A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management
Phase: NA
Conditions: Dentin Sensitivity
Sponsor: HALEON

GSK Consumer Healthcare 
Clinical Protocol 
Protocol Number: 216953 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 1 of 57 
CLINICAL PROTOCOL 
A REAL-WORLD EVIDENCE STUDY EVALUATING ORAL HEALTH 
RELATED QUALITY OF LIFE FOLLOWING THE USE OF ANTI-
SENSITIVITY TOOTHPASTE FOR DENTINE HYPERSENSITIVITY 
MANAGEMENT 
Protocol Number: 
216953 
Compound/Product Name: 
Potassium nitrate (5% w/w), sodium 
fluoride (0.15% w/v fluoride ion) dentifrice / 
Sensodyne Fresh Mint 
United States (US) Investigational 
New Drug (IND) Number: 
N/A 
European Clinical Trials Database 
(EudraCT) Number: 
N/A 
Other Regulatory Agency Identified 
Number: 
N/A 
Phase: 
N/A 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0
This document contains confidentiality statements that are not relevant for this publicly 
available version

GSK Consumer Healthcare 
Clinical Protocol 
Protocol Number: 216953 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 2 of 57 
Sponsor Information 
Sponsor Name & Legal 
Registered Address 
GlaxoSmithKline Consumer Healthcare 
(UK) Trading Limited 
980 Great West Road, 
Brentford, 
Middlesex, 
TW8 9GS, 
United Kingdom (UK) 
Sponsor Contact Details 
GlaxoSmithKline Consumer Healthcare 
(GSK CH) 
Holdings (US) LLC 
184 Liberty Corner Rd, 
Warren, New Jersey (NJ) 07059, 
United States (US) 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
Clinical Protocol 
Protocol Number: 216953 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 3 of 57 
Document History 
Document 
Version Summary of Changes 
Original protocol 
1.0 
Not applicable (N/A) 
Amendment 1 
2.0 
The following administrative changes have been made: 
1) clarifications in the administrative change letter dated 15 June
2021 have been added
2) typo correction on the DHEQ score section 2:
“Effect of life” was changed to “Effect on life” throughout the
protocol
Amendments incorporate all revisions to date, including amendments made at the request of 
country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc.   
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4  of 5 7  
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 me 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 nati o n al 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.  
•  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 uct. I a gree t o pers o nall y c on d uct 
or s u per vise t he d escri be d st u d y.  
•  I a gree t o e ns ur e t hat all ass ociates, 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 me 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 nf or ma nce wit h t he la ws a n d re g ulati o ns of t he c o u ntr y 
i n w hic h t he researc h is c o n d ucte 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  
 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
P P D
P P D
P P D

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 5 of 57 
Table of Contents 
Sponsor Information ............................................................................................................ 2 
Document History ............................................................................................................... 3 
Investigator Protocol Agreement Page ................................................................................ 4 
Table of Contents ................................................................................................................ 5 
1 
PROTOCOL SUMMARY .................................................................................................. 9 
1.1 
Synopsis ................................................................................................................... 9 
1.2 
Schedule of Activities ............................................................................................ 12 
2 
INTRODUCTION ............................................................................................................. 14 
2.1 
Study Rationale ...................................................................................................... 14 
2.2 
Background ............................................................................................................ 14 
2.3 
Mechanism of Action/Indication ........................................................................... 15 
3 
STUDY OBJECTIVES AND ENDPOINTS .................................................................... 16 
4 
STUDY DESIGN .............................................................................................................. 18 
4.1 
Overall Design ....................................................................................................... 18 
4.2 
Scientific Rationale for Study Design ................................................................... 18 
4.3 
Justification for Dose ............................................................................................. 20 
4.4 
Duration of Study Definition ................................................................................. 20 
5 
STUDY POPULATION .................................................................................................... 20 
5.1 
Type and Planned Number of Subjects ................................................................. 20 
5.2 
Inclusion Criteria ................................................................................................... 20 
5.3 
Exclusion Criteria .................................................................................................. 20 
5.4 
Randomization Criteria .......................................................................................... 21 
5.5 
Lifestyle Considerations ........................................................................................ 21 
5.6 
Screen Failures....................................................................................................... 21 
5.7 
Sponsor’s Qualified Medical Personnel ................................................................ 21 
5.8 
Rater/Clinical Assessor Qualifications .................................................................. 21 
6 
STUDY PRODUCT .......................................................................................................... 22 
6.1 
Study Product Supplies .......................................................................................... 22 
6.1.1 
Dosage Form and Packaging ................................................................. 22 
6.1.2 
Preparation and Dispensing................................................................... 23 
6.2 
Administration ....................................................................................................... 23 
6.2.1 
Medication/Dosing Errors ..................................................................... 23 
6.2.2 
Overdose ............................................................................................... 23 
6.3 
Study Product Storage ........................................................................................... 23 
6.4 
Study Product Accountability ................................................................................ 23 
6.4.1 
Destruction of Study Product Supplies ................................................. 23 
6.5 
Blinding and Allocation/Randomization ............................................................... 24 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 6 of 57 
6.6 
Breaking the Blind ................................................................................................. 24 
6.7 
Compliance ............................................................................................................ 24 
7 
Discontinuation of study intervention and participant discontinuation/withdrawal .......... 24 
7.1 
Participant Discontinuation/Withdrawal ............................................................... 24 
7.2 
Lost to Follow up ................................................................................................... 24 
8 
STUDY PROCEDURES ................................................................................................... 25 
8.1 
Screening ............................................................................................................... 25 
8.1.1 
Informed Consent .................................................................................. 25 
8.1.2 
Demographics ....................................................................................... 26 
8.1.3 
Medical History and Medications ......................................................... 26 
8.2 
Baseline Week 0 .................................................................................................... 26 
8.3 
Week 4, 8, 12, 16 and 20 ....................................................................................... 26 
8.4 
Week 24 ................................................................................................................. 26 
8.5 
Study Conclusion ................................................................................................... 27 
8.6 
Follow-up phone call ............................................................................................. 27 
9 
STUDY ASSESSMENTS ................................................................................................. 27 
9.1 
Screening Assessments .......................................................................................... 27 
9.2 
Quality of life Assessment ..................................................................................... 27 
9.2.1 
Dentine Hypersensitivity Experience Questionnaire (DHEQ) ............. 27 
9.3 
Safety and Other Assessments ............................................................................... 28 
9.3.1 
DH Pain Assessment ............................................................................. 28 
9.3.2 
Patient satisfaction with treatment ........................................................ 28 
10 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS AND PREGNANCY 
EXPOSURE ...................................................................................................................... 29 
10.1 
Definition of an Adverse Event (AE) .................................................................... 29 
10.2 
Definition of a Serious Adverse Event (SAE) ....................................................... 30 
10.3 
Definition of Human Safety Information (HSI) .................................................... 31 
10.4 
Time Period and Frequency for Collecting AE and SAE Information .................. 31 
10.5 
Procedures for Reporting AEs and SAEs .............................................................. 32 
10.6 
Procedures for Reporting HSI ............................................................................... 33 
10.7 
Procedure for reporting AEs after study completion ............................................. 33 
10.8 
Withdrawal Due to an Adverse Event ................................................................... 33 
10.9 
Pregnancy .............................................................................................................. 33 
10.9.1 
Action to be Taken if Pregnancy Occurs .............................................. 34 
11 DATA MANAGEMENT .................................................................................................. 34 
11.1 
Case Report Form .................................................................................................. 34 
11.2 
Data Handling ........................................................................................................ 35 
11.2.1 
Data Queries .......................................................................................... 35 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 7 of 57 
11.3 
Processing Patient Reported Outcomes ................................................................. 35 
12 STATISTICAL CONSIDERATIONS AND DATA ANALYSES .................................. 35 
12.1 
Sample Size Determination ................................................................................... 35 
12.2 
Populations for Analysis ........................................................................................ 35 
12.3 
Sub-Group classification ....................................................................................... 36 
12.4 
Statistical Analyses ................................................................................................ 36 
12.4.1 
Primary Analysis ................................................................................... 36 
12.4.2 
Safety Analyses ..................................................................................... 37 
12.4.3 
Other Analyses ...................................................................................... 37 
12.4.4 
Exclusion of Data from Analyses ......................................................... 38 
12.4.5 
Demographic and Baseline Characteristics ........................................... 38 
12.4.6 
Study Product Compliance and Use of Other Therapies ...................... 38 
12.4.7 
Handling of Dropouts and Missing Data .............................................. 39 
12.4.8 
Interim Analysis .................................................................................... 39 
13 STUDY GOVERNANCE CONSIDERATIONS.............................................................. 39 
13.1 
Quality Control ...................................................................................................... 39 
13.2 
Quality Assurance .................................................................................................. 39 
13.3 
Regulatory and Ethical Considerations ................................................................. 39 
13.3.1 
Institutional Review Board/ Ethics Committee..................................... 39 
13.3.2 
Ethical Conduct of the Study ................................................................ 40 
13.3.3 
Subject Information and Consent .......................................................... 40 
13.3.4 
Subject Recruitment .............................................................................. 40 
13.3.5 
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP ............................................................................................... 41 
13.4 
Posting of Information on Publicly Available Clinical Trial Registers ................. 41 
13.5 
Provision of Study Results to Investigators ........................................................... 41 
13.6 
Records Retention .................................................................................................. 41 
13.7 
Conditions for Terminating the Study ................................................................... 42 
14 REFERENCES .................................................................................................................. 42 
15 APPENDICIES.................................................................................................................. 44 
15.1 
ABBREVIATIONS ............................................................................................... 44 
15.2 
Screening questionnaire ......................................................................................... 45 
15.3 
Oral Hygiene questionnaire ................................................................................... 48 
15.4 
DHEQ-48: Dentine Hypersensitivity Experience Questionnaire .......................... 51 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 8 of 57 
List of in text tables 
Table 1-1 
Schedule of Activities ........................................................................... 12 
Table 3-1 
Study Objectives and Endpoints ........................................................... 16 
Table 6-1 
Study Product Supplies ......................................................................... 22 
Table 15-1 
Abbreviations ........................................................................................ 44 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 9 of 57 
1 
PROTOCOL SUMMARY  
1.1 
Synopsis 
Background and Rationale: 
This study is designed to generate real-world data on dentin hypersensitivity (DH) sufferers 
among a general population. This study will aim to evaluate the impact of the use of a 
desensitizing toothpaste on oral health related quality of life. Data generated will provide real 
world information on the DH experience and how DH management treatment could impact oral 
health related quality of life. 
Objectives and Endpoints: 
Objective(s) 
Endpoint(s) 
Primary 
To describe subjects’ oral health 
related quality of life over a 24 week 
period following the use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
Dentin Hypersensitivity Experience 
Questionnaire (DHEQ-48) in a population 
of DH sufferers. 
Plot over time in DHEQ mean scores (0, 4, 
8, 12, 16, 20 and 24 weeks):  
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34) 
- Individual Domain scores 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39) 
 Exploratory 
To explore subjects’ oral health 
related quality of life over a 24 week 
period following the use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
DHEQ-48 in further characterisation of DH 
sufferers by subgroups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
Plot over time in DHEQ mean scores (0, 4, 
8, 12, 16, 20 and 24 weeks) for each sub-
group: 
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34) 
- Individual Domain scores 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 10 of 57 
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39)  
To characterise subjects’ change in oral 
health related quality of life over 24 weeks 
compared to baseline, following use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
DHEQ-48, in the overall population of DH 
sufferers and in 4 subgroups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
DHEQ Mean score over time compared to 
baseline (0, 4, 8, 12, 16, 20 and 24 weeks) 
to be analysed for overall population of DH 
sufferers and each sub-group: 
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34, section 2) 
- Individual Domain scores (section 2) 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39)  
To identify the DHEQ domain items 
important to the overall population of DH 
sufferers following 24 weeks use of the 
sensitivity toothpaste 
Percentage of DH sufferers who agree 
(score 5-7) to items in each respective 
domain at baseline and week 24   
To explore the potential impact a sensitivity 
toothpaste containing 5% potassium nitrate 
has on subjects’ reported pain in relation to 
DH in the overall population of DH 
sufferers and in 4 sub-groups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
For overall population of DH sufferers and 
each sub-group: 
• Numeric Pain Rating Scale (NPRS) 
mean score over time compared to 
baseline (0, 4, 8, 12, 16, 20 and 24 
weeks)  
 
• Plot over time in NPRS mean scores (0, 
4, 8, 12, 16, 20 and 24 weeks) 
 
• Percentage of DH sufferers who achieve 
pain reduction identified as clinically 
important (pain reduction NPRS > 30%) 
To explore subjects’ overall satisfaction 
with DH treatment in the overall population 
of DH sufferers and in 4 sub-groups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
At week 24, Satisfaction Numerical rating 
scale (NRS) mean scores for overall 
population of DH sufferers and each sub-
group 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 1 1  of 5 7  
T o descri be oral h y gie ne ha bits of D H 
s ufferers acc or di n g t o or al h y gie n e  
q uesti o n naire  
At baseli ne, s u m mar y of oral h y gi e ne ha bits  
 
