n d me di cal de vice i nci de nts re vie w 
8. 1. 1  
I nf or m e d C o n s e nt 
T he i n vesti gat or, or d esi g nee, m ust o btai n i nf or m e d c o nse nt fr o m eac h s u bject partici pati n g i n 
t his st u d y aft er a de q u ate e x pla nati o n of t he ai ms, met h o ds, o bjecti ves, a n d p ote ntial hazar ds of 
t he st u d y. T he i nf or me d c o nse nt f or m (I C F) will be si g ne d a n d date d b y t h e s u bject, t he s u bject 
will recei ve a c o p y a n d t he ori gi n al  will be ke pt at site.  
T he i n vesti gat or, or desi g nee, m ust als o e x plai n t o t he s u bjects t hat t h e y are c o m pletel y free t o 
ref use t o e nter t he st u d y or t o wit h dra w fr o m it at a n y ti me.  A p pr o priat e f or ms f or d oc u me nti n g 
a si g ne d a n d date d c o nse nt will be pr o vi de d b y eit her t he i n vesti gat or or b y G S K C H.  
T he i n vesti gat or, or desi g nee, s h o ul d si g n a n d date eac h c o p y of t he I C F t o c o nfir m t hat t he 
c o nse nt pr ocess was c o m plete d c orrectl y aft er t he s u bject has si g n e d.   
T he ti me t he s u bject si g ne d t he i nf or me d c o nse nt f or m will be d oc u me nte d  i n t he C R F as t his 
is t he p oi nt fr o m w hic h all A d verse E ve nts will be ca pt ure d. 
If, d uri n g a s u bject’s partici pati o n i n t he st u d y, a n y ne w i nf or mati o n bec o mes a vaila ble t hat 
ma y affect t he s u bject’s willi n g ness t o partici pate i n t he st u d y, eac h o n g oi n g s u bject s h o ul d 
recei v e a c o p y of t his ne w i nf or mati o n a n d be re-c o nse nte d i n t o t he st u d y. Eac h s u bject s h o ul d 
be pr o vi de d wit h a c o p y of t he si g ne d a n d date d a me n de d c o nse nt f or m. T he date of re -c o ns e nt 
will be rec or de d o n t he C R F.  
After si g ni n g t he I C F, s u bjects will u n der g o t he scree ni n g assess me nts t o c o nfir m t hat t he y 
meet all  t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria. If t he s u bject is c o nfir me d 
eli gi ble b y t he i n vesti gat or ( or desi g nee) t o partici pate i n t he st u d y t he s u bject is c o nsi d ere d 
e nr olle d i n t he st u d y.  
8. 1. 2  
M e di c al Hi st or y a n d Pri or M e di c ati o n/ Tr e at m e nt  
D etails of rele v a nt me dical a n d s ur gical hist or y (i n t he last 1  year), i ncl u di n g aller gies or dr u g 
se nsiti vit y, will be d o c u me nte d i n t he C R F. 
Pri or 
me dicati o ns/treat me nts, i ncl u di n g prescri pti o n a n d n o n -prescri pti o n dr u gs, dietar y 
s u p ple me nts a n d h er bal reme dies, t a ke n i n t he last 7  da ys a n d pri or t o si g ni n g t he i nf or me d 
c o nse nt f or m, will be d oc u me nte d i n t he C R F.  
8. 1. 2. 1  
D e nt al Hi st or y  
T he i n vesti gat or, or me di call y q ualifie d desi g nee will ta ke a de ntal hist or y fr o m eac h s u bject at 
t he Scree ni n g visit. De ntal hist or y will i ncl u de i nf or mati o n of all pr ost heses i n t he m o ut h, 
ma xillar y a n d ma n di b ular, as well as i nf or mati o n re gar di n g t he a ge of de nt ures, h o w l o n g t he 
s u bject has w or n de nt ur es, t he pr ost hetic mat erial a n d w het h er t he s u bject is a re g ular user of 
de nt u re a d h esi ves. T his will be d oc u me nte d i n t he C R F. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 2  of 5 9  
8. 1. 3  
I n cl u si o n/ E x cl u si o n Crit eri a 
I n cl usi o n a n d e x cl usi o n criteria i nf or mati o n will be d oc u me nte d i n t he C R F. 
T he well -fitti n g a n d well-ma de a n d t he O S T assess me nts s h o ul d be perf or me d b y s uita bl y 
q ualifie d pers o n nel/e x a mi ner wit h e x pertise i n pr ost h o d o ntics.  T he bite f orce ass ess me nts 
s h o ul d be perf or m e d b y a n assess or a p pr o priatel y trai ne d i n t he tec h ni q u e.  
8. 1. 4  
D e m o gr a p hi c s  
T he f oll o wi n g de m o gra p hic i nf or mati o n will be rec or de d i n t he C R F: year of birt h, ge n der , race  
a n d et h nicit y.  
Et h nicit y a n d race of s u bjects will be rec or de d i n acc or da n ce wit h F D A G ui da nce f or I n d ustr y: 
C ollecti o n of Race a n d Et h nicit y Dat a i n Cli nical Trials, 2 0 0 5.  T his is re q uire d f or t his st u d y 
as t he e x peri me ntal de nt ure a d hesi v es bei n g teste d are i nte n de d t o b e mar k ete d i n t he U S. 
Descri pti ve statistics ( n u m ber of s u bjects, mea n, sta n dar d de viati o n ( S D), me dia n, mi ni m u m 
a n d ma xi m u m f or c o nti n u o us varia bles, a n d fre q u e nc y a n d perce nta ge f or cate g orical v aria bles) 
will be pr o vi de d f or de m o gra p hic a n d b aseli ne dat a.  
8. 1. 5  
D e nt ur e Cl e a ni n g  
Weari n g gl o ves, de nt ur e clea ni n g will be p erf or m e d b y s uita bl y q ualifie d site staff.  S ufficie nt 
de nt ure clea ni n g p aste will be a p plie d t o t h e s u p plie d de nt ure br us h.  All s urfaces of t he 
de nt ure(s) will be t h or o u g hl y cle a ne d t o re m o ve all visi ble traces of de nt ure fi x ati ve, pla q ue 
a n d partic ulate/ d e bris.  T he de nt ure(s) will t he n be ri nse d t h or o u g hl y wit h r u n ni n g wat er.  
De nt ure(s) s h o ul d t he n be drie d usi n g cli nical pa per t o wels.  De nt ure clea ni n g paste s h o ul d o n l y 
be use d e xtra -orall y a n d n ot directl y i n t he m o ut h.  Ha n ds s h o ul d be was he d t h or o u g hl y 
f oll o wi n g a p plicati o n a n d use of t he de nt ure clea ni n g paste.  If a s u bject h as t w o f ull de nt ur es, 
b ot h ma xillar y a n d ma n di b ular de nt ures s h o ul d be clea n e d pri or t o tr eat me nt a p plicati o n or 
pri or t o de nt ure i nserti o n if s u bject is ra n d o mize d t o n o a d hesi ve gr o u p.   T he de nt ure clea ni n g 
paste a n d/ or w ar m wat er ca n be us e d t o clea n t h e d e nt ures at t he e n d of t he d a y at t he e x a mi ner’s 
discreti o n.  
8. 1. 6  
M a n di b ul ar D e nt ur e St a bili z ati o n  
Pri or t o all bite f orce meas ure me nts, a n y ma n di b ul ar de nt ure ( partial or c o m plete) will be f ull y 
sta bilize d usi n g t he s u p plie d de nt ure a d hesi ve, t o e ns ure acc urac y of B F meas ure me nts.  T he 
ma n di b ular de nt ure will be t h or o u g hl y clea ne d as p er Secti o n 8. 1. 5  bef ore a d hesi ve a p plicati o n.  
T he de nt ure a d hesi ve will be a p plie d i n acc or da nce wit h la bel i nstr ucti o ns a n d will n ot be 
c o ntr olle d b y wei g ht t o e ns ure t he ma n di b ular de nt ure is sec urel y hel d i n place t o  a v oi d 
i nterferi n g wit h ma xillar y B F meas ure me nts.  T he ma n di b ular de nt ure ma y be re -st a bilize d a 
f urt her 2 ti mes t hr o u g h o ut t he test da y ( ma xi m u m of 3 t hree a p plicati o ns per da y) at t he 
e x a mi ner’s discreti o n.  
8. 1. 7  
S u bj e ct Eli gi bilit y  
T he i n vesti gat or a n d/ or me dicall y q u alifie d desi g nee will re vie w i ncl usi o n/e xcl usi o n criteria, 
me dical hist or y, pri or me dicati o ns t o c o nfir m s u bject eli gi bilit y t o partici pate i n t he cli nical 
trial. T his will be d oc u me nte d i n t he C R F. 
T o pre pare f or st u d y partici pati o n, s u bjects will be i nstr ucte d i n t he Lif est yle G ui deli nes  a n d 
a n y C o nc o mita nt Me dicati o n/ Treat me nt(s)  re q uire me nts of t he pr ot oc ol. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 3  of 5 9  
O nce s u bject  eli gi bilit y is c o nfir me d a gai nst scree ni n g i ncl usi o n/e xcl usi o n criteria, st u d y 
s pecific scree ni n g tests will be carrie d o ut. T hese i ncl u de t he Ka p ur Ols h a n I n d e x assess me nt, 
criteria f or w ell -ma de a n d fitti n g de nt ur es, O S T e x a m a n d B F assess me nts f or trai ni n g a n d 
q ualif yi n g bites o n t he B F tra ns d ucer. Details of eac h of t hese assess me nts are gi ve n i n Secti o n 
9. 1. 4 . All assess me nts will be d oc u me nte d i n t he C R F.  
8. 2  
St u d y P eri o d  
8. 2. 1  
Vi sit s  2 -5 / Tr e at m e nt P eri o d s  1 -4  
T here will be a was h o ut peri o d of a mi ni m u m of 1 da y ( m a x 2 8 da ys) bet wee n treat me nt visits. 
T he f oll o wi n g pr oce d ures/ assess me nts will ta ke place i n t he or der liste d bel o w as m uc h as 
p ossi ble a n d rec or de d i n t he C R F:  
•  Re vie w of c o nc o mita nt me dicati o ns  a n d n o n-dr u g treat me nts/ pr oce d ures a n d lifest yl e 
restricti o ns 
•  Re vie w of i ncl usi o n/e x cl usi o n criteria  
•  O S T e x a mi nati o n pri or t o de nt ure a d h esi ve a p plicati o n  
•  Ma n di b ular d e nt ure clea ni n g f oll o we d b y sta bilizati o n (if prese nt) 
•  B F m eas ur e me nt - practice  bites  
•  B F m eas ur e me nt - pre -treat me nt baseli ne i ncisal B F meas ure me nt 
•  S u bject c o nti n ua nce assesse d a n d c o nfir m e d  
•  Ra n d o mizati o n ( o nl y at Visit 2, Treat me nt peri o d 1)  
•  Pr o d uct a p plicati o n (f or s u bjects ra n d o mize d t o a n a d hesi ve tr eat me nt ar m). F or s u bjects 
ra n d o mize d t o n o a d hesi ve, t he ma xillar y de nt ure will be clea ne d, drie d a n d re-fitte d 
i nt o s u bject’s m o ut h. 
•  B F assess me nt at 0. 5 hrs  
•  B F m eas ur e me nt at 1 hr  
•  B F m eas ur e me nt at 3 hrs  
•  B F m eas ur e me nt at 6 hr  
•  B F m eas ur e me nt at 9 hr  
•  B F m eas ur e me nt at 1 2 hr  
•  Re m o val of de nt ure(s)  ( b y eit her site staff or s u bj ect) a n d e x cess a d hesi ve fr o m m o ut h  
( b y site staff) o nce all bit e f orce assess me nts c o m plete d  
•  O S T e x a mi nati o n p ost de nt ure a n d de nt ur e a d h esi ve re m o val  
•  O H T e x a mi nati o n ( o nl y at Visit 5, Treat me nt peri o d 4)  
•  P ost -testi n g de nt ure clea ni n g  
•  A d verse e ve nts a n d me di cal de vice i nci de nts re vie w 
•  St u d y c o ncl usi o n ( o nl y at Visit 5/ Treat me nt peri o d 4)  
 
