Clinical trial NCT03807700
Conditions: Denture Retention
Keywords: Denture, Adhesive, Gum-Health, Lifestyle
Sponsor: GlaxoSmithKline
Start date: 2019-02-04; Completion date: 2019-05-04
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the use of a denture adhesive and its ability to demonstrate the improvement in overall gum-health and to improve the oral health related quality of life (OHrQoL) in participants who wear full dentures.

Detailed description:
This study will be a single center, controlled, single-blind, randomized, two-treatment, parallel design in healthy participants with a full conventional, acrylic denture in either or both dental arches, with a treatment period of 12 weeks. The study will assess the effectiveness of an experimental denture adhesive in the improvement of denture-bearing tissue irritation related measures, and the participant's oral health related quality of life. Participants will be randomized to one of the 2 treatment groups i.e. experimental denture arm group and control arm group and will undergo an oral soft tissue (OST) examination. Participants with satisfactory dentures, adequate retention and stability and who qualify all the inclusion and exclusion criteria will continue in the study. Participants will complete the Gum Comfort, OHIP-Edent questionnaires and GOHAI questionnaire. The assessments will be made at Baseline, and after 1, 4, 8 and 12 weeks treatment.

Arms: arm 1: In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth. arm 2: In this arm, participants will not use any denture adhesive.
Interventions: intervention 1: Experimental Denture Adhesive
Intervention descriptions: intervention 1: In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.

Protocol documents:
Prot_000.pdf: 
Author(s) 
APPROVALS
Name
Reason for Approval
Approval Date CET*(MM/DD/YYYY)
11/13/2018 3:48:06 PM
11/14/2018 8:32:08 AM
11/15/2018 11:37:58 AM
Document Name 
Scope 
Document Type 
Document Subtype 
Document ID 
Version 
Approved Date in CET* 
Pages 
*CET: Central European Time
1.0
66
209510-Clinical Protocol 3
0900c3538118886a
Nov 15,2018  11:38:00 AM
209510-Clinical Protocol-209510-Clinical Protocol 3
Clinical Protocol
Studies
003 Study protocol and Amendment
PPD
PPD
PPD
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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)
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CLINICAL PROTOCOL
A randomized, single-blind, efficacy study to evaluate oral health 
and quality of life associated with use of a denture adhesive
Protocol Number:
209510
Compound/Product Name:
Carboxymethylcellulose and Carbomer
United States (US) Investigational 
New Drug (IND) Number:
N/A
European Clinical Trials Database 
(EudraCT) Number:
N/A
Other Regulatory Agency Identified 
Number:
N/A
Phase:
III
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


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Document History
Document
Version
Summary of Changes 
Original protocol
1.0
Not applicable (N/A)
Amendment 1
Amendment 2
Amendments incorporate all revisions to date, including amendments made at the request of 
country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc.  


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Principal Investigator Protocol Agreement Page

I confirm agreement to conduct the study in compliance with the protocol and any 
amendments according to the current International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) guidelines.

I acknowledge that I am responsible for overall study conduct. I agree to personally 
conduct or supervise the described study.

I agree to ensure that all associates, colleagues and employees assisting in the conduct of 
the study are informed about their obligations. Mechanisms are in place to ensure site staff 
receives all appropriate information throughout the study.

I agree to conduct this study in full conformance with the laws and regulations of the 
country in which the research is conducted and the Declaration of Helsinki.
Investigator Name:
Investigator Qualifications:
Investigator Signature:
Date of Signature/Agreement:
DD-Mmm-YYYY
PPD


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Table of Contents
Sponsor Information ............................................................................................................1
Document History................................................................................................................2
Principal Investigator Protocol Agreement Page.................................................................3
Table of Contents.................................................................................................................4
1
PROTOCOL SUMMARY...................................................................................................9
1.1
Schedule of Activities............................................................................................11
2
INTRODUCTION .............................................................................................................13
2.1
Study Rationale......................................................................................................14
2.2
Mechanism of Action/Indication ...........................................................................14
3
STUDY OBJECTIVES AND ENDPOINTS.....................................................................14
4
STUDY DESIGN ..............................................................................................................15
4.1
Overall Design .......................................................................................................15
4.2
Rationale for Study Design....................................................................................16
4.3
Justification for Dose .............................................................................................17
4.4
End of Study Definition.........................................................................................17
5
STUDY POPULATION....................................................................................................17
5.1
Type and Planned Number of Subjects..................................................................17
5.2
Inclusion Criteria....................................................................................................18
5.3
Exclusion Criteria ..................................................................................................19
5.4
Randomization Criteria..........................................................................................19
5.5
Lifestyle Considerations ........................................................................................19
5.5.1
Contraception ........................................................................................20
5.6
Screen Failures.......................................................................................................21
5.7
Sponsor’s Qualified Medical Personnel.................................................................21
5.8
Rater/Clinical Assessor Qualifications ..................................................................21
6
INVESTIGATIONAL/STUDY PRODUCTS...................................................................21
6.1
Investigational/Study Product Supplies .................................................................22
6.1.1
Dosage Form and Packaging.................................................................23
6.1.2
Preparation and Dispensing...................................................................23
6.2
Administration .......................................................................................................23
6.2.1
Medication/Dosing Errors .....................................................................23
6.3
Investigational/Study Product Storage...................................................................24
6.4
Investigational/Study Product Accountability .......................................................24
6.4.1
Destruction of Investigational/Study Product Supplies.........................24
6.5
Blinding and Allocation/Randomization ...............................................................25
6.6
Breaking the Blind .................................................................................................25
6.7
Subject Compliance ...............................................................................................25
6.8
Concomitant Medication/Treatment(s)..................................................................26


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7
DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .........................................................................26
7.1
Subject Discontinuation/Withdrawal.....................................................................26
7.2
Lost to Follow up...................................................................................................26
8
STUDY PROCEDURES...................................................................................................27
8.1
Visit 1/Screening....................................................................................................27
8.1.1
Informed Consent..................................................................................28
8.1.2
Demographics........................................................................................29
8.1.3
Inclusion/Exclusion Criteria..................................................................29
8.1.4
Medical History and Prior Medication/Treatment ................................29
8.1.5
Dental History .......................................................................................29
8.1.6
Subject Eligibility..................................................................................29
8.2
Study Period...........................................................................................................29
8.2.1
Visit 1/Day 1 (Baseline)........................................................................29
8.2.2
Visit 2 / Days 7±1..................................................................................30
8.2.3
Visit 3 / Day 28±3 .................................................................................30
8.2.4
Visit 4 / Day 56±3 .................................................................................31
8.2.5
Visit 5 / Day 84±3 .................................................................................32
8.3
Diary Review .........................................................................................................32
8.4
Study Conclusion...................................................................................................33
8.5
Follow-up Visit / Phone Call .................................................................................33
9
STUDY ASSESSMENTS .................................................................................................33
9.1
Screening Assessments ..........................................................................................33
9.1.1
Clean Dentures ......................................................................................33
9.1.2
Well Made Assessment .........................................................................34
9.1.3
Denture Bearing Tissue Score...............................................................34
9.1.4
Well-Fit Assessment, Kapur (Olshan Modification) Index...................34
9.2
Efficacy Assessments.............................................................................................35
9.2.1
Subject Questionnaires..........................................................................35
9.2.2
Mucosal Score Assessment (MSA).......................................................37
9.3
Safety and Other Assessments...............................................................................38
9.3.1
Oral Soft Tissue (OST) Examination - Edentulous...............................38
9.3.2
Pregnancy Testing .................................................................................38
10 ADVERSE EVENT AND SERIOUS ADVERSE EVENTS............................................38
10.1
Definition of an Adverse Event (AE) ....................................................................38
10.2
Definition of a Serious Adverse Event (SAE) .......................................................39
10.3
Reporting of Adverse Events.................................................................................40
10.3.1
Reporting Period....................................................................................40
10.4
Reporting Procedures.............................................................................................41


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10.4.1
Reporting of an Adverse Event .............................................................41
10.4.2
Reporting of a Serious Adverse Event ..................................................41
10.5
Evaluating Adverse Events....................................................................................42
10.5.1
Assessment of Intensity.........................................................................42
10.5.2
Assessment of Causality........................................................................43
10.6
Follow-up of Adverse Events ................................................................................43
10.7
Withdrawal Due to an Adverse Event....................................................................44
10.7.1
Sponsor’s Reporting Requirements to Regulatory Authorities and 
Ethics Committees.................................................................................44
10.8
Pregnancy...............................................................................................................44
10.8.1
Time Period for Collecting Pregnancy Information..............................44
10.8.2
Action to be Taken if Pregnancy Occurs...............................................45
10.9
Definition of and Procedure for Reporting Medical Device Incidents..................45
10.9.1
Definition of an Incident .......................................................................45
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 ..................................................................................................47
11.1
Case Report Form ..................................................................................................48
11.2
Data Handling ........................................................................................................48
11.2.1
Data Queries..........................................................................................48
11.3
Processing Patient Reported Outcomes .................................................................49
12 STATISTICAL CONSIDERATIONS AND DATA ANALYSES...................................49
12.1
Sample Size Determination....................................................................................49
12.2
Statistical Methods and Analytical Plan ................................................................49
12.2.1
Definition of Analysis Populations .......................................................50
12.2.2
Exclusion of Data from Analysis ..........................................................50
12.2.3
Demographic and Baseline Characteristics...........................................50
12.2.4
Study Drug/Product Compliance...........................................................50
12.2.5
Primary Analysis ...................................................................................50
12.2.6
Secondary Analyses...............................................................................51
12.2.7
Safety Analysis......................................................................................51
12.2.8
Handling of Dropouts and Missing Data...............................................51
12.2.9
Interim Analysis ....................................................................................51
13 STUDY GOVERNANCE CONSIDERATIONS..............................................................51
13.1
Quality Control ......................................................................................................51
13.2
Quality Assurance..................................................................................................52
13.3
Regulatory and Ethical Considerations..................................................................52
13.3.1
Institutional Review Board/ Ethics Committee.....................................52


