A Randomized, Single-Blind, Clinical Study to Assess Food Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, Edentulous Subjects
Phase: PHASE4
Conditions: Denture Retention
Sponsor: GlaxoSmithKline

Clinical Protocol 
209649 
A Randomized, Single-Blind, Clinical Study to Assess 
Food Occlusion Efficacy of a Marketed Denture 
Adhesive in Healthy, Edentulous Subjects
NCT03709810 
GlaxoSmithKline Consumer Healthcare 
184 Liberty Corner Road, Warren, NJ, 
07059, USA
1. Protocol approval date: 31-08-2018
2. Final Amendment to Protocol approval date: 08-02-2019
Copyright: GlaxoSmithKline. This document contains confidentiality statements 
that are not relevant for this publicly available version

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
This document contains confidentiality statements that are not relevant for this publicly 
available version
GlaxoSmithKline Consumer Healthcare Confidential
May not be used, divulged, published or otherwise disclosed without the consent of GSK CH. 
Template Version Effective: 18-May-18 (CCR #11475)
Page 1 of 60
CLINICAL PROTOCOL
A Randomized, Single-Blind, Clinical Study to Assess Food 
Occlusion Efficacy of a Marketed Denture Adhesive in Healthy, 
Edentulous Subjects.
Protocol Number:
209649
Compound/Product Name:
Sodium-calcium mixed partial salt of 
poly(methylvinylether/maleic acid) and 
carboxymethylcellulose
United States (US) Investigational 
New Drug (IND) Number:
Not applicable
European Clinical Trials Database 
(EudraCT) Number:
Not applicable
Other Regulatory Agency Identified 
Number:
Not applicable
Phase:
IV

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 2 of 60
Sponsor Information
Sponsor Name & Legal 
Registered Address
GlaxoSmithKline Research & Development 
Limited
980 Great West Road,
Brentford,
Middlesex,
TW8 9GS,
United Kingdom (UK)
Sponsor Contact Details
GlaxoSmithKline Consumer Healthcare (GSK CH)
184 Liberty Corner Road, Warren, NJ, 07059, 
USA

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 3 of 60
Document History
Document
Version
Summary of Changes 
Original protocol
1.0
Not applicable (N/A)
Amendment 1
2.0
1. Name of product change throughout protocol
from SuperPoligrip Max Seal (SPMS) to
COREGA Máximo Sellado/Selamento.
2. Subscript “e” added as footnote to Section 1.1
Schedule of Activities, Table 1.1 to align with
Section 8.1.
3. Section 5.4- change of duration for Lifestyle
Considerations from Visits 2-4 to Visits 2-3.
4. Section 9.1.3- modification that the denture
bearing tissue score will be recorded for both
maxillary and mandibular dentures rather than
just the mandibular denture.
Amendment 2
3.0
1. Section 12.2.6- clarification of success criteria
to align with the formal study success criteria
stated in Section 3.
Amendments incorporate all revisions to date, including amendments made at the request of 
country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc.  

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 4  of 6 0
Pri n ci p al I n v e sti g at or Pr ot o c ol A gr e e m e nt P a g e

I c o nfir m a gree 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 nal C o nfere nce o n Har m o nisati o n G o o d 
Cli nical Practice (I C H G C P) g ui deli nes a n d I S O 1 4 1 5 5: 2 0 1 1 ( E).

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 o n d uct or 
s u per vise t he descri be d st u d y.

I a gree t o e ns ure t hat all 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 ves all a p pr o priate i nf or mati o n t hr o u g h o ut t he 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 vesti gat or Na me:
I n vesti gat or Q ualificati o ns:
I n vesti 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
P P D

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 5 of 60
Table of Contents
Sponsor Information ............................................................................................................2
Document History................................................................................................................3
Principal Investigator Protocol Agreement Page.................................................................4
Table of Contents.................................................................................................................5
1
PROTOCOL SUMMARY.................................................................................................10
1.1
Schedule of Activities............................................................................................12
2
INTRODUCTION .............................................................................................................13
2.1
Study Rationale......................................................................................................13
2.2
Background............................................................................................................14
2.3
Mechanism of Action/Indication ...........................................................................15
3
STUDY OBJECTIVES AND ENDPOINTS.....................................................................15
4
STUDY DESIGN ..............................................................................................................16
4.1
Overall Design .......................................................................................................16
4.2
Rationale for Study Design....................................................................................17
4.3
Justification for Dose .............................................................................................19
4.4
End of Study Definition.........................................................................................19
5
STUDY POPULATION....................................................................................................19
5.1
Type and Planned Number of Subjects..................................................................19
5.2
Inclusion Criteria....................................................................................................19
5.3
Exclusion Criteria ..................................................................................................20
5.4
Lifestyle Considerations ........................................................................................21
5.4.1
Meals and Dietary Restrictions .............................................................21
5.4.2
Alcohol, Caffeine and Tobacco.............................................................21
5.5
Screen Failures.......................................................................................................21
5.6
Sponsor’s Qualified Medical Personnel.................................................................22
5.7
Rater/Clinical Assessor Qualifications ..................................................................22
6
INVESTIGATIONAL/STUDY PRODUCTS...................................................................22
6.1
Investigational/Study Product Supplies .................................................................22
6.1.1
Dosage Form and Packaging.................................................................23
6.1.2
Preparation and Dispensing...................................................................24
6.2
Administration .......................................................................................................24
6.2.1
Medication/Dosing Errors .....................................................................24
6.3
Investigational/Study Product Storage...................................................................25
6.4
Investigational/Study Product Accountability .......................................................25
6.4.1
Destruction of Investigational/Study Product Supplies.........................26
6.5
Blinding and Allocation/Randomization ...............................................................26
6.6
Breaking the Blind .................................................................................................26

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 6 of 60
6.7
Subject Compliance ...............................................................................................26
6.8
Concomitant Medication/Treatment(s)..................................................................27
6.9
Rescue Medication.................................................................................................27
7
DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .........................................................................27
7.1
Subject Discontinuation/Withdrawal.....................................................................27
7.2
Lost to Follow up...................................................................................................28
8
STUDY PROCEDURES...................................................................................................28
8.1
Visit 1/Screening....................................................................................................28
8.1.1
Visit 2 ....................................................................................................29
8.1.2
Visit 3 ....................................................................................................30
8.1.3
Informed Consent..................................................................................30
8.1.4
Demographics........................................................................................31
8.1.5
Inclusion/Exclusion Criteria..................................................................32
8.1.6
Medical History and Prior Medication/Treatment ................................32
8.1.7
Subject Eligibility..................................................................................32
8.1.8
Clean Dentures ......................................................................................32
8.1.9
Screening Procedures ............................................................................32
8.2
Study Period...........................................................................................................33
8.3
Study Conclusion...................................................................................................33
8.4
Follow-up Visit ......................................................................................................33
9
STUDY ASSESSMENTS .................................................................................................33
9.1
Screening Assessments ..........................................................................................34
9.1.1
Well-Fit Assessment, Kapur (Olshan Modification) Index...................34
9.1.2
Well Made Assessment .........................................................................34
9.1.3
Denture Bearing Tissue Score...............................................................35
9.1.4
Food Migration Adequacy Determination.............................................35
9.2
Efficacy Assessments.............................................................................................36
9.2.1
Food Occlusion Testing Incorporating Dislodgment Assessment ........36
9.2.2
Subject Questionnaire............................................................................38
9.2.3
Denture Photographs at Treatment Visits..............................................38
9.3
Safety and Other Assessments...............................................................................38
9.3.1
Oral Soft Tissue (OST) Examination- Edentulous................................38
10 ADVERSE EVENT AND SERIOUS ADVERSE EVENTS............................................39
10.1
Definition of an Adverse Event (AE) ....................................................................39
10.2
Definition of a Serious Adverse Event (SAE) .......................................................40
10.3
Reporting of Adverse Events.................................................................................41
10.3.1
Reporting Period....................................................................................41

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 7 of 60
10.4
Reporting Procedures.............................................................................................41
10.4.1
Reporting of an Adverse Event .............................................................42
10.4.2
Reporting of a Serious Adverse Event ..................................................42
10.5
Evaluating Adverse Events....................................................................................43
10.5.1
Assessment of Intensity.........................................................................43
10.5.2
Assessment of Causality........................................................................43
10.6
Follow-up of Adverse Events ................................................................................44
10.7
Withdrawal Due to an Adverse Event....................................................................44
10.7.1
Sponsor’s Reporting Requirements to Regulatory Authorities and 
Ethics Committees.................................................................................45
10.8
Pregnancy...............................................................................................................45
10.8.1
Time Period for Collecting Pregnancy Information..............................45
10.8.2
Action to be Taken if Pregnancy Occurs...............................................45
10.9
Definition of and Procedure for Reporting Medical Device Incidents..................46
10.9.1
Definition of an Incident .......................................................................46
10.9.2
Reporting of Incidents and Malfunctions..............................................46
10.9.3
Follow-up of Medical Device Incidents................................................47
10.9.4
Regulatory and Ethics Reporting Requirements for Incidents..............47
11 DATA MANAGEMENT ..................................................................................................48
11.1
Case Report Form ..................................................................................................48
11.2
Data Handling ........................................................................................................49
11.2.1
Data Queries..........................................................................................49
11.3
Processing Patient Reported Outcomes .................................................................49
11.4
External Data..........................................................................................................50
12 STATISTICAL CONSIDERATIONS AND DATA ANALYSES...................................50
12.1
Sample Size Determination....................................................................................50
12.2
Statistical Methods and Analytical Plan ................................................................50
12.2.1
Definition of Analysis Populations .......................................................50
12.2.2
Exclusion of Data from Analysis ..........................................................51
12.2.3
Demographic and Baseline Characteristics...........................................51
12.2.4
Study Drug/Product Compliance...........................................................51
12.2.5
Prior and Concomitant Medications......................................................51
12.2.6
Primary Analysis(es) .............................................................................51
12.2.7
Secondary Analysis(es) .........................................................................51
12.2.8
Safety Analysis(es)................................................................................52
12.2.9
Other Analysis(es).................................................................................52
12.2.10
Handling of Dropouts and Missing Data...............................................52
12.2.11
Interim Analysis ....................................................................................52

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 8 of 60
13 STUDY GOVERNANCE CONSIDERATIONS..............................................................52
13.1
Quality Control ......................................................................................................52
13.2
Quality Assurance..................................................................................................53
13.3
Regulatory and Ethical Considerations..................................................................53
13.3.1
Institutional Review Board/ Ethics Committee.....................................53
13.3.2
Ethical Conduct of the Study.................................................................53
13.3.3
Subject Information and Consent..........................................................54
13.3.4
Subject Recruitment ..............................................................................54
13.3.5
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP ...............................................................................................54
13.4
Posting of Information on Publicly Available Clinical Trial Registers.................55
13.5
Provision of Study Results to Investigators...........................................................55
13.6
Records Retention..................................................................................................55
13.7
Conditions for Terminating the Study ...................................................................56
13.8
Definition of Study End/End of Study...................................................................56
14 REFERENCES ..................................................................................................................56
15 APPENDIX........................................................................................................................57
15.1
ABREVIATIONS..................................................................................................57
15.2
Example Form to Record Number of Dislodgments and Subject Completed 
Questionnaire .........................................................................................................58
15.3
Example Subject Completed Questionnaire ..........................................................59
15.4
Product Application Instructions ...........................................................................60

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 9 of 60
List of in text tables
Table 1-1
Schedule of Activities............................................................................12
Table 3-1
Study Objectives and Endpoints............................................................15
Table 6-1
Investigational/Study Product Supplies.................................................23
Table 6-2
Sundry Items..........................................................................................23
Table 15-1
Abbreviation..........................................................................................57

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 10 of 60
1
PROTOCOL SUMMARY 
Background and Rationale
This study is designed to investigate the effectiveness of a marketed denture adhesive, dispensed 
through a precision nozzle to prevent the ingress of peanut particles under dentures, in a food 
occlusion model. The study will compare COREGA Máximo Sellado/Selamento with a 
precision nozzle versus no adhesive using the methodology that was developed under study 
208397.
Objectives and Endpoints
Objective(s)
Endpoint(s)
Primary
To assess the performance of a marketed 
denture adhesive (COREGA Máximo 
Sellado/Selamento compared to no adhesive in 
a model for food occlusion.
Mass of peanuts under combined maxillary and 
mandibular dentures.
Secondary
To compare the ability of a marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento) to prevent food particle 
ingress under upper and lower dentures versus 
no adhesive.
Mass of peanuts under maxillary dentures. 
Mass of peanuts under mandibular dentures.
To evaluate and compare subject-reported 
denture dislodgments during a food occlusion 
methodology when marketed denture adhesive 
(COREGA Máximo Sellado/Selamento) is used 
compared to no adhesive.
The number of subject reported denture 
dislodgements during chewing.
To evaluate and compare subject responses to 
a questionnaire administered after eating 
peanuts when using a marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento) compared to no adhesive.
Mean scores from Subject-completed 
questionnaire.
Safety
To assess the tolerability of marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento).
Treatment emergent adverse events.
Study Design
This will be a single center, controlled, single blind (with respect to the technician weighing the 
peanut particles that have migrated under the denture), randomized, two-treatment, two-period 
cross-over design, in subjects with well fitting (as defined by the well-made and well fit 
assessment) full upper and lower dentures (maxillary and mandibular). This study design is 
based on study 208397, where the ingress of peanut particles was compared when using 
adhesive (applied by two different methods) versus no adhesive. Whilst the objective measure 
of peanut mass is the primary endpoint of interest in this study, subject perceived efficacy will 
also be investigated by means of a subject-completed questionnaire. The number of denture 
dislodgments reported by the subjects during the chewing of the peanuts will also be collected 
and analyzed and this, and the questionnaire data, will be used to support the findings of the 
peanuts mass measure.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 11 of 60
Study Products
COREGA Máximo Sellado/Selamento will be compared to no adhesive. The adhesive will be 
applied by the clinical site dispensing staff and 1.0 g (±0.1g) will be weighed and applied to the 
maxillary denture and 0.6g (±0.1g) will be weighed and applied to the mandibular denture. No 
washout products will be required for this study and there will be a 2-7 day period between each 
visit.
Type and Planned Number of Subjects
A sufficient number of subjects will be screened to randomize 52 subjects to ensure 48 
evaluable subjects complete the entire study. Healthy edentulous subjects, between 18 and 85 
years of age with both upper and lower dentures will be recruited. 

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 12 of 60
1.1
Schedule of Activities
The schedule of activities table provides an overview of the subject visits and study procedures.  
The investigator may schedule visits (unplanned visits) in addition to those listed on the 
schedule of activities, in order to conduct evaluations or assessments required to protect the 
well-being of the subject.
Table 1-1
Schedule of Activities
Screening 
Study Period
Procedure/Assessment
Visit 1
Visit 2
Treatment 
Period 1
Visit 3
Treatment 
Period 2
Informed consent
X
Review Inclusion/Exclusion criteria
X
X
X
Medical history 
X
Demographics 
X
Current/Concomitant treatments
X
X
X
Dental history
X
OST examination edentulous
Xe
Xb
Xb
Denture bearing tissue score
X
Clean Denturesc
X
X
X
Criteria for well-made and fitting dentures (retention, 
stability, clinical acceptability and denture finish)
X
Food migration adequacy
X
Subject eligibility
X
Randomization
X
Subject continuance
X
X
Treatment application and denture insertiona
X
X
Efficacy assessment- Food occlusion testing
X
X
Efficacy assessment- Number of denture 
dislodgements
X
X
Photograph of dentures (subset of subjects’ 
dentures will be selected.)
X
X
Subject completed questionnaire
X
X
Adverse eventsd
X
X
X
Incidentsd
X
X
X
Study conclusion
Between 2 and 7 days
Between 2 and 7 days
X
a There will be a 60±5 minute wait after dentures are inserted and the commencement of the food occlusion 
testing.
b At visits 2 and 3 the OST examination will be performed before product application and also after the denture 
removal and peanut recovery.
c Dentures will be cleaned both prior to and after the food migratory adequacy (V1) or food occlusion testing 
assessment (V2 and V3)
d Any adverse event, serious adverse event or incident assessed as related to study participation that occurs 
subsequent to the signing of informed consent.
e At screening visit, the OST examination will be performed before and after the food migration adequacy 
determination as per Section 8.1.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 13 of 60
2
INTRODUCTION
Denture adhesives are recommended to denture wearers, not only to increase the retentive hold 
of dentures to the oral mucosa, but also to reduce the ingress of food particles under the denture. 
Such particles are often a cause of irritation to the mucosa. Current understanding suggests that 
restriction of food particle ingress is achieved through a tighter denture fit provided by the 
denture adhesive through its ability to both adhere the denture to the mucosa and to occlude 
gaps between the denture and the mucosa which might otherwise be susceptible to food particle 
ingress (Ozcan et al, 2005). The increased adherence to the mucosa leads to reduced movement 
of the denture whilst chewing, leading to a reduction in particle migration under the denture 
(Tarbet et al, 1980). Additionally, the hydration of denture adhesives through contact with saliva 
leads to expansion of the adhesive, occluding gaps between the denture and the underlying 
mucosa (Ozcan et al, 2005). The adhesive can therefore be thought of as forming a seal along 
the denture borders which prevents ingress of small food particles. 
Published methodologies for evaluating the performance of a denture adhesive at reducing the 
ingress of food particles under the denture are rather limited in numbers.  Tarbet et al (Tarbet 
et al, 1980) had subjects subjectively rate (on a ten-point scale) whether they experienced less 
food particles under their dentures after eating foods including celery, steak, taffy apples and 
sandwiches when using a denture adhesive compared to no adhesive.  This study showed a 
statistically significant difference (p<0.01) in subjective score in favour of the use of adhesive 
compared to no adhesive use.  Ahmad et al (Ahmad et al, 2009; Ahmad et al, 2010) described 
a quantitative methodology based upon having fully edentulous subjects chew a prescribed 
amount of peanuts whilst wearing both their maxillary and mandibular dentures.  After chewing 
the peanuts, the subjects brushed their dentures whilst still wearing them, rinsed with water then 
removed their dentures.  Study staff then removed the peanut particles from the fit surfaces of 
the dentures and any adhesive from the dentures and the denture bearing tissues, washed and 
sieved the peanut particles and dried the particles prior to weighing them.  This study was able 
to show statistically significant lower mass of peanuts collected between subjects using an 
adhesive compared to no adhesive use.  The mass of peanut particles recovered was not reported 
in full, however, a mean mass of 51mg and 35mg was found for maxillary dentures for the no-
adhesive and adhesive treatments respectively.
A GSK CH method development study, similar to that described above was conducted (Study 
208397) and was able to show that more peanut particles were recovered from dentures without 
any adhesive than those that had adhesive applied. This methodology will be employed for this 
study, and will be designed to evaluate the ability of COREGA Máximo Sellado/Selamento to 
reduce food ingress under dentures.
2.1
Study Rationale
The study will compare COREGA Máximo Sellado/Selamento with a precision nozzle versus 
no adhesive using the methodology based on that developed under Study 208397. The aim of 
the study is to evaluate if the use of denture adhesive can minimize the ingress of food particles 
under dentures. 
This study will compare the efficacy of a marketed denture adhesive against use of no adhesive.  
No adhesive has been chosen as a control group to provide a continual reference point to allow 
interpretation of the results and to facilitate comparison of the results from this study with 