All pr oce d ures a n d ass ess me nts are detaile d i n Secti o n 9 . 
C ha n ges i n c o nc o mita nt me dicati o n or n o n -dr u g treat me nts/ pr oce d ures will be d oc u m e nte d i n 
t he C R F.  
S p o nta ne o us re p orti n g of a d verse e ve nts a n d t h ose elicite d b y as ki n g s u bj ects t o res p o n d t o a 
n o n -lea di n g q uesti o n s u c h as “ H o w d o y o u feel? ” will be assesse d a n d a n y A Es rec or de d i n t he 
C R F.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 4  of 5 9  
8. 3  
St u d y C o n cl u si o n  
T he St u d y C o ncl usi o n pa ge of t he C R F will be c o m plete d f or all s u bjects w het her t he y 
c o m plete d all st u d y pr oce d ures or if t he y were disc o nti n ue d fr o m t he st u d y earl y.  If t he s u bject 
disc o nti n ue d earl y, at a n y p oi nt d uri n g t he st u d y, t he pri mar y reas o n f or wit h dra wal s h o ul d be 
rec or de d o n t he St u d y C o ncl usi o n pa ge. 
If a s u bject has a n y cli nicall y si g nifica nt, st u d y-relate d a b n or malities or A Es at t h e e n d of t he 
st u d y, t he G S K C H me dical m o nit or ( or desi g nat e d re prese nt ati ve) s h o ul d be n otifie d a n d, t he 
s u bject ma y be as ke d t o re mai n at t he cli nical site or be as k e d t o ret ur n f or a f oll o w -u p visit t o 
e ns ure a n y iss ue is r es ol v e d or dee m e d n ot cli nicall y si g nifica nt.  
8. 4  
F oll o w -u p Vi sit/ P h o n e C all  
T he st u d y sit e ma y c o nta ct a s u bject t o f oll o w u p a n A E p ost -st u d y c o m pleti o n/ wit h dra wal a n d, 
i n s o me circ u msta nces, re q uest t he y ret ur n t o t he site f or a d diti o nal f oll o w-u p visits (fi nal safet y 
assess me nts).  If n ee de d, a d diti o nal e x a mi nati o ns ma y b e carrie d o ut at s u c h visits. 
9  
S T U D Y A S S E S S M E N T S  
E ver y eff ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol re q uire d tests a n d pr oce d ures are c o m plete d 
as descri be d.  H o we v er, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be cir c u msta nces, 
o utsi de t he c o ntr ol of t he i n vesti gat o r, t hat ma y m a ke it u nfeasi ble t o c o m plete a n assess me nt.  
I n t h ese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he s afet y a n d well bei n g 
of t he s u bject.  W he n a pr ot oc ol re q uire d assess m e nt ca n n ot be perf or m e d, t he i n vesti gat or ( or 
desi g nee) will d oc u me nt t he reas o n f or t he misse d assess me nt as a pr ot oc ol de viati o n a n d a n y 
c orrecti ve a n d pre v e ntati ve acti o ns t hat he or s he has ta ke n t o e ns ure t hat re q uire d pr ocesses are 
a d here d t o as s o o n as p ossi ble.  T he S p o ns or m ust be i nf or me d of a n y  misse d assess me nts i n a 
ti mel y ma n ner. 
9. 1  
S cr e e ni n g A s s e s s m e nt s  
Scree ni n g ass ess me nts will be perf or me d b y a p pr o priatel y trai ne d staff/cli nical e xa mi ners at 
t he ti mes, a n d i n t he or der, defi ne d i n t he St u d y Pr oce d ures  s ecti o n of t his pr ot oc ol. 
9. 1. 1  
D e nt ur e B e ari n g Ti s s u e S c or e  
T he de nt ur e b eari n g tiss ue sc ore (Ka p ur, 1 9 6 7 ) will be ass esse d b y t he i n v esti gat or a n d rec or de d 
f or t he ma xillar y d e nt ure o nl y o n t he a p pr o priate C R F.  A s c ore will be all ocate d f or eac h of 
t he criteri a (ri d ge s ha pe, tiss ue resilie nc y a n d l ocati o n of b or der attac h me nt) acc or di n g t o Ta bl e 
9 -1 .  T here are n o eli gi bilit y re q uir e me nts ass ociat e d  wit h t his m eas ure i n t his bite f orce trial.  
T a bl e 9 -1  
T h e d e nt ur e b e ari n g ti s s u e s c or e (K a p ur, 1 9 6 7 ) 
S c or e  Ri d g e S h a p e  
Ti s s u e R e sili e n c y  L o c ati o n of B or d er Att a c h m e nt  
1  
Fl at  
Fl a b b y  
L o w  
2  
V -s h a p e d  
R e sili e nt  
M e di u m  
3  
S h a p e d b et w e e n U a n d V  Fir m  
Hi g h  
4  
U s h a p e d  
- 
- 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 5  of 5 9  
9. 1. 2  
K a p ur -Ol s h a n I n d e x ( W ell Fitti n g A s s e s s m e nt)  
O nl y t he ma xillar y d e nt ure  will be e x a mi ne d f or rete nti o n a n d sta bilit y d uri n g scree ni n g usi n g 
t he Ols ha n m o dificati o n of t he Ka p ur I n de x (Ols ha n et al., 1 9 9 2 , Ka p ur, 1 9 6 7 ) b y a n e x a mi ner 
wit h e x pert k n o wle d ge of pr ost h o d o ntics.  T his assess me n t is t o be perf or me d wit h n o de nt ure 
a d hesi ve prese nt.  
Rete nti o n:  
Wit h gl o ve d ha n ds, t he e x a mi ner will atte m pt t o u nseat t he ma xillar y d e nt ure b y a p pl yi n g a n 
o p p osi n g vertical f orce at t he ca ni n e/lateral i ncis or re gi o n of t he de nt ur e.  T he e x a mi ner will 
score rete nti o n  as 0 - 5 usi n g t he f oll o wi n g criteri a:  
5 = E x celle nt - de nt ure offers e x celle nt resista nce t o vertical p ull a n d lateral f orce.  
4 = Ver y G o o d - de nt ur e offers ver y g o o d resista nce t o vertical p ull a n d lateral f orce.  
3 = G o o d - de nt ur e offers m o derate resista nce t o v ertical p ull a n d lateral f orce.  
2 = Fair - de nt ur e offers m o derate resista nce t o vertical p ull a n d little or n o resista nce t o 
lateral f orce.  
1 = P o or - de nt ure offers sli g ht resista nce t o vertical p ull a n d little or n o resista nce t o la t eral 
f orce. 
0 = N o ret e nti o n - w he n t h e de nt ure is seate d i n place, it dis places itself.  
St a bility:  
Wit h gl o ve d ha n ds, t he e x a mi ner will atte m pt t o r oc k t he seate d ma xillar y de nt ure b y placi n g 
alter nate h oriz o ntal f orce at t he c us pi d a n d c o ntr alateral m ola r re gi o ns of t he u p per d e nt ure.  
T he e x a mi ner will sc ore de nt ure  st a bilit y as 0 - 4 usi n g t he f oll o wi n g criteria:  
4 = E x celle nt - w he n de nt ure offers e x celle nt sta bilit y; de m o nstrates n o r oc ki n g o n its 
s u p p orti n g str uct ur es u n d er press ure. 
3 = G o o d - w he n d e nt ure offers g o o d sta bilit y; d e m o nstrates ver y sli g ht r oc ki n g o n its 
s u p p orti n g str uct ur es u n d er press ure. 
2 = Fair - w h e n de nt ure offers s ufficie nt sta bilit y; de m o nstrates sli g ht r oc ki n g o n its 
s u p p orti n g str uct ur es u n d er press ure. 
1 = P o or - s o me sta bilit y; w he n a de nt ur e bas e de m o nstrates m o derate r oc ki n g o n its 
s u p p orti n g str uct ur es u n d er press ure. 
0 = N o sta bilit y - w h e n a de nt ure b ase d e m o nstrates e xtre me r oc ki n g o n its s u p p orti n g 
str uct ures u n der press ur e. 
9. 1. 3  
W ell M a d e a s s e s s m e nt  
T he ma xillar y de nt ur e, a n d ma n di b ular de nt ure if prese nt, will be assess e d f or t his st u d y.  
Cli nic al Acce pt a bility  
O nl y d e nt ures ha vi n g a de q uate (as j u d ge d b y a n e x a mi ner wit h e x pert k n o wle d ge of 
pr ost h o d o ntics) vertical di me nsi o n, free wa y s pace, h oriz o ntal occl usal relati o ns hi ps a n d  b or der 
e xte nsi o n will be c o nsi dere d cli nicall y acce pt a ble.  F or t he ma xillar y de nt ur e, t he e x a mi ner will 
i n dicate acce pta ble or u nacce pta ble o n t he C R F. 
De nt ure Fi nis h a n d C o nt o ur  
T he c o nt o ur a n d fi nis h of t he de nt ur e will be e x a mi ne d.  O nl y de nt ur es wit h  acce pta ble (as 
j u d ge d b y a n e x a mi ner wit h e x pert k n o wle d ge of pr ost h o d o ntics) p or osit y, tiss ue s urfaces, 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 6  of 5 9  
p olis he d s urfaces, c ol or a n d t hic k ness will be acce pte d.  F or t he ma xillar y d e nt ure, t he e x a mi ner 
will i n dicate acce pta ble or u nacce pta ble o n t he C R F.  
9. 1. 4  
M a xill ar y Bit e F or c e A s s e s s m e nt ( Tr ai ni n g a n d Q u alif yi n g Bit e s)  
T he ma n di b ular d e nt ure, if prese nt, will be sta bilize d usi n g d e nt ure a d hesi v e ( A p pe n di x 1 5. 2 ).  
S u bjects will t he n be i nstr ucte d i n t he e x ec uti o n of t he B F assess me nt.  T he s u bject will be 
i nstr ucte d sit a n d h ol d t heir hea d i n a nat ural p ositi o n s o t hat t he occl usal pla ne is parallel t o t he 
fl o or.  T he e x a mi ner will sta n d i n fr o nt of t he s u bject h ol di n g t he bite f orce tra ns d ucer parallel 
t o t he fl o or at a c o mf ort a ble le vel f or t he s u bject.  I n or der t o facilitate i nserti o n of t he B F 
tra ns d ucer, t he e x a mi ner ma y a n gle t he B F plates as necess ar y.  T o pre v e nt cr oss c o nta mi nati o n 
bet wee n s u bjects, t he e x a mi ner will place a clea n fi n ger c ot o ver t he bite f orce plates i n a d diti o n 
t o a cle a n i nfecti o n c o ntr ol s yri n ge slee v e o ver t h e tra ns d ucer h a n d piece.  T he e x a mi ner will 
i nsert t he bite f orce pl ates i nt o t he s u bject’s m o ut h a n d t he n e ns ure t h at t he m uscles of 
masticati o n are rel a x e d.  T he e x a mi ner will si g n al t he s u bject t o bite u ntil m o ve me nt o n t he 
ma xillar y d e nt ure is o bser ve d at w hic h ti me t he y will be i nstr ucte d t o release t heir bite.  If, i n 
t he o pi ni o n of t he e x a mi ner, t he s u bject will be u na ble t o s uccessf ull y c o m plete t he re q uire d 
B F s yste m trai ni n g, t he s u bject will be wit h dra w n fr o m t he st u d y.  
S h o ul d a bite descri be d bel o w be c o m pr o mise d t hr o u g h a met h o d ol o gical or i nstr u me ntal err or, 
e. g. b y misali g n me nt of t he tra ns d ucer i n t he m o ut h, t he bite ca n be re peate d at t he e x a mi ner’s 
discreti o n.  
9. 1. 4. 1  
Tr ai n i n g Bit e s 
D uri n g t he Scree ni n g visit, t he e x a mi ner will rec or d a tri plicate bite f orce m eas ure m e nt wit h o ut 
a n y d e nt ure a d hesi ve.  T he perf or ma nce of trai ni n g bites will be c o nfir me d i n t he C R F 
(i n di vi d ual trai ni n g bite val ues will n ot be rec or de d). 
9. 1. 4. 2  
Q u alif y i n g Bit e s 
F o ur f urt her B F me as ure me nts, k n o w n as q u alif yi n g bites , will be perf or m e d after t he trai ni n g 
bites.  All 4 q ualif yi n g bites m ust be ≤9l bs.  I n a d diti o n, t w o o ut of t he 4 q ualif yi n g bites m ust 
be re pr o d uci ble wit hi n ± 2l b f or a s u bject t o be eli gi ble t o partici pate i n t he st u d y.  T his will 
f or m t he s u bject eli gi bilit y/ a d h ere n ce f or st u d y c o nti n ua nce (as p er I n cl usi o n criteri o n 6). 
9. 2  
Effi c a c y A s s e s s m e nt s  
T he f oll o wi n g effic ac y assess me nts will be perf or me d b y a p pr o priatel y tr ai ne d staff/cli nical 
e x a mi ners, at t he ti mes a n d i n t he or der d efi ne d  (as m uc h as p ossi ble) i n t h e St u d y Pr oce d ures  
secti o n of t his pr ot oc ol. 
If i n t he o pi ni o n of t he e x a mi ner a s u bject is bet wee n defi ne d gra des/sc ores, a c o nser vati v e 
a p pr oac h s h o ul d be use d t o pr o vi de t he fi nal sc ore.  T he sa me a p pr oac h s h o ul d be a p plie d 
t hr o u g h o ut t he st u d y t o e ns ure c o nsiste nc y i n t he gra di n g of t he sc ores at all ti me p oi nts.  
9. 2. 1  
Tr e at m e nt D a y ( Vi sit s 2 -5) M a xill ar y Bit e F or c e A s s e s s m e nt s ( Pr a cti c e, 
B a s eli n e a n d T e st Bit e s)  
All B F meas ure me nts will be c o n d ucte d b y a n e x a mi ner ( prefera bl y b y t he sa me e x a mi ner 
t hr o u g h o ut t he st u d y) t h at is f ull y trai ne d i n t h e use of t he B F tr a ns d ucer e q ui p me nt a n d is 
e x perie nce d i n perf or mi n g B F meas ure me nts. Pri or t o a n y B F meas ure m e nts o n treat me nt da ys 
( Visit 2-5) t he ma n di b ular de nt ures, if  prese nt,  will be sta bilize d ( Secti o n 9. 1. 4 ). 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 7  of 5 9  
9. 2. 1. 1  
Pr a cti c e Bit e s  
O n eac h treat me nt d a y, t he e x a mi ner will ta ke 3 B F m eas ure me nts wit h o ut de nt ure a d h esi ve, 
k n o w n as practice bites. T he p ur p ose of t his is t o re -fa miliarize t he s u bject wit h t he B F 
tra ns d ucer e q ui p me nt a n d h o w t o perf or m a vali d bite.  
9. 2. 1. 2  
B a s eli n e Bit e  
F oll o wi n g t he practice bites, a 4 t h bite will be p erf or me d, wit h o ut a n y d e nt ur e a d hesi v e, a n d t his 
will be t he baseli ne pre -tr eat me nt B F meas ure me nt.  
F or a s u bject t o be eli gi ble, 1 of t he 3 practice bites m ust be wit hi n ± 2l bs of t he bas eli ne pre-
treat me nt bite. I n a d diti o n, o nl y s u bjects w h ose pre-treat me nt baseli ne B F is ≤9l bs will be 
eli gi ble t o pr ocee d i n t he st u d y. If a s u bject d oes n ot meet t hese criteria at a n y of t he treat me nt 
da y visits, t he y will be disc o nti n ue d fr o m t he st u d y.  
9. 2. 1. 3  
T e st Bit e s  
A d diti o nal B F meas ur e me nts will be ta ke n at 0. 5, 1, 3, 6, 9 a n d 1 2 h o urs after a p plicati o n of 
test a d hesi ve ( or n o a d hesi ve as per ra n d o mizati o n sc he d ule). T he rea di n g s h o ul d be ta ke n n o 
earlier t ha n t he state d ti m e, a n d a t olera n ce of 5 mi n ute s f or t he 3 0 mi n bite a n d 1 0 mi n utes f or 
all ot her ti me p oi nts is acce pta ble.   
9. 3  
S af et y a n d Ot h er A s s e s s m e nt s  
9. 3. 1  
Or al S oft Ti s s u e E x a mi n ati o n  
W here p ossi ble, t his pr oce d ure s h o ul d be c o n d ucte d b y a si n gle de ntal e x a mi ner or cli nicall y 
q ualifie d desi g nee f or al l s u bjects f or all visits. T he O S T e x a mi nati o n will be acc o m plis he d b y 
direct o bser vati o n a n d pal pati o n, usi n g retr acti o n ai ds as a p pr o priat e, a n d will i ncl u de 
e x a mi nati o n of t he oral la bial m uc osa (i ncl u di n g li ps), b uccal m uc osa, a n d m uc o gi n gi val f ol ds, 
ede nt ul o us gi n gi val m uc osa , i ncl u di n g a n y gi n gi val m uc osa s urr o u n di n g a n y m a n di b ular 
de ntiti o n as a p plica ble,  har d palate, s oft palat e, t o nsillar area, p har y n geal area, t o n g u e, 
s u bli n g ual area, s u b ma n di b ular area a n d sali var y gla n ds. T he res ults of t he e x a m i nati o n will be 
rec or de d i n t he C R F as eit her n or mal or a b n or mal wit h details of a n y a b n or malities. A n y 
a b n or malit y or w orse ni n g of a pre -e xisti n g c o n diti o n o bser ve d b y t he cli nical e x a mi ner or 
re p orte d b y t he s u bject fr o m t he O S T e x a mi nati o n carri e d o ut at Scree ni n g, Visit 1, will be 
rec or de d as a n A E.  
T he O S T e x a mi nati o n will be perf or me d at t he start of Scree ni n g, Visit 1, bef ore a n y a d hesi v e 
a p plicati o n (if re q uire d f or ma n di b ular sta bilizati o n) a n d/ or c o m me n ce me nt of scree ni n g B F 
assess me nts, a n d a gai n at t he e n d of t he da y f oll o wi n g de nt ur e a n d a d hesi ve re m o val (if a p plie d 
f or ma n di b ular sta biliz ati o n). 
D uri n g t he st u d y treat me nt peri o ds ( Visit 2 t o 5), a n O S T e x a mi nati o n will be perf or m e d pri or 
t o a d hesi ve a p plicati o n ( or n o a d hesi ve as p er ra n d o mizati o n sc he d ule) a n d als o after t h e 
c o m pleti o n of all efficac y ass ess me nts at t he e n d of eac h test da y f oll o wi n g de nt ur e a n d  
a d hesi ve re m o val, a n d all fi n di n gs will be rec or de d i n t he C R F.  T he O S T e x a mi nati o n s h o ul d 
be perf or me d b y a  suita bl y q ualifie d d e n tal pr ofessi o nal wit h e x pertise i n pr ost h o d o ntics.  T he 
s u bject ma y be as ke d t o perf or m a n oral ri nse wit h water t o re m o ve de bris fr o m t he m o ut h 
bef ore or d uri n g t his e x a mi nati o n, at t he e x a mi ner’s discreti o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 8  of 5 9  
9. 3. 2  
Or al H ar d Ti s s u e E x a mi n ati o n  
W here p ossi ble, t his pr oce d ure s h o ul d be c o n d ucte d b y a si n gle de ntal e x a mi ner or cli nicall y 
q ualifie d desi g nee f or all s u bjects. E x a mi nati o n of t he oral har d tiss ues (all facial, li n g ual/ 
palatal, mesial/ distal a n d occl usal s urfaces) will o nl y be carrie d o ut o n a s u bject’ s ma n di b ular 
de ntiti o n (as a p plica ble) a n d will be acc o m plis he d b y dir ect/i n direct o bser vati o n, usi n g 
retracti o n ai ds as a p pr o priate. E na mel irre g ularities, t o ot h fract ur e, defecti ve/fa ult y rest or ati o ns 
(all direct & i n direct rest orati o ns i ncl u di n g fi x e d/re m o vable  pr ost h eses), cari o us lesi o ns, n o n -