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13.3.2
Ethical Conduct of the Study.................................................................52
13.3.3
Subject Information and Consent..........................................................53
13.3.4
Subject Recruitment ..............................................................................53
13.3.5
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP ...............................................................................................53
13.4
Posting of Information on Publicly Available Clinical Trial Registers.................54
13.5
Provision of Study Results to Investigators...........................................................54
13.6
Records Retention..................................................................................................54
13.7
Conditions for Terminating the Study ...................................................................55
14 REFERENCES ..................................................................................................................55
15 APPENDIX........................................................................................................................56
15.1
ABBREVIATIONS ...............................................................................................56
15.2
Application Instructions:........................................................................................58
15.3
Example of the Gum-Comfort Questionnaire........................................................59
15.4
Example of the Oral Health Impact Profile for Edentulous Patients (OHIP-
Edent) Questionnaire..............................................................................................60
15.5
Example of the General Oral Health Assessment Index (GOHAI) 
Questionnaire .........................................................................................................63
15.6
Example of the Product Sensory Questionnaire ....................................................65


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List of in text tables
Table 1-1
Schedule of Activities............................................................................12
Table 3-1
Study Objectives and Endpoints............................................................14
Table 6-1
Investigational/Study Product Supplies.................................................22
Table 6-2
Sundry Items to be supplied ..................................................................22
Table 9-1
The functional domains of the OHIP-Edent questionnaire. ..................36
Table 9-2
The functional domains of the GOHAI questionnaire ..........................37
Table 9-3
The MSA Scale per Henriksen (Henriksen et al, 1999) ........................37
Table 15-1
Abbreviation..........................................................................................56


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1
PROTOCOL SUMMARY 
Background and Rationale
Whilst the effectiveness of denture adhesives to increase the retention of dentures and to help 
prevent food ingress under dentures is well established, the overall impact of denture adhesive 
use on the gum health of users the oral health related quality of life (OHrQoL) has been less 
well investigated.  This study will therefore evaluate whether usage of an experimental denture 
adhesive is able to impact the overall gum health and the OHrQoL of subjects through 12 weeks 
usage.  The hypothesis being investigated is that usage of the experimental adhesive will lead 
to superior outcomes compared to the usage of no adhesive.
Objectives
Endpoints
Primary
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 12 weeks of product use.
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 12 weeks (overall 
mean score).
Secondary
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 and 8 weeks of product use.
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 1, 4 and 8 weeks 
(overall mean score).
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 and 8 and 12 weeks of 
product use.
Change from baseline in mean scores of 
subject responses to the individual 
questions on the Gum Comfort 
questionnaire after 1, 4, 8 and 12 weeks.
To compare the ability of an experimental 
denture adhesive to reduce denture-bearing 
mucosal irritation compared to the use of no 
adhesive after 1, 4, 8 and 12 weeks of product 
use.
Change from baseline in examiner-
derived scores from the mucosal 
assessment after 1, 4, 8 and 12 weeks.
To compare the ability of an experimental 
denture adhesive to provide self-perceived oral-
health related quality-of-life benefits compared 
to the use of no adhesive after 1, 4, 8 and 12 
weeks of product use.
Change from baseline in mean scores of 
subject responses to the OHIP-Edent and 
GOHAI questionnaires after 1, 4, 8 and 
12 weeks (overall mean scores and 
average domain scores).
To assess the sensory attributes of an 
experimental denture adhesive.
Mean scores of subject responses to the 
sensory questionnaire after 28 days.
Safety
To assess the tolerability of an experimental 
denture adhesive.
Treatment emergent adverse events.


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Study Design
This will be a single center, controlled, single-blind (to the safety assessor and the examiner 
determining the Mucosal Score Assessment (MSA) score), randomized, two-treatment, parallel 
design in healthy subjects with a full conventional, acrylic denture in either or both dental arches, 
with a treatment period of 12 weeks, to assess the clinical effectiveness of an experimental 
denture adhesive in the improvement of denture-bearing tissue irritation related measures, and 
the subject’s oral health related quality of life.  The control arm, will have subjects use no 
denture adhesive which is representative of a significant number of denture wearers who 
currently do not use an adhesive (Coates, 2000).  The test experimental adhesive will be applied 
once per day in accordance with typical usage instructions.  Efficacy and safety will be assessed 
at Baseline, and after 1, 4, 8 and 12 weeks treatment to monitor clinical efficacy and safety.
At the Screening/Baseline visit, each subject’s dentures (either or both of mandibular and 
maxillary dentures) will be cleaned then assessed as to whether they are well made.  Subjects 
will then undergo an assessment of their denture stability and retention using the Kapur Index 
(Olshan Modification) (Kapur, 1967; Olshan et al, 1992) and undergo an oral soft tissue (OST) 
examination.  Only those subjects with satisfactory dentures, with adequate retention and 
stability and who satisfy all of the inclusion and exclusion criteria will continue in the study.  
Eligible subjects will then undergo a MSA and complete the gum-health, OHIP-Edent (Allen 
and Locker, 2002) and GOHAI (Atchison and Dolan, 1990a) questionnaires after undergoing 
instruction in how to complete these questionnaires.  Subjects will then be randomized to one 
of the 2 treatment groups.  Subjects randomized to the experimental denture group will be 
dispensed their relevant study products and instructed in their proper use.  All subjects will be 
dispensed diaries to record their product usage and denture cleaning occasions.  All subjects 
will return in 7±1 days for Visit 2.
At Visit 2, and all subsequent Visits, subjects randomized to the experimental adhesive group 
will return their diaries and treatments to the site staff to evaluate compliance.  These subjects 
will be reminded/reinstructed in the proper application of adhesive.  Subjects randomized to the 
no-adhesive group will have their diaries assessed to ensure they have not used any adhesive 
and are compliant with the denture cleaning requirements.  All subjects will then complete the 
Gum Comfort and OHIP-Edent questionnaires after undergoing instruction in how to complete 
these questionnaires.  Subjects will then remove their dentures and undergo an OST 
examination including a MSA.  Subjects will then complete the GOHAI questionnaire after 
undergoing instruction on how to complete this questionnaire.  For Visit 3 only, subjects 
randomized to the experimental adhesive group will complete the sensory questionnaire after 
undergoing instruction on how to complete this questionnaire.  At Visits 2-4, all subjects will 
have their diaries returned.  At Visits 3 and 4, those subjects randomized to the experimental 
adhesive group will have new products dispensed to them.  Subjects will then return to the site 
for their next Visit per the study schedule.
To avoid inter-examiner variation, a single examiner will be responsible for the MSA and OST 
assessments for the duration of the entire study for all study subjects.  To maintain the blinding 
to the OST/MSA assessor, this assessor should be isolated from subjects undergoing any aspect 
of this study apart from their MSA/OST assessment.  Subjects should also remove their dentures 
and any traces of adhesive from their mouths prior to the MSA/OST assessment.  The absence 
of adhesive shall be confirmed by a second (unblinded) examiner prior to the MSA/OST 
assessment.


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Safety will be assessed by examination of the oral soft tissues at the Screening/Baseline visit 
and at each of the subsequent Visits.  Incidents will be recorded from the first use of a study 
medical device.  Subject reported AEs and incidents will also be recorded.
Study Products
This study will evaluate an experimental denture adhesive containing carbomer and 
carboxymethylcellulose that will be applied to dentures once per day in accordance with the 
usage instructions.  Subjects randomized to use of the negative control will use no adhesive.
Type and Planned Number of Subjects
This study will recruit healthy volunteers, of either gender aged 18-85 years who wear at least 
one full denture.  The experimental denture adhesive, when marketed, will be indicated for the 
general population who wear dentures and therefore the inclusion criteria allows for 
investigation of typical denture users.
Sufficient subjects will be screened to randomize 126 (63 per treatment group) to ensure 114 
evaluable subjects complete the entire study. 
1.1
Schedule of Activities
The schedule of activities in Table 1-1 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.