 
St u d y D e si g n : 
T his will be a virt u al , pr os pecti ve , t we nt y-f o ur wee ks, o pe n la bel st u d y i n s u bjects wit h D H 
(self-re p orte d s y m pt o ms).  
T his st u d y will ai m t o e val uate c h a n ges i n  o ral healt h-relate d q ualit y of life (O Hr Q o L ) i n 
s u bjects s ufferi n g fr o m D H f oll o wi n g t he use of a nti -se nsiti vit y t o ot h paste f or 2 4 wee ks . 
S u bjects ’ self-perce pti o n  of D H will be e val uate d b y c o m pleti o n of a vali date d O Hr Q o L  
q uesti o n naire ( D H E Q -4 8 ) at baseli ne, 4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks . 
S ufficie nt n u m ber of s u bjects (esti mate d 5 0 % scree n fail ure) a ge d bet wee n 1 8 -6 5 years, w h o 
s uffer fr o m t o ot h se nsiti vit y, will be scree n e d t o e nr oll a p pr o xi matel y 6 5 0  t o e ns ure 4 0 0  
c o ns u mers  c o m plete t he e ntire st u d y (esti mate d 4 0 % dr o p -o ut ).  
S u bjects will be recr uite d t hr o u g h  s ocial me dia a n d ot her di gital platf or ms. S u bjects i ntereste d 
i n t he st u d y will be se nt t o a la n di n g pa ge after clic ki n g o n a n “ A d” or st u d y li n k w here t he y 
fill-o ut a n i nitial  pre -scree ni n g q u esti o n naire a n d, if t he y are eli gi ble, t he y will be se nt a n e m ail 
wit h pr o vi de d u ni q ue partici pa nt I D a n d t he li n k t o d o w nl oa d t he 
 a p p. Aft er 
d o w nl oa di n g t he 
 a p p a n d l o g gi n g i n usi n g a u ni q ue partici pa nt I D pr o vi de d, t he y 
will re vie w t he ele ctr o ni c I nf or m C o nse nt (eI C), t he y will be a ble t o c o m m u nicate wit h t he 
 virt ual site tea m via t he 
 a p p’s c hat, via p h o ne (st u d y n u m ber li n ke d 
t o t he st u d y c hat) or e mail. S u bjects  ca n us e a n y or all of t hese m et h o ds as ofte n as t he y n ee d 
t o u ntil t he y are c o mf orta ble wit h t heir decisi o n  a n d ma y t he n acce pt or decli ne t he eI C .  N o 
st u d y-s pecific d ata c ollecti o n will occ ur pri or t o s u bject c o ns e nt. S u bjects  w h o d o n ot acti vel y 
access t he st u d y-s pecifi c we bsite/a p p a n d pr o vi de c o nse nt will n ot ha ve t he p ossi bilit y t o  
c o ntri b ute st u d y d ata.  
O nce t he s u bjects si g n  t h e eI C, t he y will c o m plete a  scree ni n g q u esti o n nair e w hic h  will ai m t o 
i de ntif y a n d e x cl u de i n di vi d uals w h ose se nsiti vit y c o ul d b e ca use d b y ot her  fact ors/cli nical 
pat h ol o g y  f or w hic h de ntal healt hcare pr ofessi o nal a d vice s h o ul d be s o u g ht . S u bjects w h o  
q ualif y bas e d o n i ncl usi o n/e x cl usi o n criteria a n d t he scree ni n g q uesti o n naire  will be e nr olle d 
a n d will be se nt a des e nsitizi n g t o ot h paste ( 5 %  p otassi u m nitrate ). T he y will be as ke d t o use it  
f or 2 4 wee ks, f oll o wi n g t he c o m mercial t u be  i nstr ucti o ns, rec o m me n d e d dail y use a n d t heir 
n or mal oral healt hcare h a bits, a n d t o fill i n t he D H E Q f or m o n 7  differe nt occasi o ns ( Bas eli ne  
( pri or t o a n y pr o d u ct use) ,  4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks ). 
At eac h D H E Q ti me p oi nt, s u bjects will recei ve  re mi n ders acc or di n g t o t he  sc he d ule of 
acti vities.  
Safet y will be assess e d b y e v al uati o n of A Es a n d will be c ollecte d re m otel y via a n o nli ne, 
s u bject p ortal.  
St u d y Pr o d u ct s : 
Se ns o d y ne Fres h Mi nt T o ot h paste  (p otassi u m nitrate 5 %, s o di u m fl u ori de 0. 1 5 % w/ v fl u ori de 
i o n –  
 U S A mar ket place t o ot h paste )  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
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P P D
P P D
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C CI

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 12 of 57 
Type and Planned Number of Subjects: 
Sufficient number of subjects will be screened (estimated 50% screen failure) to enroll 
approximately 650 to ensure 400 evaluable subjects complete the entire study (estimated 40% 
drop out).  
Statistical Analyses 
For the primary objective, plots of the mean values for questions Q1-3  (section1) and for 
questions in section 2 total DHEQ score (sum Q1-34), each of the domain’s mean values: 
Restrictions (sum Q1-4), Adaptation (sum Q5-16), Social Impact (sum Q17-21), Emotional 
Impact (sum Q22-29), Identity (sum Q30-34), Global oral health (Q35) and Effect on life 
overall (sum Q36-39) will be presented for the overall population of DH sufferers over 24 weeks 
to assess QoL over time, graphically.  
The analyses for exploratory objectives are defined in the statistical section 12.4.3.  
1.2 
Schedule of Activities 
The schedule of activities table provides an overview of the study.   
Table 1-1 
Schedule of Activities 
 
Procedures 
Screening 
 
Baseline* 
Week 0 
(Day 0) 
Week 
4 
Day 28 
(± 7 days) 
Week 
8 
Day 56 
(±7 days) 
Week 
12 
Day 84 
(±7 days) 
Week 
16 
Day 112 
(±7 days) 
Week 
20 
Day 140 
(±7 days) 
Week 
24 
Day 168 
(± 7 days) 
Electronic Informed 
Consent  
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
Screening 
questionnaire 
X 
 
 
 
 
 
 
 
Subject eligibility 
X 
 
 
 
 
 
 
 
Medical History1 
X 
X 
 
 
 
 
 
 
Concomitant 
Medications 
 
X 
X 
X 
X 
X 
X 
X 
DHEQ-48 completion  
 
X 
X 
X 
X 
X 
X 
X 
NPRS scale  
 
X 
X 
X 
X 
X 
X 
X 
Oral Hygiene 
questionnaire 
 
X 
 
 
 
 
 
 
Study product shipped 
[dentifrice]2 
 
X 
 
 
 
 
 
 
Patients’ satisfaction 
with treatment (NRS) 
 
 
 
 
 
 
 
X 
AEs 3 
X 
X 
X 
X 
X 
X 
X 
X 
Study Conclusion 
 
 
 
 
 
 
 
X 
Abbreviations:  
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
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AEs: Adverse Events  
DHEQ: Dentin Hypersensitivity Experience Questionnaire 
NRS: Numerical Rating Scale 
NPRS: Numeric Pain Rating Scale 
Footnotes:  
1 Medical occurrences and AEs which subjects experience from the time of consent signature, but prior 
the use of the study product, will be recorded in the Medical History 
2 Product will be shipped only after baseline assessments have been completed 
3 Any events experienced from the first use of the product until last administration of the study product 
will be recorded as AEs. All serious AEs (SAEs) will be collected immediately after a subject provides 
consent signature until last administration of the study product. 
* Baseline activities must be conducted within 14 days from subject eligibility   
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Clinical Protocol 
Protocol Number: 216953 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
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2 
INTRODUCTION 
2.1 
Study Rationale 
GSKCH has conducted many clinical studies, showing robust and positive results on the relief 
and management of DH in clinical measurements and OHrQoL. However, these results have 
been obtained from randomized controlled trials which include a very well-defined DH 
sufferers’ population and strict study procedures. These studies do not necessarily fully reflect 
the general dental population’s behavior.  
Real-world evidence (RWE) studies offer an opportunity to gather information of a marketed 
product working in real-world heterogeneous populations that can complement clinical 
evidence, consumer insight data and post-marketing surveillance. Real world data (RWD) 
generation ranges from observational studies (prospective/retrospective) to interventional 
studies, with or without randomization, and will help to overcome the well-known limitations 
of  randomized controlled studies which make it difficult to generalize findings to larger, more 
inclusive populations of patients (Sherman et al, 2016). 
There are limited number of published RWE studies focusing on DH and most of them are part 
of a large observational dental practice-based studies which focused on the diversity of methods 
available for diagnosing and treating DH (Cunha-Cruz et al, 2010; Heft et al, 2018; Kopycka-
Kedzierawski et al, 2017a; Kopycka-Kedzierawski et al, 2017b; Litaker et al, 2019). DH is 
usually diagnosed by patient’s self-report of pain, the evaluation of the patient’s response to 
various stimuli, and the exclusion of other dental and periodontal conditions. However, studies 
from Joana Cunha-Cruz (Cunha-Cruz et al, 2010) and Kopycka-Kedzierawski (Kopycka-
Kedzierawski et al, 2017a) showed that in a routine clinical practice setting, methods chosen to 
diagnose DH were diverse and inconsistent among practitioners. In addition, majority of 
practitioners reported to use one or multiple products to manage DH, with OTC potassium 
nitrate toothpaste and fluoride formulations/treatments to be the most widely used (Heft et al, 
2018; Kopycka-Kedzierawski et al, 2017a; Kopycka-Kedzierawski et al, 2017b; Litaker et al, 
2019). The effectiveness of DH treatments (VAS scale, Labelled Magnitude scale, patients’ 
satisfaction) was also  assessed from a patient perspective and derived from the use of a therapy 
independently of the accuracy of diagnosis (Heft et al, 2018), as per nature of the real-world 
study setting. 
The aim of this study is to evaluate the impact of a commercially available toothpaste containing 
5% potassium nitrate on oral health related quality of life in a real-world setting. 
GSKCH studies have demonstrated clinical efficacy of 5% potassium nitrate, it is therefore 
relevant (and permitted) to explore its effectiveness in a real-world setting; to obtain data that 
is reflective of sufferers in their environment for a full DH experience and impact on oral health 
related QoL.   
2.2 
Background 
Dentin hypersensitivity (DH) has been defined as ‘pain derived from exposed dentine in 
response to chemical, thermal, tactile, or osmotic stimuli which can’t be explained as arising 
from any other dental defect or disease’ (Addy et al, 1985; Canadian Advisory Board on Dentin 
Hypersensitivity, 2003).  The hydrodynamic theory of DH hypothesizes that a stimulus external 
to the tooth (for example, a temperature/osmotic differential, pressure) causes movement of the 
fluid resident within exposed dentinal tubules (Brännström, 1963). This movement may 
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Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
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stimulate nerve processes in the dental pulp (Addy, 2002; Hall et al, 2000), resulting in the 
characteristic short, sharp pain of DH.  
Currently there are two approaches for the management of DH: nerve desensitization and the 
occlusion of exposed dentin tubules. Nerve depolarising agents, typically potassium salts, 
generally require a period of use (14 to 28 days) before their benefit is established. The delivery 
of potassium ions to the dentine-pulp junction (odontoblastic layer) via dentinal tubules is 
believed to result in depolarisation of the afferent nerve membrane thereby blocking the pain 
response. The second approach uses tubule occluding agents which physically block the 
exposed end of the dentinal tubules, thus reducing dentinal fluid movement and pulpal irritation. 
Tubule occluding agents such as strontium and stannous salts, bioglasses, silicas or oxalates 
serve to seal or block the dentine tubules and thereby reduce the effect of external stimuli. Such 
agents are believed to function by precipitating insoluble materials onto the dentine surface 
and/or within the dentinal tubules to reduce dentinal fluid transport. 
Recently, there have been a wider consideration to the psychosocial impacts of DH on everyday 
life (Gibson et al, 2015). One qualitative study showed that DH can be triggered by several 
stimuli and responses, not always described as pain, can affect everyday activities such as 
eating, drinking, tooth brushing, talking and social interactions (Gibson et al, 2015). 
Oral health-related quality of life (OHrQoL) questionnaires are tools increasingly used in 
dentistry to capture the impact of clinical interventions on OHrQoL, however these measures 
cover a number of oral health conditions which lead to limitations of these tools and may not 
detect the nuances of a specific condition (Bekes et al, 2009). The Dentine Hypersensitivity 
Experience Questionnaire (DHEQ) is a validated, condition specific measure of OHrQoL in 
relation to DH (Baker et al, 2014) (Boiko et al, 2010). It was developed by GSKCH in 
collaboration with Sheffield University through a robust theoretical framework, specific for DH 
(Boiko et al, 2010), and has shown reliability and validity in both a general population (Porritt 
et al, 2016) and in clinical studies (Boiko 2010, Gibson et al, 2015). The conception, 
development, validation and initial usage of the DHEQ has been published (Robinson, 2014). 
The measure has been validated with both long- and short-form versions, comprising 48 (Baker 
et al, 2014; Boiko et al, 2010) and 15 (Machuca et al, 2014) questions respectively, and has 
been translated into multiple languages (e.g., Chinese, Turkish, Portuguese) confirming its 
global relevance (Başaran and Celik, 2018) (Douglas-De-Oliveira et al, 2018) (He and Wang, 
2015a) (He and Wang, 2015b). 
Data generated as part of GSKCH efficacy clinical studies, showed robust and positive results 
on the relief and management of DH in clinical measurements and OHrQoL. However, these 
results have been obtained from randomized controlled trials which include strict study 
procedures and controlled, but contrived DH stimuli. These studies may not necessarily fully 
reflect the general dental population when challenged with real world sensitivity stimuli.  
Based on these assumptions, this will be a real-world evidence study which will include subjects 
among a general population who suffer from dentin hypersensitivity (self-reported symptoms). 
This study will aim to evaluate the impact of a recommended daily use of desensitizing 
toothpaste on oral health related quality of life. Data generated will give real world information 
on the impact of a daily use DH treatment on oral health related quality of life. 
2.3 
Mechanism of Action/Indication 
Potassium ions (K+) are thought to relieve DH by reducing the excitability of the intra-dental 
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Protocol Number: 216953 
 