cari o us har d tiss ue l oss (a brasi o n, attriti o n, a bfracti o n a n d er osi o n), a n d a n y ot her har d tiss ue 
irre g ularit y (e. g. h y p o/ h y per mi neralisati o n, decalcificati o n) will be rec or de d.   
O bser vati o ns will be liste d as ei t her a bse nt or prese nt, a n d c o n diti o ns n ote d as pres e nt will be 
descri be d i n t he C R F. A n y a b n or malit y or w orse ni n g of a pre -e xisti n g c o n diti o n o bser ve d b y 
t he cli nical e x a mi ner or re p ort e d b y t h e s u bject fr o m t he O H T e x a mi nati o n carrie d o ut at 
Scree ni n g , Visit 1, will be rec or de d as a n A E. Fi n di n gs fr o m t he s cree ni n g e x a mi nati o n will be 
use d t o deter mi ne s u bject eli gi bilit y.  
T he O H T e x a mi nati o n will be perf or me d at t he start of Scree ni n g, Visit 1, bef ore a n y a d h esi ve 
a p plicati o n (if re q uire d f or ma n di b ular sta bilizati o n) a n d/ or c o m me n ce me nt of scree ni n g B F 
assess me nts, a n d at t he e n d of t he last st u d y visit after de nt ure a n d a d hesi ve re m o v al, a n d all 
fi n di n gs will be rec or de d i n t he C R F.  T he O H T e xa mi nati o n s h o ul d be perf or me d b y a  suita bl y 
q ualifie d de ntal  pr ofessi o nal wit h e x pertise i n pr ost h o d o ntics .  T he s u bject ma y b e as ke d t o 
perf or m a n oral ri nse wit h water t o re m o ve de bris fr o m t he m o ut h bef ore or d uri n g t his 
e x a mi nati o n, at t he e x a mi ner’s discreti o n.  
1 0  
A D V E R S E E V E N T A N D S E RI O U S A D V E R S E E V E N T S  
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
re p orti n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble f or f oll o wi n g 
u p A Es t hat are s eri o us, c o nsi dere d relate d t o t he st u d y pr o d uct  or t he st u d y, or t hat ca use d t he 
s u bject t o disc o nti n ue t he st u d y pr o d uct or st u d y. 
1 0. 1  
D efi niti o n of a n A d v er s e E v e nt ( A E)  
A n A E is a n y u nt o war d me dical occ urre nce i n a cli nical st u d y s u bject, te m p orall y ass oci ate d 
wit h t he use of a st u d y pr o d uct i ncl u di n g a n y w as h o ut or lea d -i n pr o d uct ( or me dical de vice), 
w het her or n ot c o nsi dere d relate d t o t he st u d y pr o d uct, i ncl u di n g a n y was h o ut or lea d -i n pr o d uct 
( or me dical d e vice). 
N O T E: A n A E ca n t heref ore b e a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n a b n or mal 
la borat or y fi n di n g), s y m pt o m, or disease ( ne w or e x acer bate d) te m p orall y ass ociate d wit h t he 
use of a st u d y pr o d uct i n cl u di n g a n y was h o ut or l ea d -i n pr o d u ct ( or me dical de vice). 
E ve nts Meeti n g  t he A E Defi niti o n:   
•  A n y a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) or 
ot her safet y assess me nts (e. g. E C G, ra di ol o gical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w ors e n fr o m baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n v esti gat or (i.e., n ot relat e d t o pr o gressi o n of 
u n derl yi n g dise ase).  
•  E x acer bati o n of a c hr o ni c or i nter mitte nt pre -e xisti n g c o n diti o n i ncl u di n g eit her a n 
i ncreas e i n fre q u e nc y a n d/ or i nte nsit y of t he c o n diti o n. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 3 9  of 5 9  
•  Ne w c o n diti o ns detect e d or dia g n os e d after st u d y pr o d uct a d mi nistrati o n e ve n t h o u g h 
it ma y ha v e bee n prese nt bef ore t h e start of t he st u d y. 
•  Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n.  
•  Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y 
pr o d uct or a c o nc o mita nt me dicati o n. O ver d ose per se will n ot be re p ort e d as a n 
A E/ S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p ossi ble s uici dal/self -har mi n g 
i nte nt. S uc h o ver d oses s h o ul d be re p orte d re gar dless of se q uelae. 
•  " Lac k of effic ac y" or "fail ure of e x pecte d p har mac ol o gical acti o n" p er se will n ot be 
re p orte d as a n A E. S uc h i nsta nces will be ca pt ure d i n t he efficac y ass ess me nts. 
H o we ver, t he si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
effic ac y will be re p orte d as A E i f t he y f ulfill t he d efi niti o n of a n A E.  
E ve nts N O T  meeti n g t he A E defi niti o n:  
•  A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her a b n or mal 
safet y assess me nts w hic h are ass ociat e d wit h t he u n derl yi n g diseas e, u nless j u d ge d b y 
t he i n vesti gat or t o b e m ore se vere t ha n e x pecte d f or t he s u bject’s c o n diti o n.  
•  T he diseas e/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of t he 
disease/ dis or der b ei n g st u die d, u nless m ore se v ere t ha n e x pecte d f or t he s u bject’s 
c o n diti o n.  
•  Me dical or s ur gical pr oce d ure (e. g. e n d osc o p y, a p pe n dect o m y) is n ot t he A E. T he 
c o n diti o n t hat lea ds t o t he pr oce d ure is a n A E (e. g. a p pe n dicitis).  
•  Sit uati o ns w here a n u nt o war d 
me dical occ urre nce di d n ot o cc ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).  
•  A ntici pate d da y -t o-da y fl uct uati o ns of pre -e xisti n g disease(s) or c o n diti o n(s) pres e nt or 
detecte d at t he start of t h e st u d y t hat d o n ot w ors e n.  
1 0. 2  
D efi niti o n of a S eri o u s A d v er s e E v e nt ( S A E)  
A Seri o us A d v erse E ve nt ( S A E) is a p artic ular cat e g or y of a n a d verse e ve nt w here t he a d verse 
o utc o me is seri o us. If a n e ve nt is n ot a n A E p er defi niti o n a b o ve, t he n it ca n n ot be a n S A E e v e n 
if seri o us c o n diti o ns are met (e. g. h os pitalizati o n f or si g ns/s y m pt o ms of t he disease u n der st u d y, 
deat h d ue t o pr o gressi o n of disease).  
A seri o us a d verse e v e nt is a n y u nt o w ar d me dical occ urre nce at a n y d ose t h at:  
•  Res ults i n de at h  
•  Is lif e-t hre ate ni n g  
▪ T he ter m 'life -t hr eate ni n g' i n t he defi niti o n of 'seri o us' refers t o a n e v e nt i n w hic h 
t he s u bject was at ris k of deat h at t he ti me of t he e ve nt. It d o es n ot refer t o a n 
e ve nt, w hic h h y p ot heticall y mi g ht ha ve ca use d deat h, if it were m or e se vere;  
•  Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n   
▪ I n ge neral, h os pitalizati o n si g nifies t hat t he s u bject has bee n detai n e d ( us uall y 
i n v ol vi n g at least a n o v er ni g ht sta y) at t he h os pital or e mer ge nc y war d f or 
o bser vati o n a n d/ or tr eat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h ysicia n’s office or o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g 
h os pi taliz ati o n are A Es. If a c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y 
ot her seri o us criteria, t he e ve nt is seri o us. W he n i n d o u bt as t o w het her 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 0  of 5 9  
“ h os pitaliz ati o n” occ urre d, or was necessar y, t he A E s h o ul d be c o nsi dere d 
seri o us. 
▪ H os pitalizati o n f or electi ve treat me nt of a pre -e xisti n g c o n diti o n t hat di d n ot 
w orse n fr o m b aseli ne is n ot c o nsi dere d a n A E.  
•  Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y  
▪ T he ter m disa bilit y me a ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y t o c o n d uct 
n or mal life f u ncti o ns. 
▪ T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie n ces of relati vel y mi n or me dical 
si g nifica n ce s uc h as u nc o m plicate d hea dac he, n a usea, v o miti n g, diarr hea, 
i nfl ue nza, a n d acci de ntal tra u ma (e. g. s prai ne d a n kle) w hic h ma y i nterfere wit h or 
p re ve nt e v er y da y life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pti o n. 
•  Res ults i n c o n ge nit al a n o m al y/ birt h defect  
•  Ot her sit u ati o ns:  
▪ Me dical or scie ntifi c j u d g me nt s h o ul d be e x ercise d i n deci di n g w het her S A E 
re p orti n g is a p pr o priat e i n ot her sit uatio ns s uc h as i m p orta nt me dical e ve nts t hat 
ma y n ot be i m me diatel y life -t hreate ni n g or res ult i n deat h or h os pitalizati o n b ut 
ma y je o p ar dize t he s u bject or ma y re q uir e me dical or s ur gi cal i nter ve nti o n t o 
pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve defi niti o n. T hese e v e nts 
s h o ul d us uall y be c o nsi d ere d seri o us. 
▪ E x a m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me f or aller gic br o n c h os pas m, bl o o d 
d yscrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n, or de vel o p me nt of 
dr u g d e pe n de nc y or dr u g a b use.  
N ote:  Classificati o n of a n A E as ‘seri o us’ is base d o n t he o utc o me of t he e ve nt a n d is a fact or 
i n deter mi ni n g re p orti n g re q uire me nts. 
1 0. 3  
Ti m e P eri o d a n d Fr e q u e n c y f or C oll e cti n g A E a n d S A E 
I nf or m ati o n 
All A Es, a n d t heref ore all S A Es will be c ollecte d i m me diatel y after a s u bject pr o vi des c o nse nt 
t o partici pate i n t h e st u d y b y t h e c o m pleti o n (si g nat ure) of t he I C F a n d u ntil 5 da ys f oll o wi n g 
last a d mi nistrati o n of t he st u d y pr o d uct ( or last pr oce d ure).  
Me dical occ urre nces t hat be ga n bef ore o btai ni n g i nf or me d c o nse nt will be rec or de d i n t he 
Me dical Hist or y/ C urre nt Me dical C o n diti o ns  secti o n of t he C R F n ot t he A E secti o n. 
Details rec or de d b y t he s u bject o n a diar y or si milar d oc u me nt t hat meet t h e defi niti o n of a n A E 
m ust als o be disc usse d wit h t he s u bjects a n d tra ns cri be d i n t he A E secti o n of t he C R F.  
All S A Es will be rec or de d a n d re p ort e d t o t he s p o ns or or desi g nee i m me diatel y a n d u n der n o 
circ u msta nce s h o ul d t his e x cee d 2 4 h o urs. T he i n v esti ga t or will s u b mit a n y u p date d S A E data 
t o t he s p o ns or wit hi n 2 4 h o urs of it bei n g a vaila bl e . 
I n v esti gat ors are n ot o bli gat e d t o acti vel y see k A Es or S A Es after t he c o ncl usi o n of t he st u d y 
partici pati o n . H o we ver, if t he i n vesti gat or lear ns of a n y S A E, i ncl u di n g a deat h, at an y ti me 
after a s u bject has bee n disc har ge d fr o m t he st u d y, a n d he/s he c o nsi ders t he e ve nt t o be 
reas o na bl y relate d t o t he st u d y pr o d uct  or st u d y partici pati o n, t he i n vesti gat or m ust pr o m ptl y 
n otif y t he s p o ns or.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 1  of 5 9  
1 0. 4  
R e p orti n g Pr o c e d ur e s  
T he i n vesti gat or a n d a n y desi g nees are res p o nsi ble f or detecti n g, d oc u m e nti n g a n d re p orti n g 
e ve nts t hat meet t he defi niti o n of a n A E a n d re mai n res p o nsi ble f or f oll o wi n g u p o n A Es t hat 
are seri o us, c o nsi dere d relate d t o t he st u d y pr o d uct(s), partici p ati o n i n t he st u d y, or a st u d y 
pr oce d ure, or t hat c a use d t he s u bject t o disc o nti n ue t he st u d y pr o d uct or st u d y.  
S p o nta ne o us re p orti n g of a d verse e ve nts a n d t h ose elicite d b y as ki n g s u bjects t o res p o n d t o 
n o n -lea di n g q uesti o ns s u c h as “ H o w d o y o u feel” will be assess e d a n d a n y A E’s rec or de d i n 
t he C R F a n d re p orte d a p pr o priatel y. 
T he i n vesti gat or ( or m e dicall y q ualifie d desi g nee) is t o re p ort all directl y o bser ve d A Es a n d all 
A Es s p o nta ne o usl y re p orte d b y t h e st u d y s u bject. I n a d diti o n, eac h st u d y s u bj ect will b e 
q uesti o ne d a b o ut A Es.  
Eac h A E is t o be assesse d t o deter mi ne if it meets t he criteria f or a S A E.  If a n S A E occ urs, 
e x pe dite d re p orti n g will f oll o w l ocal a n d i nter nati o nal re g ulati o ns, as a p pr o priate.  
W he n a n A E occ urs, it is t he res p o nsi bilit y of t he i n v esti gat or ( or me dicall y q ualifie d desi g n ee) 
t o re vie w all d oc u me nt ati o n (e. g. h os pital pr o gress n otes, la b orat or y, a n d dia g n ostics re p orts) 
relate d t o t he e v e nt. 
T he i n vesti gat or or site staff will t he n rec or d all rele va nt i nf or m ati o n re gar di n g a n A E i n t h e 
C R F a n d all details relati n g t o a n S A E i n t he pa p er S A E F or m pr o vi de d.  
It is n ot  acce pta ble f or t he i n vesti gat or ( or m e dicall y q ualifi e d desi g nee) t o se n d p h ot oc o pies 
of t he s u bject’s me dical rec or ds t o G S K C H i n lie u of c o m pleti o n of t h e A E C R F pa ge/ S A E  
f or m. 
T here m a y be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d b y G S K 
C H.  I n t his i nsta nce, all s u bject i de ntifiers, e x ce pt f or t he s u bject n u m ber, will be re dacte d o n 
t he c o pies of t he me di cal rec or ds pri or t o s u b missi o n t o G S K C H.  
T he i n vesti gat or ( or me dicall y q ualifie d desi g nee) will atte m pt t o esta blis h a dia g n osis of t he 
e ve nt bas e d o n si g ns, s y m pt o ms, a n d/ or ot her cli nical i nf or mati o n.  T he dia g n osis will b e 
d oc u me nte d as t he A E/ S A E w here k n o w n a n d n ot t he i n di vi d ual si g ns/s y m pt o ms. (e. g. u p p er 
res pirat or y tr act i nfecti o n, seas o nal aller g y, etc. i nstea d of r u n n y n ose). 
A Es elicite d b y t h e i n vesti gat or ( or me dicall y q ualifie d desi g nee) i n a sta n dar d ma n ner at t he 
st u d y visits s h o ul d als o be rec or de d i n t he A E s ecti o n of t he C R F a n d/ or usi n g t he S A E f or m 
(s u bject t o t h e cl assificati o n of t he A E). Care will be t a ke n n ot t o i ntr o d uce bi as w he n 
q uesti o ni n g a s u bject a b o ut a n y c ha n ges i n t heir healt h. O pe n -e n d e d a n d n o n -lea di n g v er bal 
q uesti o ni n g s h o ul d be us e d.  
1 0. 4. 1  
R e p orti n g of a n A d v er s e E v e nt  
All A Es will be re p orte d o n t he A E pa ge of t he C R F b y t he i n vesti gat or or site staff.  It s h o ul d 
be n ote d t hat t h e f or m f or c ollecti o n of S A E i nf or mati o n is n ot t he sa me as t he A E C R F.  W here 
t he sa me data are c ollecte d, t he A E C R F pa ge a n d t he S A E f or m m ust be c o m plete d i n a 
c o nsiste nt ma n ner.  F or e x a m ple, t he sa me A E ter m s h o ul d be use d o n b ot h.  A Es s h o ul d b e 
re p orte d usi n g c o n cise m e dical ter mi n ol o g y o n t he C R F as well as o n t he f or m f or c ollecti o n of 
S A E i nf or mati o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 2  of 5 9  
1 0. 4. 2  
R e p orti n g of a S er i o u s A d v er s e E v e nt 
I n a d diti o n t o rec or di n g t he details of eac h A E o n t he A E C R F pa ge, a n S A E f or m s h o ul d be 
c o m plete d, as f ull y as p ossi ble. C o pies of t he S A E f or m will be pr o vi de d i n t he i n vesti gat or 
st u d y master file. Ori gi nal S A E f or ms will be retai ne d i n t he i n vesti gat or st u d y master file. 
It is esse ntial t o e nt er t he f oll o wi n g i nf or mati o n:  
•  Pr ot oc ol a n d s u bject i de ntifiers  
•  S u bject de m o gra p h y  
•  Descri pti o n of e v e nts, wit h dia g n osis if a vaila bl e  
•  I n v esti gat or o pi ni o n of relati o ns hi p t o st u d y pr o d uct ( or stu d y pr oce d ure, if a p pr o priate)  
•  Criteri o n f or seri o us ness.  
T he f oll o wi n g are desir a ble a n d are of partic ul ar rele va nce f or i n vesti gat or a n d G S K C H 
assess me nt of t he S A E re p ort:  
•  Date of o nset of A E  
•  Date A E st o p pe d, if rele v a nt  
•  St u d y pr o d uct start dat e  
•  St u d y  pr o d uct e n d d ate if rele va nt  
•  Acti o n ta ke n i n relati o n t o t he st u d y pr o d u ct  
•  O utc o me if k n o w n  
T he S A E f or m, c o m plete d as f ull y as p ossi ble, m ust be sca n n e d a n d e -maile d t o t he G S K C H 
Cli nical O perati o ns Safet y Re p orti n g e mail b o x wit h t he st u d y n u m ber a n d s u bject n u m ber i n 
t he s u bject li ne of t he e m ail i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 
h o urs  after st u d y site pers o n nel lear n of t he e ve nt. T he i n vesti gat or will s u b mit a n y u p dat e d 
S A E data t o t he s p o ns or, i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 
h o urs of it bei n g a vaila bl e. T he G S K C H St u d y M a na ger s h o ul d als o be n otifie d of t h e sit uati o n 
b y tele p h o n e or e m ail.  
E m ail Seri o us A d verse E ve nts t o:  
 