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Table 1-1
Schedule of Activities
Procedure/Assessment
Visit 1 
Screening 
/ Baseline
Day1
Visit 
2
Day 
7±1
Visit 
3
Day 
28±3
Visit 
4
Day 
56±3
Visit 
5
Day 
84±3
Informed consent
X
Review inclusion/exclusion criteria
X
X
X
X
X
Demographics
X
Medical history
X
Dental history
X
Current/concomitant medications
X
X
X
X
X
Urine pregnancy test4
X
X
X
X
X
Clean dentures
X
X
Well-made assessment of dentures
X
Denture bearing tissue score
X
Denture retention and stability assessment
X
OST examination edentulous
X
X
X
X
X
Subject eligibility
X
Mucosal score assessment
X
X
X
X
X
Subject-completed questionnaires (Gum-Comfort, 
GOHAI and OHIP-Edent)
X
X
X
X
X
Randomization
X
Dispense treatment, application instructions, diary 
(with diary completion instructions) and brushes3
X
X
X
Treatment usage demonstration1
X
X
X
X
Subject returns treatment, diary and brush5
X
X
X
X
Review of subject compliance (diaries and 
returned product)
X
X
X
X
Return of treatment and brush to subjects1
X
Return of diary to subjects
X
X
X
Subject removes dentures.  All traces of adhesive 
from mouth confirmed absent by second 
examiner2
X
X
X
X
Subject-completed sensory questionnaire1
X
Adverse events and Incidents
X
X
X
X
X
Subject continuance
X
X
X
Study conclusion
X
Abbreviations: OST = Oral Soft Tissue, OHIP-Edent = Oral Health Impact Profile-Edentulous, GOHAI = General Oral Health 
Assessment Index
Any serious adverse event, adverse event or incident assessed as related to study participation that occurs subsequent to the 
signing of informed consent will be recorded.
1 for subjects randomized to the adhesive group only.
2 the second (unblinded) examiner shall not be the examiner performing the MSA/OST assessment.
3 brushes, treatment and application instructions dispensed to subjects randomized to the denture adhesive group only.  Diary 
and application instructions will be dispensed only once at V1 unless subject requires a new copy of the instructions due to 
loss/spoilage.
4 for females of childbearing potential only.
5 subjects randomized to no-treatment use return only their diary.


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2
INTRODUCTION
Whilst dentures may ameliorate some of the problems of tooth loss, they may have unfortunate 
consequences.  In healthy dentate subjects, the stresses from mastication are transmitted through 
the teeth via the periodontal ligaments to mandibular and maxillary bones.  For denture wearers, 
especially full denture wearers, the primary stress bearing area under the denture is the oral 
mucosa where cellular swelling, increased nuclear size, and intercellular oedema can occur 
when the mucosa is under compression.  The mechanical denture injury is a common occurrence 
as result of constant denture movement and rubbing (Budtz‐Jørgensen, 1981).  Further, the 
quality of life of the denture wearer may be impacted through other effects.  Allen and Locker 
(Allen and Locker, 2002) reported that ill-fitting dentures produced consequences on taste, oral 
health discomfort and self-consciousness among adults wearing new dentures.  
Denture adhesives or fixatives have been used by edentulous patients to improve the retention 
and stability of dentures for many years (Grasso, 1996).  The primary benefit of using a denture 
adhesive is to enhance treatment outcome by increasing retention of the prosthesis and by 
reducing food entrapment (Zarb et al, 2013).  Further benefits of a denture adhesive have also 
been explored.  Tarbet (Tarbet et al, 1980) demonstrated that the use of a denture fixative was 
associated with improvements in the oral-mucosal health of subjects.  Denture adhesives have 
also been shown to reduce the number of denture dislodgements during eating and subsequently 
reduce the amount of food particles that migrate under dentures (Ahmad et al, 2010; Munoz et 
al, 2012; Tarbet et al, 1980).  The oral health related quality of life (OHrQoL) associated with 
denture adhesive use has also been evaluated in two separate studies.  OHrQoL has been defined 
as the impact of oral disease and disorders on aspects of everyday life that a subject or person 
values, that are of sufficient magnitude, in terms of frequency, severity or duration to affect 
their experience and perception of their life overall (Locker and Allen, 2007).  Nicolas (Nicolas 
et al, 2010) evaluated subject’s OHrQoL over a 6 month period of adhesive use using the 
General Oral Health Assessment Index (GOHAI) (Atchison and Dolan, 1990b) demonstrating 
that the pain/discomfort domain scores of the GOHAI statistically significantly increased 
(improved) during the course of the 6 months of the study for all subjects (all subjects in this 
monadic study used adhesive).  A further OHrQoL study (Polyzois et al, 2015) evaluated 
OHrQoL of full denture wearers using the Oral Health Impact Profile – Edentulous (OHIP-
Edent) questionnaire (Allen and Locker, 2002) through use of an adhesive for 30 days.  This 
study found that most aspects (including the pain domain) were improved over the 30 days of 
the study.  
 
 
 
 
 
The above studies withstanding, the impact of using a denture adhesive on both the oral mucosal 
health and the OHrQoL has been scarcely investigated as highlighted in the American College 
of Prosthodontists Guideline for the Care and Maintenance of Dentures (Felton et al, 2011).  
The test denture adhesive under evaluation here has previously been evaluated to assess the 
effectiveness of the adhesive at increasing retention of dentures.  A clinical study that compared 
the maximum bite force that could be achieved before the denture dislodged demonstrated that 
the denture adhesive was statistically significantly superior than using no adhesive (207545, 
2017).
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The experimental denture adhesive under test in this study is intended to be marketed and has 
been developed to provide gum comfort benefits to the user by providing greater cushioning of 
the denture.  The purpose of this study is therefore to assess the gum health and overall OHrQoL 
benefits to the user.  This study will be conducted at All Sum Research in Canada.
2.1
Study Rationale
The purpose of this study is to evaluate whether usage of an exploratory denture adhesive is 
able to demonstrate improvement in the gum-health and to improve the OHrQoL of subjects 
who wear full dentures.  This study is required to evaluate whether potential claims associated 
with this product are valid as well as to inform the dental practitioner on the potential benefits 
of denture adhesives.
Complete information for this product may be found in the single reference safety document 
(SRSD), which for this study is the safety statement.
A very similar formulation to this adhesive (containing preservative and colourant which are 
not present in the test adhesive here) has previously been evaluated in a clinical study (207545, 
2017) which found the adhesive to be well tolerated.  The benefit of the adhesive was 
demonstrated in the same study which showed that the adhesive was successful at increasing 
the maximum bite force that a subject could exert.  In conclusion the benefits outweigh the risks 
identified for the intended use of this denture adhesive.
2.2
Mechanism of Action/Indication
Denture adhesives function by forming an adhesive layer between the denture and gum surface 
that can help retain the denture to the oral tissues.  Carbomer and Carboxymethyl cellulose are 
a mixture of polymers included in an experimental denture adhesive currently being evaluated 
in subjects with a complete set of dentures in either or both dental arches.
3
STUDY OBJECTIVES AND ENDPOINTS
Table 3-1
Study Objectives and Endpoints
Objectives
Endpoints
Primary
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 12 weeks of product use.
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 12 weeks (overall 
mean score).
Secondary
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 and 8 weeks of product use.
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 1, 4 and 8 weeks 
(overall mean score).
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 and 8 and 12 weeks of 
product use.
Change from baseline in mean scores of 
subject responses to the individual 
questions on the Gum Comfort 
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To compare the ability of an experimental 
denture adhesive to reduce denture-bearing 
mucosal irritation compared to the use of no 
adhesive after 1, 4, 8 and 12 weeks of product 
use.
Change from baseline in examiner-
derived scores from the mucosal 
assessment after 1, 4, 8 and 12 weeks.
To compare the ability of an experimental 
denture adhesive to provide self-perceived oral-
health related quality-of-life benefits compared 
to the use of no adhesive after 1, 4, 8 and 12 
weeks of product use.
Change from baseline in mean scores of 
subject responses to the OHIP-Edent and 
GOHAI questionnaires after 1, 4, 8 and 
12 weeks (overall mean scores and 
average domain scores).
To assess the sensory attributes of an 
experimental denture adhesive.
Mean scores of subject responses to the 
sensory questionnaire after 28 days.
Safety
To assess the tolerability of an experimental 
denture adhesive.
Treatment emergent adverse events.
This study will be considered successful if a statistically significant difference between the 
mean scores from the Gum Comfort questionnaire is observed between subjects using the 
experimental denture adhesive compared to subjects using no adhesive in favour of the 
experimental adhesive after 12 weeks use.
4
STUDY DESIGN 
4.1
Overall Design
This will be a single center, controlled, single-blind (to the safety assessor and the examiner 
determining the MSA score), randomized, two-treatment, parallel group design in healthy 
subjects with a full conventional, acrylic denture in either or both dental arches, with a treatment 
period of 12 weeks, to assess the clinical effectiveness of an experimental denture adhesive in 
the improvement of health of the denture-bearing tissues, and the subject’s oral health related 
quality of life.  The control arm, will have subjects use no denture adhesive which is 
representative of a significant number of denture wearers who currently do not use an adhesive 
(Coates, 2000).  The test experimental adhesive will be applied once per day in accordance with 
typical use instructions.  Efficacy and safety will be assessed at Baseline, and after 1, 4, 8 and 
12 weeks treatment to monitor clinical efficacy and safety.
Approximately 126 healthy subjects with either or both maxillary and mandibular full dentures 
will be enrolled in this study.
At the Screening/Baseline visit, each subject’s dentures (either or both of mandibular and 
maxillary dentures) will be cleaned then assessed whether they are well made.  Subjects will 
then undergo an assessment of their denture stability and retention using the Kapur Index 
(Olshan Modification) (Kapur, 1967; Olshan et al, 1992) and undergo an oral soft tissue (OST) 
examination.  Only those subjects with satisfactory dentures, with adequate retention and 
stability and who satisfy all the inclusion and exclusion criteria will continue in the study.  
Eligible subjects will then undergo a MSA of the denture bearing tissues and complete the gum-
health, OHIP-Edent and GOHAI questionnaires after undergoing instruction in how to complete 
these questionnaires.  Subjects will then be randomized to one of the 2 treatment groups.  
Subjects randomized to the experimental denture group will be dispensed their relevant study 
products and instructed in their proper use.  Subjects should demonstrate appropriate use of the 