 
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nerves.  During brushing with a K+ containing toothpaste, the concentration of K+ ions at the 
tooth surface is raised and K+ ions diffuse through the dentin through the tubules and raise the 
concentration of potassium around the odontoblast and associated nerve. Repeated exposure of 
the odontoblast and neve to elevated levels of potassium maintains the nerve in a depolarized 
state (Addy and Smith, 2010). 
3 
STUDY OBJECTIVES AND ENDPOINTS 
Table 3-1 
Study Objectives and Endpoints 
Objective(s) 
Endpoint(s) 
Primary 
To describe subjects’ oral health 
related quality of life over a 24 week 
period following the use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
Dentin Hypersensitivity Experience 
Questionnaire (DHEQ-48) in a population 
of DH sufferers. 
Plot over time in DHEQ mean scores (0, 4, 
8, 12, 16, 20 and 24 weeks):  
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34) 
- Individual Domain scores 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39) 
 Exploratory 
To explore subjects’ oral health 
related quality of life over a 24 week 
period following the use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
DHEQ-48 in further characterisation of DH 
sufferers by subgroups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
Plot over time in DHEQ mean scores (0, 4, 
8, 12, 16, 20 and 24 weeks) for each sub-
group: 
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34) 
- Individual Domain scores 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39)  
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Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
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To characterise subjects’ change in oral 
health related quality of life over 24 weeks 
compared to baseline, following use of a 
sensitivity toothpaste containing 5% 
potassium nitrate, as measured by the 
DHEQ-48, in the overall population of DH 
sufferers and in 4 subgroups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
DHEQ Mean score over time compared to 
baseline (0, 4, 8, 12, 16, 20 and 24 weeks) 
to be analysed for overall population of DH 
sufferers and each sub-group: 
Section 1 
- Impact on everyday life (Q1-3) 
Section 2 
- Total Score (Q1-34, section 2) 
- Individual Domain scores (section 2) 
o Restrictions (Q1-4),  
o Adaptation (Q5-16),  
o Social Impact (Q17-21),  
o Emotional Impact (Q22-29)  
o Identity (Q30-34)  
- Global oral health score (Q35) 
- Effect on life overall score (Q36-39)  
To identify the DHEQ domain items 
important to the overall population of DH 
sufferers following 24 weeks use of the 
sensitivity toothpaste 
Percentage of DH sufferers who agree 
(score 5-7) to items in each respective 
domain at baseline and week 24   
To explore the potential impact a sensitivity 
toothpaste containing 5% potassium nitrate 
has on subjects’ reported pain in relation to 
DH in the overall population of DH 
sufferers and in 4 sub-groups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
 
For overall population of DH sufferers and 
each sub-group: 
• Numeric Pain Rating Scale (NPRS) 
mean score over time compared to 
baseline (0, 4, 8, 12, 16, 20 and 24 
weeks)  
 
• Plot over time in NPRS mean scores (0, 
4, 8, 12, 16, 20 and 24 weeks) 
 
• Percentage of DH sufferers who achieve 
pain reduction identified as clinically 
important (pain reduction NPRS > 30%) 
To explore subjects’ overall satisfaction 
with DH treatment in the overall population 
of DH sufferers and in 4 sub-groups: 
Age group  
Diagnosis  
Use of sensitivity toothpaste  
Self-reported DH frequency 
At week 24, Satisfaction Numerical rating 
scale (NRS) mean scores for overall 
population of DH sufferers and each sub-
group 
To describe oral hygiene habits of DH 
sufferers according to oral hygiene 
questionnaire 
At baseline, summary of oral hygiene habits 
 
 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 1 8  of 5 7  
I n t his st u d y is e x pecte d to o bser ve a tr e n d i n fa v or of i m pr o ve me nt i n Q o L o v er  ti me after 2 4  
wee k  treat me nt peri o d i n a ge neral p o p ulati o n of D H s ufferers , i n partic ular t he t otal D H E Q 
sc ore. 
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 virt u al, pr os pecti ve, t we nt y-f o ur wee ks, o pe n la bel st u d y i n s u bjects wit h D H 
(self-re p orte d s y m pt o ms).  
T his st u d y will ai m t o e val uate c h a n ges i n  o ral healt h-relate d q ualit y of life (O Hr Q o L ) i n 
s u bjects s ufferi n g fr o m D H s y mpt o ms  f oll o wi n g t he use of a nti -se nsiti vit y t o ot h past e f or 2 4 
wee ks . S u bjects ’ self-perce pti o n of D H will be e val uate d b y c o m pleti o n of a vali date d O Hr Q o L  
q uesti o n naire ( D H E Q -4 8 ) at baseli ne, 4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks . 
S ufficie nt n u m ber of s u bjects  (esti mate d 5 0 % scree n fail ure) a ge d bet wee n 1 8 -6 5 years, w h o 
s uffer fr o m t o ot h se nsiti vit y, will be scree n e d t o e nr oll a p pr o xi matel y 6 5 0  t o e ns ure 4 0 0 
c o ns u mers c o m plete t he e ntire st u d y (esti mate d 4 0 % dr o p o ut).   
S u bjects will be recr uite d t hr o u g h s ocial  me dia a n d ot her di gital platf or ms. S u bjects i ntereste d 
i n t he st u d y will be se nt t o a la n di n g pa ge after clic ki n g o n a n “ A d” or st u d y li n k w here t he y 
fill-o ut a n i nitial  pre -scree ni n g q uesti o n nair e a n d if t he y are eli gi ble, t he y will be se nt a n e mail 
wit h pr o vi de d u ni q ue partici pa nt I D a n d t he li n k t o d o w nl oa d t he a p p. Aft er d o w nl oa di n g t he 
 a n d l o g gi n g i n usi n g a u ni q ue partici pa nt I D pr o vi de d, t he y will re vie w t he 
electr o nic I nf or m C o nse nt (eI C ), t he y will be  a ble t o c o m m u nicate wit h t he  
virt ual 
site tea m via t he 
  a p p’s c hat, via p h o ne (st u d y n u m ber li n ke d t o t he st u d y c hat) or 
e mail. S u bjects  ca n use a n y or all of t hese met h o ds as ofte n as t he y nee d t o u ntil t he y are 
c o mf orta ble wit h t heir d ecisi o n  a n d ma y acce pt or decli ne t he eI C .   N o st u d y -s pecific data 
c ollecti o n will occ ur pri or t o s u bject c o nse nt. S u bjects  w h o d o n ot acti vel y access t he st u d y -
s pecific w e bsite/a p p a n d pr o vi de c o nse nt will n ot ha ve t he p ossi bilit y t o c o ntri b ute st u d y data.  
O nce t he s u bjects acce pt/si g n t he eI C, t h e y will be a ble t o fill -o ut a s cree ni n g q u esti o n nair e 
w hic h will ai m t o i de ntif y a n d e x cl u de i n di vi d uals w h ose se nsiti vit y c o ul d be ca use d b y ot her 
fact ors/cli nical p at h ol o g y f or w hic h de ntal h ealt hcare pr ofessi o nal a d vice s h o ul d be s o u g ht. 
S u bjects w h o q ualif y bas e d o n i ncl usi o n/e xcl usi o n criteri a a n d  t he s cree ni n g q u esti o n naire will 
be e nr olle d a n d will be se nt  a dese nsitiz i n g t o ot h paste (5 % p otassi u m nitrate ). T he y will be 
as ke d t o use it  f or 2 4 wee ks, f oll o wi n g t he c o m mercial t u be  i nstr ucti o ns, rec o m me n de d dail y 
use  a n d t heir n or mal oral healt hcare ha bits, a n d t o fill i n D H E Q  f or m o n  7  differe nt occasi o ns 
( Bas eli ne ( pri or t o a n y pr od uct use) ,  4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks ). 
At eac h D H E Q ti me p oi nt , s u bjects will recei ve re mi n der s acc or di n g t o t he  sc he d ule of 
acti vities. 
Safet y will be assess e d b y e v al uati o n of A Es a n d will be c ollecte d re m otel y via a n o nli ne, 
s u bject p ortal.  
4. 2  
S ci e ntifi c R ati o n al e f or St u d y D e si g n  
G S K  C H has ge nerate d r o b ust a n d p ositi ve efficac y res ults o n t he relief a n d ma na ge me nt of 
D H i n cli nical meas u re me nts a n d O Hr Q o L . H o we ver, t hese res ults ha ve bee n o btai ne d  fr o m 
ra n d o mize d c o ntr olle d trials w hic h i ncl u de a v er y well-defi ne d D H s ufferers’ p o p ulati o n a n d 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
P P D
P P D
P P D

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strict study procedures. These studies do not necessarily fully reflect the general dental 
population’s behavior.  
RWE studies have the potential to reflect users of products in everyday life therefore more 
accurately representing responses to an intervention and increasing their generalizability. They 
offer opportunities to gather information on marketed products in order to bolster existing 
clinical evidence and gain additional insights in the target population.  
There are limited number of published RWE studies focusing on DH and most of them are part 
of a large observational dental practice-based study which focused on the diversity of methods 
available for diagnosing and treating DH (Cunha-Cruz et al, 2010; Heft et al, 2018; Kopycka-
Kedzierawski et al, 2017a; Kopycka-Kedzierawski et al, 2017b; Litaker et al, 2019). Only one 
study has been identified which evaluated quality of life improvement using the validated Oral 
Health Impact Profile – 49 questionnaire, showing significant improvements at 24 weeks versus 
a 
negative 
control 
(https://www.colgatetalks.com/dentin-hypersensitivity-life-quality/), 
however the information available for this study is very limited. 
This will be a virtual, prospective, twenty-four weeks, open label study in healthy DH sufferers 
(self-reported symptoms) among the general population.  
In GSK CH randomized controlled trials (RCTs), an examiner clinically diagnoses DH in self-
reported DH sufferers and selects two ‘test teeth’ from those that qualify as sensitive teeth for 
clinical assessments at all study visits. In this study, subjects will be identified as DH sufferers 
in the general population using a screening questionnaire (as previously done in (Porritt et al, 
2016)) which will aim to identify and exclude individuals whose sensitivity could be caused by 
other factors/clinical pathology. They will be recruited between 18 and 65 years of age as DH 
is most frequently diagnosed between the ages of 20 and 40 years and is known to decrease 
with age above 40 years (Dababneh et al, 1999; West, 2006).  
Eligible subjects will complete the Dentine Hypersensitivity Experience Questionnaire 
(DHEQ), a validated, condition specific measure of impacts on everyday life for DH sufferers 
(Baker et al, 2014) (Boiko et al, 2010), at baseline and over 24-week period. This will the first 
study where the DHEQ will be used in a real-world setting, therefore the choice of the time 
points (0, 4, 8, 12, 16, 20 and 24 weeks) relates to published GSKCH data (Mason et al, 2019), 
which showed statistically significant changes from baseline at least after 8 weeks for DHEQ 
total score, at least after 12 weeks for the slowest domain (Identity)  and at least after 24 weeks 
for global oral health.  
In addition, to assess effectiveness, the use of NPRS scale will be used to evaluate the percentage 
of subjects who achieve pain reduction from the participant perspective (pain reduction NPRS 
> 30% has been identified as clinically important in previous pain studies (Hawker et al, 2011). 
Furthermore, subjects will be asked to rate their satisfaction with treatment after 24 weeks (Heft 
et al, 2018; van Berckel et al, 2017). 
The rationale for a single arm design in a long-term DH study which evaluates the participant-
reported OHrQoL outcomes was previously described by Mason and colleagues (Mason et al, 
2019). A commercially available toothpaste will be used in this open label study; and the dosage 
regimen will allow the subjects to use the product as recommended for sensitivity relief 
according to commercial tube instructions, as per nature of the RWE study. 
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4.3 
Justification for Dose 
Consistent with all marketed toothpastes, directions as recommended for sensitivity relief are 
stated on the commercial tube.  
4.4 
Duration of Study Definition 
The duration of the study is defined for each subject as the date that the signed eIC is provided 
through the end of the study follow-up period (168 days [+ 7days] post-baseline), subject death, 
early withdrawal from the study, lost to follow-up or overall study termination. 
5 
STUDY POPULATION 
5.1 
Type and Planned Number of Subjects 
Sufficient number of subjects will be screened (estimated 50% failure rate) to enroll 
approximately 650 to ensure approximately 400 evaluable subjects complete the entire study 
(estimated 40% drop out).  
An enrolled subject is one who has agreed to participate in the clinical study following 
completion of the informed consent process directly and successfully met eligibility criteria to 
proceed beyond screening as applicable for the protocol design.  
5.2 
Inclusion Criteria 
An individual must meet all of the following inclusion criteria to be eligible for enrollment into 
the study: 
1. Provision of consent indicating that the subject has been informed of all pertinent aspects 
of the study. 
2. All genders (male, female, not specified) aged between18 and 65 years, inclusive at the time 
of screening, willing to complete all activities as shown in the Schedule of Activities. 
3. The subject must be able to complete all activities as shown in the Schedule of Activities 
independently on their smart devices. 
4. Subject who has tooth sensitivity (self-reported symptoms). 
5.3 
Exclusion Criteria 
An individual who meets any of the following exclusion criteria will not be eligible for 
enrollment into the study: 
1. A subject whose sensitivity could be caused by other factors or clinical pathology as 
established by the screening questionnaire, which also includes:   
• A subject who has been/is on multiple prescription medications to treat severe acid 
reflux on regular basis or considered surgery for acid reflux 
• A subject with full or partial denture 
• A subject who has undergone treatment within 6 months of screening or is currently 
under treatment for periodontal or gum disease 
• A subject with active periodontitis 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 1  of 5 7  
•  A s u bject wit h acti ve cari es  
•  A s u bject wit h a n y c hr o nic a n d/ or se vere pai nf ul healt h c o n diti o ns w hic h lea d t o re g ular 
use pai n me dicati o ns ( m ore t ha n 3 da ys a wee k)  
2.  A s u bject wit h k n o w n or s us pecte d i nt olera nce or h y perse nsiti vit y t o t he st u d y m aterials ( or 
cl osel y rel ate d c o m p o u n ds) or a n y of t heir sta te d i n gre di e nts: p otassi u m nitrate ( 5 %), 
s o di u m fl u ori de ( 0. 1 5 % w/ v fl u ori de i o n), wat er, s or bit ol, h y drate d silica, gl yceri n, 
c oca mi d o pr o p yl betai ne, fla v or, x a nt ha n g u m, tita ni u m di o xi de, s o di u m sacc hari n, s o di u m 
h y dr o xi de, s ucral ose, yell o w 1 0, bl ue 1 . 
5. 4  
R a n d o mi z ati o n Crit eri a  
T here is n o ra n d o mizati o n i n t his st u d y. All s u bjects eli gi ble (s u bject w h o m eet eli gi bilit y 
criteria bas e d o n  i ncl usi o n/e x cl usi o n criteria a n d scree ni n g q u esti o n naire) will be pr o vi de d wit h 
t he sa me st u d y pr o d uct. 
5. 5  
Lif e st yl e C o n si d er ati o n s  
T his st u d y will n ot i ncl u de a n y lifest yle c o nsi derati o ns . 
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  e nr olle d i n t he st u d y i.e. d o n ot f ulfill all t he scree ni n g criteria. T o e ns ure 
tra ns pare nt re p orti n g of s cree n fail ure p artici pa nts , 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  (year of birt h , ge n d er , re gi o n/state, et h nicit y, race a n d e d ucati o n), 
screen fail ure d etails (e. g. wit h dra wal of c o nse nt)  a n d eli gi bilit y criteria .  
S u bjects  w h o d o n ot meet t he criteria f or partici p ati o n i n t his st u d y (scree n fail ure) ma y n ot be 
re-scree n e d, u nless d ue t o tec h nical iss ues wit hi n t he 
a p p/ p ort al . If re-scree ni n g is 
a p plica ble, s u bjects will be re-i n vite d wit h a ne w partici pa nt I D t o d o w nl o a d t he 
 