T he G S K C H St u d y Ma n a ger or d esi g n ee will be res p o nsi ble f or f or war di n g t he S A E f or m t o 
t he Case 
Ma na ge me nt 
Gr o u p, 
Gl o bal Cli nical Safet y a n d P har mac o vi gila nce 
mail b o x 
(
). 
T he i nitial re p ort will be f oll o we d u p wit h m ore i nf or mati o n as rele va nt, or as re q ueste d b y t h e 
G S K C H st u d y ma na ger.  
1 0. 5  
E v al u ati n g A d v er s e E v e nt s  
1 0. 5. 1  
A s s e s s m e nt of I nt e n sit y  
T he i n vesti gat or or me dicall y q u alifie d desi g nee will ma ke a n assess me nt of i nte nsit y f or eac h 
A E re p orte d d uri n g t he st u d y a n d will assi g n it t o o ne of t he f oll o wi n g cate g ories:  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 3  of 5 9  
•  Mil d:  A n e ve nt t hat is easil y t olerat e d b y t he s u bject, ca usi n g mi ni mal disc o mf ort a n d 
n ot i nterferi n g wit h e ver y d a y acti vities.  
•  M o derate:  A n e ve nt t hat is s uffi cie ntl y disc o mf orti n g t o i nterfere wit h n or m al e ver y da y 
acti vities . 
•  Se vere:  A n e ve nt t hat pr e ve nts n or mal e ver y da y acti vities.  
N O T E: A n A E t hat is assesse d as se vere s h o ul d n ot be c o nf use d wit h a n S A E. Se vere is a 
cate g or y utilize d f or rati n g t he i nte nsi t y of a n e v e nt; a n d b ot h n o n-seri o us A Es a n d S A Es ca n 
be assesse d as se vere. F or e x a m ple, a hea d ac he m a y b e se v ere (i nterferes si g nifica ntl y wit h t he 
s u bject's us u al f u ncti o n) b ut w o ul d n ot be classifi e d as seri o us u nless it met o ne of t he criteria 
f or S A Es, liste d a b o ve. A n e ve nt is defi ne d as ‘seri o us’ w he n it meets at least 1 of t he pre defi ne d 
o utc o mes as descri be d i n t he defi niti o n of a n S A E, N O T w he n it is rate d as se vere.  
1 0. 5. 2  
A s s e s s m e nt of C a u s alit y  
T he ca us alit y ass ess me nt is o ne of t he criteria use d w he n d eter mi ni n g re g ul at or y re p orti n g 
re q uire me nts.  
F or eac h A E (seri o us a n d n o n -seri o us), t he i n vesti gat or ( or me di call y q ualifie d desi g n ee) m ust  
pr o vi de a n assess me nt of ca usalit y o n t he A E C R F pa ge a n d t he S A E f or m (s u bject t o t he 
classificati o n of t he A E ). T he i n vesti gat or will als o d oc u me nt i n t he me dical n otes t hat he/s he 
has re vie we d t he A E a n d assesse d ca usalit y, w here a p plica ble.  
A “reas o na ble p ossi bilit y” of a rel ati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, a n d/ or 
ar g u me nts t o s u g gest a ca usal  rel ati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot be r ule d o ut. 
Ge nerall y, t he facts (e vi d e nce) or ar g u m e nts t o s u g gest a ca us al relati o ns hi p s h o ul d be pr o vi de d.  
T he i n vesti gat or will use cli nical j u d g me nt t o deter mi ne t he relati o ns hi p a n d will als o c o ns ult  
t he Safet y State me nt a n d/ or Pr o d uct I nf or mati o n, f or mar kete d pr o d ucts, i n t he deter mi nati o n 
of his/ her assess me nt.  Alter nati ve ca us es, s uc h as u n derl yi n g dise ase(s), c o nc o mita nt t hera p y, 
ot her ris k fact ors, a n d t he te m p oral rel ati o ns hi p of t he e ve nt t o t he st u d y pr o d uct will be 
c o nsi dere d a n d i n vesti gate d.  
F or eac h A E/ S A E, t h e i n vesti gat or m ust d oc u me nt i n t he me di cal n otes t hat he/s he has re vie we d 
t he A E/ S A E a n d has pr o vi de d a n assess me nt of ca usalit y. 
T he i n vesti gat or’s assess me nt of ca usalit y m ust be pr o vi d e d f or all A Es (seri o us a n d n o n -
seri o us); t he i n vesti gat or m ust rec or d t he ca usal relati o ns hi p i n t he C R F, as a p pr o pri ate, a n d 
re p ort s uc h a n assess me nt i n acc or da n ce wit h t he S A E re p orti n g re q uir e me nts if a p plica ble. 
T here ma y b e sit uati o ns w he n a n S A E has o cc urre d, a n d t he i n vesti gat or h as mi ni mal 
i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o G S K.  H o w e ver, it is ver y i m p ort a nt t h at t he 
i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y f or e ver y e ve nt pri or t o t he i niti al 
tr a ns missi o n of t he S A E d at a t o G S K C H. T h e i n vesti gat or m a y c ha n ge his/ her o pi ni o n of 
ca usalit y i n li g ht of f oll o w -u p i nf or mati o n a n d se n d a n S A E f oll o w -u p re p ort wit h t he u p date d 
ca usalit y assess me nt.  
1 0. 6  
F oll o w -u p of A E s a n d S A E s   
After t he i nitial A E/ S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll o w u p wit h eac h 
s u bject a n d pr o vi de f urt h er i nf or mati o n o n t he s u bject’s c o n diti o n. 
All A Es (seri o us a n d n o n -seri o us) will be f oll o we d u ntil res ol uti o n, u ntil t he c o n diti o n 
sta bilizes, u ntil t he e ve nt is ot her wise e x plai ne d, or u ntil t he s u bject is l ost t o f oll o w-u p.   
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 4  of 5 9  
T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns as ma y be i n dicate d or as re q ueste d b y G S K C H t o el uci date 
as f ull y as p ossi ble t he nat ure a n d/ or ca usalit y of t he A E. T his ma y i ncl u de a d diti o nal la b orat or y 
tests or i n vesti gati o ns, hist o pat h ol o gical e x a mi nati o ns, or c o ns ultati o n wit h ot her healt h care 
pr ofessi o nals.  
Ne w or u p d ate d i nf or m ati o n will be rec or de d o n t he A E C R F pa ge a n d o n t he S A E f o r m (s u bject 
t o t he classificati o n of t h e A E). 
T he i n vesti gat or will s u b mit a n y u p date d S A E d ata t o G S K C H wit hi n 2 4 h o urs of recei pt of 
t he i nf or mati o n. 
I n v esti gat ors are n ot o bli ge d t o acti vel y see k A Es i n f or mer s u bjects.  H o we v er, if t he 
i n vesti gat or lear ns of a S A E, i ncl u di n g d eat h, at a n y ti me after a s u bject h as bee n dis c har ge d 
fr o m t he st u d y, a n d c o nsi ders t he e ve nt reas o n a bl y rel ate d t o t he st u d y pr o d uct or st u d y 
partici pati o n, t he i n vesti gat or will pr o m ptl y n otif y G S K C H b y e maili n g t he i nf or mati o n  t o t he 
G S K C H Cli nical O p erati o ns Safet y Re p orti n g e mail b o x (
). 
T he G S K C H St u d y Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he i nf or mati o n t o 
t he Case Ma n a ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d P har mac o vi gila n ce gr o u p mail b o x at 
G S K (
). 
T he i n vesti gat or will s u b mit a n y u p dat e d S A E dat a t o G S K C H wit hi n t he desi g nat e d re p orti n g 
ti me frames.  
1 0. 7  
Wit h dr a w al D u e t o a n A d v er s e E v e nt  
Wit h dra wal d ue t o A Es s h o ul d be disti n g uis he d fr o m wit h dra wal d ue t o ot her ca us es, acc or di n g 
t o t he defi niti o n of a n A E n ote d earlier, a n d rec or de d o n t he a p pr o priate A E C R F pa ge.  
W he n a s u bject wit h dra ws beca use o f a n S A E, t he S A E m ust be re p orte d i n acc or da n ce wit h 
t he re p orti n g re q uire me nts defi ne d. 
1 0. 8  
R e g ul at or y R e p orti n g R e q uir e m e nt s f or S A E s 
G S K C H has a le gal res p o nsi bilit y t o n otif y, as a p pr o priate, t he l ocal re g ul at or y a ut h orit y a n d 
ot her re g ulat or y a ut h oritie s a b o ut t he safet y of a pr o d uct u n der cli nical i n vesti gati o n.  Pr o m pt 
n otificati o n of S A Es b y t he i n vesti gat or t o G S K C H is esse ntial s o t hat le gal o bli gati o ns a n d 
et hical res p o nsi bilities t o war ds t he safet y of s u bjects are met.  
G S K C H will c o m pl y wit h c o u ntr y s p ecific re g ulat or y re q uire m e nts relati n g t o safet y re p orti n g 
t o t he re g ulat or y a ut h orit y, I R B/ E C a n d i n vesti gat ors. 
B ot h t he i n vesti gat or a n d t he s p o ns or will c o m pl y wit h all l ocal me dical de vice re p orti n g 
re q uire me nts  
I n v esti gat or safet y re p orts m ust be pre pare d f or s us pecte d u ne x pecte d seri o us a d verse reacti o ns 
( S U S A R) acc or di n g t o l ocal re g ulat or y re q uire m e nts a n d s p o ns or p olic y a n d f or war de d t o 
i n vesti gat ors as n ecessar y. 
A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y re p ort descri bi n g a S A E or ot her s pecific 
safet y i nf or mati o n e. g. s u m mar y or listi n g of S A E fr o m t he s p o ns or will re vie w a n d t he n file it 
al o n g wit h t he Safet y State me nt  i n t he i n vesti gat or st u d y m aster file, a n d will n otif y t he 
I R B/I E C, if a p pr o priate acc or di n g t o l ocal r e q uire me nts. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 5  of 5 9  
1 0. 9  
Pr e g n a n c y  
1 0. 9. 1  
Ti m e P eri o d f or C oll e cti n g Pr e g n a n c y I nf or m ati o n  
Pre g n a nc y i nf or mati o n will be c ollecte d o n all pre g na nci es re p orte d w hile a fe male s u bject is 
partici pati n g i n t he st u d y fr o m t he si g ni n g of i nf or me d c o ns e nt u ntil 5  da ys aft er last 
a d mi nistrati o n of st u d y pr o d uct. 
1 0. 9. 2  
A cti o n t o b e T a k e n if Pr e g n a n c y O c c ur s  
T he i n vesti gat or will r ec or d pre g n a nc y i nf or mati o n o n t he a p pr o priate f or m , sca n a n d e-m ail it 
t o t he 
G S K 
C H 
Cli nical 
O perati o ns 
Safet y 
R e p orti n g e mail b o x (
) wit hi n 2 4 h o urs of lear ni n g of t he s u bject bec o mi n g pre g na nt. T he G S K C H 
St u d y Ma na ger or d esi g n ee will be res p o nsi ble f or f or war di n g t he pre g n a nc y f or m t o t he Cas e 
Ma na ge me nt 
Gr o u p, 
Gl o bal 
Cli nical 
Safet y 
a n d 
P har mac o vi gila nce 
mail b o x 
(
). Ori gi nal pre g na n c y i nf or mati o n f or ms 
will be 
retai ne d i n t he i n vesti gat or st u d y master file.  
T he s u bject will be f oll o we d t o deter mi ne t he o ut c o me of t he pre g n a nc y. I nf or mati o n o n t he 
stat us of t he m ot her a n d i nfa nt / ne o n ate (i ncl u di n g c o nc o mita nt me dicati o ns ta ke n b y t h e 
m ot her d uri n g t he pre g n a nc y) will be f or war de d b y t he i n vesti gat or t o t he G S K C H Cli nical 
O perati o ns Safet y R e p orti n g e ma il b o x a n d t he G S K C H St u d y Ma n a ger or desi g nee will 
f or war d t his i nf or mati o n t o t he Case 
Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d 
P har mac o vi gila nce 
gr o u p 
mail b o x 
at 
G S K (
). 
Ge nerall y, f oll o w -u p will be n o l o n ger t ha n 6 t o 8 wee ks f oll o wi n g t he esti mate d deli ver y dat e. 
A n y ter mi nati o n of t he pre g n a nc y will be re p orte d.  
W hile pre g na n c y itself is n ot c o nsi dere d t o be a n A E, a b n or mal pre g na nc y o utc o mes (e. g. 
s p o nta ne o us a b orti o n, fet al deat h, still birt h, c o n ge nital a n o malies, ect o pic pre g na nc y) are, a n d 
s h o ul d be rec or de d as a n S A E. 
A n y fe m ale s u bject w h o bec o mes pre g na nt w hile partici pati n g will disc o nti n ue st u d y treat me nt 
a n d be wit h dra w n fr o m t he st u d y.  
1 0. 1 0  
M e di c al D e vi c e I n ci d e nt s  
T he defi niti o ns a n d pr oce d ures det aile d are i n acc or da nce wit h I S O 1 4 1 5 5 : 2 0 2 0. 
B ot h t he i n vesti gat or a n d t he s p o ns or will c o m pl y wit h all l ocal me dical de vice re p orti n g 
re q uire me nts. 
Me dical de vi ces are bei n g pr o vi de d b y G S K C H f or use i n t his st u d y; t h e me dical de vic e s i n 
t his st u d y are t he s u p plie d de nt ure a d hesi ve crea ms, t he de nt ure clea nsi n g p aste a n d t he de nt ur e 
clea ni n g br us hes .  
1 0. 1 0. 1  D efi niti o n of a n I n ci d e nt  
A me dical de vic e i nci de nt is a n y malf u n cti o n or deteri or ati o n i n t he c haracteristics a n d/ or 
per f or ma n ce of a d e vice as well as a n y i na de q uac y i n t he la beli n g or t he i nstr ucti o ns f or use 
w hic h, directl y or i n directl y, mi g ht lea d t o or mi g ht ha ve le d t o t he deat h of a s u bject/ user/ ot her 
pers o n or t o a seri o us det eri orati o n i n his/ her state of healt h.  
N ot all i nci de nts lea d t o deat h or seri o us deteri orati o n i n healt h. T he n o n occ urre nce of s uc h a 
res ult mi g ht h a ve bee n d u e t o ot her f ort u n ate circ u msta nces or t o t he i nter ve nti o n of healt h care 
pers o n nel.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
P P D
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 6  of 5 9  
It is s ufficie nt t h at: 
A n i nci de nt ass ociate d wit h a de vice h a p pe ne d a n d  
•  T he i nci de nt was s uc h t h at, if it occ urre d a gai n, mi g ht lea d t o deat h or a s eri o us 
deteri orati o n i n he alt h.  
•  A seri o us deteri orati o n i n state of healt h ca n i ncl u de a n y of t he f oll o wi n g:  
•  Lif e -t hreate ni n g ill ness 
•  Per ma ne nt i m pair me nt of b o d y f u ncti o n or per ma n e nt da ma ge t o b o d y str uct ure  
•  C o n diti o n necessitati n g me dical or s ur gical i nter ve nti o n t o pre ve nt o ne of t he 
a b o ve  
•  Fetal distress, f etal deat h, or a n y c o n ge nital a b n or malit y or birt h defects  
E x a m ples of i nci de nts:  
•  A s u bject, user, care gi ver, or healt hcare pr ofessi o nal is i nj ure d as a res ult of a me dical 
de vice fail ure or its mis use.  
•  A s u bject’s st u d y treat me nt is i nterr u pte d or c o m pr o mise d b y a me di cal de vi ce fail ure.  
•  A mis dia g n osis d ue t o m e dical de vice fail ure lea ds t o i na p pr o pria te treat me nt. 
•  A s u bject’s healt h deteri orates d ue t o me dical de vice fail ure.  
1 0. 1 1  
R e p orti n g of I n ci d e nt s  
All i nci de nts m ust be re p orte d t o G S K C H i m me di atel y a n d u n der n o circ u mst a nce s h o ul d 
t his e xcee d 2 4 h o urs of t he i n vesti gat or or desi g n ee bec o mi n g a ware of  t h e sit uati o n. 
A n y me dical de vice i nci de nt occ urri n g d uri n g t he st u d y will be d oc u me nte d i n t he s u bject's 
me dical rec or ds, if i n acc or da nce wit h t he i n vesti gat or's n or mal cli nical practice, a n d o n t he 
a p pr o priate I nci d e nt Re p ort F or m.  I n a d diti o n, f or i n ci de nts f ulfilli n g t he defi niti o n of a n A E 
(seri o us a n d n o n-seri o us), t he a p pr o priate A E C R F pa ge a n d S A E f or m will be c o m plete d a n d 
re p orte d as per t he A E a n d S A E re p orti n g secti o ns. 
T he I nci de nt Re p ort F or m will be c o m plete d as t h or o u g hl y as p ossi ble a n d  si g ne d b y t he 
i n vesti gat or bef ore tra ns mittal t o G S K C H.  It is ver y i m p orta nt t hat t he i n vesti gat or d escri bes 
a n y c orrecti ve or re me di al acti o ns ta ke n t o pr e ve nt rec urre nce of t he i nci de nt.  
T he c o m plete d I nci d e nt Re p ort F or m s h o ul d be s ca n ne d a n d e maile d  t o t h e G S K C H Cli nical 
O perati o ns Safet y Re p orti n g e mail b o x wit h t he st u d y n u m ber a n d s u bject n u m ber i n t he s u bject 
li ne of t he e mail i m me di atel y a n d u n der n o circ u mst a nce s h o ul d t his e xcee d 2 4 h o urs after 
st u d y site pers o n n el lear n of t he e ve nt. If t here is a n S A E, t he c o m plete d S A E f or m s h o ul d be 
se nt t o get h er wit h t his re p ort f or m.  H o we ver, if a c o p y of t he S A E re p ort is se nt wit h t his f or m, 
t his d oes n ot re place t he pr oce d ure t o re p ort a n S A E.  T h e ori gi nal I nci de nt Re p ort F or m will 
be retai ne d i n t h e i n v esti gat or st u d y master file.  
T he G S K C H St u d y Ma n a ger s h o ul d be n otifie d of t he sit uati o n b y tele p h o ne or e mail.  
E m ail t he I nci de nt Re p ort F or ms t o:  
 