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denture adhesive on their dentures and then fit the dentures under supervision of site staff.  All 
subjects will be dispensed diaries for them to record their product usage and denture cleaning 
occasions.  All subjects will return in 7±1 days for Visit 2.
At Visit 2, and all subsequent Visits, subjects randomized to the experimental adhesive group 
will return their diaries and treatments to the site staff to evaluate compliance.  These subjects 
will be reminded/reinstructed in the proper application of adhesive.  Subjects randomized to the 
no-adhesive group will have their diaries assessed to ensure they have not used any adhesive 
and are compliant with the denture cleaning requirements.  All subjects will then complete the 
Gum Comfort and OHIP-Edent questionnaires after undergoing instruction in how to complete 
these questionnaires.  Subjects will then remove their dentures and undergo an OST 
examination including a MSA.  Subjects will then complete the GOHAI questionnaire after 
undergoing instruction in how to complete this questionnaire.  For Visit 3 only, subjects 
randomized to the experimental adhesive group will complete the sensory questionnaire after 
undergoing instruction on how to complete this questionnaire.  At Visits 2-4, all subjects will 
have their diaries returned.  At Visits 3 and 4, those subjects randomized to the experimental 
adhesive group will have new products dispensed to them.  Subjects will then return to the site 
for their next Visit per the study schedule.
To avoid inter-examiner variation, a single examiner will be responsible for the MSA and OST 
assessments for the duration of the entire study for all study subjects.  To maintain the blinding 
to the MSA/OST assessor, this assessor should be isolated from subjects undergoing any aspect 
of this study apart from their MSA/OST assessment.  Subjects should also remove their dentures 
and any traces of adhesive from their mouths prior to the MSA/OST assessment.  The absence 
of adhesive shall be confirmed by a second (unblinded) examiner prior to the MSA/OST 
assessment.
Safety will be assessed by examination of the oral soft tissues at the Screening/Baseline visit 
and at each of the subsequent Visits.  Incidents will be recorded from the first use of treatment 
adhesive.  Subject reported AEs and incidents will also be recorded.
4.2
Rationale for Study Design
The duration of this study will be 12 weeks.  In a previous study (Nicolas et al, 2010) the 
OHrQoL was assessed after 12 and 24 weeks use of an adhesive and whilst in general large 
improvements were observed over the 24 weeks, the greatest improvement was observed 
between baseline and 12 weeks, with more modest improvement observed thereafter.  To 
minimise subject exposure a 12-week period is therefore deemed sufficient.
Subjects who already adopt a cleaning routine will be recruited (outlined in Inclusion/ Exclusion 
Criteria) as the cleanliness of the denture may impact the efficacy of the adhesive.  All subjects 
enrolled to this study will continue to use their existing denture cleaning methodologies through 
the duration of the study.
Subjects in this study must be habitual wearers of a full denture in either or both arches to ensure 
that they are familiar with their dentures in place and are likely to continue wearing them during 
waking hours.  Subjects who are xerostomic are excluded since the proper function of denture 
adhesives requires adequate hydration from saliva.
Demographic information will be recorded as part of this study, including age, race and gender.  
In accordance with US FDA guidelines (US FDA, 2005) the ethnicity of subjects will also be 
captured.
Dentures are unique to each individual.  Therefore, the most efficient approach to evaluating 
their performance with different adhesives or ‘no adhesive’ is a within subject comparison (i.e. 


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a crossover design), however such a design is not practicable in a long-term study: a parallel 
design is therefore appropriate.  The study design does not allow for double blinding since the 
subjects themselves will know whether they are using adhesive or not.  The study examiner 
who performs the MSA and OST examination will be blinded to the treatments.  The study is 
therefore described as single-blind (safety assessor and the examiner determining the MSA 
score). 
An OST examination will be conducted at each treatment to evaluate potential AEs.
Assessment of oral mucosal health in the edentulous has been investigated by Tarbet (Tarbet et 
al, 1980) who demonstrated that the use of a denture fixative was associated with improvements 
in the oral-mucosal health of subjects.  The scoring system used in this study for evaluation of 
the oral-mucosal health was perhaps not sufficiently discriminatory enough for accurate 
evaluation of these subjects who mostly scored zero on this scale.  An alternative scoring index 
for oral mucosal health in the dentate/edentulous has been evaluated (the mucosal score (MS)) 
(Henriksen et al, 1999) although not yet used to investigate clinical interventions.  MS would 
appear to be more sensitive than the Tarbet score system for evaluation of subjects who have 
mild/moderate mucosal conditions and will therefore be used in this study.
The Kapur-Olshan index is a composite score based upon stability and retention ratings for the 
maxillary and mandibular dentures (Kapur, 1967; Olshan et al, 1992).  In this study, subjects 
presenting with a very low Kapur-Olshan score at Screening (< 3 for each denture [maxillary 
and/or mandibular]), defined as “Clinically Poor” (Olshan et al, 1992), will be excluded from 
this study since the study adhesive is not recommended for use with poor fitting dentures.
Subjects with temporomandibular joint disorders are excluded should the investigator believes 
that this could affect the subject’s participation, principally regarding the ability for the subject 
to adequately chew.  Subjects who use or have ever used bisphosphonate medications are 
specifically excluded from this study owing to the enhanced risk of bisphosphonate-related 
osteochemonecrosis of the jaw that is associated with reduced tissue tolerance to function with 
removable prostheses (Saldanha et al, 2012).
A no adhesive negative control treatment has been chosen to provide a continual reference point 
to allow interpretation of the results, and is representative of a significant number of denture 
wearers who currently do not use an adhesive (Coates, 2000).
4.3
Justification for Dose
The dose of adhesive and method and frequency of application is consistent with the intended 
label instructions for this adhesive and is also consistent with denture adhesives currently 
marketed.
4.4
End of Study Definition
A subject is considered to have completed the study if he or she has completed all phases of the 
study including the last visit or the last scheduled procedure shown in the Schedule of Activities.
The end of this study is defined as the date of the last visit of the last subject in the study.
5
STUDY POPULATION
5.1
Type and Planned Number of Subjects
This study will recruit healthy volunteers, of either gender aged 18-85 years who wear at least 
one full denture.  The experimental denture adhesive, when marketed, will be indicated for the 


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general population who wear dentures and therefore the inclusion criteria allows for 
investigation of typical denture users.
Sufficient subjects will be screened to randomize 126 to ensure 114 evaluable subjects complete 
the entire study. 
This study can fulfill its objectives only if appropriate subjects are enrolled.  The following 
eligibility criteria are designed to select subjects for whom participation in the study is 
considered appropriate.  All relevant medical and non-medical conditions should be taken into 
consideration when deciding whether a subject is suitable for this protocol.  
Subject eligibility to participate in the clinical study should be reviewed and documented by an 
appropriate member of the investigator’s study team before subjects are included in the study.
5.2
Inclusion Criteria
An individual must meet all of the following inclusion criteria to be eligible for enrollment into 
the study:
1. Subject provision of a signed and dated informed consent document indicating that the 
subject has been informed of all pertinent aspects of the study before any assessment is 
performed.
2. Subject is male or female who, at the time of screening, is between the ages of 18 and 85 
years, inclusive.
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. Female subjects of childbearing potential and at risk for pregnancy must agree to use a 
highly effective method of contraception throughout the study and for 5 days after the last 
dose of assigned treatment.  Female subjects who are not of childbearing potential must 
meet requirements in Section 5.5.1.
6. Subject has denture prostheses that fulfil all of the following:
a. A conventional acrylic full denture in either or both of the upper and lower arches.  
The full denture may be opposed by a partial denture, natural teeth or another full 
denture.
b. Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index 
Sum Score ≥ 3 for each denture [maxillary and/or mandibular]) (Olshan et al, 1992) 
with no individual stability or retention scores <1.
c. Denture(s) are well made (according to the well-made assessment).
7. Subject is a habitual wearer of their denture(s) defined as subjects who wear their dentures 
for the majority of their time whilst awake.
8. Subject has worn their full denture(s) for at least a year.
9. Subject has not used any denture adhesive in the last year.
10. Subject currently adopts acceptable denture cleansing habits and routine (a minimum 
would include daily brushing with a chemical cleaner such as toothpaste or soap, in 
addition to at least once a week soaking in commercial denture cleansing product).  Note 
unacceptable cleaning would include cleaning with water alone or using other non-
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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 GlaxoSmithKline 
Consumer Healthcare (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.
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. A subject who has previously been enrolled in this study.
10. A subject who has had recent (within 30 days) gingival surgery.
11. Taking or have taken a bisphosphonate drug (i.e. Fosamax, Actonel, Boniva).
12. A subject with any clinically significant or relevant oral abnormality (e.g. 
temporomandibular joint problems) that, in the opinion of the investigator, could affect the 
subject’s participation in the study.
13. A subject with any condition or medication which, in the opinion of the investigator, is 
currently causing xerostomia.
14. A subject with recent history (within the last year) of alcohol or other substance abuse.
15. A subject with OST examination findings such as stomatitis, open sores, lesions, or swelling 
which in the opinion of the investigator, would interfere with the conduct of the study.  Mild, 
chronic conditions commonly expected from the use of dentures in the investigators opinion, 
are acceptable in this study.
16. A subject who is using any medication that, in the opinion of the investigator, would 
interfere with the conduct of the study.
5.4
Randomization Criteria
Subjects will be randomized into the study provided they have satisfied all subject selection 
criteria.
5.5
Lifestyle Considerations
During the entire study (screening – completion of study):


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
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 
ensure that the denture fit will not be altered during the study.