a p p. 
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 pri atel y q ualifie d m e dical/ de nt al pers o n nel f or t he 
st u d y is doc u me nte d i n t he  St u d y C o ntact List hel d b y 
 
T he c o nta ct n u m ber is o nl y t o be use d b y 
 see ki n g a d vice o n me dical/ de nt al 
q uesti o ns or pr o ble ms i n t he e v e nt t hat t he est a blis he d c o m m u nicati o n pat h wa ys are n ot 
a vaila ble. T he c o ntact n u m ber is n ot i nte n de d f or direct use b y st u d y  s u bjects.   
T o facilitate access t o a p pr o priatel y q ualifie d me dical/ de ntal pers o n nel o n st u d y -relat e 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 i nf or mati o n i n 
t he 
a p p or will be a ble t o use t he c h at f u ncti o n i n t he 
 a p p.   
5. 8  
R at er/ Cli ni c al A s s e s s or Q u alifi c ati o n s  
N/ A  
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 2  of 5 7  
6  
S T U D Y P R O D U C T  
F or t he p ur p oses of t his st u d y, per I nter nati o nal C o nfere n ce o n Har m o nizati o n (I C H) 
g ui deli nes, a n d G S K p oli c y, st u dy i nter ve nti o n  is d efi ne d as an 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 o c ol.  
6. 1  
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 uct will  be s u p plie d b y t h e Cli nical S u p plies De part me nt, G S K C H:  
T a bl e 6 -1  
St u d y Pr o d u ct S u p pli e s  
 
 
St u d y pr o d uct  
Pr o d uct N a me  
Se ns o d y ne Fres h Mi nt  
( U S A mar ket place t o ot h paste) 
P ac k D esi g n  
Cart o n of 1 2  t u bes 
Dis pe nsi n g Det ails  
O ne cart o n s hi p pe d t o s u bject ( baseli ne)  
Pr o d uct M aster 
F or m ul ati o n C o de ( M F C)  
C o m mercial Pr o d uct i n t he mar ket w h ere t h e st u d y is d o ne 
(
) 
D ose/ A p plic ati o n  
A s per directi o ns state d o n t he c o m mercial t u be  
R o ute of A d mi nistr ati o n  
Oral  T o pical  
Us a ge I nstr ucti o ns  
As per  directi o ns state d  o n t he c o m mercial t u be  
Ret ur n Re q uire me nts  
S u bject s ca n kee p u n us e d pr o d uct a n d ca n dis p ose of  use d 
pr o d uct at t he e n d of t he st u d y , aft er defaci n g or re m o vi n g 
t he st u d y la bel. S u bjects will c o nfir m  via t he 
 
a p p t hat t he i nstr ucti o ns a b o ve ha v e bee n f oll o we d  a n d 
h o w ma n y u n us e d t u bes t he y h a ve re mai ni n g . 
 