T he G S K C H St u d y Ma n a ger or d esi g n ee will be res p o nsi ble f or f or war di n g t he I n ci de nt Re p ort 
F or m t o t he Case Ma na ge m e nt Gr o u p, Gl o bal Cli nical Safet y a n d P har mac o vi gila nce gr o u p 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 7  of 5 9  
mail b o x (
), res p o nsible f or t h e st u d y a n d ot her G S K 
C H pers o n nel as a p pr o priate.  
T he i nitial re p ort will be f oll o we d u p wit h m ore i nf or mati o n as rele va nt, or as re q ueste d b y t h e 
G S K C H st u d y ma na ger.  
T he i n vesti gat or will f oll o w t he f oll o wi n g directi o ns re gar di n g t h e re p orti n g of a de vi ce fail ure 
( malf u ncti o n): 
•  N otif y G S K C H i m me di atel y ( b y f oll o wi n g t he pr ocess descri be d a b o v e).  
•  Sc he d ule t he s u bject t o ret ur n t o t he site pr o m ptl y t o ret ur n t he faile d d e vice.  
•  Rec or d a n y i nci d e nts o n t he C R F a n d I n ci de nt Re p ort F or m f oll o wi n g i nstr u cti o ns gi ve n 
i n t he secti o n a b o ve. 
•  F or a n y i nci d e nt/ malf u ncti o n occ urri n g wit h a me dical de vice (i ncl u di n g t h ose t hat are 
part of c o m bi nati o n pr o d ucts) s u p plie d b y G S K C H, r et ur n t he faile d de vice t o t he 
s p o ns or as s o o n as p ossi ble, i ncl u di n g d oc u m e ntati o n of t he details of t he fail ure . 
•  F or a n y i nci d e nt/ malf u ncti o n occ urri n g wit h a me dical de vice (i ncl u di n g t h ose t hat are 
part of c o m bi nati o n pr o d ucts) s u p plie d b y t he I n vesti gat or site, re p ort t he i n ci de nt t o t he 
de vice ma n ufact ur er a n d f oll o w t he ma n ufact urer i nstr ucti o ns f or t he ret ur n of t he faile d 
de vice ( w hilst ke e pi n g G S K C H i nf or me d).  
1 0. 1 2  
F oll o w -u p of M e di c al D e vi c e I n ci d e nt s  
Me dical d e vice i nci de nts i n v ol vi n g a n A E will be f oll o we d a n d re p orte d i n t he sa me ma n ner as 
ot her A Es. T his a p plies t o al l s u bjects, i ncl u di n g t h ose w h o disc o nti n ue st u d y pr o d uct or are 
wit h dra w n fr o m t he st u d y.  
T he i n vesti gat or is res p o nsi ble f or e ns uri n g t hat f oll o w -u p i ncl u des a n y s u p ple me nt al 
i n vesti gati o ns as i n dicate d t o el uci date t he nat ur e a n d/ or ca us alit y of t he i n ci de nt. 
Ne w or u p date d i nf or mati o n will be rec or de d o n t h e ori gi nall y c o m plete d I n ci de nt Re p ort f or m 
wit h all c ha n ges si g ne d a n d date d b y t he i n vesti gat or.  
1 0. 1 3  
R e g ul at or y R e p orti n g R e q uir e m e nt s f or M e di c al D e vi c e I n ci d e nt s 
T o f ulfill re g ulat or y re p orti n g o bl i gati o ns w orl d wi de, t he i n vesti gat or is res p o nsi ble f or t he 
detecti o n a n d d oc u me ntati o n of e ve nts meeti n g t h e defi niti o ns of i nci de nt or malf u ncti o n t hat 
occ ur d uri n g all peri o ds of t he st u d y i n w hic h t h e me dical de vice is us e d.  
T he i n vesti gat or will pr o m ptl y re p ort all i nci de nts occ urri n g wit h a n y me di cal de vice pr o vi de d 
f or use i n t he st u d y i n or der f or t h e s p o ns or t o f ulfill t he le gal res p o nsi bilit y t o n otif y a p pr o priate 
re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safet y i nf or mati o n relati n g t o me dical 
de vices bei n g use d i n cli nical st u dies.  
T he i n vesti gat or, or res p o nsi ble pers o n acc or di n g t o l ocal re q uir e me nts (e. g. t he hea d of t he 
me dical i nstit uti o n), will c o m pl y wit h t he a p plica ble l ocal re g ulat or y re q uire me nts relati n g t o 
t he re p orti n g of i nci de nts t o t he I R B/I E C.  
1 1  
D A T A M A N A G E M E N T  
As use d i n t his pr ot oc ol, t he ter m C R F is u n derst o o d t o refer t o eit her a pa per f or m or a n 
electr o nic data rec or d or b ot h, de pe n di n g o n t he d ata c ollecti o n met h o d.  F or t his st u d y, s u bj ect 
data will be c ollecte d  o n pa per C R F’s.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 8  of 5 9  
T he s o urce d o c u me nts (e. g. h os pital rec or ds, cli nical a n d office c harts, la b orat or y n otes, 
me m ora n da, s u bject diaries, q uesti o n naires, e val uati o n c hec klists, p har mac y dis pe nsi n g 
rec or ds, rec or de d data fr o m a ut o mate d i nstr u me nts, micr ofic hes, p h ot o gra p hic n e gati ves, 
micr ofil m or ma g n etic me dia, x -ra ys, s u bject files a n d rec or ds ke pt at t he p har mac y, at t h e 
la b orat or y a n d at t he m e dic o-tec h ni cal de p art m e nts i n v ol ve d i n t he cli nical st u d y) w hic h 
c o ntai n t he s o urce of dat a rec or de d i n t he C R F s h o ul d be s pecifie d.  T he C R F  ca n be use d as a 
s o urce d oc u m e nt at t he discreti o n of data ma n a ge me nt. 
Eac h s u bject will be assi g ne d a n d i d e ntifie d b y a u ni q ue Scree ni n g S u bject N u m ber. A n y 
refere nce ma de t o a n i n di vi d ual s u bject wit hi n t he st u d y m ust be d o ne usi n g t heir u ni q ue 
Scree ni n g S u bject N u m b er.  
1 1. 1  
C a s e R e p ort F or m  
A C R F is a pri nte d, o ptical, or electr o ni c d oc u me nt desi g ne d t o rec or d t he pr ot oc ol re q uire d 
i nf or mati o n t o be re p ort e d t o t he s p o ns or o n eac h trial s u bject. 
F or eac h s u bject w h o h as gi ve n i nf o r me d c o nse nt/asse nt t he C R F m ust b e c o m plete d a n d si g ne d 
b y t he Pri nci pal I n v esti gat or ( or a ut h orize d desi g nee) t o certif y t hat t he data are c o m plete a n d 
c orrect.  T he i n v esti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce dat a) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t h e C R F.  
T o pr otect t he pri vac y of s u bjects, n o Pers o nal I nf or mati o n ( PI) (i ncl u di n g t he s u bject's n a me 
or i nitials or f ull birt h date) is t o be rec or de d i n t he C R F or as part of t h e q u er y te xt.  
All C R F pa ges s h o ul d be c o m plete d d uri n g a s u bject assess me nt w he n t he C R F h as b ee n 
desi g nat e d as t he s o urce.  Data t hat is s o urce d else w here s h o ul d be e ntere d i nt o t he C R F i n a n 
a gree d u p o n ti mefra me b et wee n t he I n vesti gat or a n d S p o ns or.   
G S K C H will o btai n a n d retai n all C R Fs a n d ass ociate d st u d y  d ata as a p plica ble at t he 
c o m pleti o n of t he st u d y.  
1 1. 2  
D at a H a n dli n g  
Ma na ge me nt of cli nic al data will be perf or m e d i n acc or da nce wit h O H RI sta n dar ds a n d dat a 
clea ni n g pr oce d ures wit h o versi g ht b y G S K C H t o e ns ure i nte grit y of t he d ata, f or e x a m ple, t o 
re m o ve err ors a n d i nc o nsiste ncies i n t he data.  
D oc u me ntati o n of all d ata ma na ge me nt acti vities s h o ul d all o w ste p -b y -ste p retr os p ecti ve 
assess me nt of data q u alit y a n d st u d y p erf or m a nce.  
All st u d y data will be tra nscri be d fr o m pa per s o urce d oc u me ntati o n i nt o t he  electr o nic R E D Ca p 
s yste m.  A n y c h a n ges or c orrecti o ns t o data will be perf or me d i n t he R E D Ca p E lectr o nic Dat a 
Ca pt ure ( E D C) S yst e m, a n d it will i ncl u de rati o nale f or c ha n ges. T he E D C s yste m has a n a u dit 
trail, w hic h will pr o vi de a c o m plete rec or d of t h e cha n ges a n d c orrecti o ns e n d orse d b y t he 
I n v esti gat or. 
1 1. 2. 1  
D at a Q u eri e s  
Pr o gra m me d e dit c hec ks will be ge n erat e d a ut o maticall y, as t he d ata are bei n g e nt ere d i nt o t he 
s yste m; t he desi g n will fa v or e ntr y fr o m li mite d o pti o ns o ver free e ntr y t o f urt her re d uce err o rs. 
I n a d diti o n, q ualit y c h ec ks will be pr o gra m me d i n S A S versi o n 9. 4 a n d r u n after t he first s u bject, 
e ver y 8 w ee ks . L o gs a n d re p orts of eac h q u er y r u n will be retai ne d. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 4 9  of 5 9  
T he st u d y m o nit or will perf or m o n g oi n g re vie w t he of t he C R Fs i n acc or da n ce wit h t he 
m o nit ori n g pla n, t o c o nfir m t hat data e ntere d i nt o t he C R F b y a ut h orize d site pers o n nel are 
acc urate, c o m plet e, a n d verifia ble fr o m s o urce d oc u me nts; t hat t he safet y a n d ri g hts of 
partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g c o n d uct e d i n a cc or da n ce wit h t he 
c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y a gree m e nts, I C H G C P, a n d all a p plica bl e 
re g ulat or y re q uire me nts. 
A n y q u eries f o u n d usi n g S A S c hec ks will be e nt ere d i n t h e E D C S yste m a n d r o ute d t o t he 
I n v esti gat or or desi g nee, e na bli n g t he err ors t o be a d dresse d i n parallel wit h Data M a na ge me nt 
re vie w. T he c o urs e a n d o utc o me of eac h q uer y will be trac ke d a n d st or e d wit hi n t he E D C 
s yste m a n d tra nsferre d t o t he RE D Ca p s yste m t o be mai ntai ne d as part of t he a u dit trail. T he  
st u d y m o nit or ca n als o r u n re p orts a n d listi n gs o n t he C R Fs, t o raise ma n ual q ueries as nee de d 
f or site clarifi cati o n or c orrecti o n. 
1 2  
S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A A N A L Y S E S  
1 2. 1  
S a m pl e Si z e D et er mi n ati o n  
S ufficie nt s u bjects will be scree ne d t o ra n d o mize at least 4 5 s u bjects  t o e ns ure t hat at least 4 2 
e val ua ble s u bjects c o m plete t he st u d y.  A s a m ple siz e of 4 2 s u bjects c o m pleti n g all treat me nt 
peri o ds will pr o vi de 9 0 % p o wer t o de m o nstrate st u d y s u ccess. St u d y s u ccess is defi ne d as 
ac hie vi n g b ot h (a) st u d y v ali dit y ( S u per P oli gri p Free s u p eri or t o n o a d hesi ve) a n d ( b) 
s u peri orit y of eit her or b ot h of t he e x peri me ntal de nt ure a d hesi ves  pr o d ucts c o m pare d t o n o 
a d hesi ve (t w o pri mar y o bjecti ves). Pri or cli nical data s u p p orts a delta of 2. 3 0 l bs f or A O B 0 -1 2, 
usi n g t w o -si de d t-tests wit h fa mil y wis e si g nifi ca nce le vel of 5 % b ase d o n t he D u n nett’s
a dj ust me nt wit h a 5 % si g nifica nce l e vel  ass u mi n g a resi d ual sta n dar d de viati o n (s q uare r o ot of 
wit hi n mea n s q uare err or) of 2. 8 3 l bs. T h e esti mat e of resi d ual sta n dar d de viati o n was o btai ne d 
as t he hi g her of t he o bser ve d varia bilit y fr o m t w o pre vi o us bite f orce st u dies c o n d ucte d at O H RI 
( G S K st u dies 
). 
1 2. 2  
P o p ul ati o n s f or A n al y s e s  
S afet y  
All a nal ys es of safet y will be ma de o n t he s afet y p o p ulati o n w hic h will be defi ne d as  all s u bjects 
w h o are ra n d o mize d a n d recei ve d tr eat me nt at least o nce d uri n g t he st u d y. T h e safet y p o p ulati o n 
will be a nal yze d as per treat me nt recei ve d.  
Effic ac y  
Efficac y a nal yses will be base d o n t he M o difie d I nte nti o n-T o -Treat ( M I T T) p o p ulati o n w hic h 
is defi ne d as all ra n d o miz e d s u bjects wit h at least o ne p ost baseli ne assess me nt of efficac y. 
T his will be t he pri mar y p o p ulati o n f or t he efficac y a n al ysis w hic h will be perf or me d as per t he 
pla n ne d ra n d o mize d treat me nt.  
T he Per -Pr ot oc ol ( P P) p o p ulati o n will be a s u bs et of t h e M I T T p o p ulati o n. S u bjects wit h a 
pr ot oc ol vi olati o n t hat is dee me d t o affect efficac y assess me nts i n all st u d y peri o ds will be 
e x cl u de d fr o m t he P P p o p ulati o n. S u bjects wit h a pr ot oc ol vi olati o n t hat  is dee me d t o affect 
effic ac y assess me nts i n s o me ( b ut n ot all) st u d y p eri o ds will be part of t he P P p o p ulati o n, b ut 
t heir data will be e x cl u de d fr o m t he peri o d(s) affecte d b y t h e pr ot oc ol vi olati o n f or a P P 
a nal ysis. A n a n al ysis o n t he P P p o p ulati o n will be perf or m e d f or t he pri mar y effi cac y varia bl e 
if t he n u m ber of s u bjects e val ua ble i n a n y of t he treat me nt gr o u ps f or t he M I T T a n d P P 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 0  of 5 9  
p o p ulati o ns differs b y 1 0 % or m ore. T h e decisi o n o n w het her a P P a nal ysis will be perf or me d 
will be ma de pri or t o st u d y u n bli n di n g.  
1 2. 3  
St ati sti c al A n al y s e s  
A d diti o nal details of t he pr o p ose d statistical a nal ysis will be d o c u me nte d i n t he statistical 
a nal ysis pl a n ( S A P), w hic h will be writte n f oll o wi n g fi n alizati o n of t he pr ot oc ol a n d pri or t o 
data base l o c k, a gree me nt of st u d y p o p ulati o ns a n d st u d y a n al ysis. T his secti o n is a s u m mar y of 
t he pla n ne d statistical a nal yses of t he m ost i m p orta nt e n d p oi nts i ncl u di n g pri mar y a n d k e y 