Subjects will not be able to use any denture adhesive product other than that supplied 
by the investigator.

Subjects should continue using their usual denture cleansing methodology throughout 
the study.
5.5.1
Contraception
Female subjects who are of childbearing potential and are sexually active and at risk for 
pregnancy must agree to use a highly effective method of contraception consistently and 
correctly for the duration of the active study period and for 5 days after the last dose of 
investigational product. 
The investigator or his or her designee will discuss with the subject the need to use highly 
effective contraception consistently and correctly according to the schedule of activities and 
document such conversation.  In addition, the investigator or his or her designee will instruct 
the subject to call immediately if the selected contraception method is discontinued or if 
pregnancy is known or suspected in the subject or the subject’s partner. 
The following is the all-inclusive list of the highly effective methods for avoiding pregnancy 
that meets the GSK definition (i.e., have a failure rate of less than 1% per year when used 
consistently and correctly and, when applicable, in accordance with the product label). 
The list does not apply to females of reproductive potential with same sex partners or for 
subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long 
term and persistent basis, when this is their preferred and usual lifestyle. Periodic abstinence 
(e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not 
acceptable methods of contraception.
1. Contraceptive subdermal implant
2. Intrauterine device or intrauterine system
3. Combined estrogen and progestogen oral contraceptive (Hatcher and Nelson, 2007))
4. Injectable progestogen (Hatcher and Nelson, 2007)
5. Contraceptive vaginal ring (Hatcher and Nelson, 2007)
6. Percutaneous contraceptive patches (Hatcher and Nelson, 2007)
7. Male partner sterilization with documentation of azoospermia prior to the female 
subject's entry into the study, and this male is the sole partner for that subject (Hatcher 
and Nelson, 2007). The documentation on male sterility can come from site personnel 
review of subject’s medical records, medical examination and/or semen analysis, or 
medical history interview provided by her or her partner.
These allowed methods of contraception are only effective when used consistently, correctly 
and in accordance with the product label. The investigator is responsible for ensuring that 
subjects understand how to properly use these methods of contraception.
Female subjects of non-childbearing potential must meet at least one of the following criteria:

Achieved postmenopausal status, defined as follows: cessation of regular menses for 
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cause; status may be confirmed by having a serum follicle-stimulating hormone  level 
confirming the post-menopausal state;  

Have undergone a documented hysterectomy and/or bilateral oophorectomy;

Have medically confirmed ovarian failure.
All other female subjects (including females with tubal ligations) will be considered to be of 
childbearing potential.
5.6
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 
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.
5.7
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.  
5.8
Rater/Clinical Assessor Qualifications 
The assessor performing the well-made, denture retention and stability, denture bearing tissue 
score, MSA and OST assessments shall be a suitably qualified dentist with expert knowledge 
of prosthodontics.
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 
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6.1
Investigational/Study Product Supplies
The following study products will be supplied by the Clinical Supplies Department, GSK CH:
Table 6-1
Investigational/Study Product Supplies
Test Product
Negative 
Control
Product Name
Experimental Denture Adhesive
No 
Adhesive
Pack Design
Denture adhesive tube fitted with a precision nozzle
N/A
Dispensing Details
New tubes of denture adhesive will be dispensed at each 
study visit
N/A
Product Master 
Formulation Code 
(MFC)
N/A
Dose/Application
A sufficient quantity of denture adhesive to be applied to 
the maxillary and/or mandibular dentures once per day in 
the pattern described in the application instructions.
N/A
Route of 
Administration
Applied to denture which is placed in mouth
N/A
Usage Instructions
As per the Product Application Instructions (Section 15.2)
N/A
Return Requirements
All used/unused samples to be returned to GSK CH
N/A
Table 6-2
Sundry Items to be supplied
Return/Disposal Details
Item
Supplied 
By
Pack 
Design
Dispensing Details
Used 
Samples
Unused 
Samples
Oral B Denture 
brushes (Canadian 
marketplace)
GSK CH
Commercial 
pack
1 at screening for use 
by site to clean the 
dentures
1 for subjects to use at 
home to remove 
denture adhesive at 
end of day.  The at 
home brush to be 
replaced at each visit
Destroy at site 
using site 
disposal 
procedures
Return
Polident Dentu 
Crème Denture 
cleansing paste 
(Canadian 
marketplace)
GSK CH
Commercial 
pack
Screening visit
Destroy at site 
using site 
disposal 
procedures
Return
Urine Pregnancy 
Tests (Canadian 
marketplace)
GSK CH
Commercial 
pack
Use as per study 
schedule
Destroy at site 
using site 
disposal 
procedures
Return
Detailed instructions for the return of study product/study supplies for the accountability checks 
and subsequent destruction which will be provided by GSK CH during the course of the study 
in time for study close out visit.
The test product is a Class I device in Canada and as such there is no requirement to obtain an 
Investigational Testing Authorization from Health Canada prior to study start.
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6.1.1
Dosage Form and Packaging
The experimental denture adhesive will be supplied in individual tubes.
The content of the product labels will be in accordance with all applicable regulatory 
requirements and will be the responsibility of the GSK CH Global Clinical Supplies group. 
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. Subjects should be instructed to not remove or deface any part of the study label.
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
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.
Study product will be dispensed by qualified unblinded site personnel per the 
dosage/administration instructions. These staff members will not be involved in any safety, 
efficacy assessments or other aspects other study that could be influenced by the knowledge of 
product a subject has been assigned to use.  An additional site member of site staff, should 
ensure the dispensing procedures are completed accurately.  Additional re-dispensing of denture 
adhesive and denture brushes should occur at each visit to the site.  The dispensing should be 
performed in a room away from other subjects and blinded study staff (especially the examiner 
performing the MSA and OST assessments, who will be prevented from viewing subjects once 
they have their study products).
Subjects should be advised as to correct product application in accordance with the Application 
Instructions at each visit.
6.2
Administration
Subjects will be instructed to self-administer their assigned product per the usage instructions 
Application Instructions provided to the subject. 
6.2.1
Medication/Dosing Errors
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 dosing errors occurring to a study subject are to be captured in the case report form (CRF).  
If a dosing error is accompanied by an AE, as determined by the investigator, the dosing error 
and any associated adverse event(s) are to be captured in the CRF AE form. 


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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.  
Site staff will instruct subjects on the proper storage requirements for all take-home products. 
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. Study products are to be dispensed only to subjects enrolled in the study in accordance 
with the protocol, by authorized site staff.
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. 
All unused product should be returned to the study site by the subjects at each visit.
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 will 
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using the return instructions provided.  Used denture brushes, denture cleansing paste and 
pregnancy test kits should be disposed of in accordance with the site disposal procedures.
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.
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 (the safety assessor and the examiner determining the 
denture-bearing tissue score clinical examiner will be blinded to the product received). 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. 
To ensure the examiner remains blinded throughout the study, staff involved in the dispensing 
of study products will work in a separate area. The examiner is not permitted in any area where 
study product is stored, dispensed, or in use. 
Subjects will be instructed not to remove study products from the opaque bags provided outside 
of the dispensing room, while at the study site.  Subjects randomized to test adhesive use will 
have the study test product, the denture cleaning brush and their diary and usage instructions 
contained within the bag, whilst the subjects randomized to no adhesive usage will have their 
diary in the bag.
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 be required to inform the Institutional Review 
Board / Ethics Committee (IRB/EC) if the blind is broken. 
6.7
Subject Compliance
Subjects randomized to the test denture adhesive arm will be instructed in/reminded of the 
correct usage of the product at every visit by the dispensing staff.


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A diary will be supplied to promote compliance and to capture details of product use throughout 
the study period. Subjects may also record additional information such as AEs or medications 
used. Any additional details relevant to efficacy or safety should be reviewed by the investigator 
(or suitably qualified designee) with the subjects, and transcribed to the CRF as appropriate.
The number of any missed or additional applications or doses will be captured as protocol 
deviations and transcribed from the diary into the CRF. Subjects will be re-instructed in the 
correct usage requirements and diary completion as needed.
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 or 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 and any medications that 
in the opinion of the investigator would interfere with the conduct of this study per the inclusion/ 
exclusion criteria.
Medication/treatments taken within 7 days prior to signing the informed consent form will be 
documented as a prior medication/treatment.  Medications/treatments taken after signing the 
informed consent form will be documented as concomitant medication/treatments.
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 

Unblinding of the subject 

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. 
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. 