6. 1. 1  
D o s a g e F or m a n d P a c k a gi n g  
T he  st u d y pr o d uct will be s u p plie d t o  
preferre d ve n d or b y G S K C H . Pr o d ucts will 
be s u p plie d i n c o m mercial t u bes w hic h will be place d i nt o a cart o n. S t u d y la bels will be a p plie d 
o n t he t u bes a n d o n t he cart o n  b y G S K C H .  
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 me nts a n d will b e 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  a n d ‘cli nical trial use o nl y’ 
state me nt.  
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 3  of 5 7  
Care s h o ul d be ta ke n b y 
preferre d ve n d or a n d s u bjects wit h t he s u p plie d pr o d ucts 
a n d t heir la b els s o t hat t he y are mai 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 h e st u d y.  
6. 1. 2  
Pr e p ar ati o n a n d Di s p e n si n g  
T he st u d y p r o d uct will be pre pare d a n d/ or dis pe nse d b y 
preferre d ve n d or 
acc or di n g t o i nstr ucti o n  a n d t heir pr oce d ures . T he 
 preferre d v e n d or staff m e m bers 
will  e ns ure t he dis pe nsi n g pr oce d ures are c o m plet e d acc uratel y.  
Eac h eli gi ble  s u bj ect will recei ve s ufficie nt t u bes of pr o d uct t o c o v er us a ge d uri n g t he st u d y 
peri o d.  
6. 2  
A d mi ni str ati o n  
O nl y s u bjects e nr olle d i n t he st u d y (s u bj ects w h o meet i ncl usi o n/e xcl usi o n criteria)  ma y recei v e 
st u d y pr o d ucts . Pr o d uct s hi p me nt will be trac ke d , s u bjects wi ll be as ke d t o c o nfir m  t hat t he y 
ha ve recei ve d t h e pr o d uct  via t he 
a p p   a n d t o f oll o w c o m merci al t u be i nstr ucti o ns 
as rec o m me n de d f or se nsiti vit y relief. S u bjects will be als o as ke d t o c o nfir m t he first use of t he 
pr o d uct.  
6. 2. 1  
M e di c ati o n/ D o si n g Err or s  
N/ A  
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 h e pr ot oc ol ( use of t he pr o d uct as per c o m mercial t u be i nstr ucti o ns ). O ver d ose is 
n ot li kel y t o occ ur i n t his st u d y.  
6. 3  
St u d y Pr o d u ct St or a g e   
As per nat ure of R W E st u dies , n o s pecific te m perat ur e 
m o nit ori n g is re q uire d at t he 
 preferre d v e n d or sites.  
6. 4  
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.  
 preferre d ve n d or m ust mai ntai n a de q uate rec or ds d o c u me nti n g t he recei pt, 
s hi p me nt, l oss, or ot her dis p ositi o n of all t he pr o d uct s u p plies. O nl y  st u d y pr o d ucts st ore d/ n o n-
dis pe nse d  i n t he 
 preferre d ve n d or site will be acc o u nt e d f or usi n g t he st u d y 
pr o d uct acc o u nta bilit y f or m/rec or d. 
preferre d ve n d or  is res p o nsi ble f or 
acc o u nta bilit y, rec o nciliati o n, a n d rec or d mai nte na nce  of  st u d y pr o d ucts st ore d/ n o n-dis pe nse d 
i n t he 
 preferre d ve n d or site.  
6. 4. 1  
D e str u cti o n of 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 a p pr o priate desi g n ee, wit h t he g ui da nce fr o m t he G S K C H Cli nical 
s u p pl y s p ecialist will i n ve nt or y o nl y u n us e d st u d y pr o d ucts st or e d/ n o n-dis pe nse d  i n t he 
preferre d v e n d or site o n t he acc o u nta bilit y rec or d. O nl y  u n use d st u d y pr o d uct s 
st ore d/ n o n-dis pe nse d  i n t he 
 preferre d ve n d or site f or t his cli nical st u d y will be 
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 4  of 5 7  
ret ur ne d f or destr ucti o n t o t he G S K C H Cli nical S u p plies De part me nt or desi g nate d v e n d or 
usi n g t he ret ur n i nstr ucti o ns pr o vi de d. Detaile 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 nt a bilit y c hec ks a n d s u bs e q u e nt destr ucti o n 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 os e o ut visit . St u d y s u bjects ca n kee p t he u n use d pr o d ucts.  
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  
T his is a n o pe n la bel st u d y, a n d n o bli n di n g is re q uire d.  
6. 6  
Br e a ki n g t h e Bli n d  
N/ A   
6. 7  
C o m pli a n c e  
T he s u bjects will be as ke d t o f oll o w c o m mercial t u be i nstr ucti o ns as rec o m me n d e d f or 
se nsiti vit y relief . I n or der t o 
mai ntai n a d here nce, t he 
 a p p will se n d 
n otificati o ns/re mi n ders t o t he s u bjects o n pre -defi ne d basis, a n d virt ual st u d y tea m ma y reac h 
o ut t o t he m if t here is still lac k of a d here n ce.  Als o, c o nsi deri n g t he virt ual n at ure of t his st u d y, 
s u bjects will be d oi n g t he st u d y fr o m t h e c o mf ort of t heir h o me vi a g ui da nce fr o m t he  
 a p p a n d virt ual st u d y tea m ma y als o i nter ve ne if dr o p o ut is li kel y. T he 
 a p p will als o se n d wee kl y  c h ec k i n s (e. g. ha ve y o u us e d t he st u d y pr o d uct e ver y  
da y ? H as t he c o m mercial t u be i nstr ucti o n s bee n f oll o we d?) a n d s u bject s will c o nfir m h o w ma n y 
u n use d t u be s t he y ha ve re mai ni n g at t he e n d of t h e st u d y. 
7  
D i s c o nti n u ati o n of st u d y i nt er v e nti o n a n d p arti ci p a nt 
di s c o nti n u ati o n/ wit h dr a w al  
7. 1  
P arti ci p a nt Di s c o nti n u ati o n/ Wit h dr a w al  
A s u bject ma y wit h dra w fr o m t he st u d y at a n y ti m e at his or her o w n re q uest . T hese ri g hts a n d 
i nf or mati o n o n h o w t o wit h dra w c o nse nt will be i ncl u de d i n t he electr o nic i nf or me d c o ns e nt 
f or m (e I C F). S h o ul d t he s ubject  wit h dra w fr o m t h e st u d y, all f urt her s c he d ule d c o m m u nicati o n 
will be disc o nti n ue d  (e-mail a n d/ or te xt messa ge  a n d/ or n otificati o ns ).  
T he reas o ns f or s u bjects n ot c o m pleti n g t he st u d y will be rec or de d i n t he electr o nic Case Re p ort 
F or m ( eC R F ) (
 p ortal ), if a vaila ble. 
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 a d diti o nal data s h o ul d be c ollecte d. G S K C H  ma y retai 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.  
7. 2  
L o st t o F oll o w u p  
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 peat e dl y is u na ble t o be c o ntacte d 
b y 
 wit hi n t he per mitte d misse d  re mi n ders (l o gi ns) a n d u p t o  1 6 8 da ys ( + 7 da ys). 
Bef ore a s u bject is dee m e d l ost t o f ollo w u p, 
m ust ma ke e v er y eff ort t o re gai n 
c o ntact wit h t he p artici pa nt  ( w here p ossi ble, 3 n otificati o ns ). T hes e c o ntact atte m pts s h o ul d be 
d oc u me nte d  if occ urre d  o utsi de 
a p p . 
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.  
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 5  of 5 7  
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 ti me p oi nt. H o we ver, as 
per nat ure of R W E st u dies , if a s u bject fails t o c o m plete D H E Q -4 8 q uesti o n naire or N P R S scale  
at a n y ti me p oi nt p ost baseli ne, s u bject  will  be per mitte d  c o nti n u i n g i n t he st u d y.  
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 . 
8. 1  
S cr e e ni n g  
T he f oll o wi n g d ata will b e c ollecte d  wit hi n 
a p p: 
•  I nf or me d C o nse nt 
•  De m o gra p hics  
•  I n cl usi o n/e x cl usi o n criteria 
•  Scree ni n g q uesti o n nair e   
•  S u bject eli gi bilit y  
•  Me dical hist or y   
•  A d verse e v e nts ( S A Es will be c ollecte d fr o m i m me di ately after a s u bject pr ovi des 
c o nse nt si g n at ure  u ntil l ast a d mi nistr ati o n of t he st u dy pr o d uct ) 
8. 1. 1  
I nf or m e d C o n s e nt 
T he e le ctr o nic I nf or me d Co nse nt ( e I C) pr ocess will be perf or me d via t he 
a p p  o n 
t he s u bject’s m o bile de vice. T h is s yste m will be us e d t o c o nse nt t he s u bjects wit h t he be nefit of 
hel pi n g t he m u n dersta n d t he researc h t he y are ta ki n g part i n a n d t o c o ntr ol t he c o nse nt pr ocess.  
O nce t he y  h a ve h a d t he o p p ort u nit y t o rea d t he c o nse nt , s u bjects will be a ble t o c o m m u nicate 
wit h t he
virt ual site tea m via t h e
 a p p’s  c hat, vi a p h o ne (st u d y n u m ber 
li n ke d t o t he st u d y c hat) or e mail. Partici pa nts ca n use a n y or all of t hese met h o ds as ofte n as 
t he y nee d t o u ntil t he y are c o mf orta ble wit h t heir decisi o n, a n d t he n t he y ca n electr o nicall y si g n 
t he eI C i n 
 a p p. O nce a decisi o n h as bee n re n dere d b y t he partici pa nt i n t he 
 a p p, a s cree n messa ge will pr o m ptl y a p p ear a n d prese nt t he partici pa nt wit h a n 
o p p ort u nit y t o re q uest a n e maile d c o p y of t heir si g ne d eI C. T his o pti o n will als o be a v aila ble at 
all ti mes wit hi n t he 
 a p p f or i m me di ate access. All c o nse nt f or ms are u ni q uel y 
pass w or d pr otecte d o n b ot h t he s u bject a n d 
virt ual site tea m  si de. A li mite d 
n u m ber of virt ual st u d y t ea m me m bers will ha ve access t o t he o nli ne p ortal w here t he si g ne d 
eI Cs are st ore d s o t he y m a y perf or m t heir assi g n e d d uties, s uc h as e ns uri n g c o nse nt si g n at ures 
are pr o perl y c o m plete d b y eac h e nr olle d s u bject. 
 a n d its 
 a p p will be use d t o pr o vi de t he s yste m a n d trai ni n g .  A hel p 
des k will be pr o vi de d a n d s u bject s ca n access it as nee de d.  
If, d uri n g 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 bl e t hat ma y affect t he 
s u bject’ willi n g ness t o c onti n ue  wit h  t he st u d y, eac h o n g oi n g s u bject s h o ul d recei ve t his ne w 
i nf or mati o n a n d be re-c o nse nte d i nt o t he st u d y.  
After si g ni n g t he eI C, s u bjects will u n der g o t he scree ni n g pr oce d ures . If t h e s u bject is c o nfir me d 
eli gi ble, t he s u bject is c o nsi dere d e nr olle d i n t he st u d y. 
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 6  of 5 7  
8. 1. 2  
D e m o gr a p hi c s  
T he f oll o wi n g d e m o gra p hic i nf or mati o n will b e rec or de d wit hi n
 a p p: year of birt h, 
ge n d er , re gi o n/state , et h nicit y, race  a n d e d u cati o n  (di d n ot gra d uat e hi g h sc h o ol, hi g h sc h o ol 
gra d uate or G E D, T ec h ni cal sc h o ol or ass o ciates d e gree, 4 year de gree, p ost gra d uate de gree ). 
8. 1. 3  
M e di c al Hi st or y a n d M e di c ati o n s  
Details of rele va nt me dical a n d s ur gical hist or y, i ncl u di n g aller gies or dr u g se nsiti vit y, will be 
c ollecte d i n t he e C R F (
 a p p).  
Me dical occ urre nces a n d A Es w hic h s u bjects e x perie nce fr o m t he ti me of c o nse nt si g nat ur e,  
b ut pri or t he use of t he st u d y pr o d uct, will  be  rec or de d i n t he Me dical Hist or y secti o n of t he 
e C R F (
 p ortal).  
Me dicati o ns/treat me nts, i ncl u di n g prescri pti o n a n d n o n -pres cri pti o n  dr u gs, dietar y s u p ple me nts 
a n d her bal re me dies, a n d rece nt vacci nes t a ke n fr o m si g ni n g t he I C F will be d oc u m e nte d as  
c o nc o mita nt me dicati o n/treat me nts  i n t he e C R F (
 a p p).  
Details of a n y me dicati o ns use d b y t he s u bjects t hr o u g h o ut t he st u d y wil l be c ollecte d i n t he 
e C R F (
 a p p) wit h reas o n f or use, u nit d ose, dail y d os e, a n d start a n d st o p d ates of 
a d mi nistrati o n.   
8. 2  
B a s eli n e W e e k 0  
Baseli ne acti vities m ust be c o n d ucte d wit hi n 1 4 da ys fr o m s u bject eli gi bilit y a n d c ollect e d  
wit hi n 
 a p p:  
•  Me dical Hist or y  
•  Me dicati o ns  
•  D H E Q -4 8  q uesti o n nair e  
•  N P R S scale  
•  Oral h y gi e ne  q u esti o n naire  
•  Pr o d uct s hi p me nt ( o nly after b aseli ne assess me nts h ave bee n c o m plet e d ) 
•  A d verse e ve nts (A Es  w hi c h s u bjects ex peri e nce fr o m t he first use of t h e pr o d uct u ntil 
l ast a d mi nistr ati o n of t he st u dy pr o d uct, a n d S A Es ) 
8. 3  
W e e k 4, 8, 1 2, 1 6  a n d  2 0  
T he f oll o wi n g d ata will b e c ollecte d  wit hi n 
 a p p: 
•  C o nc o mita nt Me dicati o ns  
•  D H E Q -4 8  q uesti o n nair e  
•  N P R S  scale 
•  A d verse e ve nts   
8. 4  
W e e k 2 4  
T he f oll o wi n g d ata will b e c ollecte d  wit hi n 
 a p p: 
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Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 7  of 5 7  
•  C o nc o mita nt Me dicati o ns  
•  D H E Q -4 8  q uesti o n nair e  
•  N P R S scale  
•  Patie nts’ satisfacti o n wit h treat me nt ( NR S)  
•  A d verse e ve nts   
8. 5  
St u d y C o n cl u si o n  
T he St u d y C o n cl usi o n pa ge of t he e C R F (
 p ortal ) will be c o m plete d f or all s u bjects  
b y 
 virt ual site tea m.  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 b e rec or de d o n t he St u d y C o ncl usi o n pa ge, if 
a vaila ble. 
If a s u bject has a n y A Es at t he e n d of t he st u d y, G S K C H s h o ul d be n otifie d. A E s will be mar ke d 
as u nres ol v e d a n d st u d y PI/ d o ct or will as k t he s u bject t o see k a p pr o priate h ealt hcare 
pr ofes si o nal care, if a p plica ble.  
8. 6  
F oll o w -u p p h o n e c all  
 will  c o ntact a s u bject t o f oll o w u p o n S A E p ost -st u d y c o m pleti o n/ wit h dra wal  t o 
e ns ure a n y iss ues are res ol ve d . 
 m ust ma ke e v er y eff ort t o re gai n c o ntact wit h t he 
s u bject ( w here p ossi ble, 3 n otificati o ns). S h o ul d t he s u bject c o nti n ue t o be u nreac h a ble, t he 
S A E will be c o nsi dere d u nres ol ve d .  
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 acti vities are c o m plete d as  
descri be d .  
9. 1  
S cr e e ni n g A s s e s s m e nt s  
S u bject e li gi bilit y will be deter mi ned  base d o n t he i ncl usi o n/e xcl usi o n criteria a n d  scree ni n g 
q uesti o n naire . 
9. 2  
Q u alit y of lif e A s s e s s m e nt  
9. 2. 1  
D e nti n e H y p er s e n siti vit y E x p eri e n c e Q u e sti o n n air e  ( D H E Q) 
T he D H E Q -4 8  is a c o n diti o n-s pecific q uesti o n n aire t hat h as bee n pre vi o usl y vali date d i n  
lo n git u di nal st u dies a n d s h o w n t o be res p o nsi v e t o treat me nts  ( Ba k er et al, 2 0 1 4). T he 
brea k d o w n of t he D H E Q t otal sc ore i nt o 5 se p arat e d o mai n sc ores all o ws f or a m or e  gra n ular 
u n dersta n di n g of w hic h s pecific areas of i m pr o ve me nt s u bjects e x perie n ce i n  t heir oral h ealt h 
relate d q ualit y of life ( O Hr Q O L). T h e 5 d o mai ns, fr o m a s u bject’s p ers pecti ve, are:  
•  Restricti o ns  (t he wa ys i n w hic h a n y s e nsati o ns i n y o ur teet h affect y o u i n y o ur dail y 
life: c o m pile d fr o m s u bje ct res p o nses t o Secti o n 2, Q 1-4 ) 
•  A d a pt ati o n  (t he wa ys i n w hic h t he se nsati o ns i n y o ur teet h ha ve f orce d y o u t o c ha n ge 
t hi n gs i n y o ur dail y life: c o m pile d fr o m s u bject r es p o nses t o Secti o n 2, Q 5 -1 6 ) 
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May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 28 of 57 
• Social Impact (the ways the sensations affect you when you are with other people or in 
certain situations: compiled from subject responses to Section 2, Q17-21) 
• Emotional Impact (the way the sensations in your teeth make you feel: compiled from 
subject responses to Section 2, Q22-29) 
• Identity (about what the sensations in your teeth mean for you: compiled from subject 
responses to Section 2, Q30-34). 
In addition, the DHEQ provides further specific information through: 
• The Global Oral Health Rating (the subject’s perception of the overall health of their 
gums, mouth and teeth: compiled from subject responses to Section 2, Q35) 
• Effect on Life Overall Rating (the subject’s perception of the impact of DH on their 
overall quality of life (QoL): compiled from subject responses to Section 2, Q36-39).  
9.3 
Safety and Other Assessments 
There will not be any safety assessment. AEs will be monitored, recorded and handled during 
the entire study. 
9.3.1 
DH Pain Assessment 
The 11-item Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual 
analog scale (VAS) in which a respondent selects a number (0–10) that best reflects the intensity 
of his/her pain (Hawker et al, 2011; ROCHA et al, 2020). 
Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. 
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to 
'10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain 
imaginable”). 
 
Subjects will be asked to indicate the numeric value on the segmented scale that best describes 
their pain intensity and to report pain intensity “in the last 24 hours”. 
Scores range from 0-10 points, with higher scores indicating greater pain intensity. 
9.3.2 
Patient satisfaction with treatment 
The 11-item Numerical Rating Scale is an 11-point ordinal scale assessing satisfaction with the 
overall management of the condition for which the subjects sought help from treatment, from 0 
(completely dissatisfied) to 10 (completely satisfied). Higher scores depict higher satisfaction 
(van Berckel et al, 2017). 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 2 9  of 5 7  
S u bjects  will be as ke d t o i n dicate t he n u meric val ue o n t he se g me nte d scale t hat best descri bes 
t heir satisfacti o n wit h t he treat me nt after 2 4 wee k s of use.  
 
S u bjects  will be als o as ke d t o rec or d c o m me nts o n t heir sa tisfacti o n wit h treat me nt (e. g. Please 
gi ve m ore details o n w h y y o u are satisfie d or dissatisfie d wit h t he pr o d uct ) 
1 0  
A D V E R S E E V E N T S , S E RI O U S A D V E R S E E V E N T S  A N D 
P R E G N A N C Y E X P O S U R E  
 
 is 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  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  or t he st u d y, or t hat ca use d t he s u bject t o disco nti n ue 
t he st u d y pr o d u ct 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 was 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 b orat 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 m al 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 m eas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y si g nifi ca nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or (i.e., n ot relate 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 nic 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. 
•  Ne w c o n diti o ns dete cte d or dia g n ose 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 ve 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 pe r se will n ot be re p orte 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. 
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Page 30 of 57 
Events NOT meeting the AE definition:  
• Any clinically significant abnormal laboratory findings (if applicable) or other abnormal 
safety assessments which are associated with the underlying disease, unless judged by 
the investigator to be more severe than expected for the subject’s condition.  
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s 
condition.  
• Medical or surgical procedure (e.g. endoscopy, appendectomy) is not the AE. The 
condition that leads to the procedure is an AE (e.g. appendicitis). 
• Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen.  
10.2 
Definition of a Serious Adverse Event (SAE) 
A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse 
outcome is serious. If an event is not an AE per definition above, then it cannot be an SAE even 
if serious conditions are met (e.g. hospitalization for signs/symptoms of the disease under study, 
death due to progression of disease). 
A serious adverse event is any untoward medical occurrence at any dose that: 
• Results in death 
• Is life-threatening  
▪ The term 'life-threatening' in the definition of 'serious' refers to an event in which 
the subject was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe; 
• Requires inpatient hospitalization or prolongation of existing hospitalization  
▪ In general, hospitalization signifies that the subject has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether 
“hospitalization” occurred, or was necessary, the AE should be considered serious. 
▪ Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
• Results in persistent or significant disability/incapacity 
▪ The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
▪ This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (e.g. sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption 
• Results in congenital anomaly/birth defect 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 1  of 5 7  
•  Ot her sit u ati o ns:  
▪ Me dical or s cie ntific j u d g me nt s h o ul d be e x ercise d i n deci di n g w het h er S A E 
re p orti n g is a p pr o priate i n ot her sit uati o ns s uc h as i m p orta nt me dical e v e nts t hat 
ma y n ot b e i m me diatel y life -t hreate ni n g or res ult i n deat h or hos pitalizati o n b ut 
ma y j e o par dize t he s u bj ect or ma y re q uire me dical or s ur gical i nter ve nti o n t o 
pre ve nt o n e of t he ot her o utc o mes liste d i n t he a b o ve d efi niti o n. T hese e ve 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 o r mali g na nt ca ncers, i nte nsi ve tr eat 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 nc 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 
de pe n de n c y or dr u g a b us e.  
N ote:  Classificati o n of a n A E as ‘se ri 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  
D efi niti o n of H u m a n S af et y Inf or m ati o n ( H SI )  
H SI is defi n e d as i nf or m ati o n relati n g t o h u ma n h ealt h a n d/ or well bei n g f oll o wi n g e x p os ure t o 
G S K pr o d ucts. I n a d diti o n t o eve nts m eeti n g t h e A E d efi niti o n , H SI ca n als o i ncl u de:  
•  Fail ure t o pr o d u ce e x pecte d be nefits (i.e. l ac k of efficac y)  
•  Off -la b el use  
•  Dr u g a b use or effects of dr u g wit h dra wal  
•  Occ u pati o nal e x p os ure  
•  Patie nts ta ki n g G S K pr o d ucts w hilst pre g n a nt or breastfee di n g  
•  Pater nal e x p os ure t o a G S K pr o d uct bef ore a n d d uri n g pre g na n c y  
•  Tra ns missi o n of a n i nfecti o us a ge nt via a me dici nal pr o d uct  
•  Safet y i nf or mati o n recei v e d as part of a pr o d u ct q ualit y c o m plai nt  
•  U ne x pecte d t hera p e utic be nefits (i.e. a n u n e x pecte d i m pr o ve me nt i n a c o nc urre nt 
c o n diti o n ot her t ha n t he o ne bei n g treat e d)  
1 0. 4  
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 
A n y a d verse e ve nts  t h e s u bject e x perie nces i m me diatel y after t he y pr o vi de c o nse nt t o 
partici pate i n t he st u d y , b y t he c o m pleti o n (si g nat ure) of t he eI C, b ut pri or t he use of t he st u d y 
pr o d uct will be c ollecte d as M e dical H ist or y i n t he e C R F (
 a p p).  
A n y e ve nts e x perie nce d fr o m t he first us e of st u d y pr o d uct u ntil last a d mi nistrati o n of t he st u d y 
pr o d uct  will be rec or de d as A d verse E ve nts. 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 si g nat ur e  u ntil last a d mi nistrati o n of t he st u d y pr o d uct . 
Details rec or de d b y t h e s u bject o n t he 
 a p p t hat meet t he defi niti o n of a n A E m ust 
als o be disc usse d wit h t he s u bjects.  
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Pr ot oc ol N u m ber : 2 1 6 9 5 3  
 