sec o n dar y e n d p oi nts. 
1 2. 3. 1  
Pri m ar y A n al y si s  
T he pri mar y efficac y e n d p oi nt is A O B o ver 1 2 h o urs f or t he i ncis al b ite f orce (l bs) ( de n ote d b y 
A O B 0 -1 2) f or eac h e x peri me ntal a d hesi ve.  T he pri mar y o bjecti ve s are t o c o m pare i ncisal bite 
f orce of t he t w o test a d hesi ves vers us n o a d hesi ve o ver 1 2 h o urs, A O B0 -1 2.  T he st u d y vali dit y 
will first be e val uate d b y c o m p ari n g S u p er P oli gri p Free vs n o a d h esi ve f or A O B 0 -1 2. 
De m o nstrati n g st u d y vali dit y ( p < 0. 0 5 f or S u per P oli gri p Free vs n o a d hesi ve) is a prere q uisite 
t o perf or mi n g all ot her treat me nt c o m paris o ns. N o f urt her si g nifica nce testi n g will be p erf or me d 
if t he i nitial validati o n ste p is n ot ac hie ve d.  T heref ore, st u d y s uccess is defi ne d as ac hie vi n g 
b ot h (a) st u d y v ali dit y ( S u per P oli gri p Free s u peri or t o n o a d hesi ve) a n d ( b) s u peri orit y of t he 
e x peri me ntal de nt ure a d h esi ve 1 c o m pare d t o n o a d hesi ve , or e x peri me ntal de nt ure  a d h esi ve 2 
c o m pare d t o n o a d h esi ve.  
T o calc ul ate A O B 0 -1 2, first t he A U C is calc ul ate d fr o m 0 t o 1 2 h o urs usi n g t h e tra p ez oi d met h o d; 
we de n ote t his b y A U C 0 -1 2. A O B0 -1 2 is defi ne d as ( A U C0 -1 2)/ 1 2 mi n us baseli ne B F (l bs). T his 
tra nsf or mati o n will ret ur n t he meas ure me nt t o t he sa me scale as t he ori gi n al o bser vati o ns w hilst 
als o l o o ki n g at t he a vera ge a m o u nt of i m pr o ve d f orce o v er ti me b y s u btracti n g t h e baseli n e 
val ue. Hi g h er val ues of A O B de m o nstrat e a str o n ger B F o ver ti me t ha n l o wer val ues. Missi n g 
rea di n gs will be i g n ore d a n d i nter p olati o n will be ma de bet wee n pre a n d p ost t he missi n g val ues, 
if necessar y. I n t he case of m ore t ha n o ne missi n g val ue or if t h e 1 2-h o ur v al ue is missi n g, t he 
A O B will be set t o missi n g.  
A n A N C O V A m o del will be use d t o a nal y z e A O B 0 -1 2, wit h treat me nt a n d peri o d as fi x e d effects 
f or eac h e x peri me ntal a d hesi ve; t he c o vari ates i n t his m o del are t he s u bject le vel baseli ne a n d 
peri o d le vel b aseli ne mi n us s u bject le vel bas eli ne. S u bject will be i ncl u de d as a ra n d o m effect. 
Pair wise tr eat me nt c o m paris o ns will be o btai ne d as a differe n ce i n a dj uste d mea ns a n d 
prese nte d wit h 9 5 % c o nfi de nce i nter vals ( CI) a n d ass ociate d p -val u es. Vi olati o ns of n or malit y 
a n d h o m o ge neit y of v ari a nce ass u m pti o ns ma y  b e e val uat e d a n d if f o u n d will be o verc o me 
usi n g tra nsf or m ati o ns or perf or mi n g a n o n -p ara m etric a nal ysis. T he pri mar y o bjecti ve s are t o 
c o m pare i n cisal bite f orce of t he test a d hesi ve 1 a n d als o test a d h esi ve 2 vers us n o a d h esi ve 
o ver 1 2 h o urs, A O B 0 -1 2. T he st u d y vali dit y will first be e val uate d b y c o m p ari n g S u per P oli gri p 
Free vs n o a d hesi v e f or A O B 0 -1 2. 
1 2. 3. 2  
S e c o n d ar y A n al y s e s  
A O B 0 -0. 5, A O B0 -1, A O B0 -3, A O B0 -6, A O B0 -9 A O B f or 0. 5, 1, 3, 6 a n d 9 h o urs will be defi ne d 
a n d a nal yz e d i n a si milar ma n ner as A O B 0 -1 2  f or eac h e x peri me ntal a d hesi ve. Fr o m eac h 
A N C O V A m o del, treat m e nt differe nces will be pr o vi de d al o n g wit h 9 5 % CIs a n d p -val ues.   I n 
t he e ve nt t hat t he m o del ass u m pti o ns are vi olate d, a tra nsf or mati o n or n o n-para metri c a nal ysis 
will be perf or me d. N o a dj ust me nts f or m ulti plicit y will be carri e d o ut.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 1  of 5 9  
1 2. 3. 3  
S af et y A n al y si s  
Safet y will be assesse d base d o n a n y oral A Es (t his i ncl u des t h ose t h at are i de ntifie d as 
Treat me nt E mer ge nt O S T a b n or malities a n d s p o nta ne o usl y re p orte d oral A Es).  A Es will be 
cate g orize d as oral a n d n o n -oral b y t he e x a mi ner pri or t o dat a base l oc k. A Es will be dee me d t o 
be treat me nt e m er ge nt if t he y o cc ur after t h e first s u per vise d use of t he ra n d o mize d treat me nt. 
N o f or mal statistical a n al ys es of A Es will be p erf or me d. A list of i nci de nts will als o be i ncl u de d 
as part of t he safet y a n al yses.   N o s pecific ris ks or a ntici pate d a d verse de vice effects are 
e x pecte d t o be o bser ve d wit hi n t his st u d y, h o we v er all A Es a n d me dical de vice i nci de nts will 
be assesse d t o e v al uate t h e t olera bilit y a n d safet y of t he treat me nts . 
1 2. 3. 4  
E x cl u si o n of D at a fr o m A n al y si s 
T he f oll o wi n g will be c o nsi dere d vi olati o ns t hat ma y lea d t o t he e x cl usi o n of data fr o m t he P P 
p o p ulati o n a n d he nce P P a nal ys es:  
•
Vi olati o n of i ncl usi o n or e x cl usi o n criteria at scree ni n g t hat ma y affect efficac y
•
Vi olati o n of pre -tr eat me nt baseli ne bite f orce c o nti n ua nce criteria
•
Treat me nt a d mi nistrati o n err ors
•
Use of pr o hi bite d treat me nt or me dicati o n bef ore or d uri n g t he st u d y, w hic h it is felt
will affect t he assess me nt of efficac y.
Ot her reas o ns f or pr ot oc ol vi olati o ns will be pr o vi de d i n t he S tatistical A nal ysis Pla n ( S A P) as 
necessar y. Vi olati o ns will be a gree d b et wee n t he Bi ostatisticia n a n d Cli nical Researc h 
Direct or/ Scie ntist or desi g nee, a hea d of brea ki n g t he st u d y bli n d. F urt her d etails of 
met h o d ol o g y f or i d e ntif yi n g data t o b e i ncl u de d i n P P a nal ysis will be pr o vi de d i n t he S A P.  
E x cl usi o n of a n y data fr o m t he a nal yses will be deter mi ne d d uri n g a Bli n d Data Re vie w ( B D R) 
Meeti n g pri or t o data bas e l oc k. A n y reas o ns f or e x cl usi o n fr o m a n a nal ysis p o p ulati o n will be 
liste d, if a p plica ble.  
1 2. 3. 5  
D e m o gr a p hi c a n d B a s eli n e C h ar a ct eri sti c s  
Descri pti ve statistics ( n u m ber of s u bjects, mea n, sta n dar d de viati o n ( S D), me dia n, mi ni m u m 
a n d ma xi m u m f or c o nti n u o us varia bles, a n d fre q u e nc y a n d perce nta ge f or cate g orical v aria bles) 
will be pr o vi de d f or de m o gra p hic a n d b aseli ne dat a.  
1 2. 3. 6  
St u d y Pr o d u ct C o m pli a n c e  
C o m plia nce wit h t he pla n ne d treat me nt re gi me will be ta b ulate d a n d s u m marize d f or t h e safet y 
a n d MI T T p o p ulati o ns.  
1 2. 3. 6. 1  Pri or a n d C o n c o mit a nt M e di c ati o n s  
Pri or me dicati o ns a n d c o nc o mita nt me dicati o ns ( me dicati o ns ta ke n bet w ee n scree ni n g a n d Visit 
5) will be liste d as a p pr o priate, s u m mar y ta bles m a y b e pr o d uce d if dee me d necessar y.
1 2. 3. 7  
H a n dli n g of Dr o p o ut s a n d Mi s si n g D at a 
N o i m p utati o ns will be m a de f or missi n g dat a.  A d diti o nal detail o n d ata h a n dli n g r ul es f or eac h 
ti me p oi nt a n d e n d p oi nt will be s pecifie d i n t he S A P.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
Cli nical Pr ot oc ol  
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 2  of 5 9  
1 2. 3. 8  
I nt eri m A n al y si s  
N o i nteri m a nal yses are pla n ne d f or t his st u d y.  
1 3  
S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S  
1 3. 1  
Q u alit y C o ntr ol 
I n acc or da n ce wit h a p pli ca ble re g ulati o ns i ncl u di n g G C P, a n d G S K C H pr oce d ures, G S K C H 
o r desi g nee (i. e. t hir d-p art y v e n d or) m o nit ors will c o ntact t he site pri or t o t he start of t h e st u d y 
t o re vie w wit h t he site staff t he pr ot oc ol, st u d y re q uire me nts, a n d t heir res p o nsi bilities t o satisf y 
re g ulat or y, et hical, a n d G S K C H re q uire me nts. 
W he n re v ie wi n g data c ollecti o n pr oce d ures, t he disc ussi o n 
will i ncl u de i de ntificati o n, 
a gree m e nt a n d d oc u me ntati o n of data ite ms f or w hic h t he C R F will ser ve as t h e s o urce 
d oc u me nt.  
G S K C H or desi g n ee will m o nit or t he st u d y a n d site acti vit y t o verif y t hat t he:  
•
Da ta are a ut he ntic, acc urate, a n d c o m plete.
•
Safet y a n d ri g hts of s u bjects are b ei n g pr otecte d.
•
St u d y is c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her
st u d y a gree me nts, G C P, a n d all a p plica ble re g ulat or y re q uire m e nts.
T he e xte nt a n d n at ure of m o nit ori n g will b e des cri be d i n a writte n m o nit ori n g pl a n o n file at 
G S K C H. T he i n vesti gat or ( or desi g n ee) a grees t o all o w t he m o nit or direct access t o all rel e va nt 
d oc u me nts a n d a grees t o c o -o perate wit h t he m o nit or t o e ns ure t hat a n y pr o ble ms detecte d i n 
t he c o urse of t h ese m o nit ori n g visits are res ol ve d. 
1 3. 2  
Q u alit y A s s ur a n c e  
T o e ns ure c o m plia nce wit h G C P a n d all a p plica ble re g ulat or y re q uire me nts, G S K C H ma y 
c o n d uct a q ualit y ass ur a nce assess me nt a n d/ or a u dit of t he site rec or ds, a n d t he re g ul at or y 
a ge ncies ma y c o n d u ct a re g ulat or y i ns pe cti o n at a n y ti me d uri n g or aft er c o m pleti o n of t he 
st u d y.  
I n t he e v e nt of a n assess me nt, a u dit or i ns pecti o n, t he i n vesti gat or (a n d i nstit uti o n) m ust a gree 
t o gra nt t he a d vis or(s), a u dit or(s) a n d i ns pect or(s) direct access t o all rele va nt d oc u me nts a n d 
t o all ocate t heir ti me a n d t he ti me of t heir staff t o disc uss t he c o n d uct of t he st u d y, a n y 
fi n di n gs/rele v a nt iss ues a n d t o i m ple me nt a n y c orrecti ve a n d/ or pre ve ntati v e acti o ns t o a d dress 
a n y fi n di n gs/iss ues i de n tifie d. 
T he i n vesti gat or(s) will n otif y G S K C H or its a ge nts i m me diatel y of a n y re g ulat or y i ns pe cti o n 
n otificati o n i n relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate wit h G S K C H 
or its a ge nts t o pre pare t he st u d y site f or t h e i ns p ecti o n  a n d will all o w G S K C H or its a ge nt, 
w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pe cti o n. T he i n vesti gat or will pr o m ptl y a p pl y 
c o pies of t he i ns pe cti o n fi n di n g t o G S K C H or its a ge nt. Bef ore res p o ns e s u b missi o n t o t he 
re g ulat or y a ut h orit y, t he i n vesti gat or will pr o vi de G S K C H or its a ge nts wit h a n o p p ort u nit y t o 
re vie w a n d c o m me nt o n r es p o nses t o a n y s uc h fi n di n gs.  
T he s p o ns or will be a vail a ble t o hel p i n vesti gat ors pre pare f or a n i ns pecti o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 3  of 5 9  
1 3. 3  
R e g ul at or y a n d Et hi c al C o n si d er ati o n s  
1 3. 3. 1  
I n stit uti o n al R e vi e w B oar d  
It is t he res p o nsi bilit y of t he i n vesti gat or t o ha v e pr os pecti ve a p pr o val of t he st u d y pr ot o c ol, 
pr ot oc ol a me n d me nts, i nf or me d c o nse nt d oc u m e nts, i n vesti gat or br oc h ure/safet y state me nt 
(i ncl u di n g a n y u p d ates) a n d ot her rele va nt d o c u me nts, e. g. recr uitme nt a d vertise me nts, if 
a p plica ble, fr o m t he I R B.  All c orres p o n de nce wit h t he I R B s h o ul d be retai ne d i n t he 
i n vesti gat or file.  C o pies of I R B a p pr o vals s h o ul d be f or war de d t o G S K C H pri or t o t he 
i nitiati o n of t he st u d y, a n d als o w he n s u bse q ue nt a me n d me nts t o t he pr ot oc ol are ma de. 
T he o nl y circ u msta n ce i n w hic h a n a me n d me nt ma y b e i nitiate d pri or t o I R B a p pr o val is w here 
t he c ha n ge is n ecess ar y t o eli mi nate a p p are nt i m me diate hazar ds t o t he s u bjects.  I n t hat e v e nt, 
t he i n vesti gat or 
m ust n otif y t h e I R B a n d G S K C H i n 
writi n g i m me diatel y after t he 
i m ple me ntati o n. 
1 3. 3. 2  
Et hi c al C o n d u ct of t h e St u d y  
T he st u d y will be c o n d ucte d i n acc or da n ce wit h t he pr ot oc ol a n d le gal a n d re g ulat or y 
re q uire me nts, as w ell as t he ge n eral pri nci ples set f ort h i n t he I nter n ati o nal Et hical G ui deli nes 
f or Bi o me di cal Researc h I n v ol vi n g H u m a n S u bjects (C o u ncil f or I nt er nati o nal Or ga nizati o ns 
of 
Me dical Sci e nces, 2 0 0 2 ), I nter n ati o nal Et hical G ui deli nes f or Healt h-Relate d Researc h 
I n v ol vi n g H u m a ns (C o u ncil f or I nter nati o nal Or ga nizati o ns of 
Me dical Scie nces, 2 0 1 7 ), 
g ui deli nes f or G C P  (I C H, N o v 2 0 1 6), a n d t he Decl arati o n of Helsi n ki (W orl d 
Me dical 