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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 AEs.
Final safety assessments may be carried out when the subject returns to the study site, at the 
investigator’s discretion, which could include an OST (edentulous) 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 prior to administration of the investigational product to confirm that 
they meet the subject selection criteria for the study.  
The following Screening procedures will be completed, in the following order (wherever 
possible), and the findings recorded in the CRF:

Informed Consent

Inclusion/Exclusion Criteria

Demographics

Medical History and Prior Medication/Treatment

Dental History

Clean Dentures

Well-Made Assessment of Dentures

Denture Bearing Tissue Score


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
Denture Retention and Stability Assessment

OST (Edentulous) Examination

Urine Pregnancy Testing (for females of child-bearing potential only)

Subject Eligibility
8.1.1
Informed Consent
The investigator, or designee, must obtain informed consent 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 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.


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8.1.2
Demographics
The following demographic information will be recorded 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.
8.1.3
Inclusion/Exclusion Criteria
Inclusion and exclusion criteria information will be documented in the CRF.  The well-made 
assessment of dentures, denture retention and stability assessment, denture bearing tissue score, 
MSA and OST examination should be performed by suitably qualified personnel with expertise 
in prosthodontics.
8.1.4
Medical History and Prior Medication/Treatment
Details of relevant medical and surgical history (in the last year), including allergies or drug 
sensitivity, will be documented in the CRF.
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.
8.1.5
Dental History
The Investigator, or medically qualified designee, will take a dental history from each subject.  
Dental history will include information of all prostheses in the mouth, maxillary and 
mandibulary, 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 has used denture adhesives 
in the past (including the reason for abstaining from adhesive use and how long since abstaining 
from adhesive use).
8.1.6
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. 
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.
8.2
Study Period
Remind subject to inform the site if they experience any untoward medical occurrence or use 
any medications while enrolled in the study.
8.2.1
Visit 1/Day 1 (Baseline)
Following screening, enrolled subjects will undergo, in the following order (wherever possible), 
and findings documented in the CRF:

Mucosal Score Assessment.

Subjects complete the Gum Comfort questionnaire.

Subjects complete the OHIP-Edent questionnaire.

Subjects complete the GOHAI questionnaire.

Randomization of subject to treatment group.

Dispense subject diaries to all subjects.


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
For subjects randomized to the denture adhesive treatment:- 

Dispense denture cleaning brushes, study test product and application 
instructions.

Demonstrate adhesive application.

Subject applies adhesive to dentures and fits dentures under supervision of site 
staff.

Instruct all subjects in diary completion.

AEs and incidents recorded.
8.2.2
Visit 2 / Days 7±1
Subjects will undergo, in the following order (wherever possible), and findings documented in 
the CRF:

Changes in concomitant medication or non-drug treatments/procedures. 

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.

Urine Pregnancy Test (for females of child-bearing potential only).

Subject returns diary, treatment and brush.

Subjects compliance to treatment and denture cleaning assessed through examination 
of subject diary and product usage.

Review of inclusion/exclusion criteria.

Decision on whether subject continues in the study.

Subjects complete the Gum Comfort questionnaire.

Subjects complete the OHIP-Edent questionnaire.

For subjects randomized to the denture adhesive treatment the absence of denture 
adhesive in the mouth/ on the dentures should be confirmed by a second (non-
blinded) examiner to ensure the blinded MSA/OST assessor is not inadvertently 
unblinded.  Any residual adhesive present should be removed by the subject/ second 
(non-blinded) examiner prior to MSA/OST examination.

Subject undergo an OST examination and MSA.

Subjects complete the GOHAI questionnaire.

For subjects randomized to the denture adhesive treatment:- 

Return of their denture cleaning brushes and study test product.

Demonstration of adhesive application.

Subject applies adhesive to dentures and fits dentures under supervision of site 
staff.

Return of diaries to all subjects and instruction to all subjects in diary completion.

AEs and incidents recorded.
8.2.3
Visit 3 / Day 28±3 
Subjects will undergo, in the following order (wherever possible), and findings documented in 
the CRF:

Changes in concomitant medication or non-drug treatments/procedures. 

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.


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
Urine Pregnancy Test (for females of child-bearing potential only).

Subject returns diary, treatment and brush.

Subjects compliance to treatment and denture cleaning assessed through examination 
of subject diary and product usage.

Review of inclusion/exclusion criteria.

Decision on whether subject continues in the study.

Subjects complete the Gum Comfort questionnaire.

Subjects complete the OHIP-Edent questionnaire.

For subjects randomized to the denture adhesive treatment the absence of denture 
adhesive in the mouth/ on the dentures should be confirmed by a second (non-
blinded) examiner to ensure the blinded MSA/OST assessor is not inadvertently 
unblinded.  Any residual adhesive present should be removed by the subject/ second 
(non-blinded) examiner prior to MSA/OST examination.

Subject undergo an OST examination and MSA.

Subjects complete the GOHAI questionnaire.

For subjects randomized to the denture adhesive treatment:- 

Subject completes the sensory questionnaire.

Dispensation of denture cleaning brushes and study test product.

Demonstration of adhesive application.

Subject applies adhesive to dentures and fits dentures under supervision of site 
staff.

Return of diaries to all subjects and instruction to all subjects in diary completion.

AEs and incidents recorded.
8.2.4
Visit 4 / Day 56±3
Subjects will undergo, in the following order (wherever possible), and findings documented in 
the CRF:

Changes in concomitant medication or non-drug treatments/procedures. 

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.

Urine Pregnancy Test (for females of child-bearing potential only).

Subject returns diary, treatment and brush.

Subjects compliance to treatment and denture cleaning assessed through examination 
of subject diary and product usage.

Review of inclusion/exclusion criteria.

Decision on whether subject continues in the study.

Subjects complete the Gum Comfort questionnaire.

Subjects complete the OHIP-Edent questionnaire.

For subjects randomized to the denture adhesive treatment the absence of denture 
adhesive in the mouth/ on the dentures should be confirmed by a second (non-
blinded) examiner to ensure the blinded MSA/OST assessor is not inadvertently 
unblinded.  Any residual adhesive present should be removed by the subject/ second 
(non-blinded) examiner prior to MSA/OST examination.

Subject undergo an OST examination and MSA.


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
Subjects complete the GOHAI questionnaire.

For subjects randomized to the denture adhesive treatment:- 

Dispensation of denture cleaning brushes and study test product.

Demonstration of adhesive application.

Subject applies adhesive to dentures and fits dentures under supervision of site 
staff.

Return of diaries to all subjects and instruction to all subjects in diary completion.

AEs and incidents recorded.
8.2.5
Visit 5 / Day 84±3
Subjects will undergo, in the following order (wherever possible), and findings documented in 
the CRF:

Changes in concomitant medication or non-drug treatments/procedures. 

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.

Urine Pregnancy Test (for females of child-bearing potential only).

Subject returns diary, treatment and brush.

Subjects compliance to treatment and denture cleaning assessed through examination 
of subject diary and product usage.

Review of inclusion/exclusion criteria.

Decision on whether subject continues in the study.

Subjects complete the Gum Comfort questionnaire.

Subjects complete the OHIP-Edent questionnaire.

For subjects randomized to the denture adhesive treatment the absence of denture 
adhesive in the mouth/ on the dentures should be confirmed by a second (non-
blinded) examiner to ensure the blinded MSA/OST assessor is not inadvertently 
unblinded.  Any residual adhesive present should be removed by the subject/ second 
(non-blinded) examiner prior to MSA/OST examination.

Subject undergo an OST examination and MSA.

Clean dentures.

Subjects complete the GOHAI questionnaire.

AEs and incidents recorded.

Subjects reminded to inform the site if they experience any untoward medical 
occurrence in the next 5 days.  All ongoing AEs to be followed up by site.

Study conclusion.
8.3
Diary Review
The diary should be reviewed at every visit by the investigator, or suitably qualified designee, 
and the subject. Any subject comment captured in the diary which is considered an adverse 
event will be assessed and reported as per the defined procedure in this protocol. Adverse event 
reporting procedures are summarized in Adverse Event and Serious Adverse Events. 
Any additional comments relating to medications/treatments provided in the diary will be 
reviewed by the investigator or medically qualified designee with the subject and entered into 
the CRF as appropriate. 


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Additional and missed product applications will be considered deviations from the protocol and 
will be recorded on the Deviations Log.
8.4
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. 
8.5
Follow-up Visit / Phone Call
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, in 
particular further OST examinations.
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.
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
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 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.
Dentures should be cleaned at screening and at the end of the study (V5) prior to the subject 
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9.1.2
Well Made Assessment
Clinical Acceptability
Each denture (maxillary and mandibular) will be examined.  Only dentures having adequate (as 
judged by an examiner with expert knowledge of prosthodontics) vertical dimension, freeway 
space, 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 by the investigator and recorded 
for both or either of the maxillary/mandibular dentures as appropriate on the appropriate CRF.  
There are no eligibility requirements associated with this measure in this clinical trial.
* Note, the entire index (for maxillary and mandibular arches) is presented below.  Due to an 
inconsistency observed in the original printed publication, the two descriptors below marked 
by an asterisk (*) have been modified (by inverting their order) to better reflect the authors 
intent and align with the grading scale.
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 *
9.1.4
Well-Fit Assessment, Kapur (Olshan Modification) Index
Each denture (maxillary and mandibular) will be examined for retention and stability using the 
Kapur Index (Olshan Modification) (Kapur, 1967; Olshan et al, 1992) by an examiner with 
expert knowledge of prosthodontics.  A sum score (retention + stability) of ≥ 3 for each denture 
is required for inclusion.  This assessment is to be performed with no denture adhesive present.