 
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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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
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All S A Es will be rec or de d a n d re p orte d t o G S K C H  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. 
 will s u b mit a n y u p date d S A E data t o G S K C H  wit hi n 
2 4  h o urs of it bei n g a vail a ble . 
 is n ot o bli gate 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 v er, if 
 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 c o nsi ders t he e v e 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 p artici pati o n, 
 m ust 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 perati o ns Safet y R e p orti n g e mail b o x 
. T he 
G S K C H St u d y 
M a na ger or desi g nee 
will be 
res p o nsi ble f or f or war di n g t h e i nf or m ati o n t o t h e Case Ma na ge me nt Gr o u p, Gl o bal  Safet y 
gr o u p mail b o x at G S K 
. 
 will s u b mit a n y u p d ate d S A E data t o G S K C H wit hi n t he d esi g nat e d re p orti n g 
ti me fra mes. 
1 0. 5  
Pr o c e d ur e s f or R e p orti n g A E s a n d S A E s   
S p o nta ne o us re p orti n g of a d verse e ve nt s will be rec or de d i n t he 
 a p p a n d re p orte d 
a p pr o priatel y. Care will be ta ke n n ot t o i ntr o d uce bias 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. Partici pa nts will ha ve t he a bilit y t o re p ort c ha n ges t o t heir healt h via t he 
 a p p t hr o u g h t he Healt h C ha n ge F or m or c hat. Partici pa nt ma y als o c h o os e t o 
c o m m u nicate wit h t he virt ual site st u d y t ea m via e mail or p h o ne call t o re p ort a c ha n ge t o t heir 
healt h.  U p o n re p orti n g of healt h c ha n ge b y t he partici pa nt t hr o u g h t hes e met h o d ol o gies, st u d y 
d oct or or d esi g n ee will be alert e d t o reac h o ut t o t he partici pa nt t o f oll o w -u p f or a p ossi bl e 
a d verse e ve nt a n d d o c u m e nt t heir fi n di n gs wit hi n t he 
 st u d y p ortal. 
Eac h A E is t o be assesse d b y t he virt ual PI t o det er mi ne if it meets t he criteria f or a S A E. If a 
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.  
T he A Es/ S A Es will be rec or de d wit hi n 
 a p p. It is n ot acce pta bl e f or 
 
t o s hare a n y 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 he A E f or m. 
I n a d diti o n t o t he s u bject rec or di n g t he e v e nt o n t he 
 a p p, all S A Es will be re p orte d 
t o Case Ma na ge me nt Gr o u p ( C M G), Gl o bal Safet y at G S K C H ( G S K C M G).  
F oll o wi n g c o m pleti o n of t he s u bje ct A E pa ge wit hi n 
 a p p, 
 me dical 
q ualifie d pers o n will re vie w t he self -re p orte d i nf or mati o n a n d assess if t he A E meets t he 
defi niti o n of a n S A E. 
 will e nter a vail a ble i nf or mati o n i nt o t he S A E f or m a n d will 
f or war d t he c o m plete d S A E f or m t o G S K C M G wit hi n 2 4 h o urs  of recei vi n g t he q uesti o n nair e 
data.  
If a d diti o nal details are re q uire d fr o m t he s u bject i n or der t o deter mi ne if t he re p orte d A E meets 
S A E criteria, 
 will re -c o ntact t he s u bject t o q uer y t h e A E details.  If it is n ot p ossi ble 
t o re-c o ntact t he s u bject wit hi n 2 4 h o urs, 
 will c o m plete t he S A E f or m t o t he e xte nt 
p ossi ble wit h t he a vaila ble i nf or mati o n a n d will s e n d t o G S K C M G wit hi n t he 2 4 h o ur ti me 
fra me. 
 will c o ntact t he s u bject o n a  f urt her 3 occasi o ns t o atte m pt t o c ollect f urt her 
details a n d will s hare a d diti o nal i nf or mati o n  wit h G S K C M G.  
All c ollecte d S A E -relate d data s h o ul d be s e nt t o G S K 
C M G 
, G S K C H Cli nical O perati o ns Safet y R e p orti n g e m ail b o x 
 a n d t h e G S K cli nical st u d y m a na ger ass o ciate d wit h t he prese nt st u d y.  
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 3  of 5 7  
I n or der t o mai ntai n c o m plia nce wit h i nter nati o nal a n d nati o nal re g ul at or y b o dies, t he s u bject 
will be n otifie d i n t he eI C t hat t he y ma y be f urt her c o ntacte d i n or der t o c ollect a d diti o nal 
i nf or mati o n re q uire d t o e val uate t he p ote ntial e ve nt. 
A Es/ S A Es will be re p orte d t o l ocal a n d re gi o nal he alt h a ut h orities b y G S K C H, w he n 
a p pr o priate, i n acc or da n ce wit h a p plica ble l ocal a n d re gi o n al re g ulati o ns. Pr o m pt n otificati o n 
of S A Es b y 
 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 bj ects 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, etc. B ot h 
 a n d G S K C H will c o m pl y wit h all 
l ocal me dical de vice re p orti n g re q uir e me nts Safet y re p orts m ust be pre p are 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 ul at or y re q uir e me nts a n d 
s p o ns or p olic y. 
1 0. 6  
Pr o c e d ur e s f or R e p orti n g  H SI  
H SI  will be  m o nit ore d o n s ocial me dia  d uri n g s u bject recr uit me nt . If 
 i de ntifies 
H SI  i n c o m me nts/ p ost s u n der a d v ertise me nt material w hic h relate t o s u bject partici pati o n t o t he 
st u d y, 
 is res p o nsi ble t o e ns ure t he H SI  will be  s u b mitte d usi n g re p orti n g f or m 
pr o vi de d b y G S K C H  wit hi n 2 4 h o urs of a ware ness ( or ne xt w or ki n g da y if o ver a wee k e n d)  
via a  sec ure e m ail or f a x  t o: 
E mail a d dress: 
  
Fa x:  
 
G S K C M G 
 a n d t he G S K cli nical st u d y m a na ger 
ass ociate d wit h t he prese nt st u d y  will be c o pie d i n t he e mail . 
 is res p o nsi ble t o ret ai n rec or d t h at t he H SI  w as se nt/recei v e d f or A E 
rec o ncili ati o n at t he e n d of t he st u d y .  
1 0. 7  
Pr o c e d ur e f or r e p orti n g A E s  aft er st u d y c o m pl eti o n  
T he st u d y s u bjects will be all o we d t o retai n u n use d pr o d uct s after c o m pleti n g t he st u d y. 
S u bjects  will be as ke d t o re m o ve t he st u d y la bel fr o m t he t o ot h paste t u bes a n d t he y will be 
as ke d t o re p ort a n y iss ues/ q uesti o ns or c o m me nts as per c o m mercial t u be i nstr ucti o ns .  
1 0. 8  
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 an A E n ote d earlier, a n d rec or de d o n t he a p pr o priate A E e C R F (
 
a p p) pa ge.  
W he n a s u bject wit h dra ws beca use of 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. 9  
Pr e g n a n c y  
F or G S K C H st u dies i n w hic h n o dr u g i s utilize d or st u dies of si n gle-use mar kete d pr o d ucts t hat 
are classifie d as a n o n -m e dici nal pr o d uct i n t he mar ket w here t he testi n g is occ urri n g a n d t here 
is n o pre g na nc y war ni n g o n la belli n g, a pre g n a nc y test will n ot be re q uire d a n d it will n ot  be  a n 
e x cl usi o n criteria  f or t his st u d y. Pre g na nc y i nf or mati o n will be c ollecte d o nl y f or s p o nta n e o us 
pre g na nc y re p orts . 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 4  of 5 7  
1 0. 9. 1  
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  
 will rec or d pre g na nc y i nf or mati o n o n t he a p pr o priate f or m a n d e -mail it  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 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 n a nt. T he G S K  C H St u d y Ma n a ger or 
desi g nee will be res p o nsi ble f or f or war di n g t he pre g na n c y f or m t o t he  Case Ma n a ge me nt 
Gr o u p, Gl o bal Safet y mail b o x  
.  
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 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 a n d t he G S K C H St u d y Ma n a ger or d esi 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 Safet y 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 o ll o wi n g t he esti mate d deli ver y date. A n y ter mi nati o n of t he pre g na 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. 
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 e C R F is u n derst o o d t o refer t o a n electr o nic data rec or d 
(
 p ortal ).  
F or t his st u d y, s u bject data will be e ntere d i nt o t he 
 a p p, a vali date d s yste m. Dat a 
relati n g t o S A Es a n d pre g na n c y will als o be c ollecte d o n s pecifi c f or ms. 
 is res p o nsi ble f or verif yi n g t h at data e ntries are acc urate i n t he e C R F. 
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 bje ct 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 or me d c o nse nt  the eC R F (
 p ortal ) m ust be 
c o m plete d a n d re vie we d f or c o m pleti o n a n d acc urac y. 
 m ust mai ntai n acc urate 
d oc u me ntati o n t hat s u p p orts t he i n f or mati o n e ntere d i n t he e C R F. 
Ma na ge me nt of cli nical data will be perf or me d i n acc or da nce wit h 
 a p plica bl e 
sta n dar ds a n d data 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 
data, 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. 
T o pr otect t he pri v ac y of s u bjects, n o Pers o nal l y I de ntifia ble I nf or mati o n ( PII) (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 eC R F or as part of t he q u er y 
te xt. 
Data c ollecti o n, pr o cess es as o utli ne d i n 
 pr ocesses a n d S O Ps will be d oc u me nte d 
via Data Ma n a ge me nt Pla n.   
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 5  of 5 7  
All eC R F  (
 p ortal ) pa ges s h o ul d b e c o m plete d b y  s u bjects w he n t he eC R F has b ee n 
desi g nat e d as t he s o urce.    
G S K C H will o btai n a n d retai n all eC R Fs a n d ass ociate d st u d y data 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  
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.  
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 Electr o nic Data Ca pt ure ( E D C) 
S yste m, 
 a p p, a n d it will i ncl u de rati o nale f or c ha n ges. T he E D C s yst e 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 he c h a n ges a n d c orrect i o ns e n d orse d b y 
 
A d verse e v e nts will be c o de d usi n g Me di cal Di cti o nar y f or Re g ulat or y Acti vities ( Me d D R A) 
a n d a n y c o n c o mita nt me dicati o ns ter ms (if a p plica ble) usi n g a n i nter nal v ali date d me dicati o n 
dicti o nar y,  
.   
1 1. 2. 1  
D at a Q u eri e s  
T he 
 data ma na ge me nt tea m will perf or m e dit c hec ks as t he data are bei n g e ntere d 
i nt o t he s yste m, a n d q u eries will be e ntere d o n a d ata iss ues l o g f or t h e dece ntralize d site staff 
t o a d dress. T he Cli nical Dicti o nar y De vel o p me nt a n d Ma n a ge me nt Gr o u p will  raise q u eries as 
nee de d o n safet y data t o c o de t he ter ms ( A Es a n d Dr u gs or c o nc o mita nt me dicati o n) 
a p pr o priatel y.   
1 1. 3  
Pr o c e s si n g P ati e nt R e p ort e d O ut c o m e s  
Electr o nic Patie nt re p ort e d o utc o me (e P R O) dat a will  be c ollect e d usi n g el ectr o nic d e vices a n d 
tra nsferre d el ectr o nicall y t o G S K C H or 
 
T o pr otect t he pri vac y of s u bjects, n o PI I (i n cl u di n g t he s u bject's na m e or i nitials or birt h date) 
is t o be rec or de d o n a n y P R O/e P R O t hat will be f or war de d t o G S K C H or 
 