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 1 4  of 6 0
pre vi o us w or k, a n d is re prese ntati ve of a si g nifica nt n u m ber of de nt ure wearers w h o c urre ntl y 
d o n ot use a n a d hesi ve.
T he a p plicati o n of t he a d hesi ve will be c o ntr olle d b y mass, w here 1. 0 g ( ± 0. 1 g) will be wei g he d 
a n d a p plie d t o t he ma xillar y de nt ure a n d 0. 6 g ( ± 0. 1 g) will be wei g he d a n d a p plie d t o t he 
ma n di b ular de nt ure (i n li ne wit h pre vi o us G S K C H st u dies 
 a n d 2 0 8 3 9 7). 
T he tec h nicia n w h o will wei g h t he pea n uts rec o vere d fr o m t he de nt ures will be differe nt t o t he 
tec h nicia n t hat will was h, sie ve a n d dr y t he pea n uts, a n d will t heref ore be bli n de d t o t he 
treat me nts, he nce t his is a si n gle bli n d st u d y.
De nt ure a d hesi ve ac hie ves its f u ncti o n b y p h ysical mea ns a n d o nce c o m pletel y re m o ve d fr o m 
t he de nt ure d oes n ot ha ve a n y resi d ual carr y- o ver effects. T heref ore t he 2- 7 da y peri o d bet wee n 
eac h visit is c o nsi dere d a de q uate rest f or t he oral s oft tiss ue fr o m t he stresses of masticati o n 
e nc o u ntere d i n t his st u d y. S u bjects will be per mitte d t o c o nti n ue usi n g t heir n or mal oral h y gie ne 
pr o d ucts, i ncl u di n g de nt ure a d hesi ve, bet wee n st u d y visits. T he st u d y will als o n ot e xcl u de 
c urre nt de nt ure a d hesi ve users as t he test a d hesi ve is i nte n de d t o be s uita ble f or b ot h c urre nt 
a d hesi ve users as well as t h ose n ot c urre ntl y usi n g a d hesi ve. T he safet y a n d efficac y o utc o mes 
of t his st u d y desi g n are c o nsi dere d i n de pe n de nt of w het her or n ot a s u bject has use d a d hesi ve 
bet wee n st u d y peri o ds.
T his is a P hase I V st u d y t hat is pla n ne d t o be perf or me d b y a cli nical site wit h e x perie nce i n 
t his met h o d ol o g y. C O R E G A Má xi m o Sella d o/ Sela me nt o, w hilst mar kete d i n ma n y c o u ntries 
is c urre ntl y n ot c o m merciall y a vaila ble i n t he U S A, a n d t heref ore t he st u d y pr o d uct will be 
i m p orte d t o t he U S A f or t he st u d y. T he pr o d uct is c o nsi dere d a n o n-si g nifica nt ris k de vice i n 
t he U S A a n d t heref ore t he I R B will be re q uire d t o ratif y (i.e. I R B re vie w of t he pr ot oc ol) t his 
bef ore i m p orti n g t he st u d y pr o d ucts t o t he U S A. N o healt h a ut h orit y re g ulat or y a p pr o val will 
be re q uire d t o c o n d uct t he pr o p ose d st u d y. 
C o m plete i nf or mati o n f or t he C O R E G A Má xi m o Sella d o/ Sela me nt o ma y be f o u n d i n t he si n gle 
refere nce safet y d oc u me nt ( S R S D), w hic h f or t his st u d y is t he Safet y State me nt. 
2. 2  
B a c k gr o u n d
C CI
T his st u d y is desi g ne d t o i n vesti gate t he effecti ve ness of a mar kete d de nt ure a d hesi ve, dis pe nse d 
t hr o u g h a precisi o n n ozzle i n a f o o d occl usi o n m o del. T he st u d y will c o m pare C O R E G A 
Má xi m o Sella d o/ Sela me nt o pac ka ge d wit h a precisi o n n ozzle vers us n o a d hesi ve usi n g t he 
met h o d ol o g y base d o n t hat de vel o pe d d uri n g G S K C H st u d y 2 0 8 3 9 7.
Cli nical st u d y 2 0 5 9 1 5 ai me d t o e val uate t he relati ve efficac y of a n e x peri me ntal de nt ure 
a d hesi ve t o re d uce f o o d i n gress u n der de nt ures c o m pare d t o a sta n dar d mar kete d a d hesi ve 
( C O R E G A Má xi m o Sella d o/ Sela me nt o De nt ure A d hesi ve Crea m), a n d n o a d hesi ve. Briefl y, 
s u bjects wit h b ot h f ull u p per a n d l o wer de nt ures were assi g ne d t o eit her t he test de nt ure 
a d hesi ve ( C O R E G A Má xi m o Sella d o/ Sela me nt o), a p ositi ve c o ntr ol a d hesi ve ( S P F) or t he 
ne gati ve c o ntr ol ( n o a d hesi ve gr o u p) i n t his t hree- treat me nt, t hree- peri o d, cr oss- o ver st u d y. 
O ne h o ur after t he a p plicati o n of t he de nt ure a d hesi ve t o b ot h u p per a n d l o wer de nt ures b y t he 
e xa mi ner, s u bjects were i nstr ucte d t o c he w a defi ne d mass of pea n uts i n a c o ntr olle d ma n ner. 
After a ri nsi n g pr oce d ure wit h water, t he de nt ures were t he n re m o ve d, a n d a n y pea n uts t hat ha d 
mi grate d u n der eac h de nt ure were c ollecte d a n d wei g he d after a dr yi n g pr ocess.
T he res ults s h o we d t hat t here was n o si g nifica nt differe nce i n t he mass ( g) of pea n uts rec o vere d 
fr o m t he s u bjects usi n g t he p ositi ve c o ntr ol or t he n o a d hesi ve ( ne gati ve c o ntr ol) gr o u ps a n d it 
was t heref ore c o ncl u de d t hat t he st u d y faile d t o de m o nstrate assa y se nsiti vit y.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 15 of 60
One major learning from the 205915 study concerned the way in which the denture adhesive 
was applied to the dentures. The adhesives were applied directly from the tubes by the study 
staff, following the package usage instructions without weighing. Although this was intended 
to replicate typical consumer usage, it resulted in the mass of adhesive being uncontrolled. The 
mean mass of the positive-control adhesive used for the upper and lower dentures combined 
was 0.63g (range 0.3–1.0g; SD 0.16g). This dose was considerably lower, with much greater 
variability, than that used in previous studies (standardized and controlled at 1.6g), which may 
have contributed to the lack of differentiation in mass of peanut particles retrieved between the 
adhesives compared to no adhesive. A further point to consider for any future studies was to 
optimize the rinsing procedure and collection of peanut particles following chewing.
Based on these results and findings, a method development study was conducted (study 208397). 
This study was a three-treatment, three-period, cross-over design study with the main aim of 
this study to validate a food occlusion methodology.  The study results showed that there were 
more peanut particles recovered under dentures when using no-adhesive compared to using 
adhesive. This updated methodology will now be used for the basis of the study design for the 
proposed study outlined in this protocol.
2.3
Mechanism of Action/Indication
Sodium-calcium 
mixed 
partial 
salt 
of 
poly 
(methylvinylether/maleic 
acid) 
and 
carboxymethylcellulose is currently included in a denture adhesive marketed by GSK CH. 
Denture adhesives work through their ability to both adhere the denture to the mucosa and to 
occlude gaps between the denture and the mucosa which might otherwise be susceptible to food 
particle ingress (Özcan, 2005). The increased adherence to the mucosa leads to reduced 
movement of the denture whilst chewing, leading to a reduction in particle migration under the 
denture (Tarbet, 1980). Additionally, the hydration of denture adhesives through contact with 
saliva leads to expansion of the adhesive, occluding gaps between the denture and the 
underlying mucosa (Özcan, 2005). The adhesive can therefore be thought of as forming a seal 
along the denture borders which prevents ingress of small food particles. 
COREGA Máximo Sellado/Selamento is a medical device that is currently being investigated 
in fully edentulous subjects with both maxillary and mandibular full dentures.
3
STUDY OBJECTIVES AND ENDPOINTS
Table 3-1
Study Objectives and Endpoints
Objective(s)
Endpoint(s)
Primary
To assess the performance of a marketed 
denture adhesive (COREGA Máximo 
Sellado/Selamento) compared to no adhesive in 
a model for food occlusion.
Mass of peanuts under combined maxillary and 
mandibular dentures.
Secondary
To compare the ability of a marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento) to prevent food particle 
ingress under upper and lower dentures versus 
no adhesive.
Mass of peanuts under maxillary dentures. 
Mass of peanuts under mandibular dentures.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 16 of 60
To evaluate and compare subject-reported 
denture dislodgments during a food occlusion 
methodology when marketed denture adhesive 
(COREGA Máximo Sellado/Selamento) is used 
compared to no adhesive.
The number of subject reported denture 
dislodgements during chewing.
To evaluate and compare subject responses to 
a questionnaire administered after eating 
peanuts when using a marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento) compared to no adhesive.
Mean scores from Subject-completed 
questionnaire.
Safety
To assess the tolerability of marketed denture 
adhesive (COREGA Máximo 
Sellado/Selamento).
Treatment emergent adverse events.
This study will be considered successful if there is a statistically significant difference between 
the mass of peanuts under dentures of subjects using denture adhesive versus when using no 
adhesive. 
4
STUDY DESIGN 
4.1
Overall Design
This Phase IV study will be a single center, controlled, single blind (with respect to the 
technician weighing the peanut particles that have migrated under the denture), randomized, 
two-treatment, two-period, cross-over design, in subjects with full upper and lower dentures. 
Each treatment period will consist of one day of testing with at least two days between adjacent 
treatment visits.
A sufficient number of subjects will be screened to randomize 52 subjects to ensure 48 
evaluable subjects complete the entire study. Healthy edentulous subjects, between 18 and 85 
years of age with both upper and lower dentures will be recruited.
At the screening visit, following an oral soft tissue (OST) examination, each subject’s denture 
(maxillary and mandibular) will be cleaned and assessed for retention and stability using the 
Kapur Index (Olshan Modification) [Kapur, 1967; Olshan, 1992] and whether they are well 
made. Only those subjects with dentures (both maxillary and mandibular) that satisfy both of 
these criteria will then undergo the food migration adequacy assessment, where the peanuts 
under the dentures will be visually assessed after the subject chews a portion of peanuts. A 
visual observation and rating of location and extent of peanut particle migration adequacy must 
indicate > 0 on a 0-3 scale. Subjects meeting all the inclusion criteria with no exclusions will 
then be randomized at Visit 2.
On each test day (Visit 2 and 3), subjects will undergo an OST examination (edentulous) and 
have their dentures cleaned using denture cleanser as per the denture cleansing procedure. 
Treatment (or no treatment as per randomization schedule) will then be applied as per the 
application instructions (Appendix 15.3) and the dentures worn by the subject. Then, 60±5 
minutes after inserting their dentures, each subject will be given a standardized portion of 
peanuts to consume, following a prescribed chewing and swallowing method. Whilst chewing 
the peanuts, subjects will record the number of denture dislodgements that occur during the 
chewing procedure. After this, subjects will rinse their mouths with water for up to 10 seconds 
to remove peanut particles that have not migrated under the dentures. The rinsing step may be 

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 17 of 60
repeated as required, if necessary, in the opinion of the examiner, to ensure peanut particles that 
have not migrated under the dentures are cleared from the oral cavity. The examiner will then 
remove the mandibular denture and any peanut particles or adhesive remaining on the 
mandibular edentulous ridge will be removed using gauze. The examiner will then remove the 
maxillary denture and any peanut particles or adhesive remaining on the maxillary edentulous 
ridge will be removed using new gauze. Each gauze (including peanut particles) will be retained 
separately. Once all peanuts particles have been collected from the dentures, they will be 
retained for cleaning.  The subject will then complete a questionnaire on efficacy and a further 
OST examination will then be performed, before the cleaned dentures are returned to the subject.
Peanut particles will then be collected from the fit surface of the dentures using gauzes and then 
weighed to evaluate the mass of food particles that had migrated under the denture (keeping the 
particles associated with the upper and lower dentures separate).
For the first 5 randomized subjects in the study, the fit surface of their dentures will be 
photographed before peanuts are collected from the dentures (no photographs of the subjects 
themselves will be taken).  It is expected that where possible, consistency of subjects between 
treatments is maintained (i.e. a subject will be identified at visit 2) as being suitable for denture 
imaging and have their dentures photographed at visits 2 and 3.
These subjects will be repeated in a cross-over manner. There will be 2-7 days between 
treatment visits to allow for recovery from the mastication procedures.
Safety will be assessed by examination of the oral soft tissues at the Screening Visit and before 
and after each treatment assessment has been completed at each of the treatment visits. 
Abnormalities reported after informed consent will be considered as adverse events (AEs). 
Incidents will be recorded from informed consent. In addition, subject reported outcome/AEs 
will also be recorded.
4.2
Rationale for Study Design
This study will be a controlled study in order to show the benefit of food occlusion from the use 
of denture adhesive versus no adhesive (negative control).  A positive control has not been 
included in this study since there is insufficient evidence to support a denture adhesive being 
considered as a “gold-standard” in this model.
Whilst the objective measure of peanuts is the primary endpoint of interest in this study, subject 
derived opinion of efficacy will also be measured by means of a subject-completed 
questionnaire. The number of denture dislodgements reported by the subjects during the 
chewing of the peanuts will also be collected and analysed and this, and the questionnaire data, 
will be used to better understand the findings of the peanut mass measure.
An oral soft tissue (OST) examination will be conducted at each treatment visit before treatment 
is applied to ensure the subject’s oral health is sufficient to allow the subject to complete the 
assessments at that visit. A further OST exam will be performed at each treatment visit after the 
completion of assessments in order to screen for abnormalities.
This study will be single blind, with respect to the technician who will be carrying out the final 
weighing of peanut particles recovered from dentures and the edentulous ridges. This technician 
will be separate from the personnel that will be washing, sieving and drying the peanuts after 
removal from subjects’ mouths and will therefore remain blinded to treatment used.