Ass ociat i o n, 2 0 1 3). 
I n a d diti o n, t he st u d y will be c o n d u cte d i n acc or da nce wit h t he pr ot oc ol, t he I C H g ui deli ne o n 
G C P, a p plica ble p orti o ns of E U M D R 2 0 1 7/ 7 4 5, I S O 1 4 1 5 5: 2 0 1 1 a n d I S O 1 4 1 5 5: 2 0 2 0  a n d 
a p plica ble l ocal re g ulat or y re q uire me nts a n d l a ws.  
1 3. 3. 3  
S u bj e ct I nf o r m ati o n a n d C o n s e nt 
All parties will e ns ure pr otecti o n of s u bj ect p ers o nal data a n d will n ot i ncl u de s u bject na mes or 
ot her i de ntifia ble data i n a n y re p orts, p u blicati o ns, or ot her discl os ures, e x ce pt w here re q uire d 
b y la ws.  
W he n st u d y data are c o m pile d f or tr a nsfer t o G S K C H a n d ot her a ut h orize d parties, s u bject 
na mes, a d dresses, a n d ot her i de ntifia ble d ata will be re pl ace d b y n u merical c o des b ase d o n a 
n u m beri n g s yste m pr o vi d e d b y G S K C H i n or der t o de -i de ntif y st u d y s u bj ects.   
T he st u d y site will mai nt ai n a c o nfi de ntial list of s u bjects w h o partici pate d i n t he st u d y, li n ki n g 
eac h s u bject’s n u merical c o de t o his or her act u al i de ntit y.  I n cas e of data tra nsfer, G S K C H 
will mai ntai n hi g h sta n dar ds of c o nfi de ntialit y a n d pr otecti o n of s u bj ects’ pers o nal d at a 
c o nsiste nt wit h a p plica ble pri vac y la ws.  
T he i nf or m e d c o ns e nt d o c u me nts m ust be i n c o m plia nce wit h I C H G C P, a p plica ble p orti o ns of 
I S O 1 4 1 5 5, l ocal re g ulat or y re q uire me nts a n d le gal re q uire me nts, i ncl u di n g a p plica bl e pri vac y 
la ws. 
T he i nf or me d c o nse nt d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess m ust be re vie we d 
a n d a p pr o ve d b y t h e s p o ns or, a p pr o ve d b y t he I R B/ E C bef ore use, a n d a vail a ble f or i ns pe cti o n.  
T he i n vesti gat or m ust e ns ure t hat eac h st u d y s u bj ect,  is f ull y i nf or me d a b o ut t he nat ur e a n d 
o bjecti ves of t he st u d y a n d p ossi ble ris ks ass ociate d wit h partici pati o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 4  of 5 9  
1 3. 3. 4  
S u bj e ct R e cr uit m e nt  
A d vertise me nts a p pr o ve d b y I R Bs/ E Cs a n d i n v esti gat or data bas es ma y be use d as recr uit me nt 
pr oce d ures.   Use of et hics c o m mittee a p pr o ve d, ge neric, prescree ni n g q u esti o n naire t o assess 
basic s u bject c haracteristics t o deter mi ne ge neral eli gi bilit y f or t his st u d y is all o we d.   T his 
ge n eric q uesti o n naire ma y b e use d b y sites as a p h o ne scri pt a n d/ or t o re vie w i nter nal d ata bas es 
t o i de ntif y s u bjects.   
G S K C H will ha ve a n o p p ort u nit y t o re vie w a n d a p pr o ve t he c o nte nt of a n y st u d y recr uit me nt 
materials direct e d t o p ote ntial st u d y s u bj ects bef ore s uc h materi als are us e d.  
1 3. 3. 5  
R e p orti n g of S af et y I s s u e s a n d S eri o u s Br e a c h e s of t h e Pr ot o c ol or 
I C H G C P  
Wit hi n G S K C H a seri o us br eac h is defi ne d as a breac h li kel y t o affect t o a si g nifica nt de gree 
t he safet y a n d ri g hts of a s u bject or t he relia bilit y a n d r o b ust ness of t he dat a ge nerate d i n G S K 
C H -s p o ns ore d h u ma n s u bject researc h st u dies.  
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (i.e., cli nical h ol d) b y a n a p plica bl e 
c o m pete nt a ut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y n e w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be n efits a n d ris ks of t he i n vesti gati o nal 
pr o d uct, G S K C H s h o ul d be i nf or me d i m me diatel y.  
I n a d diti o n, t he i n vesti gat or will i nf or m G S K C H i m me diatel y of a n y ur ge nt safet y m eas ures 
ta ke n b y t h e i n vesti gat or t o pr otect t he st u d y s u bjects a gai nst a n y i m me diate hazar d, a n d of a n y 
seri o us breac hes of t his pr ot oc ol or of I C H G C P t hat t he i n vesti gat or bec o m es a ware of. 
1 3. 4  
P o sti n g of I nf or m ati o n o n P u bli cl y A v ail a bl e Cli ni c al Tri al 
R e gi st er s  
St u d y i nf or mati o n fr o m t his pr ot oc ol will be p oste d o n p u blicl y a v aila ble cli nical trial re gisters 
bef ore e nr oll me nt of s u bj ects be gi ns i n acc or da n ce wit h a p plica ble G S K C H pr ocess es. 
G S K i nte n ds t o ma ke a n o n y mize d s u bject -le vel data fr o m t his trial a vaila ble t o e xter nal 
researc hers f or s cie ntific a nal ys es or t o c o n d u ct f urt her researc h t hat ca n hel p a d va nce m e dical 
scie nce or i m pr o ve patie nt care. T his hel ps e ns ure t he d ata pr o vi d e d b y trial partici pa nts are 
use d t o ma xi m u m effect i n t he creati o n of k n o wle d ge a n d u n derst a n di n g  
1 3. 5  
Pr o vi si o n of St u d y R e s ult s t o I n v e sti g at or s  
W here re q uire d b y a p plica ble re g ulat or y re q uir e me nts, a n i n vesti gat or 
si g nat or y will be 
i de ntifie d f or t he a p pr o val of t he cli nical st u d y re p ort.  T he i n vesti gat or will be pr o vi de d 
reas o na bl e access t o statistical ta bles, fi g ures, a n d rele va nt re p orts a n d will ha ve t he o p p ort u nit y 
t o re vie w t he c o m plet e st u d y res ults at a G SK C H site or ot her m ut uall y -a greea ble l o cati o n.  
G S K C H will als o pr o vi de t he i n vesti gat or wit h t he f ull s u m mar y of t he st u d y res ults.  T he 
i n vesti gat or is e n c o ura ge d t o s hare t he s u m mar y res ults wit h t he st u d y s u bj ects, as a p pr o priate. 
T he pr oce d ures a n d ti mi n g f or p u blic discl os ure of t he res ults s u m mar y a n d f or de vel o p me nt of 
a ma n uscri pt f or p u blicati o n will be i n acc or da n ce wit h G S K C H P olic y.  
A ma n uscri pt will be pr o gresse d f or p u blicati o n i n t he scie ntific literat ur e if t he res ults pr o vi d e 
i m p orta nt scie ntific or me dical k n o wle d ge. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 5  of 5 9  
1 3. 6  
R e c or d s R et e nti o n  
F oll o wi n g cl os ure of t he st u d y, t he i n vesti gat or m ust mai ntai n all site st u d y rec or ds (e x ce pt f or 
t h ose re q uire d b y l oc al re g ulati o ns t o be mai ntai ne d else w here), i n a s afe a n d sec ure l o cati o n.   
T he rec or ds (st u d y/ site master file) m ust be mai ntai ne d t o all o w eas y a n d ti mel y retrie val, w he n 
nee de d (e. g. f or a G S K C H a u dit or re g ulat or y i ns pecti o n) a n d m ust be a vaila ble f or re vie w i n 
c o nj u ncti o n wit h assess me nt of t he facilit y, s u p p orti n g s yst e ms, a n d  rel e va nt site staff. 
W here per mitte d b y l ocal la ws/re g ulati o ns or i nstit uti o nal p olic y, s o me or all of t hese rec or ds 
ca n be mai ntai ne d i n a f or mat ot her t ha n har d c o p y (e. g. micr ofic he, s ca n ne d, el ectr o nic); 
h o we ver, ca uti o n nee ds t o be e x ercise d bef ore s u c h acti o n is ta ke n.  
T he i n vesti gat or m ust e ns ure t hat all re pr o d ucti o ns are le gi ble a n d are a tr u e a n d acc urate c o p y 
of t he ori gi nal a n d meet accessi bilit y a n d retrie v al sta n dar ds, i ncl u di n g re -ge nerati n g a h ar d 
c o p y, if re q uire d.  F urt her m ore, t he i n ves ti gat or m ust e ns ure t h ere is a n acce pta ble b ac k-u p of 
t hese re pr o d ucti o ns a n d t hat a n acce pta ble q ualit y c o ntr ol pr ocess e xists f or ma ki n g t hese 
re pr o d ucti o ns. 
T he i n vesti gat or m ust ass ure t hat t he s u bject’s a n o n y mit y will be mai ntai ne d.  O n C R Fs or ot her 
d oc u me nts s u b mitte d t o G S K C H, s u bjects s h o ul d n ot be i de ntifie d b y t heir na mes or i nitials, 
b ut b y a n i de ntificati o n c o de. T he i n vesti gat or s h o ul d kee p a se parate l o g of s u bjects’ c o des, 
na mes a n d a d dress es.  D o c u me nts n ot f or s u b missi o n t o G S K C H, e. g. s u bjects’ writte n c o ns e nt 
f or ms, s h o ul d be mai ntai ne d b y t h e i n vesti gat or i n strict c o nfi de nce. 
Rec or ds a n d d o c u me nts, i ncl u di n g si g ne d I C F, pertai ni n g t o t he c o n d uct of t his st u d y m ust be 
retai ne d b y t he i n vesti gat or as per t he si g ne d c o ntr act ual a gree me nt , fr o m t he iss ue of t he fi nal 
Cli nical St u d y Re p ort ( C S R) or e q ui vale nt s u m mar y,  u nless l ocal re g ulati o ns or i nstit uti o nal 
p olicies re q uir e a l o n ger rete nti o n peri o d. T he mi ni m u m rete nti o n ti me will meet t he strictest 
sta n dar d a p plica bl e t o t hat site f or the st u d y, as dictate d b y a n y i nstit uti o nal re q uire me nts or 
l ocal la ws or re g ulati o ns, G S K C H sta n dar ds/ pr oce d ures, a n d/ or i nstit uti o nal re q uire m e nts.   
N o st u d y d o c u me nt s h o ul d be destr o ye d wit h o ut a pri or writte n a gree m e nt bet wee n G S K C H 
a n d t he i n vesti ga t or. T h e i n vesti gat or m ust n otif y G S K C H of a n y c h a n ges i n t he arc hi val 
arra n ge me nts, i ncl u di n g, b ut n ot li mite d t o, arc hi val at a n off -site facilit y or tra nsfer of 
o w ners hi p of t he rec or ds i n t he e ve nt t he i n vesti gat or is n o l o n ger ass ociate d wit h t he sit e. 
1 3. 7  
C o n diti o n s f or T er mi n ati n g t h e St u d y  
Pre mat ure ter mi nati o n of t his st u d y ma y o cc ur beca use of a re g ulat or y a ut h orit y decisi o n, 
c ha n ge i n o pi ni o n of t he I R B/ E C, or st u d y pr o d uct safet y pr o ble ms, or at t he discreti o n of G S K 
C H.  I n a d diti o n, G S K C H retai ns t he ri g ht t o disc o nti n ue de vel o p me nt of t he e x peri me ntal 
de nt ure a d h esi ves  at a n y ti me.  
If a st u d y is pre mat urel y t er mi nate d, G S K C H will pr o m ptl y n otif y t h e i n vesti gat or.  After 
n otificati o n, t he i n vesti gat or m ust pr o m ptl y c o ntact all partici pati n g s u bjects a n d s h o ul d ass ur e 
a p pr o priate t hera p y/ f oll o w -u p f or t he s u bjects.  As directe d b y G S K C H, all st u d y materials 
m ust be c ollecte d a n d all C R F’s  c o m plete d t o t he greatest e xte nt p ossi ble. W here re q uir e d b y 
t he a p plica ble re g ulat or y re q uir e me nts, G S K CH s h o ul d i nf or m t he re g ul at or y a ut h orit y(ies) 
a n d t he i n vesti gat or s h o ul d pr o m ptl y i nf or m t he I R B/ E C a n d pr o vi de t h e I R B/ E C a detaile d 
writte n e x pla nati o n of t he ter mi nati o n or s us pe nsi o n.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 6  of 5 9  
If t h e I R B/ E C ter mi nates or s us pe n ds its a p pr o val/fa v ora ble o pi ni on of a trial, t he i n vesti gat or 
s h o ul d pr o m ptl y n otif y t he G S K C H a n d pr o vi de G S K C H wit h a detaile d writte n e x pla nati o n 
of t he ter mi nati o n or s us pe nsi o n.  
U p o n c o m pleti o n or pre mat ure disc o nti n uati o n of t he st u d y, t he G S K C H m o nit or will c o n d uct 
site cl os ure acti vities wit h t he i n vesti gat or or site staff, as a p pr o priate, i n acc or da nce wit h 
a p plica ble re g ulati o ns i ncl u di n g G C P, a n d G S K C H Sta n dar d O perati n g Pr oce d ures.  
1 4  
R E F E R E N C E S  
[ 2 0 0 9-0 9 G C S P B ( 2 0 0 9)] E val uati o n of t he Bite F orce of a n E x pe ri me ntal De nt ure A d hesi v e 
Crea m.  
[ A x e A, J ai n R, Var g hese R, et al. ( 2 0 1 8)] Ra n d o mize d Cli nical St u d y C o m pari n g T hree 
E x peri me ntal De nt ure A d hesi ves a n d Fi x o de nt( R) vers us N o A d hesi ve. J Cli n De nt; 
2 9( 4): 6 9 -7 4.  
[ C he w C, B o o ne M, S wartz M, et al. ( 1 9 8 5)] De nt ure a d hesi ves: t heir effects o n de nt ur e 
rete nti o n a n d sta bilit y. J o ur nal of de ntistr y; 1 3( 2): 1 5 2-9.  
[ C he w C, P hilli ps R, B o o ne 
M, et al. ( 1 9 8 4)] De nt ure sta bilizati o n wit h a d hesi ves: a 
ki nesi o gra p hic st u d y. T h e C o m pe n di u m of c o nti n ui n g e d u cati o n i n de n tistr y: S 3 2. 
[ C o u ncil f or I nter nati o n al Or ga nizati o ns of Me dical Scie nces ( 2 0 0 2)] I nter nati o nal et hical 
g ui deli nes f or bi o me di cal researc h i n v ol vi n g h u ma n s u bjects. B ulleti n of me dical et hics; 
( 1 8 2): 1 7-2 3.  
[ C o u ncil f or I nter nati o n al Or ga nizati o ns of Me dical Scie nces ( 2 0 1 7)] I nter nati o nal et hical 
g ui deli nes f or h ealt h -relate d researc h i n v ol vi n g h u ma ns. I nter nati o nal et hical g ui deli nes 
f or healt h-relate d researc h i n v ol vi n g h u ma ns. 
[ F D A ( 2 0 0 5)] G ui da nce f or I n d ustr y Gi n gi vitis: De vel o p me nt a n d E v al uati o n of Dr u gs f or 
Treat me nt or Pre ve nti o n.  
[ Grass o J E ( 2 0 0 4)] De nt ure a d hesi v es. De ntal Cli nics of N ort h A meri ca; 4 8( 3): 7 2 1-3 3.  
 