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  
N o f or mal sa m ple siz e calc ulati o n has bee n  perf or me d f or t his st u d y h o we v er s ufficie nt s u bjects 
will be scree ne d (esti mat e d scree n fail ure 5 0 %) t o ha ve a p pr o xi matel y 6 5 0  s u bjects e nr olle d 
a n d 4 0 0 c o m pleters  (esti mate d 4 0 % dr o p -o ut) .   
T here is n o pri or i nf or m ati o n f or t he use of D H E Q i n D H s ufferers i n a R W E s etti n g. It is 
belie ve d t hat f or t his st u d y 4 0 0 s u bjects are dee me d s ufficie nt t o o bser ve a tre n d o ver ti me fr o m 
baseli ne at 2 4 wee ks i n t otal sc ore.  
1 2. 2  
P o p ul ati o n s  for A n al y si s  
T he S cree ne d p o p ulati o n will i ncl u de s u bjects w h o si g n t he eI C  a n d e nter t he scree ni n g pr ocess 
of assess me nt of i ncl usi o n a n d e x cl usi o n criteria.  
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C CI

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 36 of 57 
The Enrolled population will include all subjects who meet the inclusion/exclusion criteria and 
identified by the screening questionnaire 
The Safety population will include all subjects who receive at least one dose of study product. 
Safety population will be used of safety variables. 
The modified Intent-To-Treat (mITT) population will include all subjects who receive at least 
one dose of study product and have at least one post baseline DHEQ-48 questionnaire data. 
Efficacy data will be summarized using the mITT population only. 
12.3 
Sub-Group classification  
A total of 4 different groups will be identified at screening for the purposes of sub-group 
analyses:  
• Age group  
o ≤ 40 years old 
o > 40 years old 
• Diagnosis  
o self-reported DH without previous diagnosis by a dentist 
o self-reported DH with previous diagnosis by a dentist 
• Use of sensitivity toothpaste  
o Non-users – will include subjects who are not currently using a sensitivity 
toothpaste e.g. first-time user  
o Intermittent users – will include subjects who sometimes use a sensitivity 
toothpaste 
o current users – will include subjects who regularly (daily) use a sensitivity 
toothpaste  
• Self-reported DH frequency 
o frequent = Several times a day, Once a day, Several times a week 
o less frequent = Once a week, Several times a month, once a month, less than 
once a month 
12.4 
Statistical Analyses 
Additional details of the proposed statistical analysis will be documented in the statistical 
reporting and analysis plan (RAP), which will be written following finalization of the protocol 
and prior to study analysis (as appropriate). This section is a summary of the planned statistical 
analyses including primary and exploratory endpoints. Additional details for exploratory 
endpoints will be further described in detail in the RAP. 
12.4.1 
Primary Analysis  
For the primary objective, plots of the mean values for section 1 questions Q1-3, and questions 
in section 2 for total DHEQ score – section 2 (sum Q1-34), each of the domain’s mean values 
(Restrictions – sum Q1-4, Adaptation – sum Q5-16, Social Impact – sum Q17-21, Emotional 
Impact – sum Q22-29, Identity – sum Q30-34), Global oral health (Q35) and Effect on life 
overall (sum Q36-39) will be presented over 24 weeks to assess QoL over time in the overall 
population of DH sufferers, graphically.  
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 7  of 5 7  
1 2. 4. 2  
S af et y A n al y s e s  
All A Es will be c o de d usi n g Me d D R A. A Es will be cate g orize d  as oral a n d n o n -oral b y 
 pri or t o data base l oc k. T he n u m ber of A Es / S A Es a n d n u m ber of s u bjects wit h 
A Es / S A Es will be liste d a n d ta b ulate d . 
1 2. 4. 3  
Ot h er A n al y s e s  
T he e x pl orat or y e n d p oi nts will be a nal yz e d as f oll o ws . F urt her d etails will be pr o vi de d i n t he 
R A P.  
•  Pl ot o ver ti me i n D H E Q mea n  sc ores f or eac h s u b-gr o u p  
F or t he e x pl orat or y o bje cti ve  relatin g t o s u b -gr o u ps , pl ots of t he mea n v al ues f or secti o n 1 
q uesti o ns Q 1 -3 , a n d q uesti o ns f or secti o n 2 t otal D H E Q sc ore –  secti o n 2 (s u m Q 1-3 4), eac h of 
t he d o mai n’s me a n val u es ( Restricti o ns –  s u m Q 1-4, A da ptati o n –  s u m Q 5-1 6, S ocial I m pact –  
s u m Q 1 7-2 1, E m oti o nal I m p act –  s u m Q 2 2-2 9, I d e ntit y –  s u m Q 3 0-3 4), Gl o bal oral healt h 
( Q 3 5) a n d Effect on  life o verall (s u m Q 3 6-3 9)  will be prese nte d o ver 2 4 wee ks t o a ssess Q o L 
o ver ti me i n t he  f urt her c haracterisati o n of D H s ufferers b y s u b-gr o u p classificati o n , 
gra p hicall y.  
•  D H E Q Mea n sc ores o ver ti me c o m pare d t o b aseli ne ( 0, 4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks ) t o be 
a nal ys e d f or o ve rall D H s ufferers a n d eac h s u b -gr o u p  
T he e x pl orat or y res p o ns e varia ble is t he D H E Q mea n sc ore at 0, 4, 8, 1 2, 1 6, 2 0 a n d 2 4 wee ks  
res pecti vel y i n t otal sc ore, eac h of t he D H E Q d o mai n sc ores, q uesti o ns Q1 -3 , Gl o bal oral healt h 
a n d Effect o n  life o verall.   
A n A nal ysis of V aria n ce ( A N O V A) m o d el will be use d t o a nal yz e t he D H E Q sc ore as t he 
res p o nse varia bl e a n d ti me p oi nt as t he de pe n de nt varia ble.  S u bject will be i ncl u de d as a ra n d o m 
effect. Eac h p ost baseli ne ti me p oi nt will be c o m pare d t o baseli ne usi n g t h e  a dj uste d mea ns fr o m 
t he ti me varia ble fr o m t he m o del. 
F or t he a nal ysis of t h e 4 s u b gr o u ps, a n e xtra fact or f or t he s u b gr o u p will be i ncl u de d al o n g wit h 
t he s u b gr o u p *ti me p oi nt i nteracti o n. T his will e n a ble t o l o o k at t he differe nces b et wee n s u b-
gr o u p a n d t he i nteracti o n ter m will e na ble a dj uste d mea ns of eac h s u b gr o u p o ver ti me.  
F or t he A N O V A if t he u n derl yi n g ass u m pti o ns are n ot met, alter nati ve met h o ds will be s o u g ht, 
i ncl u di n g tra nsf or mati o ns or n o n-para metric met h o ds .  
•  P erce nta ge of D H s ufferers w h o a gree (sc ore 5 -7) t o ite ms i n eac h res pecti ve d o mai n at 
baseli ne a n d w ee k 2 4  
A ta ble f or perce nta ge of c o ns u mers w h o a gree (sc ore 5 -7) t o ite ms i n eac h d o mai n at baseli n e 
a n d at wee k 2 4  res p ecti v el y will als o be prese nte d as part of t his o bjecti ve  
•  N u m eric Pai n Rati n g Scale ( N P R S) Mea n sc ores o ver ti me c o m pare d t o baseli ne ( 0, 4, 8, 
1 2, 1 6, 2 0 a n d 2 4 wee ks ) t o be a nal yse d f or o verall D H s ufferers a n d eac h s u b -gr o u p  
T he e x pl orat or y res p o nse varia ble is t he N P R S mea n sc ore at 0, 4, 8, 1 2, 1 6, 2 0 a n d 2 4 we e ks. 
A n A nal ysis of V aria nce ( A N O V A) m o del will be use d t o a nal yze t he N P R S sc ore as t he 
res p o nse varia ble a n d ti m e p oi nt as t he de pe n d e nt varia ble. S u bject will be i n cl u de d as a ra n d o m 
effect. Eac h p ost baseli ne ti me p oi nt will be c o m pare d t o baseli ne usi n g t h e a dj uste d mea ns fr o m 
t he ti me varia ble fr o m t he m o del.  
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GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 38 of 57 
For the analysis of the 4 subgroups, an extra factor for the subgroup will be included along with 
the subgroup*timepoint interaction.  This will enable to look at the differences between sub-
group and the interaction term will enable adjusted means of each subgroup over time.    
For the ANOVA analyses if the underlying assumptions are not met, alternative methods will 
be sought, including transformations or non-parametric methods.  
A plot over time in NPRS mean scores will also be presented along with a table reporting the 
percentage of participants who achieve pain reduction identified as clinically important (pain 
reduction NPRS > 30%)  
• Satisfaction Numerical rating scale (NRS)  
The satisfaction Numerical rating scale will be summarized using frequencies at week 24. 
Similar summaries will be presented for overall population and each of the subgroups.   
• Oral hygiene habits of DH sufferers according to oral hygiene questionnaire  
A summary of oral hygiene habits at baseline will be provided as part of this objective 
12.4.4 
Exclusion of Data from Analyses  
Exclusion of any data from the analyses will be determined during a data review meeting prior 
to database lock and pre-defined in the RAP. Any reasons for exclusion from an analysis 
population will be listed, if applicable. As there is no PP analysis planned, only an assessment 
of subjects being in the safety and mITT populations will be made.  
12.4.5 
Demographic and Baseline Characteristics 
Age and other continuous demographic and baseline variables will be summarized using 
descriptive statistics such as mean, range, median and standard deviation. Gender, race, 
ethnicity and other categorical demographic and baseline variables will be summarized using 
frequency counts and percentages for the safety and mITT populations. 
12.4.6 
Study Product Compliance and Use of Other Therapies 
12.4.6.1 Study Product Compliance 
Study product compliance and compliance to the study schedule will be tabulated and 
summarized for the safety population. 
Summaries will include a simple yes/no frequency (and percent) count at each timepoint: 
• Summary of completion to study schedule and assessments (yes/no) 
• Summary of product usage according to product instructions (yes/no) 
• Summary of number of tubes remaining at the end of the study (number remaining) 
12.4.6.2 Prior and Concomitant Medications 
Concomitant medications taken during the study will be listed for the safety population. 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 3 9  of 5 7  
1 2. 4. 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  
Missi n g data d u e t o ge n eral dr o p o ut/ wit h dra wals will be assesse d o n a n o n g oi n g basis d uri n g 
t he st u d y. A n y f urt her se nsiti vit y a nal ys es nee d e d d ue t o missi n g data will be re vie we d at t he 
ti me of data re vie w.  
F or t he D H E Q data, f or a n y ti me p oi nt  if res p o nse is missi n g will be e x cl u de d fr o m t he pri mar y 
a nal ysis h o w e ver t he dat a a vaila ble f or eac h s u bj ect (e ve n t h o u g h s o me ti me p oi nts ma y be 
missi n g) will still be i ncl u de d i n t he a nal ysis.  
1 2. 4. 8  
I nt eri m A n al ysi s  
N o i nteri m a nal ysis is 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  
W he n re vie 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 eC R F will se r ve as t he s o urce 
d oc u me nt.  
D uri n g t h e st u d y, t he d at a will be m o nit ore d t o verif y t h at:  
•  Data 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.  
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 ass ess me nt a n d/ or a u dit of t he 
 rec or ds, a n d t h e 
re g ulat or y a ge nci es ma y c o n d uct a re g ulat or y i ns pecti o n at a n y ti me d uri n g or after c o m pleti o n 
of t he st u d y.  
I n t he e ve nt of a n assess me nt, a u dit or i ns pe cti 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) dir ect access t o all rele va nt d oc u me nts a n d t o all ocate 
t heir ti me 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 va 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 nt ati ve acti o ns t o a d dress a n y fi n di n gs/iss ues i de ntifie d.  
 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.  
T he G S K C H  will be a vaila ble t o hel p 
 pre pare f or a n i ns pecti o n.  
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 o ar d/ Et hi c s C o m mitt e e  
It is t he res p o nsi bilit y of 
 t o ha ve pr os pecti ve a p pr o val of t he st u d y pr ot oc ol, 
pr ot oc ol 
a me n d me nts,  i nf or m 
c o ns e nt d oc u me nts, 
a n d 
ot her rele va nt 
d o c u me nts, 
e. g. recr uit me nt a d vertise me nts, if a p plica bl e, fr o m t he I R B/ E C. All c orres p o n de nce wit h t he 
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 0  of 5 7  
I R B/ E C s h o ul d be retai n e d i n t he e T M F. C o pies of I R B/ E C 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 m a 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/ E C a p pr o val is 
w here t h e c h a n ge is ne cessar 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 ve nt, t he i n vesti gat or m ust n otif y t he I R B/ E C 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 Scie n ces 2 0 0 2), 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 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 6), 
g ui deli nes f or G C P (I C H 1 9 9 6 a n d re visi o n 2), a n d t he Declarati o n of Helsi n ki ( W orl d Me dical 
Ass ociati 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 n d a p plica ble l ocal re g ul at or y re q uire me nts a n d la ws.  
1 3. 3. 3  
S u bj e ct I nf or 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.   
 will mai ntai n a c o nfi de n tial list of s u bjects w h o p artici 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 dat a 
c o nsiste nt  wit h a p plica ble pri vac y la ws.  
T he  i nf or m eI C  d oc u me nts 
m ust be i n c o m plia nce 
wit h I C H 
G C P, l ocal re g ulat or y 
re q uire me nts, a n d l e gal r e q uire me nts, i ncl u di n g a p plica ble pri vac y l a ws. 
T he  i nf or m eI C 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 he s p o ns or, a p pr o ve d b y t he I R B/ E C bef ore us e, a n d a vaila ble f or i ns pecti o n.  
 m ust e ns ure t hat eac h st u d y s u bject,  is f ull y i nf or me d a b o ut t he nat ure 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 partic i pati o n.  
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 ma y be use d as recr uit me nt pr oce d ures.   Us e of et hics 
c o m mittee a p pr o ve d, ge n eric, pre -scree ni n g q u esti o n naire t o assess b asic s u bject c haracteristics 
t o deter mi ne ge neral eli gi bilit y f or this st u d y is all o we d.  T his pre -scree ni n g q uesti o n naire will 
be accesse d b y s u bjects clic ki n g o n a ds o n s oci al me dia , w hic h will direct t he m t o a la n di n g 
pa ge.      
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Cli nical Pr ot oc ol  
 