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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 pull and lateral force. 
3= Good- denture offers moderate resistance to vertical pull and lateral force.
2= Fair- denture offers moderate resistance to vertical pull and little or no resistance to 
lateral forces. 
1= Poor- denture offers slight resistance to vertical pull and little or no resistance to 
lateral force.
0= No retention- when the 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 upper and lower 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 structures under 
pressure.
2= Fair- when denture base has slight rocking on its supporting structures under pressure.
1= Poor- when denture base has moderate rocking on its supporting structures under 
pressure.
0= No stability- when denture base has extreme rocking under pressure.
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
Subject Questionnaires
On assessment days, the subject will complete 3 questionnaires that assess the subject’s gum 
health and OHrQoL and at Visit 3 subjects randomized to the denture adhesive groups will also 
complete a questionnaire to evaluate the sensory attributes of the adhesive.  The subject 
responses should be transcribed by the study staff to the CRF.  The study staff should be mindful 
that whilst the questionnaires do not solicit safety information, any information on safety 
outcomes recorded by subjects on a questionnaire should be evaluated by the investigator to 
ensure all AEs are recorded.  To ensure that the examiner who performs the MSA and OST 
assessments is blinded to the assignment of denture adhesive treatment, the examiner will not 
have access to these questionnaires and should not have knowledge of who is completing the 
questionnaires and will remain blinded to the distribution and completion of all questionnaires.
Questionnaires should be completed one at a time, and the next questionnaire should not be 
administered to the subject until they have returned the previous completed questionnaire.  For 
consistency purposes, it is intended that the order that subjects receive their questionnaires 
remains regular for the duration of the study.  The gum-comfort questionnaire is the first to be 
administered since this is the primary endpoint for this study. The OHIP-Edent will then be 
administered and then the subject will have the MSA/OST assessments performed.  Finally the 


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GOHAI questionnaire should be administered. This ordering has been chosen to allow the 
subject some respite from questionnaires with the OST/MSA between the OHIP-Edent and 
GOHAI questionnaires.
Subjects should be advised in the correct completion of the questionnaires at every visit and 
should ambiguous response be given (i.e. more than one result circled for a question) be 
clarified with the subject before they leave the study site.
9.2.1.1
Gum-Comfort Questionnaire
The gum-comfort questionnaire will be administered to the subjects prior to their OST 
examination and administration of the OHIP-Edent questionnaire at the baseline and all 
assessment visits (Visits 1-5).  This questionnaire is comprised of 5 questions that inform on 
the subject-perceived comfort of their denture-bearing tissues.  The questions have 5 possible 
responses (Agree Strongly, Agree Somewhat, Neither Agree or Disagree, Disagree Somewhat, 
Disagree Strongly) and are scored on a 0 (Agree Strongly) to 4 (Disagree Strongly) scale for all 
questions.  Thus, the range of the total questionnaire score is 0-20 where a low score is more 
favorable.
9.2.1.2
OHIP-Edent Questionnaire
The OHIP-Edent questionnaire is a well-established questionnaire for evaluation of OHrQoL 
(Allen and Locker, 2002).  This questionnaire will be administered to subjects after completion 
of the gum comfort questionnaire and prior to their OST examination at the baseline and all 
assessment visits (Visits 1-5).  This questionnaire is comprised of 19 questions grouped into 6 
functional domains per Table 9-1.  The questions have 5 possible responses (Never, Rarely, 
Occasionally, Often and Very Often) that the subjects should indicate by marking the 
appropriate box.  The responses are scored on a 0 (Never) to 4 (Very Often) scale for all 
questions and thus a low score is more favorable and the overall score range is 0-76 where 0 is 
the best possible score.
Table 9-1
The functional domains of the OHIP-Edent questionnaire.
Domain
Questions
Score range
Functional limitations
1-3
0-12
Physical pain
4-7
0-16
Psychological discomfort
8-9
0-8
Physical disability
10-12
0-12
Psychological disability
13-14
0-8
Social disability
15-19
0-20
9.2.1.3
GOHAI Questionnaire
The GOHAI questionnaire (Atchison and Dolan, 1990a) will be administered to the subjects at 
all assessment visits after the gum-comfort questionnaire has been completed.  This 
questionnaire is comprised of 12 questions with 6 possible responses to each question (always, 
very often, often, sometimes, seldom and never).  The responses are scored on a 0 (always) -5 
(never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and thus the range 
of scores for the questionnaire is 0-60, where 60 is the best possible score.  The questions are 
grouped into 3 domains as in Table 9-2.


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Table 9-2
The functional domains of the GOHAI questionnaire
Domain
Questions
Score range
Meaning
Functional
1-4
0-20
Subject’s ability to eat, speak and swallow
Psychosocial
6,7,9-11
0-25
Subject’s concerns, relationships and 
appearance
Pain/Discomfort
5,8,12
0-15
Subject’s discomfort during chewing, 
sensitivity to hot/cold/sweets and use of 
medications to manage oral pain.
9.2.1.4
Sensory Questionnaire
The sensory questionnaire will be completed by subjects after the GOHAI questionnaire has 
been completed and retrieved at Visit 3 only.  This questionnaire comprises 6 questions that 
inform on the sensory attributes of the adhesive, and thus will only be administered to subjects 
randomized to the adhesive group.  The questionnaire allows for 5 possible responses (Agree 
Strongly, Agree Somewhat, Neither Agree or Disagree, Disagree Somewhat, Disagree Strongly) 
and are scored on a 0 (Agree Strongly) to 4 (Disagree Strongly) scale for all questions.  Thus 
the range of the questionnaire score is 0-24 where a low score is more favorable.
9.2.2
Mucosal Score Assessment (MSA)
The health of the denture-bearing tissues should be assessed using the scale described by 
Henriksen et al (Henriksen et al, 1999) and summarized in Table 9-3.
The MSA should be performed by a suitably qualified dental professional and ideally the same 
examiner should be used throughout the study.  The MSA will be made on the denture bearing 
tissues for either/both of the subject’s dentures across the whole mouth and therefore the 
examiner should record the highest applicable score (ie should a subject have normal 
appearance of their mandibula denture-bearing tissue, yet display ulcers caused by denture in 
the maxillary tissue, a score of 3 should apply).  The result of the examination will be recorded 
in the CRF.
The MSA may be performed at the same time as the OST examination.  The absence of any 
residual denture adhesive in the mouth must be confirmed by a second (non-blinded) examiner 
prior to the subject attending to the MSA or OST examination to ensure the OST/MSA assessor 
remains blinded to treatment.
Table 9-3
The MSA Scale per Henriksen (Henriksen et al, 1999)
Score
Appearance
1
Normal appearance of the gingiva and oral mucosa
2
Mild inflammation

slight redness and/or hypertrophy/hyperplasia of the gingiva

slight redness in some areas of the palatal mucosa, including red spots indicating 
inflamed salivary duct orifices
3
Moderate inflammation

marked redness and hypertrophy/hyperplasia of the gingiva, which bleeds easily 
when pressure is applied

marked redness in large areas (2/3 or more) of the palate

marked inflammatory redness of the oral mucosa in sites other than in the palate

ulceration(s) caused by denture(s)

red and inflamed fibro-epithelial hyperplasias caused by denture(s)
4
Severe inflammation

severe redness and hypertro hypertrophy/hyperplasia of the gingiva

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Score
Appearance

marked palatal granulations

inflamed oral mucosal areas which easily “break” and bleed under pressure, e.g., 
when dentures are inserted
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 by a suitably qualified dental professional and 
ideally the same examiner should be used throughout the study.  The OST Exam-Edentulous 
will include the labial mucosa (including lips), buccal mucosa, tongue, edentulous 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.  
An OST examination should be performed at screening and at each visit to the study site and 
the findings recorded in the CRF.  A single examiner should complete this assessment for all 
the subjects. If this is not possible, then the same examiner should perform this procedure for 
the same subject for all the visits wherever possible.
The OST examination may be performed at the same time as the MSA.  The absence of any 
residual denture adhesive in the mouth must be confirmed by a second (non-blinded) examiner 
prior to the subject attending to the MSA or OST examination to ensure the OST/MSA assessor 
remains blinded to treatment.
9.3.2
Pregnancy Testing
For female subjects of childbearing potential, a urine pregnancy test, will be performed at every 
visit to the study site.  Results will be obtained prior to dosing during each period.  
The investigator and site personnel will remind subjects at each visit to inform site personnel if 
their menstrual cycle has changed or if they have any other reason to suspect they may be 
pregnant (e.g. had unprotected intercourse since the last visit).
A negative pregnancy result is required before the subject may receive the investigational 
product.  Pregnancy tests will also be done whenever one menstrual cycle is missed during the 
active study period (or when potential pregnancy is otherwise suspected). Pregnancy tests may 
also be repeated as per request of IRBs/ECs or if required by local regulations.
In the case of a positive confirmed pregnancy, the subject will be withdrawn from 
administration of investigational product and from the study.
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), 


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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. 