 
 
 
 
  
 
 
 
 
 
 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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C CI

G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 7  of 5 9  
[ H o well A, Ma nl y R ( 1 9 4 8)] A n electr o nic str ai n ga u ge f or meas uri n g oral f orces. J. De nt. Res; 
2 7( 6): 7 0 5 -1 2.  
[I C H ( N o v 2 0 1 6)] T o pic E 6 ( R 2) G ui deli ne f or G o o d Cli nical Practice. 
[J ose A, Var g h ese R, R o o h p o ur N, et al. ( 2 0 1 8)] A Ra n d o mize d Pr o of-of -Pr i nci ple Bite F orce 
St u d y of T w o E x peri me ntal De nt ure A d hesi ves a n d a C o m merci all y A vaila bl e 
A d hesi ve. T he I nter nati o nal j o ur nal of pr ost h o d o ntics; 3 1( 4): 3 5 1 -8.  
[ Ka p ur K K ( 1 9 6 7)] A cli nical e val uati o n of d e nt ure a d hesi v es. J Pr ost het De nt; 1 8( 6): 5 5 0-8.  
[ Mu n oz C A, Ge n drea u L, S ha n ga G, et al. ( 2 0 1 2)] A Cli nical St u d y t o E val uate De nt ur e 
A d hesi ve Use i n W ell ‐ Fitti n g De nt ur es. J. Pr ost h o d o nt.; 2 1( 2): 1 2 3 -9.  
[ Ols ha n A, R oss N, Ma n k o di S, et al. ( 1 9 9 2)] A m o difie d Ka p ur s cale f or e val uati n g de nt ur e 
rete nti o n a nd sta bilit y: m et h o d ol o g y st u d y. A m. J. De nt.; 5( 2): 8 8 -9 0.  
[ R H 0 2 4 4 3 G C S ( 2 0 1 4)] A n E x pl orat or y Bite F orce St u d y Usi n g a C o m merciall y A vaila bl e 
De nt uire A d h esi ve a n d a Test A d hesi ve.  
[ Sal dan ha S, S he n o y V K, Eac ha m pati P, et al. ( 2 0 1 2)] De ntal i m plicati o ns o f bis p h o p h o nate‐
relate d oste o n ecr osis. Ger o d o nt ol o g y; 2 9( 3): 1 7 7-8 7.  
[ S ha y K ( 1 9 9 7)] T he rete nti o n of c o m plete de nt ures. B o uc h er's pr ost h o d o ntic treat me nt f or 
e de nt ul o us patie nts: 4 0 0 -1 1.  
[ Tar bet 
WJ, B o o ne M, Sc h mi dt N F ( 1 9 8 0)] Effect Of A De nt ure A d hesi ve O n C o m plete 
De nt ure Disl o d ge me nt D uri n g Masticati o n. J. Pr ost het. De nt.; 4 4( 4): 3 7 4 -8.  
[ Var g h ese R, B ur nett G R, S o u verai n A, et al. ( 2 0 1 9)] A ra n d o mise d bite f orce st u d y assessi n g 
t w o curre ntl y m ar kete d d e nt ure a d hesi ve pr o d ucts c o m pare d wit h n o ‐ a d hesi ve c o ntr ol. 
Cli nical a n d E x peri me ntal De ntal Researc h.  
[ W orl d 
Me dical 
Ass ociati o n ( 2 0 1 3)] 
Declarati o n of Helsi n ki, 6 4t h Ge neral 
Asse m bl y, 
F ortaleza.  
[ Zar b G A, H o b kir k J, Ec kert S, et al. 2 0 1 3] Pr ost h o d o ntic Treat me nt f or E de nt ul o us Patie nts-
E -B o o k: C o m plete 
D e nt ures a n d I m pla nt -S u p p orte d Pr ost heses. Else vier 
Healt h 
Scie nces.  
 
1 5  
A P P E N DI CI E S  
1 5. 1  
A B B R E VI A TI O N S  
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y b e use d i n t he pr ot oc ol.  
T a bl e 1 5 -1  
A b br e vi ati o n s  
 
A b br e vi ati o n  
T er m  
A E  
a d v er s e e v e nt  
A N O V A  
a n al y si s of v ari a n c e  
A O B  
ar e a o v er b a s eli n e  
B D R  
bli n d e d d at a r e vi e w  
B F  
Bit e f or c e  
CI  
c o nfi d e n c e i nt er v al  
C M C  
C ar b o x y m et h yl c ell ul o s e  
C R F  
c a s e r e p ort f or m  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 8  of 5 9  
A b br e vi ati o n  
T er m  
E u dr a C T  
E ur o p e a n Cli ni c al Tri al s D at a b a s e  
F D A  
F o o d a n d Dr u g A d mi ni str ati o n ( U nit e d St at e s)  
G C P  
G o o d Cli ni c al Pr a cti c e  
G S K C H  
Gl a x o S mit h Kli n e C o n s u m er H e alt h c ar e  
I C F 
I nf or m e d c o n s e nt f or m 
I C H 
I nt er n ati o n al C o nf er e n c e o n H ar m o ni s ati o n 
I N D 
i n v e sti g ati o n al n e w dr u g  
I R B 
i n stit uti o n al r e vi e w b o ar d 
I S O 
I nt er n ati o n al or g a ni z ati o n f or st a n d ar di s ati o n 
 
 
N/ A  
n ot a p pli c a bl e  
N S R  
N o n -si g nifi c a nt ri s k  
O H T  
Or al h ar d ti s s u e  
O S T  
Or al s oft ti s s u e  
PI  
pri n ci p al i n v e sti g at or  
S A E  
s eri o u s a d v er s e e v e nt  
S O P  
st a n d ar d o p er ati n g pr o c e d ur e  
S P F  
S u p er P oli gri p Fr e e  
T M J  
T e m p or o m a n di b ul ar j oi nt  
U S A  
U nit e d St at e s  of A m eri c a  
 
1 5. 2  
A p pli c ati o n I n str u cti o n s  
1 5. 2. 1  
M a xill ar y D e nt ur e A d h e si v e A p pli c ati o n I n str u cti o n s f or E x p eri m e nt al 
A d h e si v e s  
 
1.  Clea n a n d dr y de nt ur es.  
2.  A p pl y pr o d uct directl y fr o m pri mar y p ac k a gi n g i n l o n g, c o nti n u o us stri ps as s h o w n i n  
t he dia gra m, n ot t o o cl os e t o t he de nt ure e d ge.  A t otal of 1. 0 0 ± 0. 0 5 g ( wei g he d) of 
de nt ure a d h esi ve will be a p plie d t o t he u p per de nt ure.  
3.  Ha ve t he s u bject ri nse t h eir m o ut h wit h p ota ble water a n d e x pect orate bef ore i nserti n g 
t he de nt ure.  
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
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G S K C o ns u mer Healt hcare  
 
Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 8 0 4 2  
 
Pr o pert y of G S K C o ns u mer Healt hcare  - C o nfi de ntial   
Ma y n ot b e use d, di v ul ge d, p u blis he d or ot her wise discl ose d wit h o ut t he c o nse nt of G S K C H  
 Cli nical Pr ot oc ol Te m plate v 7. 0 
Pa ge 5 9  of 5 9  
4.  Ha ve s u bject press de nt ures i nt o place, h ol d fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d. 
 
1 5. 2. 2  
M a xill ar y D e nt ur e A d h e si v e A p pli c ati o n I n str u cti o n s f or C o ntr ol 
A d h e si v e  
 
 
1.  Clea n a n d dr y de nt ur es.  
2.  A p pl y pr o d u ct directl y fr o m pri mar y p ac k a gi n g i n s h ort stri ps as s h o w n i n t he dia gra ms, 
n ot t o o cl ose t o t he de nt ure e d ges ( 3 stri ps s h o ul d be a p plie d t o t he u p per de nt ure ). A t otal 
of 1. 0 0 ± 0. 0 5 g ( wei g he d) of de nt ure a d hesi ve will be a p plie d t o the u p per de nt ure.  
3.  Ha ve t he s u bject ri nse t h eir m o ut h wit h p ota ble water bef ore i nserti n g d e nt ure.  
4.  Ha ve s u bjects press de nt ures i nt o place, h ol d fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d. 
 
1 5. 2. 3  
M a n di b ul ar D e nt ur e A d h e si v e A p pli c ati o n I n str u cti o n s –  t o st a bili z e 
t h e m a n di b ul ar d e nt ur e o nl y (if r e q uir e d) 
 
1.  Clea n a n d dr y de nt ur e . 
2.  A p pl y pr o d uct i n s h ort stri ps as s h o w n i n t he dia gra ms, n ot t o o cl ose t o t he de nt ure 
e d ges ( 2 stri ps o n t he l o wer de nt ure i n t he p osteri or re gi o ns, a t hir d stri p ma y be a p pli e d 
i n t he a nteri or re gi o n as nee de d). 
3.  Ha ve s u bjects ri nse t heir m o ut h wit h water bef ore i nserti n g de nt ur es.  
4.  Ha ve s u bjects press de nt ures i nt o place, h ol d fir ml y, a n d bite d o w n f or a fe w sec o n ds t o 
sec ure h ol d. 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
C CI

Si g nat ure Pa ge f or  2 1 8 0 4 2 T M F- 2 1 6 1 0 1 v 2. 0
Si g nat ure Pa ge f or T M F- 2 1 6 1 0 1 v 2. 0
Reas o n f or si g ni n g: A p pr o ve d
Na me: 
R ole: A
nat ure: 
Pr ot oc ol  1 4 Mar 2 0 2 2 | T M F- 2 1 6 1 0 1 | 2. 0
P P D
P P D
P P D