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 1 8  of 6 0
De nt ure a d hesi ve ac hie ves its f u ncti o n b y p h ysical mea ns a n d o nce c o m pletel y re m o ve d fr o m 
t he de nt ure is n ot e x pecte d t o ha ve a n y resi d ual carr y- o ver effects. T heref ore t he 2- 7 da y peri o d 
bet wee n eac h visit is c o nsi dere d a de q uate rest f or t he oral s oft tiss ue fr o m t he stresses of 
masticati o n e nc o u ntere d i n t his st u d y. S u bjects will be per mitte d t o c o nti n ue usi n g t heir n or mal 
oral h y gie ne pr o d ucts, i ncl u di n g de nt ure a d hesi ve as it is belie ve d t hat t he o bjecti ve meas ure 
will n ot be affecte d if s u bjects are c urre nt a d hesi ve users or n ot. We will als o n ot be e xcl u di n g 
c urre nt a d hesi ve users fr o m t he st u d y as t his pr o d uct is i nte n de d f or b ot h c urre nt a n d n o n- users 
of a d hesi ves. 
I n t his st u d y, de nt ure a d hesi ve will be a p plie d usi n g a c o nti n u o us stri p patter n as per la bel 
i nstr ucti o ns o n t he mar kete d C O R E G A Má xi m o Sella d o/ Sela me nt o pr o d uct. T he a p plicati o n 
will be c o ntr olle d b y mass ( 1. 0 g o n t he ma xillar y de nt ure a n d 0. 6 g o n t he ma n di b ular de nt ure) 
i n li ne wit h pre vi o us G S K C H st u dies (
 a n d 2 0 8 3 9 7) a n d as descri be d i n 
t he pr o d uct a p plicati o n i nstr ucti o ns (A p pe n di x 1 5. 4) .
De nt ures are u ni q ue t o eac h i n di vi d ual.  T heref ore, t he m ost efficie nt a p pr oac h t o e val uati n g 
t heir perf or ma nce wit h differe nt a d hesi ves or ‘ n o a d hesi ve’ is a wit hi n s u bject c o m paris o n (i.e. 
a cr oss o ver desi g n).  
Pea n uts were c h ose n as t he m o del f o o d i n t his met h o d ol o g y beca use t he y are a brittle f o o d t hat, 
w he n masticate d, brea k i nt o s mall particles t hat ca n be rec o vere d.  Pea n uts ha ve t heref ore bee n 
retai ne d as a m o del f o o d f or t his st u d y a n d t o all o w c o m paris o n wit h pre vi o us data.
I n or der f or s u bjects t o be eli gi ble t he y m ust re p ort t hat t he y get f o o d tra p pe d u n der t heir 
de nt ures a n d t his m ust be e vi de nt f oll o wi n g t he sta n dar dise d pea n ut mi grati o n a de q uac y testi n g 
at scree ni n g ( Visit 1).  T his is t o e ns ure t hat meas ura ble a m o u nts of pea n ut particles mi grate 
u n der t he de nt ure w he n n o de nt ure a d hesi ve is bei n g use d.  W hilst pea n ut aller g y is s pecific, 
pea n uts s u p plie d f or t his st u d y ma y t he msel ves be c o nta mi nate d wit h ot her n uts o wi n g t o t he 
ma n ufact uri n g pr ocess.  T heref ore, s u bjects wit h a n y n ut aller g y are e xcl u de d fr o m t his st u d y.  
S h o ul d h o we ver, a s u bject s uffer a n a d verse reacti o n t o t he pea n uts c o ns u me d i n t his st u d y t he n 
t he st u d y staff will a d mi nister a p pr o priate first ai d i ncl u di n g t he use of a dre nali ne i n t he case of 
a na p h yla xis . S u bjects wit h te m p or o ma n di b ular j oi nt dis or ders are e xcl u de d s h o ul d t he 
i n vesti gat or belie ve t hat t his c o ul d affect t he s u bject’s partici pati o n, pri nci pall y re gar di n g t he 
a bilit y f or t he s u bject t o a de q uatel y c he w t he pea n uts.  S u bjects w h o use or ha ve e ver use d 
bis p h os p h o nate me dicati o ns are s pecificall y e xcl u de d fr o m t his st u d y o wi n g t o t he e n ha nce d 
ris k of bis p h os p h o nate-relate d oste oc he m o necr osis of t he ja w ( B R O NJ) t hat is ass ociate d wit h 
re d uce d tiss ue t olera nce t o f u ncti o n wit h re m o va ble pr ost heses (Sal da n ha et al, 2 0 1 2 ).  S u bjects 
i n t his st u d y m ust be ha bit ual wearers of f ull de nt ures t o e ns ure t hat t he y are fa miliar wit h 
c he wi n g wit h t heir de nt ures i n place.  S u bjects w h o are xer ost o mic are e xcl u de d si nce t he pr o per 
f u ncti o n of de nt ure a d hesi ves re q uires a de q uate h y drati o n fr o m sali va.
D uri n g t his st u d y, p h ot o gra p hs of de nt ures wit h pea n ut particles attac he d will be ta ke n.  T he 
p ur p ose of t his is t o gat her re prese ntati ve p h ot o gra p hs of t he de nt ures t o ai d i n t he disse mi nati o n 
a n d i nter pretati o n of t he res ults, e. g. i n ma n uscri pt pre parati o n.  N o pers o nall y i de ntifia ble 
i nf or mati o n will be i ncl u de d i n t hese p h ot o gra p hs.
De m o gra p hic i nf or mati o n will be rec or de d as part of t his st u d y, i ncl u di n g a ge, race a n d ge n der.  
I n acc or da nce wit h t he U nite d States F o o d a n d Dr u g A d mi nistrati o n ( U S F D A) g ui deli nes 
(F D A, 2 0 0 5 ) t he et h nicit y of s u bjects will als o be ca pt ure d.
T he Ka p ur- Ols ha n i n de x is a c o m p osite sc ore base d u p o n sta bilit y a n d rete nti o n rati n gs f or t he 
ma xillar y a n d ma n di b ular de nt ures ( Ka p ur, 1 9 6 7 ; Ols ha n et al, 1 9 9 2
C CI
).  S u bjects prese nti n g wit h 

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 1 9  of 6 0
a ver y l o w Ka p ur- Ols ha n sc ore at Scree ni n g ( < 6), defi ne d as “ Cli nicall y P o or” ( Ols ha n et al, 
1 9 9 2 ), will be e xcl u de d fr o m t his st u d y.
De nt ure a d hesi ve ac hie ves its f u ncti o n b y p h ysical mea ns a n d o nce c o m pletel y re m o ve d fr o m 
t he de nt ure d oes n ot ha ve a n y resi d ual effects.  T heref ore, t he 2- 7 da y peri o d bet wee n eac h test 
da y is c o nsi dere d a de q uate rest f or t he oral s oft tiss ues fr o m t he stresses of masticati o n 
e nc o u ntere d i n t his st u d y.
4. 3 
J u stifi c ati o n f or D o s e
T he C O R E G A Má xi m o Sella d o/ Sela me nt o a d hesi ve will be a p plie d directl y fr o m t he pri mar y 
pr o d uct pac ka gi n g, wit h 1. 0 g ( ± 0. 1 g) bei n g wei g he d a n d a p plie d t o t he ma xillar y de nt ure a n d 
0. 6 g ( ± 0. 1 g) bei n g wei g he d a n d a p plie d t o t he ma n di b ular de nt ure. T his d osi n g is i n li ne wit h 
pre vi o us G S K C H st u dies ( 
 a n d 2 0 8 3 9 7), a n d eli mi nates varia bilit y ass ociate d wit h 
n ot c o ntr olli n g t he mass of t he a d hesi ve.
4. 4 
E n d of St u d y D efi niti o n
A s u bject is c o nsi dere d t o ha ve c o m plete d t he st u d y if he or s he has c o m plete d all p hases of t he 
st u d y i ncl u di n g t he last visit or t he last sc he d ule d pr oce d ure s h o w n i n t he Sc he d ule of Acti vities .
T he e n d of t his st u d y is defi ne d as t he date of t he last visit of t he last s u bject i n t he st u d y. 
5 
S T U D Y P O P U L A TI O N
5. 1 
T y p e a n d Pl a n n e d N u m b er of S u bj e ct s
T his st u d y will recr uit healt h y v ol u nteers, of eit her ge n der a ge d 1 8- 8 5 years w h o are c o m pletel y 
e de nt ul o us a n d wear f ull ma xillar y a n d ma n di b ular de nt ures.  T he test de nt ure a d hesi ve is 
i n dicate d f or t he ge neral p o p ulati o n w h o wear de nt ures a n d t heref ore t he i ncl usi o n criteria 
all o ws f or i n vesti gati o n of t y pical de nt ure users.
A s ufficie nt n u m ber of s u bjects will be scree ne d t o ra n d o mize 5 2 t o e ns ure 4 8 e val ua ble 
s u bjects c o m plete t he e ntire st u d y. 
T his st u d y ca n f ulfill its o bjecti ves o nl y if a p pr o priate s u bjects are e nr olle d.  T he f oll o wi n g 
eli gi bilit y criteria are desi g ne d t o select s u bjects f or w h o m partici pati o n i n t he st u d y is 
c o nsi dere d a p pr o priate.  All rele va nt me dical a n d n o n- me dical c o n diti o ns will be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a s u bject is s uita ble f or t his pr ot oc ol.  
S u bject eli gi bilit y t o partici pate i n t he cli nical st u d y will be re vie we d a n d d oc u me nte d b y a n 
a p pr o priate me m ber of t he i n vesti gat or’s st u d y tea m bef ore s u bjects are i ncl u de d i n t he st u d y.
5. 2 
I n cl u si o n Crit eri a
A n i n di vi d ual m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y:
1.
S u bject pr o visi o n of a si g ne d a n d date d i nf or me d c o nse nt d oc u me nt i n dicati n g t hat t he 
s u bject has bee n i nf or me d of all perti ne nt as pects of t he st u d y bef ore a n y assess me nt is 
perf or me d.
2.
S u bject is male or fe male w h o, at t he ti me of scree ni n g, is  
C CI
bet wee n t he a ges of 1 8 a n d 8 5 
years, i ncl usi ve.

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3. A subject who is willing and able to comply with scheduled visits, treatment plan and 
other study procedures.
4. A subject in good general and mental health with, in the opinion of the investigator or 
medically qualified designee, no clinically significant/relevant abnormalities in medical 
history or upon oral examination, or condition, that would impact the subject’s safety, 
wellbeing or the outcome of the study, if they were to participate in the study, or affect the 
individual’s ability to understand and follow study procedures and requirements.
5. Self-reports experience of getting food trapped under their denture.
6. Is a habitual wearer of both of their dentures defined as subjects who wear both of their 
dentures for the majority of their time whilst awake.
7. Have denture protheses that fulfil all of the following:
a) A qualifying conventional acrylic full denture in both the upper and lower arch.
b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability 
Index Sum Score ≥6) (Olshan et al, 1992) with no individual stability or retention 
scores <1.
c) Dentures are well made (according to the well-made assessment).
d) Has a peanut particle migration rating >0 for each denture.
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 who is an employee of the investigational site, either directly involved in the 
conduct of the study or a member of their immediate family; or an employee of the 
investigational site otherwise supervised by the investigator; or, a GSK CH employee 
directly involved in the conduct of the study or a member of their immediate family.
2. A subject who has participated in other studies (including non-medicinal studies) 
involving investigational product(s) within 30 days prior to study entry and/or during 
study participation.
3. A subject with, in the opinion of the investigator or medically qualified designee, an acute 
or chronic medical or psychiatric condition or laboratory abnormality that may increase 
the risk associated with study participation or investigational product administration or 
may interfere with the interpretation of study results and, in the judgment of the 
investigator or medically qualified designee, would make the subject inappropriate for 
entry into this study.
4. A subject who is a pregnant female (self-reported).
5. A subject who is a breastfeeding female.
6. A subject with known or suspected intolerance or hypersensitivity to the study materials 
(or closely related compounds) or any of their stated ingredients. 
7. A subject who, in the opinion of the investigator or medically qualified designee, should 
not participate in the study.
8. A subject unwilling or unable to comply with the Lifestyle Considerations described in 
this protocol. 
9. History of swallowing difficulties or choking.
10. Currently taking or have taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).

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11. Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] 
problems) that, in the opinion of the investigator, could affect the subject’s participation in 
the study.
12. Known allergy to peanuts or any other nut.
13. Any condition or medication which, in the opinion of the investigator, is currently causing 
xerostomia.
14. Recent history (within the last year) of alcohol or other substance abuse.
15. OST examination findings such as stomatitis, open sores, lesions, redness or swelling which 
in the opinion of the investigator, would interfere with the conduct of the study or the safety 
of the subject.
16. Use of any medication that, in the opinion of the investigator, would interfere with the 
conduct of the study.
17. A serious chronic disease requiring intermittent hospital visits.
18. Having been previously enrolled in this study.
19. Any subject, in the opinion of the investigator, who should not participate in the study.
Subjects will be randomized into the study provided they have satisfied all subject selection 
criteria. 
5.4
Lifestyle Considerations
During the entire study (screening – LSLV):

Subjects will not be permitted to have any dental/denture work performed during the time 
they are in the study, unless discussed and permitted by the examiner. This is to assure 
that the denture fit will not be altered during the study.
During the treatment visits (Visits 2-3):

Subjects will not be allowed to use tobacco or nicotine or nicotine-containing products 
following denture insertion until after their dentures are returned at completion of the food 
occlusion testing.

Subjects will not be able to use any oral healthcare product other than those supplied by 
the investigator following denture insertion until after their dentures are returned at 
completion of the food occlusion testing.
5.4.1
Meals and Dietary Restrictions
Subjects will not be allowed to consume any food (including chewing gum) or drinks following 
denture insertion until after their dentures are returned at completion of food occlusion testing 
with the exception of small sips of water to alleviate thirst, to aid chewing the peanuts or to 
assist with medication.
5.4.2
Alcohol, Caffeine and Tobacco
Subjects will not be allowed to use tobacco or nicotine or nicotine-containing products 
following denture insertion until after their dentures are returned at completion of the food 
occlusion testing.
5.5
Screen Failures
Screen failures are defined as subjects who consent to participate in the clinical study but are 
not subsequently randomized. To ensure transparent reporting of screen failure subjects, a 

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minimal set of screen failure information will include demography, screen failure details (e.g. 
withdrawal of consent), eligibility criteria, and any adverse events or incidents as applicable. 
Individuals who do not meet the criteria for participation in this study (screen failure) may not 
be re-screened.
5.6
Sponsor’s Qualified Medical Personnel
Contact information for the sponsor's appropriately qualified medical/dental personnel for the 
study is documented in the Study Contact List located in the investigator study master file held 
at the study site.
The contact number is only to be used by investigational staff seeking advice on medical/ dental 
questions or problems in the event that the established communication pathways between the 
investigational site and the study team are not available.  
The contact number is not intended for direct use by study subjects.  To facilitate access to 
appropriately qualified medical/dental personnel on study-related medical/dental questions or 
problems, subjects will be provided with a contact card.  The contact card will provide, as a 
minimum, protocol identifiers, the subject’s study identification number, contact information 
for the investigational site, and contact details in the event that the investigational site cannot 
be reached to provide advice on a medical question or problem identified by a healthcare 
professional other than the investigator.  
5.7
Rater/Clinical Assessor Qualifications 
Suitably-qualified dental professionals with expertise in prosthodontics will be required to 
perform the OST examination and the screening assessments relating to denture fit and 
condition for this study.
6
INVESTIGATIONAL/STUDY PRODUCTS
For the purposes of this study, per International Conference on Harmonisation (ICH) guidelines, 
and GSK policy, investigational product is defined as a pharmaceutical form of an active 
ingredient, a non-medicinal product (marketed or investigational), or a placebo, being tested or 
used as a reference (positive or negative control), in a clinical trial. This includes a product with 
a marketing authorization when used or assembled (formulated or packaged) in a way different 
from the approved form, or when used for an unapproved indication, or when used to gain 
further information about an approved use. 
6.1
Investigational/Study Product Supplies
The following study products will be supplied by the Clinical Supplies Department, GSK CH:

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 2 3  of 6 0
T a bl e 6- 1 
I n v e sti g ati o n al/ St u d y Pr o d u ct S u p pli e s
T e st Pr o d u ct
C o ntr ol
Pr o d u ct N a m e
C O R E G A M á xi m o S ell a d o/ S el a m e nt o
N o A d h e si v e
P a c k D e si g n
Pr e ci si o n n o z zl e t u b e
N/ A
Di s p e n si n g D et ail s
N/ A
N/ A
Pr o d u ct M a st er 
F or m ul ati o n C o d e 
( M F C)
N/ A
D o s e/ A p pli c ati o n
1. 6 g of a d h e si v e a p pli e d a s 1. 0 g ( ± 0. 1 g) f or m a xill ar y 
d e nt ur e a n d 0. 6 g ( ± 0. 1 g) f or m a n di b ul ar d e nt ur e.
N/ A
R o ut e of 
A d mi ni str ati o n
A p pli e d t o u p p er a n d l o w er d e nt ur e w hi c h i s t h e n pl a c e d 
i n m o ut h
N/ A
U s a g e I n str u cti o n s
S e e u s a g e i n str u cti o n s ( A p p e n di x 1 5. 4 )
N/ A
R et ur n R e q uir e m e nt s
All u s e d/ u n u s e d s a m pl e s t o b e r et ur n e d t o t h e s p o n s or
N/ A
C O R E G A Má xi m o Sella d o/ Sela me nt o, w hilst mar kete d i n ma n y c o u ntries is c urre ntl y n ot 
c o m merciall y a vaila ble i n t he U S A, a n d t heref ore t he st u d y pr o d uct will be i m p orte d t o t he 
U S A f or t he st u d y. As per t he Re g ulat or y Deter mi nati o n f or t his st u d y, t he e x peri me ntal 
a d hesi ve is cate g orize d as a me dical de vice, a n d t heref ore a N o nsi g nifica nt Ris k ( N S R) 
a p plicati o n will be perf or me d as part of t he I R B s u b missi o n t o c o n d uct t his st u d y i n t he U S A. 
T a bl e 6- 2 
S u n dr y It e m s
S u n dr y Ite ms t o be s u p plie d:
R et ur n/ Di s p o s al D et ail s
It e m
S u p pli e d B y
U s e d S a m pl e s
U n u s e d S a m pl e s
Or al B  D e nt ur e br u s h e s
G S K C H
D e str o y at sit e u si n g sit e 
di s p o s al pr o c e d ur e s
R et ur n
P ol y d e nt D e nt u Cr è m e D e nt ur e 
cl e a n si n g p a st e ( U S A m ar k et pl a c e)
G S K C H
D e str o y e d at sit e u si n g 
sit e di s p o s al pr o c e d ur e s
R et ur n
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 nta bilit y c hec ks 
a n d s u bse q ue nt destr ucti o n w hic h will be pr o vi de d b y G S K C H d uri n g t he c o urse of t he st u d y 
i n ti me f or st u d y cl ose o ut visit.
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 test pr o d uct is i nte n de d f or oral use, a n d will be a d mi nistere d t o de nt ures e xter nall y t o t he 
m o ut h, wit h t he de nt ures t he n re place d i n t he s u bject’s m o ut h as detaile d i n t he Pr o d uct 
A p plicati o n I nstr ucti o ns ( A p pe n di x 1 5. 4)
C CI
. T he test pr o d uct will be s u p plie d b y G S K C H i n 
c o m merciall y mar kete d t u bes. T he c o nte nts of t he pr o d uct la bel will be i n acc or da nce wit h all 
a p plia nce re g ulat or y re q uire me nts a n d will be t he res p o nsi bilit y of t he Gl o bal Cli nical S u p plies 
gr o u p. 
All s u n dr y ite ms will be s u p plie d i n t heir c o m mercial pac ka gi n g f or use b y st u d y staff as 
re q uire d.