 
Pr ot oc ol N u m ber : 2 1 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 1  of 5 7  
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 breac 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 
 is a ware of a n y ne 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 b e nefits 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, 
 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 
t o pr otect t he st u d y s u bj ects a gai nst a n y i m me di ate hazar d, a n d of a n y s eri o us breac hes of t his 
pr ot oc ol or of I C H G C P t ha t 
 bec o mes 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  
N/ A  
1 3. 6  
R e c or d s R et e nti o n  
F oll o wi n g cl os ur e of t he st u d y, 
 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 eC R Fs or ot her d oc u me nts s u b mitte d t o G S K C H, s u bj ects s h o ul d n ot b e 
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. 
 s h o ul d kee p a 
se parat e l o g of s u bjects’ c o des, na mes a n d a d dresses.  D oc u me nts n ot f or s u b missi o n t o G S K 
C H, s h o ul d be mai ntai ne d b y 
 i n strict c o nfi de nce. 
Rec or ds a n d d oc u m e nts, i ncl u di n g si g n e d e I C, 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 
 as per t he si g ne d c o ntr act ual a gr ee me nt, fr o m t h e 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 ble t o t hat site f or t he st u d y ( U S re q uire me nt is 3 0 years), 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 me 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 
. 
 m ust n otif y G S K C H of a n y c ha n ges i n t he arc hi val 
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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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 2  of 5 7  
arra n ge me nts, i ncl u di n g, b ut n ot li mite d t o, tra nsfer of o w ners hi p of t h e rec or ds i n t he e v e nt t he 
i n vesti gat or is n o l o n ger ass ociate d wit h t he site. 
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.   
If a st u d y is pre mat urel y ter mi nat e d, G S K C H will pr o m ptl y n otif y 
 After 
n otificati o n, 
 m ust pr o m ptl y c o ntact all partici p ati n g s u bj ects a n d s h o ul d ass ure 
a p pr o priate 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 mate rials 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 uire d b y t h e 
a p plica ble re g ulat or y re q uire me nts, G S K C H s h o ul d i nf or m t he re g ul at or y a ut h orit y(i es) a n d 
 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 he 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.   
If t he I R B/ E C ter mi nates or s us pe n ds its a p pr o val/fa v ora bl e o pi ni o n of a trial, 
 
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 
o f 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 st u d y acc o u nta ble 
pers o n will c o n d uct cl os ure acti vities wit h 
 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  
A d d y M, M ostafa P, A bsi E , et al., e dit ors. C er vical de nti n h y p erse nsiti vit y: Eti ol o g y a n d 
ma na ge me nt 
wit h parti c ular refere nce t o de ntifrices. Pr ocee di n gs of S y m p osi u m o n 
H y p erse nsiti ve D e nti n: Ori gi n a n d M a na ge m e nt; 1 9 8 5: U ni versit y of Mic hi ga n.  
A d d y M. D e nti ne h y p ers e nsiti vit y: Ne w pers pecti ves o n a n ol d pr o ble m. I nter nati o nal De ntal 
J o ur nal. 2 0 0 2; 5 2( 5 ( S u p ple me nt 1)): 3 6 7-7 5.  
A d d y M, S mit h S. De nti n h y p erse nsiti vit y: A n o v er vie w o n w hic h t o base t u b ule occl usi o n as 
a ma na ge m e nt c o nce pt. T he J o ur nal of cli nical de ntistr y. 2 0 1 0; 2 1( 2): 2 5.  
Ba ker S R, Gi bs o n BJ, S ufi F , et al. T he de nti ne h y perse nsiti vit y e x perie nce q uesti o n naire 
( d he q): A l o n git u di nal vali dati o n st u d y. J Cli n Peri o d o nt ol. 2 0 14; 4 1: 5 2 -9. d oi: 1 0. 1 0 1 6/ B 9 7 8 -
0 -1 2 -8 0 1 6 3 1 -2. 0 0 0 0 9 -9.  
Başara n S, Celi k C. T ur kis h a da ptati o n of de nti ne h y p erse nsiti vit y e x perie nce q uesti o n nair e 
( d he q). C o m m u nit y De nt Healt h. 2 0 1 8; 3 5( 1): 4 7-5 1.  
Be kes K, J o h n M T, Sc haller H G , et al. Oral healt h ‐ relate d q u alit y of life i n patie nts see ki n g 
care f or de nti n h y perse nsiti vit y. J o ur nal of oral r e ha bilitati o n. 2 0 0 9; 3 6( 1): 4 5-5 1.  
B oi k o O V, Ba ker S R, Gi bs o n BJ , et al. C o nstr ucti o n a n d vali dati o n of t he q ualit y of life 
meas ure f or 
de nti ne 
h y perse nsiti vit y ( d he q). 
J o ur nal  of 
cli nical 
peri o d o nt ol o g y. 
2 0 1 0; 3 7( 1 1): 9 7 3 -8 0.  
Brä n nstr ö m M. A h y dr o d y na mic mec h a nis m i n t he tra ns missi o n of pai n -pr o d uci n g sti m uli 
t hr o u g h t he d e nti ne. I n: A n ders o n DJ, e dit or. Se ns or y mec ha nis ms i n de nti ne; R o yal S ociet y of 
Me dici ne, L o n d o n: O xf or d: Pe r ga m o n Press; 1 9 6 3. p. 7 3-9.  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
P P D
P P D
P P D
P P D
P P D

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 43 of 57 
Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for 
the diagnosis and management of dentin hypersensitivity. Journal (Canadian Dental 
Association). 2003;69(4):221-6. 
Cunha-Cruz J, Wataha JC, Zhou L, et al. Treating dentin hypersensitivity: Therapeutic choices 
made by dentists of the northwest precedent network. The Journal of the American Dental 
Association. 2010;141(9):1097-105. 
Dababneh R, Khouri A, Addy M. Dentine hypersensitivity - an enigma? A review of 
terminology, mechanisms, aetiology and management. British dental journal. 1999;187:606-11. 
Douglas-De-Oliveira DW, Lages FS, Paiva SM, et al. Cross-cultural adaptation of the brazilian 
version of the dentine hypersensitivity experience questionnaire (dheq-15). Brazilian oral 
research. 2018;32. 
Gibson BJ, Boiko OV, Baker SR, et al. The everyday impact of dentine sensitivity: Personal 
and functional aspects.  Dentine hypersensitivity: Elsevier; 2015. p. 89-107. 
Hall RC, Embery G, Shellis RP, editors. Biological and structural features of enamel and 
dentine: Current concepts relevant to erosion and dentine hypersensitivity. Tooth Wear and 
Sensitivity; 2000: Martin Dunitz. 
Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual analog scale for pain 
(vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short‐
form mcgill pain questionnaire (sf‐mpq), chronic pain grade scale (cpgs), short form‐36 
bodily pain scale (sf‐36 bps), and measure of intermittent and constant osteoarthritis pain 
(icoap). Arthritis care & research. 2011;63(S11):S240-S52. 
He S-l, Wang J-h. Reliability and validity of the chinese version of the short form of the dentine 
hypersensitivity 
experience 
questionnaire 
(dheq-15). 
Quality 
of 
Life 
Research. 
2015a;24(6):1465-9. 
He S, Wang J. Development of the chinese version of the dentine hypersensitivity experience 
questionnaire.  Dentine hypersensitivity: Elsevier; 2015b. p. 165-75. 
Heft MW, Litaker MS, Kopycka-Kedzierawski DT, et al. Patient-centered dentinal 
hypersensitivity treatment outcomes: Results from the national dental pbrn. JDR Clinical & 
Translational Research. 2018;3:76-82. 
Kopycka-Kedzierawski DT, Meyerowitz C, Litaker MS, et al. Management of dentin 
hypersensitivity by national dental practice-based research network practitioners: Results from 
a questionnaire administered prior to initiation of a clinical study on this topic. BMC oral health. 
2017a;17(1):41. 
Kopycka-Kedzierawski DT, Meyerowitz C, Litaker MS, et al. Management of dentin 
hypersensitivity by practitioners in the national dental practice-based research network. The 
Journal of the American Dental Association. 2017b;148(10):728-36. 
Litaker MS, Kopycka-Kedzierawski DT, Rindal DB, et al. Concordance between practitioner 
questionnaire responses and observed clinical treatment recommendations for treatment of 
dentin hypersensitivity: Findings from the national dental practicebased research network. 
BMC Oral Health. 2019;19:112. 
Machuca C, Baker S, Sufi F, et al. Derivation of a short form of the dentine hypersensitivity 
experience questionnaire. J Clin Periodontol 2014;41:46–51. 
Mason S, Burnett GR, Patel N, et al. Impact of toothpaste on oral health-related quality of life 
in people with dentine hypersensitivity. BMC Oral Health. 2019;19:1-11. 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

GSK Consumer Healthcare 
 
Clinical Protocol 
 
 
Protocol Number: 216953 
 
 
Property of GSK Consumer Healthcare - Confidential  
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
SOP-208661 Clinical Protocol Template v6.0 
Page 44 of 57 
Porritt JM, Sufi F, Baker SR. Utilising daily diaries to examine oral health experiences 
associated with dentine hypersensitivity. BMC Oral health. 2016;16:1-11. doi: 10.1186/s12903-
016-0286-9. 
Robinson PG. Dentine hypersensitivity: Developing a person-centred approach to oral health: 
Academic Press; 2014. 
ROCHA MOC, CRUZ AACF, SANTOS DO, et al. Sensitivity and specificity of assessment 
scales of dentin hypersensitivity–an accuracy study. Brazilian Oral Research. 2020;34. 
Sherman RE, Steven A. Anderson, Pan GJD, et al. Real-world evidence — what is it and what 
can it tell us? n engl j med 2016;375:2293-7. 
van Berckel MM, Bosma NH, Hageman MG, et al. The correlation between a numerical rating 
scale of patient satisfaction with current management of an upper extremity disorder and a 
general measure of satisfaction with the medical visit. Hand. 2017;12(2):202-6. 
West N. Dentine hypersensitivity. In: Lussi A, editor. Dental erosion. Monogr oral sci. 20. 
Basel: Kager; 2006. p. 173-89. 
 
15 
APPENDICIES 
15.1 
ABBREVIATIONS 
The following is a list of abbreviations that may be used in the protocol. 
Table 15-1 
Abbreviations 
 
Abbreviation 
Term 
AE 
adverse event 
ANOVA 
analysis of variance 
CMG 
Case Management Group 
CSR 
Clinical study report 
DH 
Dentin hypersensitivity 
DHEQ 
Dentin hypersensitivity experience questionnaire 
EC 
ethics committee 
ECG 
Echocardiogram 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
eICF 
Electronic informed consent form 
ePRO 
Patient reported outcome 
eTMF 
Electronic trial master file 
GCP 
Good Clinical Practice 
GSKCH 
GlaxoSmithKline Consumer Healthcare 
HSI 
Human subject information 
ICH 
International Conference on Harmonization 
IRB 
institutional review board 
K 
potassium 
MedDRA 
Medical dictionary for regulatory activities 
216953 | Protocol clinical protocol 08 Jul 2022 | TMF-194147 | 2.0

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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 5  of 5 7  
A b br e vi ati o n  
T er m  
M F C  
M a st er F or m ul ati o n C o d e  
N/ A  
n ot a p pli c a bl e  
N P R S  
N u m eri c P ai n R ati n g S c al e  
N R S  
N u m eri c R ati n g S c al e  
O Hr Q o L  
Or al h e alt h r el at e d  q u alit y of lif e  
PI I 
P er s o n al I d e ntifi a bl e Inf or m ati o n  
R A P  
r e p orti n g a n d a n al y si s pl a n 
R C T s  
R a n d o mi z e d c o ntr oll e d tri al s  
R W D  
R e al w orl d d at a  
R W E  
R e al w orl d e vi d e n c e  
S A E  
S eri o u s a d v er s e e v e nt  
S U S A R  
S u s p e ct e d u n e x p e ct e d s eri o u s a d v er s e e v e nt  
V A S  
Vi s u al a n al o g u e s c al e  
 
1 5. 2  
S cr e e ni n g q u e sti o n n air e  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 6  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 7  of 5 7  
 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 8  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 4 9  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 0  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 1  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 2  of 5 7  
 
 
 
 
S E C TI O N T W O  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 3  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 4  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 5  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 6  of 5 7  
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 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 6 9 5 3  
 
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  
S O P -2 0 8 6 6 1 Cli nical Pr ot oc ol Te m plate v 6. 0  
Pa ge 5 7  of 5 7  
 
 
 
 
 
 
 
 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
C CI

Si g nat ure Pa ge f or  2 1 6 9 5 3 T M F- 1 9 4 1 4 7 v 2. 0
Si g nat ure Pa ge f or T M F- 1 9 4 1 4 7 v 2. 0
Reas o n f or si g ni n g: A p pr o ve d
Na me: 
R ole: A
Date of si g nat ure: 
Reas o n f or si g ni n g: A p pr o ve d
Na me: 
R ole: A
Date of si g nat ure: 
Reas o n f or si g ni n g: A p pr o ve d
Na me: 
R ole:
Date 
2 1 6 9 5 3 | Pr ot oc ol cli nical pr ot oc ol 0 8 J ul 2 0 2 2 | T M F- 1 9 4 1 4 7 | 2. 0
P P D
P P D
P P D
P P D
P P D
P P D