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All investigational study products will be overwrapped. Each study label will contain, but not 
be limited to, protocol number, directions for use and storage requirements. 
Care should be taken with the supplied products and their labels so that they are maintained in 
good condition.  It is important that all labels remain intact and legible for the duration of the 
study. 
All products supplied are for use only in this clinical study and should not be used for any other 
purpose.
6.1.2
Preparation and Dispensing 
COREGA Máximo Sellado/Selamento will be applied to the dentures by qualified unblinded 
site personnel according to the Product Application Instructions instruction (Appendix 15.4). 
Subjects will be assigned to products in accordance with the randomization schedule generated 
by an approved GSK CH vendor, prior to the start of the study, using validated software.
These staff members will not be involved in any safety, efficacy assessments or other study 
aspects that could be influenced by the knowledge of product a subject has been assigned to 
use. 
6.2
Administration
Subject’s dentures will first be cleaned prior to application of adhesive.  For subjects 
randomized to no adhesive, the cleaning will still be performed in order to standardize the 
cleanliness of the denture prior to commencement of the food occlusion testing. Using the 
supplied denture brush and cleansing paste, both the upper and lower dentures will be 
thoroughly cleaned to remove all traces of denture fixative, plaque and particulates/debris. 
Dentures should then be dried.
Adhesive will be applied from the primary product packaging onto the dentures as per the 
Product Application Instructions (Appendix 15.4). The dentures will then be returned to the 
subject who should reposition the dentures in their mouth and bite down to secure hold. For 
subjects on the “no adhesive” treatment visit, the dentures should be cleaned and dried as above, 
and refitted by the subject.
6.2.1
Medication/Dosing Errors
Medication/dosing errors may result, in this study, from the administration or consumption of: 

the wrong product,

by the wrong subject, 

at the wrong time, 

or at the wrong dosage. 
Such medication/dosing errors occurring to a study subject are to be captured in the CRF. 
Medication/dosing errors are reportable irrespective of the presence of an associated AE, 
including:

Medication/dosing errors involving subject exposure to any of the study products;

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
Potential medication/dosing errors or uses outside of what is foreseen in the protocol 
that do or do not involve the participating subject.
If a medication/dosing error is accompanied by an AE, as determined by the investigator, the 
medication/dosing error and, any associated adverse event(s) are to be captured in the CRF AE 
form. 
6.3
Investigational/Study Product Storage 
The investigator, or designee, will ensure that all study products are stored in a secured area 
with controlled access under required storage conditions and in accordance with applicable 
regulatory requirements and the product label.  
Site systems must be capable of measuring and documenting (for example, via a log), at a 
minimum, daily minimum and maximum temperatures for all site storage locations (as 
applicable, including frozen, refrigerated, and/or room-temperature products).  This should be 
captured from the time of first product receipt throughout the study.  Even for continuous 
monitoring systems, a log or site procedure that ensures active daily evaluation for excursions 
should be available.  The operation of the temperature-monitoring device and storage unit (for 
example, refrigerator), as applicable, should be regularly inspected to ensure it is maintained in 
working order. 
Any excursions from the product-label storage conditions should be reported to appropriate site 
staff upon discovery and communicated to sponsor as soon as possible.  The site should actively 
pursue options for returning the product to the storage conditions as described in the labeling, 
as soon as possible.  Excursions from the storage requirements, including any actions taken, 
must be documented as a protocol deviation and reported to the Sponsor.  
Once an excursion is identified, the affected product (or products) must be quarantined and not 
used until the sponsor provides documentation of permission to use. Use of any of the affected 
product(s) prior to sponsor approval will be considered a protocol deviation.  
6.4
Investigational/Study Product Accountability
All products supplied are for use only in this clinical study and should not be used for any other 
purpose.
All study products must be received by a designated person at the study sites, handled and stored 
safely and properly, and kept in a secured location to which only the staff have access. Upon 
receipt, all study products should be stored according to the instructions specified on the product 
labels. 
The investigative site must maintain adequate records documenting the receipt, use, loss, or 
other disposition of all the product supplies. All study products will be accounted for using the 
investigational/study product accountability form/record. The investigator is responsible for 
study product accountability, reconciliation, and record maintenance. 
The accountability records must be available for inspection by the study monitor during the 
study. Monitoring of product accountability will be performed by the monitor during site visits 
and at the completion of the study. 

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6.4.1
Destruction of Investigational/Study Product Supplies 
At the conclusion of the study, the Principal Investigator or an appropriate designee, and a 
representative of GSK CH (study monitor) will inventory all used and unused study products 
and sundry items.  The investigational/study product accountability record for returned study 
products will then be completed. All study product (used and unused) for this clinical study 
(including empty containers), will be returned for destruction to the GSK CH Clinical Supplies 
Department or designated vendor using the return instructions provided. 
6.5
Blinding and Allocation/Randomization
All subjects will be centrally randomized to one of the study arms using an Interactive Response 
Technology (IRT). Before the study is initiated, training, login information and directions for 
the IRT will be provided to each site. Study products will be dispensed according to the 
instruction received through the IRT at the appropriate study visits.
Open or used study products should not be re-dispensed to any subject.
The investigator’s knowledge of the product allocation should not influence the decision to 
enroll a particular subject or affect the order in which subjects are enrolled.
This study is described as single blind (with respect to the technician weighing the peanut 
particles). The study statistician, data management staff, other employees of the Sponsor and 
vendors acting on behalf of the Sponsor, who may influence study outcomes will also be blinded 
to the product allocation. 
Dispensing staff will not be involved in any efficacy/safety assessment procedures during the 
study.  
6.6
Breaking the Blind
At the initiation of the study, the study site will be instructed on the method for breaking the 
blind.  The method will be an electronic process.
The electronic system will be programmed with blind-breaking instructions. In case of an 
emergency, the investigator has the sole responsibility for determining if unblinding of a 
subject’s product assignment is warranted. Subject safety must always be the first consideration 
in making such a determination. If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the sponsor prior to unblinding a subject’s 
product assignment unless this could delay emergency treatment of the subject.
If a subject’s product assignment is unblinded, the sponsor must be notified within 24 hours 
after breaking the blind. The date and reason that the blind was broken must be recorded in the 
source documentation and case report form, as applicable.
Any AE associated with breaking the blind must be recorded and reported as specified in this 
protocol. The study site may also be required to inform the IRB/EC if the blind is broken. 
6.7
Subject Compliance
Study products will be administered by site staff and this will be controlled by mass, and this 
will be documented in the CRF.  The number of any missed or additional applications or doses 
will be captured as protocol deviations and transcribed into the CRF.

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6.8
Concomitant Medication/Treatment(s)
Any medications, treatments or vaccine (including over-the-counter or prescription medicines, 
vitamins, and/or herbal supplements) taken during the study, from signing the informed consent, 
must be recorded in the CRF with indication, reason for use, unit dose, daily dose, and start and 
stop dates of administration.  All subjects will be questioned about concomitant medication/ 
treatments at each site visit.
Details of any relevant dental, medical or surgical history (within the last year), including 
allergies of drug sensitivity, will be recorded in the CRF. The use of concomitant medications 
is permitted in this study except for the use of bisphosphonate drugs (exclusion criteria 10) and 
any medications that in the opinion of the investigator would interfere with the conduct of this 
study (exclusion criteria 16).
Medication/treatment taken within 7 days of signing the informed consent form will be 
documented as a prior medication/treatment.  Treatment taken after the first dose of study 
investigational product will be documented as concomitant treatment.
All concomitant treatments taken during the study must be recorded with indication, unit dose, 
daily dose, and start and stop dates on administration. All subjects will be questioned about 
concomitant treatment at each clinic visit.
Subjects will be asked not to have any non-emergency dental/denture work performed during 
the times they are in the study, unless discussed and permitted by the examiner. This is to assure 
that the denture fit will not be altered during the study.
6.9
Rescue Medication 
No specific rescue therapy is required in this study.
7
DISCONTINUATION OF STUDY INTERVENTION AND 
SUBJECT DISCONTINUATION/WITHDRAWAL
7.1
Subject Discontinuation/Withdrawal 
A subject may withdraw from the study at any time at his or her own request, or may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral 
reasons, or the inability of the subject to comply with the protocol-required schedule of study 
visits or procedures.  
The following circumstances require discontinuation of study product and/or premature subject 
withdrawal:

Protocol violation that may impact the subject’s safety

Withdrawal of informed consent

Subject lost to follow-up 

Pregnancy
If a subject is discontinued or prematurely withdraws from the study, the reason(s) for 
discontinuation or withdrawal and the associated date must be documented in the relevant 
section(s) of the CRF. 

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7.2
Lost to Follow up
A subject will be considered lost to follow up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
If a subject fails to return to the site for a required study visit, the site must attempt to contact 
the subject and reschedule the missed visit as soon as possible and counsel the subject on the 
importance of maintaining the assigned visit schedule and ascertain whether or not the subject 
wishes to and/or should continue in the study.
Before a subject is deemed lost to follow up, the investigator or designee must make every effort 
to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified 
letter to the subject’s last known mailing address or local equivalent methods). These contact 
attempts should be documented. If contact is made with the subject, the investigator should 
inquire about the reason for withdrawal, request that the subject return all products that they 
had been dispensed and if appropriate request that the subject return for a final visit, and 
follow-up with the subject regarding any unresolved adverse events (AEs).
Final safety assessments may be carried out when the subject returns to the study site, at the 
investigator’s discretion, which may include an OST examination. 
Should the subject continue to be unreachable, he/she will be considered to have withdrawn 
from the study and lost to follow up. 
Lack of completion of all or any of the early termination procedures will not be viewed as 
protocol deviations so long as the subject’s safety was preserved.
If the subject withdraws from the study and also withdraws consent for disclosure of future 
information, no further evaluations should be performed and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
8
STUDY PROCEDURES
This section lists the procedures to be completed at each planned study visit.  The timing of 
each procedure is listed in the Schedule of Activities section.
Adherence to the study design requirements, including all procedures are essential and required 
for study conduct.
8.1
Visit 1/Screening
Screening procedures will be conducted by the Investigator, or suitably qualified designee.
Subjects will be screened within 2–7 days prior to administration of the investigational product 
to confirm that they meet the subject selection criteria for the study.  
The following procedures/assessments will be completed in the order listed below (where 
possible), and recorded in the CRF:

Obtain written informed consent.

Collect demography (year of birth, gender, race and ethnicity).

Obtain medical history, including history of illegal drugs, alcohol and tobacco use.

Obtain dental history.

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
Obtain complete medication history of all prescription or non-prescription drugs, and 
dietary and herbal supplements taken within 7 days prior to planned first dose.

Perform OST Examination-Edentulous.

Perform the denture bearing tissue score assessment.

Clean the subject’s dentures using the supplied denture brush and cleansing paste, both the 
upper and lower dentures will be thoroughly cleaned to remove all visible traces of 
denture fixative, plaque and particulates/debris. Dentures should then be dried.

Perform the Well-Made Assessment.

Perform the Well-Fit Assessment.

Perform the Food Migration Adequacy Assessment.

Perform OST Examination-Edentulous.

Review Inclusion and Exclusion criteria. Pregnancy status will be confirmed verbally by 
the subject.

Assess subject eligibility.
To prepare for the study participation, subjects will be instructed on the use of the Lifestyle 
Considerations and Concomitant Treatment(s) sections of the protocol.
8.1.1
Visit 2
Subjects will be admitted to the clinical site 2-7 days after screening. The following procedures 
will be completed in the following order (wherever possible) and recorded in the CRF:

Review Inclusion and Exclusion criteria. Pregnancy status will be confirmed verbally by 
the subject.

Review changes in the subject’s medical history including medication history since 
Screening.  Any exacerbation of pre-existing medical history will be recorded as AEs.

Perform OST Examination- Edentulous.

Assess subject continuance.

Randomize subject to a treatment sequence group.

Clean the subject’s dentures using the supplied brush and cleansing paste. Both upper and 
lower dentures will be thoroughly cleaned to remove all visible traces of denture fixative, 
plaque and particulates/debris. Dentures should then be dried.

Apply the denture adhesive (or no adhesive per the randomization schedule) and insert 
dentures per the Product Application Instructions.

60±5 minutes after denture insertion, begin Food Occlusion Testing including Subject 
Denture Dislodgment Assessment. (This includes peanut chewing, and peanut retrieval 
from dentures and the oral cavity).

Subjects report the number of denture dislodgments during peanut chewing.

Subjects complete questionnaire (as per Appendix 15.3) once dentures have been 
removed.

Photograph dentures of the first five randomized subjects.

Perform OST Examination-Edentulous.

Dentures will be cleaned and returned to subject.

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
Record AEs and incidents. Assess symptoms by spontaneous reporting of adverse events 
and by asking the subjects to respond to a non-leading question such as “How do you 
feel?”
8.1.2
Visit 3
Subjects will be admitted to the clinical site between 2-7 days after Visit 2. The following 
procedures will be completed in the following order (wherever possible) and recorded in the 
CRF:

Review Inclusion and Exclusion criteria. Pregnancy status will be confirmed verbally by 
the subject.

Review changes in the subject’s medical history since Screening. Any exacerbation of pre-
existing medical history will be recorded as AEs.

Perform OST Examination- Edentulous.

Assess subject continuance.

Clean the subject’s dentures using the supplied denture brush and cleansing paste. Both 
upper and lower will be cleaned to remove all traces of denture fixative, plaque and 
particulates/debris. Dentures should then be dried.

Apply denture adhesive (or no adhesive per the randomization schedule) and insert 
dentures per the Product Application Instructions.

60±5 minutes after denture insertion, begin Food Occlusion Testing including Subject 
Denture Dislodgment Assessment. (This includes peanut chewing, and peanut retrieval 
from dentures and the oral cavity).

Subjects report the number of denture dislodgments during peanut chewing.

Subjects complete questionnaire (as per Appendix 15.3) once dentures have been removed

Photograph dentures of the first five randomized subjects at Visit 2.

Perform OST Examination-Edentulous.

Dentures will be cleaned and returned to subject.

Records AEs and incidents. Assess symptoms by spontaneous reporting of adverse events 
and by asking the subjects to respond to a non-leading question such as (How do you 
feel?”

Study Conclusion.
If a subject has any clinically significant, study-related abnormalities at the conclusion of 
scheduled inpatient portion of the study, the GSK CH monitor (or designated representative) 
should be notified and depending on the abnormality, the subject may be asked to remain at the 
clinical site until such abnormalities are deemed not clinically significant, or it is safe for 
outpatient follow-up. If the subject is unable or unwilling to remain at the clinical site and /or 
when outpatient follow up is deemed appropriate, the GSK CH medical monitor (or designated 
representative) should be notified, and the investigator, should make every effort to arrange 
follow-up evaluations at appropriate intervals to document the course of the abnormalities.
8.1.3
Informed Consent
The investigator, or designee, must obtain informed consent at the screening visit from each 
subject participating in this study after adequate explanation of the aims, methods, objectives, 
and potential hazards of the study. Two copies of the informed consent form (ICF) will be 

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signed and dated by the subject, the subject will retain one copy and the other will be kept at 
site.
The investigator, or designee, must also explain to the subjects that they are completely free to 
refuse to enter the study or to withdraw from it at any time.  Appropriate forms for documenting 
a signed and dated consent will be provided by either the investigator or by GSK CH.
The investigator, or designee, should sign and date each copy of the ICF to confirm that the 
consent process was completed correctly after the subject has signed.  
The time the subject signed the informed consent form will also be captured on the Informed 
Consent Form as this is the point at which all Adverse Events will be captured from. The date 
and time of consent will be transcribed to the CRF.
If, during a subject’s participation in the study, any new information becomes available that 
may affect the subject’s willingness to participate in the study, each ongoing subject should 
receive a copy of this new information and be re-consented into the study. Each subject should 
be provided with a copy of the signed and dated amended consent form. The date of re-consent 
will be recorded on the CRF.
After signing the ICF, subjects will undergo the screening assessments to confirm that they 
meet all the inclusion criteria and none of the exclusion criteria. If the subject is confirmed 
eligible by the investigator (or designee) to participate in the study the subject is considered 
enrolled in the study.
e-Consent is a tool that assists in the consent process by using multimedia components delivered 
by an electronic system (e.g. IPad/tablet). The multimedia components consist of video, audio, 
knowledge review, dictionary and electronic signature.
The site staff can use the system to consent the subject with the benefit of helping the subject 
understand the research they are taking part in and to control the consent process.
The system will allow for a copy of the consent to be printed and given to the subject and for 
consent documents to be retained by the site in PDF format.
A GSK CH approved vendor will be used to provide the system and training and help desk will 
be provided as needed.
If the country and/or site does not have approval to use the e-Consent system, or the subject 
does not want to use the e-Consent system, then the conventional paper process will be followed. 
It is possible to use the e-Consent system to educate the subject while using paper to obtain 
signatures.
8.1.4
Demographics
The following demographic information will be recorded at the screening visit by the 
investigator or designee in the CRF: year of birth, gender, ethnicity and race.
Ethnicity and race of subjects will be recorded in accordance with FDA Guidance for Industry: 
Collection of Race and Ethnicity Data in Clinical Trials, 2005. This is required for this study as 
the product is intended to be marketed in the US and allows for summary of data across different 
clinical studies, and different launch markets. This aids in a better understanding of potential 
differences across ethnicities.

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8.1.5
Inclusion/Exclusion Criteria
Inclusion and exclusion criteria information will be documented at the screening visit in the 
CRF by the investigator or designee. The well-made assessment of dentures, denture bearing 
tissue assessment, denture retention and stability assessment, and OST examination should be 
performed by suitably qualified personal with expertise in prosthodontics.
8.1.6
Medical History and Prior Medication/Treatment
Details of relevant medical and surgical history (in the last 1 year), including allergies or drug 
sensitivity, will be documented in the CRF at the screening visit by the investigator or designee.
Prior medications/treatments, including prescription and non-prescription drugs, dietary 
supplements and herbal remedies, taken in the last 7 days and prior to signing the informed 
consent form, will be documented in the CRF.
8.1.6.1
Dental History
The Investigator, or medically qualified designee, will take a dental history from each subject 
at the screening visit. Dental history will include information of all prostheses in the mouth, 
maxillary and mandibular, as well as information regarding the age of the dentures, how long 
the subject has worn dentures, the prosthetic teeth material and whether the subject is a regular 
user of denture adhesives. This will be documented in the CRF.
8.1.7
Subject Eligibility
The investigator and/or medically qualified designee will review inclusion/exclusion criteria, 
medical history, prior medications to confirm subject eligibility to participate in the clinical trial 
at the screening visit. This will be documented in the CRF.
To prepare for study participation, subjects will be instructed in the Lifestyle Guidelines and 
any Concomitant Medication/Treatment(s) requirements of the protocol.
8.1.8
Clean Dentures
Denture cleansing will be performed by suitably qualified site staff. Enough denture cleansing 
paste will be applied to the supplied denture brush. All surfaces of the dentures will be 
thoroughly cleaned to remove all visible traces of denture fixative, plaque and 
particulates/debris. The dentures will then be rinsed thoroughly with running water.
Dentures should then be dried using clinical paper towels. Please note that the denture cleansing 
paste is to be used extra-orally and not for use in the mouth. Hands should be washed thoroughly 
following application and use of the denture cleansing paste.  This procedure should be 
performed at all study visits.
8.1.9
Screening Procedures
The following assessments will be performed at times defined in the Study Procedure section 
of this protocol.

Well-fit assessment, Kapur Olshan Modification Index

Well-made assessment

Denture bearing tissue assessment

Food migration adequacy training

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8.2
Study Period
The following efficacy and safety assessments will be performed at time defined in the Study 
Procedures section of this protocol.

Oral soft tissue (OST) examination- edentulous

Food occlusion testing incorporating denture dislodgment

Subject questionnaire

Denture photographs at treatment visits
Remind subject to inform the site if they experience any untoward medical occurrence or use 
any medications in the next visit. Changes in concomitant medication or non-drug 
treatments/procedures will be documented in the CRF. 
Spontaneous reporting of adverse events and those elicited by asking subjects to respond to a 
non-leading question such as “How do you feel?” will be assessed and any AEs recorded in the 
CRF.
All procedures listed above will be carried out at Visit 2 and 3. As visit 3 is the last study visit, 
study close out procedures will also be carried out here.
Additional and missed product applications will be considered deviations from the protocol and 
will be recorded on the Deviations Log. 
8.3
Study Conclusion
The Study Conclusion page of the CRF will be completed for all subjects whether they 
completed all study procedures or if they were discontinued from the study early.  If the subject 
discontinued early, at any point during the study, the primary reason for withdrawal should be 
recorded on the Study Conclusion page.
If a subject has any clinically significant, study-related abnormalities or AEs at the conclusion 
of the study, the GSK CH medical monitor (or designated representative) should be notified 
and, the subject may be asked to remain at the clinical site or be asked to return for a follow-up 
visit to ensure any issue is resolved or deemed not clinically significant. 
8.4
Follow-up Visit
The study site may contact a subject to follow up an AE post-study completion/withdrawal and, 
in some circumstances, request they return to the site for additional follow-up visits (final safety 
assessments). If needed, additional examinations may be carried out at such visits.
9
STUDY ASSESSMENTS
Every effort should be made to ensure that protocol-required tests and procedures are completed 
as described.  However, it is anticipated that from time to time there may be circumstances, 
outside the control of the investigator that may make it unfeasible to complete an assessment.  
In these cases, the investigator must take all steps necessary to ensure the safety and well-being 
of the subject.  When a protocol-required assessment cannot be performed, the investigator (or 
designee) will document the reason for the missed assessment as a protocol deviation and any 
corrective and preventative actions that he or she has taken to ensure that required processes are 
adhered to as soon as possible.  The Sponsor must be informed of any missed assessments in a 
timely manner.

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9.1
Screening Assessments
Screening assessments will be performed by appropriately trained staff/clinical examiners at 
the times, and in the order, defined in the Study Procedures section of this protocol 
9.1.1
Well-Fit Assessment, Kapur (Olshan Modification) Index
At Screening, each denture (maxillary and mandibular) will be examined for retention and 
stability using the Kapur Index (Olshan Modification) (Kapur, 1967; Olshan, 1992) by an 
examiner with the expert knowledge of prosthodontics. The subject should not be using any 
denture adhesives during this examination. A sum score (maxillary and mandibular) of ≥6 is 
required for inclusion.
Retention:
With gloved hands, the examiner will attempt to unseat the maxillary and mandibular denture 
by applying an opposing vertical force at the canine/lateral incisor region of the denture. The 
examiner will score retention as 0-5 using the following criteria:
5= Excellent- denture offers excellent resistance to vertical pull and lateral force.
4= Very Good- denture offers very good resistance to vertical and lateral force.
3= Good- denture offers moderate resistance to vertical and lateral force.
2= Fair- denture offers moderate resistance to vertical pull and little or no resistance to lateral 
force.
1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral 
force.
0= No retention- when denture is seated in place, it displaces itself.
Stability
With gloved hands, the examiner will attempt to rock the seated dentures by placing alternate 
horizontal force at the cuspid and contralateral molar regions of the maxillary and mandibular 
dentures. The examiner will score denture stability as 0-4 using the following criteria.
4= Excellent- when denture base offers no rocking on its supporting structures under pressure.
3= Good- when denture base has very slight rocking on its supporting structure under pressure
2= Fair- when denture base has slight rocking on its supporting structure under pressure.
1= Poor- when denture base has moderate rocking on its supporting structure under pressure.
Sum score (upper + lower denture) of <6 = dentures with poor retention and stability. 
Sum score (upper + lower denture) 6-9 = dentures with fair retention and stability. 
Sum score (upper + lower denture) 10-14 = dentures with good retention and stability. 
Sum score (upper + lower denture) >14 = dentures with very good retention and stability.
9.1.2
Well Made Assessment
This assessment should be performed at screening.
Clinical Acceptability
Each denture (maxillary and mandibular) will be examined. Only having adequate (as judged 
by an examiner with expert knowledge of prosthodontics) vertical dimension, freeway space, 

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horizontal occlusal relationships and border extension will be considered clinically acceptable. 
For each denture (maxillary and mandibular), the examiner will indicate acceptable or 
unacceptable on the CRF.
Denture Finish and Contour
The contour and finish of each denture (maxillary and mandibular) will be examined. Only 
dentures with acceptable (as judged by an examiner with expert knowledge of prosthodontics) 
porosity, tissue surfaces, polished surfaces, color and thickness will be accepted. For each 
denture (maxillary and mandibular), the examiner will indicate acceptable or unacceptable on 
the CRF.
9.1.3
Denture Bearing Tissue Score
The denture bearing tissue score (Kapur, 1967) will be assessed at the screening visit by an 
examiner with the expert knowledge of prosthodontics and recorded for the maxillary and 
mandibular dentures on the appropriate CRF.  There are no eligibility requirements associated 
with this measure in this clinical trial.
Ridge Shape (for both Maxillary and Mandibular)
1= Flat
2= V-shaped
3= Shaped between U and V
4= U shaped
Tissue Resiliency (for both Maxillary and Mandibular)
1= Flabby
2= Resilient
3= Firm
Location of Border Tissue Attachment
Maxillary Arch
Mandibular Arch
1= Low
1=
High
2= Medium
2=
Medium *
3= High
3=
Low *
Due to an inconsistency observed in the original printed publication, the two descriptors above 
marked by an asterisk (*) have been modified (by inverting their order) to better reflect the 
authors intent and align with the grading scale.
9.1.4
Food Migration Adequacy Determination
Subjects must complete the food migration adequacy assessment at the screening visit by an 
appropriately trained/experienced staff whilst using no denture adhesives/fixatives. Dentures 
should have been cleaned and dried by the study staff and replaced in the subject’s mouth. 
Subjects will be provided with 30-32 grams (accurately weighed) of non-salted peanuts, divided 
into smaller portions of approximately eight peanut halves. Each portion should be chewed for 
approximately 20 seconds, after which the subject will be instructed to swallow at any time they 
are comfortable. Subjects will be allowed small sips of water during the peanut consumption to 
aid chewing as appropriate. After completion of the peanut consumption, the subject will rinse 
their mouth with water for up to 10 seconds before removing their denture. The rinsing step 

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may be repeated as required, if necessary, in the opinion of the examiner, to ensure peanut 
particles that have not migrated under the dentures are cleared from the oral cavity, Subjects 
will be asked to remove their dentures (the examiner may assist in this if required) and place 
them into a labelled tray (with subject screening number) teeth side down, and may remove any 
residual peanut particles from their mouth with water and a gauze pad (not for collection). The 
amount of food particles on each denture will be visually assessed according to the scale below 
and recorded in the CRF to determine if there is evidence of peanut particle migration under the 
dentures. The following 0 – 3 assessment scale will be used. Subjects who present no evidence 
of peanut particles under either the upper or lower denture (i.e. if either denture scores as 0) will 
not be eligible. 
The location and extent of peanut particle migration will be rated as follows: 
0= None – No peanut migration under the denture. 
1= Minimal – Slight migration of peanuts under the denture. 
2= Moderate – Migration of peanuts over the internal walls of the denture. 
3= Extensive – Peanuts migration on the crest of the denture.
Dentures should be cleaned thoroughly prior to returning to the subject.
9.2
Efficacy Assessments
The following efficacy assessments will be performed by appropriately trained staff/clinical 
examiners, at the times and in the order defined in the Study Procedures section of this protocol.
9.2.1
Food Occlusion Testing Incorporating Dislodgment Assessment
Food Occlusion will be measured by a trained or experienced operator at Visits 2 and 3 using 
the method described below. 60±5 minutes after the dentures have been inserted:
1. The subject will be instructed to bite down firmly on their dentures. The subject will 
then rinse their mouth vigorously with water. The site staff will remove any adhesive 
that is oozing from the dentures. Note: The subject must not eat any food during the 
60±5 minutes period with the exception of small sips of water.
2. The subjects will be given the denture dislodgement sheet to record the number of 
denture dislodgements experienced during the chewing of the peanuts.  Subjects will 
also be instructed in this procedure using the standardized script.
3. The subject will be given 30-32g of non-salted, dry roasted peanuts to chew and swallow. 
The 32g portion of peanuts will be divided by the staff into smaller portions of 
approximately 8 peanut halves (approximately 4 g). The subject will be asked to chew 
each pre-measured portion of peanuts for at least 20 seconds, after which they may 
swallow at any time they are comfortable. The subject may sip water during peanut 
consumption to aid swallowing where required.
4. Whilst consuming the peanuts, the subject should tick a box (as per Appendix 15.2) 
every time they feel their denture dislodge. The total number of denture dislodgments 
for the subject should be recorded by the study site staff in the CRF.
5. Should a subject be unable to fully complete the chewing procedure above owing to 
excessive discomfort arising from peanut particles under their dentures or for any other 
reason, the chewing procedure should cease immediately and the subject’s dentures 

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removed, cleaned and returned to them. The subject should undergo an OST 
examination per study schedule, but no efficacy measures (peanut mass, questionnaire 
responses, number of denture dislodgements) should be performed. The subject can 
continue for any remaining visits or be rescheduled to repeat the assessment. The reason 
for an absence of efficacy measures should be recorded in the eCRF. The examiner 
should assess whether the reason the subject was unable to complete the chewing 
procedure qualifies as an adverse event or incident and record in the eCRF as appropriate.
6. After consuming all of the peanuts, the subject will gently rinse their mouth with water 
whilst biting their dentures together for up to 10 seconds and then expectorate in order 
to remove any peanut particles not retained under the dentures.  The rinsing step may 
be repeated as required, if necessary, in the opinion of the examiner, to ensure peanut 
particles that have not migrated under the dentures are cleared from the oral cavity
7. The examiner will clear the vestibular and sub-lingual areas (maxillary and mandibular) 
of any food particulates and then carefully remove the subject’s mandibular denture and 
place it on a tray, teeth side down and remove any residual adhesive and/ or peanut 
particles from the lower edentulous ridge with a piece of gauze that will be placed in a 
separate beaker coded with the subject’s screening number, treatment period (not 
treatment) and identifier to indicate mandibular denture.
8. The examiner will carefully remove the subject’s maxillary denture and place it on a 
small tray, teeth side down and remove any residual adhesive and/ or peanut particles 
from the upper edentulous ridge/palate with a piece of gauze that will be placed in a 
separate beaker coded with the subject’s screening number, treatment period (not 
treatment) and identifier to indicate maxillary denture.
9. All of the non-fitting surfaces of the dentures will be checked for residual peanuts. If 
any is found on any surface other than those in contact with oral soft tissue, it will be 
removed with a spatula and discarded.
10. For a subset of approximately 5 subjects at each treatment visit, a photograph of the 
fitting surface of the dentures will be taken as per section 9.2.3.
11. The maxillary and mandibular dentures of each subject will be placed in the coded 
beakers with the gauze (maxillary and mandibular separately).
12. Immediately following removal of the prostheses, the subject will complete the study 
questionnaire per section 9.2.2.
13. In the laboratory, approximately 100mls (or enough to cover the prostheses) of warm 
deionized water (approximately 50°C/122°F) will be added to each beaker. The beakers 
will be sonicated for at least 30 minutes to loosen any adhering peanut particles.
14. After sonication, any peanuts particles still remaining on the prosthesis or the gauze will 
be washed out into the beaker. The gauze pieces will be discarded and the dentures will 
be cleaned and returned to the subject.
15. The dentures should be cleaned thoroughly (section 8.1.8) before returning to the subject.
16. The solutions in the beakers (mixture of water, adhesive and saliva and peanut particles) 
will be heated to boiling with frequent stirring to dissolve any undissolved adhesive.
17. The hot solution in each beaker will be strained through a standard testing sieve, USA 
#60 (coded in the same manner as the beakers above).

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18. The residue remaining on the screen will be washed repeatedly with hot water to remove 
any adhesive or saliva.
19. The collected peanut particles will be air-dried overnight on the screen.
20. The dried particles will be transferred from the screen to the pre-weighed coded (in the 
same manner as the beakers and sieves above) aluminum weighing pans using a spatula 
and then will be dried in an oven at 40°C (105°F) for 5 hours.
21. The pan will be removed from the oven, cooled to room temperature and then weighed 
(in grams, to 4 decimal places) to determine the mass of the particles from each denture. 
The weighing of the peanut particles will be carried out by a different operator than the 
operator that has carried out steps 1-19 and this operator will be blinded to treatment 
allocation.
Prior to commencing this testing, the subjects will have their entire food occlusion and denture 
dislodgement assessment procedure explained to them at each visit. A standard script will be 
used to ensure consistency in procedures.
9.2.2
Subject Questionnaire
After the food occlusion testing and following removal of the dentures on Test Days (Visits 2 
and 3), the subject will complete a questionnaire (Appendix 15.3) on their experience during 
the chewing procedure. The subject responses should be transcribed by the study staff to the 
CRF. The study staff should be mindful that whilst the questionnaire does not solicit safety 
information, any information on safety outcomes recorded by subjects on the questionnaire 
should be evaluated to ensure all AEs are recorded prior to the subject leaving the site. Subjects 
who answer no to question 1 will not be required to answer question 2-4, and they will 
automatically be assigned a score of 0 for these questions.
9.2.3
Denture Photographs at Treatment Visits
For the first five randomized subjects in the study at Visits 2 and 3, extra oral digital 
photographs will be taken of the underside of each denture immediately after their removal to 
document the appearance of migrated particles for sponsor review. This procedure should be 
performed by appropriately trained/experienced staff.  It is expected that approximately 5 sets 
of dentures be photographed per treatment, and where possible that consistency of subjects 
between treatments is maintained (i.e. a subject will be identified at visit 2 as being suitable for 
denture imaging and will have their dentures photographed at visit 2 and 3). Digital photographs 
and their filenames will not contain any personally identifiable information. The digital file 
should be appropriately named to identify the subject screening number and the treatment 
period. The only photographs that will be taken will be of dentures outside of the mouth. No 
images of subjects will be obtained.
9.3
Safety and Other Assessments
The following safety assessments will be performed by appropriately trained staff/clinical 
examiners, at the times and in the order defined in the Study Procedures section of this protocol.  
9.3.1
Oral Soft Tissue (OST) Examination- Edentulous
The OST examination should be performed at every visit by a qualified dentist and ideally the 
same examiner should be used. The OST Exam- Edentulous will include the labial mucosa 

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(including lips), buccal mucosa, tongue, gingival mucosa, sublingual area, hard and soft palates, 
mucogingival folds, submandibular area, salivary glands, tonsilar and pharyngeal areas. 
Observations will be made of any erythema, desquamation and ulcerations, and other relevant 
clinical observations. The results of the examination will be recorded in the CRF as either 
normal or abnormal. The location and brief description of any abnormalities will also be 
recorded.  Any obvious deposits present in the mouth e.g. food, calculus or denture adhesive 
observed during any of the OST examinations should be removed by the subject/examiner.
10
ADVERSE EVENT AND SERIOUS ADVERSE EVENTS
10.1
Definition of an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study subject, temporally associated 
with the use of a study product including any washout or lead-in product (or medical device), 
whether or not considered related to the study product, including any washout or lead-in product 
(or medical device).
NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally/ associated with the 
use of a study product including any washout or lead-in product (or medical device).
Events Meeting the AE Definition:  

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (e.g. ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator (i.e., not related to progression of 
underlying disease).

Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.

New conditions detected or diagnosed after study product administration even though 
it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
product or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae.

"Lack of efficacy" or "failure of expected pharmacological action" per se will not be 
reported as an AE. Such instances will be captured in the efficacy assessments. 
However, the signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy will be reported as AE if they fulfill the definition of an AE. 
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. 

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 40 of 60

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

Other situations:

Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the subject or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 41 of 60

Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse.
Note: Classification of an AE as ‘serious’ is based on the outcome of the event, and is a factor 
in determining reporting requirements.
10.3
Reporting of Adverse Events
10.3.1
Reporting Period 
All AEs, and therefore all SAEs will be collected immediately after a subject consents to 
participate in the study by the completion (signature) of the ICF and until 5 days following last 
administration of the study product (or last procedure). 
Medical occurrences that began before obtaining informed consent will be recorded in the 
Medical History/Current Medical Conditions section of the CRF not the AE section.
Details recorded by the subject on a diary or similar document that meet the definition of an AE 
must also be discussed with the subjects and transcribed in the AE section of the CRF. 
10.4
Reporting Procedures
The investigator and any designees are responsible for detecting, documenting and reporting 
events that meet the definition of an AE and remain responsible for following up on AEs that 
are serious, considered related to the study product(s), participation in the study, or a study 
procedure, or that caused the subject to discontinue the study product or study. 
The investigator (or medically qualified designee) is to report all directly observed AEs and all 
AEs spontaneously reported by the study subject. In addition, each study subject will be 
questioned about AEs. 
Each AE is to be assessed to determine if it meets the criteria for a SAE.  If an SAE occurs, 
expedited reporting will follow local and international regulations, as appropriate.
When an AE occurs, it is the responsibility of the investigator (or medically qualified designee) 
to review all documentation (e.g. hospital progress notes, laboratory, and diagnostics reports) 
related to the event.
The investigator or site staff will then record all relevant information regarding an AE in the 
CRF and all details relating to an SAE in the paper SAE Form provided.
It is not acceptable for the investigator (or medically qualified designee) to send photocopies 
of the subject’s medical records to GSK CH in lieu of completion of the AE CRF page/SAE 
form.
There may be instances when copies of medical records for certain cases are requested by GSK 
CH.  In this instance, all subject identifiers, with the exception of the subject number, will be 
redacted on the copies of the medical records prior to submission to GSK CH.
The investigator (or medically qualified designee) will attempt to establish a diagnosis of the 
event based on signs, symptoms, and/or other clinical information.  The diagnosis will be then 
documented as the AE/SAE where known and not the individual signs/symptoms. (e.g. upper 
respiratory tract infection, seasonal allergy, etc. instead of runny nose).

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 42 of 60
AEs elicited by the investigator (or medically qualified designee) in a standard manner at the 
study visits should also be recorded in the AE section of the CRF and/or using the SAE form 
(subject to the classification of the AE). Care will be taken not to introduce bias when 
questioning a subject about any changes in their health. Open-ended and non-leading verbal 
questioning should be used. 
10.4.1
Reporting of an Adverse Event
All AEs will be reported on the AE page of the CRF by the investigator or site staff.  It should 
be noted that the form for collection of SAE information is not the same as the AE CRF.  Where 
the same data are collected, the AE CRF page and the SAE form must be completed in a 
consistent manner.  For example, the same AE term should be used on both.  AEs should be 
reported using concise medical terminology on the CRF as well as on the form for collection of 
SAE information.
10.4.2
Reporting of a Serious Adverse Event
In addition to recording the details of each AE on the AE CRF page, an SAE form should be 
completed, as fully as possible. Hard copies of the ‘paper’ SAE form will be provided in the 
investigator study master file. Original SAE forms will be retained in the investigator study 
master file.
It is essential to enter the following information: 

Protocol and subject identifiers

Subject demography

Description of events, with diagnosis if available

Investigator opinion of relationship to study product (or study procedure, if appropriate)

Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and GSK CH 
assessment of the SAE report:

Date of onset of AE 

Date AE stopped, if relevant

Study product start date

Study product end date if relevant

Action taken in relation to the study product

Outcome if known
The SAE form, completed as fully as possible, must be scanned and e-mailed to the GSK CH 
Clinical Operations Safety Reporting email box with the study number and subject number in 
the subject line of the email immediately and under no circumstance should this exceed 24 
hours after study site personnel learn of the event. The investigator will submit any updated 
SAE data to the sponsor, immediately and under no circumstance should this exceed 24 
hours of it being available. The GSK CH Study Manager should also be notified of the situation 
by telephone or email.

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 4 3  of 6 0
E m ail Seri o us A d verse E ve nts t o:
T he G S K C H St u d y Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he S A E f or m t o 
t he Case 
Ma na ge me nt 
Gr o u p, 
Gl o bal Cli nical Safet y a n d P har mac o vi gila nce 
mail b o x 
(
).
T he i nitial re p ort will be f oll o we d u p wit h m ore i nf or mati o n as rele va nt, or as re q ueste d b y t he 
G S K C H st u d y ma na ger.
1 0. 5 
E v al u ati n g A d v er s e E v e nt s 
1 0. 5. 1  
A s s e s s m e nt of I nt e n sit y
T he i n vesti gat or or me dicall y q ualifie d desi g nee will ma ke a n assess me nt of i nte nsit y f or eac h 
A E re p orte d d uri n g t he st u d y a n d will assi g n it t o o ne of t he f oll o wi n g cate g ories:

Mil d:  A n e ve nt t hat is easil y t olerate d b y t he s u bject, ca usi n g mi ni mal disc o mf ort a n d 
n ot i nterferi n g wit h e ver y da y acti vities.

M o derate:  A n e ve nt t hat is s ufficie ntl y disc o mf orti n g t o i nterfere wit h n or mal e ver y da y 
acti vities

Se vere:  A n e ve nt t hat pre ve nts n or mal e ver y da y acti vities. 
N O T E: A n A E t hat is assesse d as se vere s h o ul d n ot be c o nf use d wit h a n S A E. Se vere is a 
cate g or y utilize d f or rati n g t he i nte nsit y of a n e ve nt; a n d b ot h n o n-seri o us A Es a n d S A Es ca n 
be assesse d as se vere. F or e xa m ple, a hea dac he ma y be se vere (i nterferes si g nifica ntl y wit h t he 
s u bject's us ual f u ncti o n) b ut w o ul d n ot be classifie d as seri o us u nless it met o ne of t he criteria 
f or S A Es, liste d a b o ve. A n e ve nt is defi ne d as ‘seri o us’ w he n it meets at least 1 of t he pre defi ne d 
o utc o mes as descri be d i n t he defi niti o n of a n S A E, N O T w he n it is rate d as se vere.
1 0. 5. 2  
A s s e s s m e nt of C a u s alit y
T he ca usalit y assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y re p orti n g 
re q uire me nts. F or eac h A E (seri o us a n d n o n-seri o us), t he i n vesti gat or ( or me dicall y q ualifie d 
desi g nee) m ust  pr o vi de a n assess me nt of ca usalit y o n t he A E C R F pa ge a n d t he S A E f or m 
P P D
(s u bject t o t he classificati o n of t he A E). T he i n vesti gat or will als o d oc u me nt i n t he me dical 
n otes t hat he/s he has re vie we d t he A E a n d assesse d ca usalit y, w here a p plica ble. 
A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, a n d/ or 
ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot be r ule d o ut. 
Ge nerall y, t he facts (e vi de nce) or ar g u me nts t o s u g gest a ca usal relati o ns hi p s h o ul d be pr o vi de d.
T he i n vesti gat or will use cli nical j u d g me nt t o deter mi ne t he relati o ns hi p a n d will als o c o ns ult 
t he I n vesti gat or Br oc h ure (I B), Safet y State me nt a n d/ or Pr o d uct I nf or mati o n, f or mar kete d 
pr o d ucts, i n t he deter mi nati o n of his/ her assess me nt.  Alter nati ve ca uses, s uc h as u n derl yi n g 
disease(s), c o nc o mita nt t hera p y, ot her ris k fact ors, a n d t he te m p oral relati o ns hi p of t he e ve nt t o 
t he st u d y pr o d uct will be c o nsi dere d a n d i n vesti gate d.
F or eac h A E/ S A E, t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat he/s he has re vie we d 
t he A E/ S A E a n d has pr o vi de d a n assess me nt of ca usalit y.
P P D

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 4 4  of 6 0
T he i n vesti gat or’s assess me nt of ca usalit y m ust be pr o vi de d f or all A Es (seri o us a n d n o n-
seri o us); t he i n vesti gat or m ust rec or d t he ca usal relati o ns hi p i n t he C R F, as a p pr o priate, a n d 
re p ort s uc h a n assess me nt i n acc or da nce wit h t he S A E re p orti n g re q uire me nts if a p plica ble.
T here ma y be sit uati o ns w he n a n S A E has occ urre d a n d t he i n vesti gat or has mi ni mal 
i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o G S K.  H o we ver, it is ver y i m p ort a nt t h at t he 
i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y f or e ver y e ve nt pri or t o t he i niti al 
tr a ns missi o n of t he S A E d at a t o G S K C H. T he i n vesti gat or ma y c ha n ge his/ her o pi ni o n of 
ca usalit y i n li g ht of f oll o w- u p i nf or mati o n a n d se n d a n S A E f oll o w- u p re p ort wit h t he u p date d 
ca usalit y assess me nt. 
1 0. 6 
F oll o w- u p of A d v er s e E v e nt s 
After t he i nitial re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll o w u p wit h eac h s u bject 
a n d pr o vi de f urt her i nf or mati o n o n t he s u bject’s c o n diti o n.
All A Es (seri o us a n d n o n-seri o us) will be f oll o we d u ntil res ol uti o n, u ntil t he c o n diti o n sta bilizes, 
u ntil t he e ve nt is ot her wise e x plai ne d, or u ntil t he s u bject is l ost t o f oll o w- u p.  
T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns as ma y be i n dicate d or as re q ueste d b y G S K C H t o el uci date 
as f ull y as p ossi ble t he nat ure a n d/ or ca usalit y of t he A E. T his ma y i ncl u de a d diti o nal la b orat or y 
tests or i n vesti gati o ns, hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt h care 
pr ofessi o nals.
Ne w or u p date d i nf or mati o n will be rec or de d o n t he A E C R F pa ge a n d o n t he S A E f or m (s u bject 
t o t he classificati o n of t he A E).
T he i n vesti gat or will 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 recei pt of 
t he i nf or mati o n.
I n vesti gat ors are n ot o bli ge d t o acti vel y see k A Es i n f or mer s u bjects.  H o we ver, if t he 
i n vesti gat or lear ns of a S A E, i ncl u di n g deat h, at a n 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 ve nt reas o na bl y relate d t o t he st u d y pr o d uct or st u d y 
partici pati o n, t he i n vesti gat or will pr o m ptl y n otif y G S K C H b y e maili n g t he i nf or mati o n t o t he 
G S K C H Cli nical O perati o ns Safet y Re p orti n g e mail b o x (
. 
T he G S K C H St u d y Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he i nf or mati o n t o 
t he Case Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d P har mac o vi gila nce gr o u p mail b o x at 
G S K (
).
T he i n vesti gat or 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 t he desi g nate d re p orti n g 
ti me fra mes.
1 0. 7  
Wit h dr a w al D u e t o a n A d v er s e E v e nt 
Wit h dra wal d ue t o A Es s h o ul d be disti n g uis he d fr o m wit h dra wal d ue t o ot her ca uses, acc or di n g 
t o t he defi niti o n of a n A E n ote d earlier, a n d rec or de d o n t he a p pr o priate A E C R F 
P P D
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 nce wit h 
t he re p orti n g re q uire me nts defi ne d.
P P D

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 4 5  of 6 0
1 0. 7. 1 
S p o n s or’ s R e p orti n g R e q uir e m e nt s t o R e g ul at or y A ut h oriti e s a n d 
Et hi c s C o m mitt e e s
G S K C H has a le gal res p o nsi bilit y t o n otif y, as a p pr o priate, t he l ocal re g ulat or y a ut h orit y a n d 
ot her re g ulat or y a ut h orities a b o ut t he safet y of a pr o d uct u n der cli nical i n vesti gati o n.  Pr o m pt 
n otificati o n of S A Es b y t he i n vesti gat or t o G S K C H is esse ntial s o t hat le gal o bli gati o ns a n d 
et hical res p o nsi bilities t o war ds t he safet y of s u bjects are met.
G S K C H will c o m pl y wit h c o u ntr y s pecific re g ulat or y re q uire me nts relati n g t o safet y re p orti n g 
t o t he re g ulat or y a ut h orit y, I R B/ E C a n d i n vesti gat ors.
I n vesti gat or safet y re p orts m ust be pre pare d f or s us pecte d u ne x pecte d seri o us a d verse reacti o ns 
( S U S A R) acc or di n g t o l ocal re g ulat or y re q uire me nts a n d s p o ns or p olic y a n d f or war de d t o 
i n vesti gat ors as necessar y.
A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y re p ort descri bi n g a n S A E or ot her s pecific 
safet y i nf or mati o n e. g. s u m mar y or listi n g of S A E fr o m t he s p o ns or will re vie w a n d t he n file it 
al o n g wit h t he I n vesti gat or’s Br oc h ure i n t he i n vesti gat or st u d y master file, a n d will n otif y t he 
I R B/I E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
1 0. 8 
Pr e g n a n c y
1 0. 8. 1 
Ti m e P eri o d f or C oll e cti n g Pr e g n a n c y I nf or m ati o n
Pre g na nc y i nf or mati o n will be c ollecte d o n all pre g na ncies re p orte d w hile a fe male s u bject is 
partici pati n g i n t he st u d y fr o m t he si g ni n g of i nf or me d c o nse nt u ntil 5 da ys after last 
a d mi nistrati o n of st u d y pr o d uct.
1 0. 8. 2  
A cti o n t o b e T a k e n if Pr e g n a n c y O c c ur s
P P D
T he i n vesti gat or 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 sca n 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 na nt. T he G S K C H 
St u d y Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he pre g na nc y f or m t o t he Case 
Ma na ge me nt 
Gr o u p, 
Gl o bal 
Cli nical 
Safet y 
a n d 
P har mac o vi gila nce 
mail b o x 
). 
Ori gi nal pre g na nc y i nf or mati o n f or ms 
will be retai ne d i n t he 
i n vesti gat or st u d y master file. 
T he s u bject will be f oll o we d t o deter mi ne t he o utc o me of t he pre g na 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 nate (i ncl u di n g c o nc o mita nt me dicati o ns ta ke n b y t he 
m ot her d uri n g t he pre g na nc y) will be f or war de d b y t he i n vesti gat or t o t he G S K C H Cli nical 
O perati o ns Safet y Re p orti n g e mail b o x a n d t he G S K C H St u d y Ma na ger or desi g nee will 
f or war d t his i nf or mati o n t o t he Case 
Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d 
P har mac o vi gila nce gr o u p mail b o x at G S K (
). Ge nerall y, f oll o w- u p will 
be n o l o n ger t ha n 6 t o 8 wee ks f oll o wi n g t he esti mate d deli ver y 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 nc 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, fetal deat h, still birt h, c o n ge nital a n o malies, ect o pic pre g na nc y) are, a n d 
s h o ul d be rec or de d as a n S A E.
A n y fe male s u bject w h o bec o mes pre g na nt w hile partici pati n g will be wit h dra w n fr o m t he st u d y.
P P D
P P D

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
Page 46 of 60
10.9
Definition of and Procedure for Reporting Medical Device 
Incidents
Medical devices are being provided by GSK CH for use in this study; the medical devices in 
this study are the COREGA Máximo Sellado/Selamento Denture Adhesive, the denture brushes 
and denture cleansing paste. 
10.9.1
 Definition of an Incident
A medical device incident is any malfunction or deterioration in the characteristics and/or 
performance of a device as well as any inadequacy in the labeling or the instructions for use 
which, directly or indirectly, might lead to or might have led to the death of a subject/user/other 
person or to a serious deterioration in his/her state of health.
Not all incidents lead to death or serious deterioration in health. The nonoccurrence of such a 
result might have been due to other fortunate circumstances or to the intervention of health care 
personnel.
It is sufficient that:
An incident associated with a device happened and

The incident was such that, if it occurred again, might lead to death or a serious 
deterioration in health.

A serious deterioration in state of health can include any of the following:

Life-threatening illness

Permanent impairment of body function or permanent damage to body structure

Condition necessitating medical or surgical intervention to prevent one of the 
above 

Fetal distress, fetal death, or any congenital abnormality or birth defects
Examples of incidents:

A subject, user, caregiver, or healthcare professional is injured as a result of a medical 
device failure or its misuse.

A subject’s study treatment is interrupted or compromised by a medical device failure.

A misdiagnosis due to medical device failure leads to inappropriate treatment.

A subject’s health deteriorates due to medical device failure.
10.9.2
Reporting of Incidents and Malfunctions
All incidents must be reported to GSK CH within 24 hours (or sooner if possible) of the 
investigator or designee becoming aware of the situation.
Any medical device incident occurring during the study will be documented in the subject's 
medical records, if in accordance with the investigator's normal clinical practice, and on the 
appropriate Incident Report Form.  In addition, for incidents fulfilling the definition of an AE 

S o di u m-calci u m mi xe d partial salt ( met h yl vi n ylet her/ maleic aci d) a n d car b o x y met h ylcell ul ose/
C O R E G A Má xi m o Sella d o/ Sela me nt o 
Pr ot oc ol N u m ber 2 0 9 6 4 9
Cli nical Pr ot oc ol V 3. 0
Gla x o S mit h Kli ne C o ns u mer Healt hcare C o nfi de ntial 
Te m plate Versi o n Effecti ve: 1 8- Ma y- 1 8 ( C C R # 1 1 4 7 5)
Pa ge 4 7  of 6 0
(seri o us a n d n o n-seri o us), t he a p pr o priate A E C R F pa ge a n d S A E f or m will be c o m plete d a n d 
re p orte d as per t he A E a n d S A E re p orti n g secti o ns.
T he I nci de nt Re p ort F or m will be c o m plete d as t h or o u g hl y as p ossi ble a n d si g ne d b y t he 
i n vesti gat or bef ore tra ns mittal t o G S K C H.  It is ver y i m p orta nt t hat t he i n vesti gat or descri bes 
a n y c orrecti ve or re me dial acti o ns ta ke n t o pre ve nt rec urre nce of t he i nci de nt.
T he c o m plete d I nci de nt Re p ort F or m s h o ul d be sca n ne d a n d e maile d t o t he G S K C H Cli nical 
O perati o ns Safet y Re p orti n g e mail b o x wit h t he st u d y n u m ber a n d s u bject n u m ber i n t he s u bject 
li ne of t he e mail as s o o n as p ossi ble, b ut n ot m ore t h a n 2 4 h o urs  after st u d y site pers o n nel 
lear n of t he e ve nt. If t here is a n S A E, t he c o m plete d S A E f or m s h o ul d be se nt t o get her wit h t his 
re p ort f or m.  H o we ver, if a c o p y of t he S A E re p ort is se nt wit h t his f or m, t his d oes n ot re place 
t he pr oce d ure t o re p ort a n S A E.  T he ori gi nal I nci de nt Re p ort F or m will be retai ne d i n t he 
i n vesti gat or st u d y master file. 
T he G S K C H St u d y Ma na ger s h o ul d be n otifie d of t he sit uati o n b y tele p h o ne or e mail.
E m ail t he I nci de nt Re p ort F or ms t o:
T he G S K C H St u d y Ma na ger or desi g nee will be res p o nsi ble f or f or war di n g t he I nci de nt Re p ort 
F or m t o t he Case Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y a n d P har mac o vi gila nce gr o u p 
mail b o x (
), res p o nsi ble f or t he st u d y a n d ot her G S K C H pers o n nel as 
a p pr o priate.
T he i nitial re p ort will be f oll o we d u p wit h m ore i nf or mati o n as rele va nt, or as re q ueste d b y t he 
G S K C H st u d y ma na ger.
T he i n vesti gat or will f oll o w t he f oll o wi n g directi o ns re gar di n g t he re p orti n g of a de vice fail ure 
( malf u ncti o n):

N otif y G S K C H i m me diatel y ( b y f oll o wi n g t he pr ocess descri be d a b o ve).

Sc he d ule t he s u bject t o ret ur n t o t he site pr o m ptl y t o ret ur n t he faile d de vice.

Rec or d a n y i nci de nts o n t he C R F a n d I nci de nt Re p ort F or m f oll o wi n g i nstr ucti o ns gi ve n 
i n t he secti o n a b o ve.

Ret ur n t he faile d de vice t o t he s p o ns or as s o o n as p ossi ble, i ncl u di n g d oc u me ntati o n of 
t he details of t he fail ure 
1 0. 9. 3 
F oll o w- u p of M e di c al D e vi c e I n ci d e nt s
Me dical de vice i nci de nts i n v ol vi n g a n A E will be f oll o we d a n d re p orte d i n t he sa me ma n ner as 
ot her A Es. T his a p plies t o all s u bjects, i ncl u di n g t h ose w h o disc o nti n ue st u d y pr o d uct or are 
wit h dra w n fr o m t he st u d y.
T he i n vesti gat or is res p o nsi ble f or e ns uri n g t hat f oll o w- u p i ncl u des a n y s u p ple me ntal 
i n vesti gati o ns as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of t he i nci de nt.
Ne w or u p date d i nf or mati o n will be rec or de d o n t he ori gi nall y c o m plete d I nci de nt Re p ort f or m 
wit h all c ha n ges si g ne d a n d date d b y t he i n vesti gat or.
1 0. 9. 4  
R e g ul at or y a n d Et hi c s R e p orti n g R e q uir e m e nt s f or I n ci d e nt s
P P D
T o f ulfill re g ulat or y re p orti n g o bli gati o ns w orl d wi de, t he i n vesti gat or is res p o nsi ble f or t he 
detecti o n a n d d oc u me ntati o n of e ve nts meeti n g t he defi niti o ns of i nci de nt or malf u ncti o n t hat 
occ ur d uri n g all peri o ds of t he st u d y i n w hic h t he me dical de vice is use d. 
P P D

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The investigator will promptly report all incidents occurring with any medical device provided 
for use in the study in order for the sponsor to fulfill the legal responsibility to notify appropriate 
regulatory authorities and other entities about certain safety information relating to medical 
devices being used in clinical studies.
The investigator, or responsible person according to local requirements (e.g. the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to 
the reporting of incidents to the IRB/IEC.
11
DATA MANAGEMENT
As used in this protocol, the term CRF is understood to refer to either a paper form or an 
electronic data record or both, depending on the data collection method. 
For this study, subject data will be entered into an electronic CRF (eCRF), using a validated 
system. Data relating to SAEs, pregnancy and incidents will also be collected on paper forms.
The investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF.
The source documents (e.g. hospital records, clinical and office charts, laboratory notes, 
memoranda, subject diaries, questionnaires, evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, microfiches, photographic negatives, microfilm or 
magnetic media, x-rays, subject files and records kept at the pharmacy, at the laboratory and at 
the medico-technical departments involved in the clinical study) which contain the source of 
data recorded in the CRF should be specified in Section 8 and 9.  The CRF can be used as a 
source document at the discretion of data management.
Each subject will be assigned and identified by a unique Screening Subject Number. Any 
reference made to an individual subject within the study must be done using their unique 
Screening Subject Number.
11.1
Case Report Form
A CRF is a printed, optical, or electronic document designed to record the protocol required 
information to be reported to the sponsor on each trial subject.
For each subject who has given informed consent/assent the CRF must be completed and signed 
by the Principal Investigator (or authorized designee) to certify that the data are complete and 
correct.  The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
Management of clinical data will be performed in accordance with Third Party Biostats and 
Data Management (BDM) Vendor applicable standards and data cleaning procedures with 
oversight by GSK CH to ensure integrity of the data, for example, to remove errors and 
inconsistencies in the data. 
To protect the privacy of subjects, no Personally Identifiable Information (PII) (including the 
subject's name or initials or full birth date) is to be recorded in the CRF or as part of the query 
text.
All CRF pages should be completed during a subject assessment when the CRF has been 
designated as the source.  Data that is sourced elsewhere should be entered into the CRF in an 
agreed upon timeframe between the Investigator and Sponsor.  

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GSK CH will obtain and retain all CRFs and associated study data as applicable at the 
completion of the study. 
11.2
Data Handling
Documentation of all data management activities should allow step-by-step retrospective 
assessment of data quality and study performance. 
Any changes or corrections to data will be performed in the Electronic Data Capture (EDC) 
System, and it will include rationale for changes. The EDC system has an audit trail, which will 
provide a complete record of the changes and corrections endorsed by the Investigator.
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA) 
and any concomitant medications terms (if applicable) using an internal validated medication 
dictionary, GSKDrug.  
11.2.1
Data Queries
Programmed edit checks will be generated automatically, as the data are being entered into the 
system. Reports and listings on the CRF data will also be run, in addition to the queries already 
programmed and generated by the system, to raise manual queries as needed for site 
clarification or correction. The Clinical Dictionary Development and Management Group will 
raise queries as needed on safety data to code the terms (AEs and Drugs or concomitant 
medication) appropriately. 
The study monitor will perform ongoing review of the CRFs in accordance with the monitoring 
plan, to confirm that data entered into the CRF by authorized site personnel are accurate, 
complete, and verifiable from source documents; that the safety and rights of participants are 
being protected; and that the study is being conducted in accordance with the currently approved 
protocol and any other study agreements, ICH GCP, and all applicable regulatory requirements.
Any queries will be generated in the EDC System to the Investigator or designee, enabling the 
errors to be addressed in parallel with Data Management review. The study monitor can also 
run reports and listings on the CRFs, to raise manual queries as needed for site clarification or 
correction.
11.3
Processing Patient Reported Outcomes
Paper based patient reported outcome (PRO) data will be collected from a diary, questionnaire, 
or other specified document, etc. and entered into the data management system (DMS).  
Electronic Patient reported outcome (ePRO) data may be collected using electronic devices and 
transferred electronically to GSK CH or Third-party DM vendor.
All PRO source data should be reviewed by the study staff and the study monitor in order to 
ensure accurate transcription of data and that any potential AEs or concomitant medications 
reported on these documents are discussed with the subject and transcribed accurately to the 
CRF and/or DMS.  PROs that are classed as source data will be retained by the investigator and 
true/certified copies may be sent to a designated vendor or GSK CH as required.
To protect the privacy of subjects, no Personally Identifiable Information (PII) (including the 
subject's name or initials or birth date) is to be recorded on any PRO/ePRO that will be 
forwarded to GSK CH or Third-Party Vendor.

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11.4
External Data 
External Data are subject data obtained externally to the CRF. These data are generated from 
laboratory instruments, computers or other sources and then transcribed into a file and format 
agreed upon by GSK CH to identify the subject and time point referenced in the CRF and/or 
protocol. 
An agreed quality control process will be performed against the transcribed data to the source 
to ensure the accuracy of the transcription. The transcribed data is transmitted in an agreed upon 
format to GSK CH. 
Reconciliation will be performed between the transcribed data and the clinical database to 
ensure subject and time point referenced in the Clinical Database match before Clinical 
Database Freeze (locking of the database) can occur.
12
STATISTICAL CONSIDERATIONS AND DATA ANALYSES
12.1
Sample Size Determination
The primary endpoint is the combined mass (mg) of peanuts from both dentures. Based upon a 
Modified Intent to Treat (MITT) analysis of a previous study data 208397 using a logarithmic 
transformation and an estimate of the within subject variability as the square-root of the (208397 
study) Mean Square Error (MSE) (0.5075), 48 subjects in a 2-period crossover design analyzed 
with a logarithmic transformation (base 10), will have 81% power to detect a multiplicative 
difference of 2 (0.3010 on log scale), i.e. 2-fold more peanuts (indicating twice as many peanuts 
by mass) with no adhesive compared to the active adhesive subjects using a two-sided 
significance test at the 5% level. For a multiplicative difference of 2.25 (0.3522 on log scale) 
the power will be approximately 91% with 48 evaluable subjects. 52 subjects should be 
randomized to ensure 48 are evaluable. 
These were calculated using the Power Analysis and Sample Size (PASS) software for a two-
period crossover trial and using the Sw option for the variability estimate as 0.5075. An 
extensive simulation study, supported the above calculations conducted in PASS.
A non-parametric alternative (Wilcoxon Signed Rank Test) if the logarithmic transformation is 
not indicated will have similar power.
12.2
Statistical Methods and Analytical Plan
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 Database lock.
12.2.1
Definition of Analysis Populations

The Safety population will comprise all randomized subjects who receive at least one dose 
of the study product. This population will be based on the product the subject received.

The MITT (Treated or Exposed) population will comprise all randomized subjects who 
receive at least one dose of study product and have at least one on therapy assessment of 
efficacy.  This population will be based on the study product to which the subject was 
randomized. Any subject who receives a randomization number will be considered to have 
been randomized.

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
The Per-Protocol (PP) population includes all subjects who fully comply with all study 
procedures and restrictions. Deviations will be determined and applied prior to unblinding 
and consist of variations in criteria likely to affect the interpretation of the efficacy 
parameters. 
12.2.2
Exclusion of Data from Analysis 
Exclusion of any data from the analyses will be determined during a Blind Data Review 
Meeting prior to database lock. Any reasons for exclusion from an analysis population will be 
listed, if applicable. 
12.2.3
Demographic and Baseline Characteristics
Age and other continuous variables will be summarized using descriptive statistics such as 
means, medians and standard deviation. Gender, race and other categorical variables will be 
summarized using frequency counts and percentages for the safety and MITT populations.
12.2.4
Study Drug/Product Compliance
Compliance to the study product use will be tabulated and summarized for the safety and MITT 
populations.
12.2.5
Prior and Concomitant Medications
Prior medications, concomitant medications and significant non-drug therapies taken during 
treatment will be listed for the safety population. 
12.2.6
Primary Analysis(es) 
Food occlusion will be measured by mass of peanut particles (mass of retrieved peanuts in 
milligrams). Analysis will be performed on the Log10 transformed masses of peanuts recovered 
from the combined mandibular and maxillary dentures. Raw means, standard deviations, 
standard errors, minimum and maximum values will be reported by treatment.
A Mixed model ANOVA will be used with Log10 peanut mass as response and treatment and 
period as fixed explanatory effects and subject as a random effect. In case of any zero counts a 
small value will be used in the analysis. In case of issues with model assumptions (residual 
distributions etc), alternative transformations may be sought or non-parametric equivalents 
(Wilcoxon Signed Rank Test) used. 
The study will be considered successful if there is a statistically significant difference between 
the mass of peanuts under dentures of subjects using denture adhesive versus when using no 
adhesive. The MITT population will be considered primary for this analysis.
12.2.7
Secondary Analysis(es)
An identical analysis will be conducted on the peanut mass (g) obtained on each of the two 
dentures separately. In case of any zero counts a small value will be used in the analysis. 
The number of denture dislodgments will also be analysed. Raw means, standard deviations, 
standard errors, minimum and maximum values will be reported by treatment. 
For the subjects’ responses to questionnaires (0-10), descriptive statistics (number of subjects 
and percentages) will be provided for each question response category by treatment. 

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Secondary variables include the number of denture dislodgments and subject responses to 
questionnaires (0-10), similar statistical presentations will follow the primary analysis approach 
without transformation.
For all secondary analyses the MITT population is primary.  No alpha adjustments will be made 
for multiple secondary endpoints due to the exploratory nature of the inferences.
No interim analyses are planned.
12.2.8
Safety Analysis(es)
All AEs will be coded using MedDRA. AEs will be categorised as oral and non-oral by the 
Clinical Research Scientist (CRS) prior to database lock. Treatment-emergent adverse events 
(Oral AEs as well as all AEs) will be associated with the most recent treatment received. The 
number of AEs and number of subjects with AEs will be listed and tabulated by treatment. The 
results of OST exams will be tabulated and any abnormality from an OST examination will be 
regarded as an adverse event. Incidents will be listed.
12.2.9
Other Analysis(es)
The photographs will be presented in the study report and may be included with any 
publications / presentations arising from this study in order to help explain the study findings.
12.2.10
Handling of Dropouts and Missing Data 
Missing data will not be replaced or imputed. Dropouts will be included in the analysis up to 
the last assessments at the point of discontinuation.
12.2.11
Interim Analysis 
No interim analysis is planned for this study
13
STUDY GOVERNANCE CONSIDERATIONS
13.1
Quality Control 
In accordance with applicable regulations including GCP, and GSK CH procedures, GSK CH 
or designee (i.e. third-party vendor) monitors will contact the site prior to the start of the study 
to review with the site staff the protocol, study requirements, and their responsibilities to satisfy 
regulatory, ethical, and GSK CH requirements.
When reviewing data collection procedures, the discussion will include identification, 
agreement and documentation of data items for which the CRF will serve as the source 
document.
GSK CH or designee will monitor the study and site activity to verify that the:

Data are authentic, accurate, and complete.

Safety and rights of subjects are being protected.

Study is conducted in accordance with the currently approved protocol and any other 
study agreements, GCP, and all applicable regulatory requirements.

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The extent and nature of monitoring will be described in a written monitoring plan on file at 
GSK CH. The investigator (or designee) agrees to allow the monitor direct access to all relevant 
documents and agrees to co-operate with the monitor to ensure that any problems detected in 
the course of these monitoring visits are resolved.
13.2
Quality Assurance
To ensure compliance with GCP and all applicable regulatory requirements, GSK CH may 
conduct a quality assurance assessment and/or audit of the site records, and the regulatory 
agencies may conduct a regulatory inspection at any time during or after completion of the study. 
In the event of an assessment, audit or inspection, the investigator (and institution) must agree 
to grant the advisor(s), auditor(s) and inspector(s) direct access to all relevant documents and 
to allocate their time and the time of their staff to discuss the conduct of the study, any 
findings/relevant issues and to implement any corrective and/or preventative actions to address 
any findings/issues identified.
The investigator(s) will notify GSK CH or its agents immediately of any regulatory inspection 
notification in relation to the study. Furthermore, the investigator will cooperate with GSK CH 
or its agents to prepare the study site for the inspection and will allow GSK CH or its agent, 
whenever feasible, to be present during the inspection. The investigator will promptly apply 
copies of the inspection finding to GSK CH or its agent. Before response submission to the 
regulatory authority, the investigator will provide GSK CH or its agents with an opportunity to 
review and comment on responses to any such findings. 
The sponsor will be available to help investigators prepare for an inspection.
13.3
Regulatory and Ethical Considerations
13.3.1
Institutional Review Board/ Ethics Committee 
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, informed consent documents, investigator brochure/safety statement 
(including any updates) and other relevant documents, e.g. recruitment advertisements, if 
applicable, from the IRB/EC.  All correspondence with the IRB/EC should be retained in the 
investigator file.  Copies of IRB/EC approvals should be forwarded to GSK CH prior to the 
initiation of the study, and also when subsequent amendments to the protocol are made.
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In that 
event, the investigator must notify the IRB/EC and GSK CH in writing immediately after the 
implementation. As per the Regulatory Determination for this study, the experimental adhesive 
is categorized as a medical device and therefore a Nonsignificant Risk (NSR) application will 
be required as part of the IRB submission to conduct this study in the US. 
13.3.2
Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
the general principles set forth in the International Ethical Guidelines for Biomedical Research 
Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), 
International Ethical Guidelines for Health-Related Research Involving Humans (Council for 

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Template Version Effective: 18-May-18 (CCR #11475)
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International Organizations of Medical Sciences, 2016), guidelines for GCP (ICH 1996 and 
revision 2), and the Declaration of Helsinki (World Medical Association 2013). 
In addition, the study will be conducted in accordance with the protocol, the ICH guideline on 
GCP, and applicable local regulatory requirements and laws.
13.3.3
Subject Information and Consent
All parties will ensure protection of subject personal data and will not include subject names or 
other identifiable data in any reports, publications, or other disclosures, except where required 
by laws. 
When study data are compiled for transfer to GSK CH and other authorized parties, subject 
names, addresses, and other identifiable data will be replaced by numerical codes based on a 
numbering system provided by GSK CH in order to de-identify study subjects.  
The study site will maintain a confidential list of subjects who participated in the study, linking 
each subject’s numerical code to his or her actual identity.  In case of data transfer, GSK CH 
will maintain high standards of confidentiality and protection of subjects’ personal data 
consistent with applicable privacy laws.
The informed consent documents must be in compliance with ICH GCP, local regulatory 
requirements, and legal requirements, including applicable privacy laws.
The informed consent documents used during the informed consent process must be reviewed 
and approved by the sponsor, approved by the IRB/EC before use, and available for inspection.
The investigator must ensure that each study subject is fully informed about the nature and 
objectives of the study and possible risks associated with participation. 
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject before any study-specific activity is performed.  The investigator will 
retain the original of each subject's signed informed consent document.
13.3.4
Subject Recruitment 
Advertisements approved by IRBs/ECs and investigator databases may be used as recruitment 
procedures.  Use of ethics committee approved, generic, prescreening questionnaire to assess 
basic subject characteristics to determine general eligibility for this study is allowed.  This 
generic questionnaire may be used by sites as a phone script and/or to review internal databases 
to identify subjects.  
GSK CH will have an opportunity to review and approve the content of any study recruitment 
materials directed to potential study subjects before such materials are used. 
13.3.5
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP 
Within GSK CH a serious breach is defined as a breach likely to affect to a significant degree 
the safety and rights of a subject or the reliability and robustness of the data generated in GSK 
CH-sponsored human subject research studies. 
In the event of any prohibition or restriction imposed (i.e., clinical hold) by an applicable 
competent authority in any area of the world, or if the investigator is aware of any new 

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information that might influence the evaluation of the benefits and risks of the investigational 
product, GSK CH should be informed immediately. 
In addition, the investigator will inform GSK CH immediately of any urgent safety measures 
taken by the investigator to protect the study subjects against any immediate hazard, and of any 
serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
13.4
Posting of Information on Publicly Available Clinical Trial 
Registers
Study information from this protocol will be posted on publicly available clinical trial registers 
before enrollment of subjects begins in accordance with applicable GSK CH processes.
GSK intends to make anonymized subject-level data from this trial available to external 
researchers for scientific analyses or to conduct further research that can help advance medical 
science or improve patient care. This helps ensure the data provided by trial participants are 
used to maximum effect in the creation of knowledge and understanding
13.5
Provision of Study Results to Investigators
Where required by applicable regulatory requirements, an investigator signatory will be 
identified for the approval of the clinical study report.  The investigator will be provided 
reasonable access to statistical tables, figures, and relevant reports and will have the opportunity 
to review the complete study results at a GSK CH site or other mutually-agreeable location.
GSK CH will also provide the investigator with the full summary of the study results.  The 
investigator is encouraged to share the summary results with the study subjects, as appropriate.
The procedures and timing for public disclosure of the results summary and for development of 
a manuscript for publication will be in accordance with GSK CH Policy.
A manuscript will be progressed for publication in the scientific literature if the results provide 
important scientific or medical knowledge.
13.6
Records Retention
Following closure of the study, the investigator must maintain all site study records (except for 
those required by local regulations to be maintained elsewhere), in a safe and secure location.  
The records (study/ site master file) must be maintained to allow easy and timely retrieval, when 
needed (e.g. for a GSK CH audit or regulatory inspection) and must be available for review in 
conjunction with assessment of the facility, supporting systems, and relevant site staff.
Where permitted by local laws/regulations or institutional policy, some or all of these records 
can be maintained in a format other than hard copy (e.g. microfiche, scanned, electronic); 
however, caution needs to be exercised before such action is taken. 
The investigator must ensure that all reproductions are legible and are a true and accurate copy 
of the original and meet accessibility and retrieval standards, including re-generating a hard 
copy, if required.  Furthermore, the investigator must ensure there is an acceptable back-up of 
these reproductions and that an acceptable quality control process exists for making these 
reproductions.
The investigator must assure that the subject’s anonymity will be maintained.  On CRFs or other 
documents submitted to GSK CH, subjects should not be identified by their names or initials, 

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but by an identification code. The investigator should keep a separate log of subjects’ codes, 
names and addresses.  Documents not for submission to GSK CH, e.g. subjects’ written consent 
forms, should be maintained by the investigator in strict confidence.
Records and documents, including signed ICF, pertaining to the conduct of this study must be 
retained by the investigator for 25 years from the issue of the final Clinical Study Report (CSR) 
or equivalent summary, unless local regulations or institutional policies require a longer 
retention period. The minimum retention time will meet the strictest standard applicable to that 
site for the study, as dictated by any institutional requirements or local laws or regulations, GSK 
CH standards/procedures, and/or institutional requirements.  
No study document should be destroyed without a prior written agreement between GSK CH 
and the investigator. The investigator must notify GSK CH of any changes in the archival 
arrangements, including, but not limited to, archival at an off-site facility or transfer of 
ownership of the records in the event the investigator is no longer associated with the site.
13.7
Conditions for Terminating the Study 
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB/EC, or study product safety problems, or at the discretion of GSK 
CH.  In addition, GSK CH retains the right to discontinue development of denture adhesives at 
any time. For multicenter studies (if applicable), this can occur at one or more or at all sites.  
If a study is prematurely terminated, GSK CH will promptly notify the investigator.  After 
notification, the investigator must promptly contact all participating subjects and should assure 
appropriate therapy/ follow-up for the subjects.  As directed by GSK CH, all study materials 
must be collected and all CRFs completed to the greatest extent possible. Where required by 
the applicable regulatory requirements, GSK CH should inform the regulatory authority(ies) 
and the investigator should promptly inform the IRB/EC and provide the IRB/EC a detailed 
written explanation of the termination or suspension. 
If the IRB/EC terminates or suspends its approval/favorable opinion of a trial, the investigator 
should promptly notify the GSK CH and provide GSK CH with a detailed written explanation 
of the termination or suspension.
Upon completion or premature discontinuation of the study, the GSK CH monitor will conduct 
site closure activities with the investigator or site staff, as appropriate, in accordance with 
applicable regulations including GCP, and GSK CH Standard Operating Procedures.
13.8
Definition of Study End/End of Study
The end of the study will be the date of the Last Subject Last Visit (LSLV). For this study the 
LSLV date will be the primary completion date (PCD).
14
REFERENCES
Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F, Kowal D, editors. Contraceptive 
Technology. 19th edition. New York: Ardent Media, 2007(b): 28.
ICH Topic E6 (R2) Guideline for Good Clinical Practice, Nov 2016.
World Medical Association Declaration of Helsinki, 64th General Assembly, Fortaleza 2013.
Ahmad M, Ibrahim DFA, Hazmi NH, et al. The effect of denture adhesive on food occlusion. 
Malaysian Dent J. 2009;30(2):146-7.

Sodium-calcium mixed partial salt (methylvinylether/maleic acid) and carboxymethylcellulose/
COREGA Máximo Sellado/Selamento 
Protocol Number 209649
Clinical Protocol V3.0
GlaxoSmithKline Consumer Healthcare Confidential 
Template Version Effective: 18-May-18 (CCR #11475)
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Ahmad M, Ibrahim DFA, Hazmi NH, et al. An investigation into the effect of denture 
adhesives in limiting the food impaction. Malaysian Dent J. 2010;31(2):65-70.
FDA U. Guidance for industry: Collection of race and ethnicity data in clinical trials. 2005.
Kapur KK. A clinical evaluation of denture adhesives. J Prosthet Dent. 1967;18(6):550-8.
Olshan A, Ross N, Mankodi S, et al. A modified kapur scale for evaluating denture retention 
and stability: Methodology study. Am J Dent. 1992;5(2):88-90.
Ozcan M, Kulak Y, de Baat C, et al. The effect of a new denture adhesive on bite force until 
denture dislodgement. J Prosthodont. 2005;14(2):122-6. doi: 10.1111/j.1532-
849X.2005.00020.x. PubMed PMID: 16011623.
Saldanha S, Shenoy VK, Eachampati P, et al. Dental implications of bisphophonate‐related 
osteonecrosis. Gerodontology. 2012;29(3):177-87.
Tarbet WJ, Boone M, Schmidt NF. Effect of a denture adhesive on complete denture 
dislodgement during mastication. J Prosthet Dent. 1980;44(4):374-8. Epub 1980/10/01. 
PubMed PMID: 6997464.
15
APPENDIX
15.1
ABREVIATIONS
The following is a list of abbreviations that may be used in the protocol.
Table 15-1
Abbreviation
Abbreviation
Term
°C 
Degree Centigrade 
°F 
Degree Fahrenheit 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
BDM
Biostats and Data Managment
CI 
Confidence Interval 
CRF 
Case Report Form 
CRS
Clinical Research Scientist
CSA 
Clinical Study Agreement 
CTA 
Clinical Trial Application 
eCRF 
Electronic Case Report Form 
EDC
Electronic Data Capture
EudraCT 
European Clinical Trials Database 
FDA 
Food and Drug Administration (United States) 
FDAAA 
Food and Drug Administration Amendments Act (United States) 
g 
Gram 
GCP 
Good Clinical Practice 
GSK 
GlaxoSmithKline 
GSK CH 
GlaxoSmithKline Consumer Healthcare 
ICF
Inform Consent Form
ICH 
International Conference on Harmonisation 

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Abbreviation
Term
IRB 
Institutional Review Board 
MITT
Modified Intent to Treat
LSLV 
Last Subject Last Visit 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg
milligram
N/A 
Not Applicable 
OST 
Oral Soft Tissue 
PASS
Power Analysis and Sample Size
PI 
Principal Investigator 
PP
Per Protocol
RAP
Reporting and Analysis Plan
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
SRSD
Single Reference Safety Document
SS 
Safety Statement 
US
United States
15.2
Example Form to Record Number of Dislodgments and Subject 
Completed Questionnaire
Date:
Subject Number:
Visit Number:
Tick a new box every time you feel your denture dislodge whilst you are chewing the 
peanuts.

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15.3
Example Subject Completed Questionnaire
Date:
Subject Number:
Visit Number:
The following questions are about the peanut chewing you have just undertaken. Thinking about 
only the peanuts you have just chewed please circle one answer for each question. 
If you have answered “No” to question 1, you do not need to answer questions 2 and 3.
1
2
3
4
5
6
7
8
9
10
2) On a scale of 0 to 10 how would you rate the amount of peanut pieces that went 
under your denture? (Please circle your answer) 
None
Lots
0
1
2
3
4
5
6
7
8
9
10
3) On a scale of 0 to 10 how bothered were you by the peanut pieces that went under 
your denture? (please circle your answer) 
Not at all
Bothered
Extremely
Bothered
0
1) Were you aware of peanut pieces under your denture? (Please circle your answer) 
Ye
No

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Template Version Effective: 18-May-18 (CCR #11475)
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15.4
Product Application Instructions
For the Test group:
1. Clean and dry dentures
2. Apply product directly from primary packaging in long, continuous strips as shown in 
the diagram, not too close to the denture edge:
a.
1g of product should be applied to the upper denture (3 strips should be applied 
to the upper denture)
b. 0.6g of product should be applied to the lower denture (1 strip should be applied 
to the lower denture)
3. Have the subject rinse their mouth with water and expectorate before inserting the 
dentures.
4. Have the subject press dentures into place firmly, and bite down for a few seconds to 
secure hold.
For the Control group:
1. Clean and dry dentures.
2. Have the subjects rinse their mouth with water and expectorate before inserting the 
dentures.
3. Have the subject press dentures into place firmly, and bite for a few seconds to secure 
hold.