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:


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
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.

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.


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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 the 
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).
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 


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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.
Email Serious Adverse Events to:
The GSK CH Study Manager or designee will be responsible for forwarding the SAE form to 
the Case Management Group, Global Clinical Safety and Pharmacovigilance mailbox 
(
).
The initial report will be followed up with more information as relevant, or as requested by the 
GSK CH study manager.
10.5
Evaluating Adverse Events 
10.5.1
Assessment of Intensity
The investigator or medically qualified designee will make an assessment of intensity for each 
AE reported during the study and will assign it to one of the following categories:

Mild:  An event that is easily tolerated by the subject, causing minimal discomfort and 
not interfering with everyday activities.

Moderate:  An event that is sufficiently discomforting to interfere with normal everyday 
activities
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
Severe:  An event that prevents normal everyday activities. 
NOTE: An AE that is assessed as severe should not be confused with an SAE. Severe is a 
category utilized for rating the intensity of an event; and both non-serious AEs and SAEs can 
be assessed as severe. For example, a headache may be severe (interferes significantly with the 
subject's usual function) but would not be classified as serious unless it met one of the criteria 
for SAEs, listed above. An event is defined as ‘serious’ when it meets at least 1 of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe.
10.5.2
Assessment of Causality
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. For each AE (serious and non-serious), the investigator (or medically qualified 
designee) must provide an assessment of causality on the AE CRF page and the SAE form 
(subject to the classification of the AE). The investigator will also document in the medical 
notes that he/she has reviewed the AE and assessed causality, where applicable. 
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
Generally, the facts (evidence) or arguments to suggest a causal relationship should be provided.
The investigator will use clinical judgment to determine the relationship and will also consult 
the Investigator Brochure, Safety Statement and/or Product Information, for marketed products, 
in the determination of his/her assessment.  Alternative causes, such as underlying disease(s), 
concomitant therapy, other risk factors, and the temporal relationship of the event to the study 
product will be considered and investigated.
For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed 
the AE/SAE and has provided an assessment of causality.
The investigator’s assessment of causality must be provided for all AEs (serious and non-
serious); the investigator must record the causal relationship in the CRF, as appropriate, and 
report such an assessment in accordance with the SAE reporting requirements if applicable.
There may be situations when an SAE has occurred and the investigator has minimal 
information to include in the initial report to GSK.  However, it is very important that the 
investigator always make an assessment of causality for every event prior to the initial 
transmission of the SAE data to GSK CH. The investigator may change his/her opinion of 
causality in light of follow-up information and send an SAE follow-up report with the updated 
causality assessment. 
10.6
Follow-up of Adverse Events 
After the initial report, the investigator is required to proactively follow up with each subject 
and provide further information on the subject’s condition.
All AEs (serious and non-serious) will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the subject is lost to follow-up.  
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as may be indicated or as requested by GSK CH to elucidate 
as fully as possible the nature and/or causality of the AE. This may include additional laboratory 
tests or investigations, histopathological examinations, or consultation with other health care 
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New or updated information will be recorded on the AE CRF page and on the SAE form (subject 
to the classification of the AE).
The investigator will submit any updated SAE data to GSK CH within 24 hours of receipt of 
the information.
Investigators are not obliged to actively seek AEs in former subjects.  However, if the 
investigator learns of a SAE, including death, at any time after a subject has been discharged 
from the study, and considers the event reasonably related to the study product or study 
participation, the investigator will promptly notify GSK CH by emailing the information to the 
GSK CH Clinical Operations Safety Reporting email box (
). 
The GSK CH Study Manager or designee will be responsible for forwarding the information to 
the Case Management Group, Global Clinical Safety and Pharmacovigilance group mailbox at 
GSK 
).
The investigator will submit any updated SAE data to GSK CH within the designated reporting 
time frames.
10.7
Withdrawal Due to an Adverse Event 
Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according 
to the definition of an AE noted earlier, and recorded on the appropriate AE CRF page. 
When a subject withdraws because of an SAE, the SAE must be reported in accordance with 
the reporting requirements defined.
10.7.1
Sponsor’s Reporting Requirements to Regulatory Authorities and 
Ethics Committees
GSK CH has a legal responsibility to notify, as appropriate, the local regulatory authority and 
other regulatory authorities about the safety of a product under clinical investigation.  Prompt 
notification of SAEs by the investigator to GSK CH is essential so that legal obligations and 
ethical responsibilities towards the safety of subjects are met.
GSK CH will comply with country specific regulatory requirements relating to safety reporting 
to the regulatory authority, IRB/EC and investigators.
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
(SUSAR) according to local regulatory requirements and Sponsor policy and forwarded to 
investigators as necessary.
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information e.g. summary or listing of SAE from the Sponsor will review and then file it 
along with the Investigator’s Brochure in the investigator study master file, and will notify the 
IRB/IEC, if appropriate according to local requirements.
10.8
Pregnancy
10.8.1
Time Period for Collecting Pregnancy Information
Pregnancy information will be collected on all pregnancies reported while a female subject is 
participating in the study from the signing of informed consent until 5 days after last 
administration of study product.
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10.8.2
Action to be Taken if Pregnancy Occurs
The investigator will record pregnancy information on the appropriate form scan and e-mail it 
to the GSK CH Clinical Operations Safety Reporting email box (
) within 24 hours of learning of the subject becoming pregnant. The GSK CH 
Study Manager or designee will be responsible for forwarding the pregnancy form to the Case 
Management 
Group, 
Global 
Clinical 
Safety 
and 
Pharmacovigilance 
mailbox 
(
). Original pregnancy information forms will be retained in the 
investigator study master file. 
The subject will be followed to determine the outcome of the pregnancy. Information on the 
status of the mother and infant / neonate (including concomitant medications taken by the 
mother during the pregnancy) will be forwarded by the investigator to the GSK CH Clinical 
Operations Safety Reporting email box and the GSK CH Study Manager or designee will 
forward this information to the Case Management Group, Global Clinical Safety and 
Pharmacovigilance group mailbox at GSK (
). Generally, follow-up will 
be no longer than 6 to 8 weeks following the estimated delivery date. Any termination of the 
pregnancy will be reported.
While pregnancy itself is not considered to be an AE, abnormal pregnancy outcomes (e.g. 
spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are, and 
should be recorded as an SAE.
Any female subject who becomes pregnant while participating will discontinue study treatment 
and be withdrawn from the study
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 test denture adhesive, the denture brush and the 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 
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
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 
(serious and non-serious), the appropriate AE CRF page and SAE form will be completed and 
reported as per the AE and SAE reporting sections.
The Incident Report Form will be completed as thoroughly as possible and signed by the 
investigator before transmittal to GSK CH.  It is very important that the investigator describes 
any corrective or remedial actions taken to prevent recurrence of the incident.
The completed Incident Report Form should be scanned and emailed to the GSK CH Clinical 
Operations Safety Reporting email box with the study number and subject number in the subject 
line of the email as soon as possible, but not more than 24 hours after study site personnel 
learn of the event. If there is an SAE, the completed SAE form should be sent together with this 
report form.  However, if a copy of the SAE report is sent with this form, this does not replace 
the procedure to report an SAE.  The original Incident Report Form will be retained in the 
investigator study master file. 
The GSK CH Study Manager should be notified of the situation by telephone or email.
Email the Incident Report Forms to:
The GSK CH Study Manager or designee will be responsible for forwarding the Incident Report 
Form to the Case Management Group, Global Clinical Safety and Pharmacovigilance group 
mailbox (
), responsible for the study and other GSK CH personnel as 
appropriate.
The initial report will be followed up with more information as relevant, or as requested by the 
GSK CH study manager.
The investigator will follow the following directions regarding the reporting of a device failure 
(malfunction):

Notify GSK CH immediately (by following the process described above).

Schedule the subject to return to the site promptly to return the failed device.

Record any incidents on the CRF and Incident Report Form following instructions given 
in the section above.

Return the failed device to the Sponsor as soon as possible, including documentation of 
the details of the failure 
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All communications regarding a medical device incident should be directed towards the GSK 
CH study manager.  In order to maintain blinding, these communications will not involve the 
study statistician or the study clinical research scientist.  The study manager will assess if follow 
up action is required, and if necessary utilize study-independent scientists who will not be 
involved in the analysis and reporting of this study.
10.9.3
Follow-up of Medical Device Incidents
Medical device incidents involving an AE will be followed and reported in the same manner as 
other AEs. This applies to all subjects, including those who discontinue study product or are 
withdrawn from the study.
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the incident.
New or updated information will be recorded on the originally completed Incident Report form 
with all changes signed and dated by the investigator.
10.9.4
Regulatory and Ethics Reporting Requirements for Incidents
To fulfill regulatory reporting obligations worldwide, the investigator is responsible for the 
detection and documentation of events meeting the definitions of incident or malfunction that 
occur during all periods of the study in which the medical device is used. 
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 and/or diary 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 
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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 Biostatistics 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.  
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 the 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 


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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 may 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 GSKCH or Third-party data management 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 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.
12
STATISTICAL CONSIDERATIONS AND DATA ANALYSES
12.1
Sample Size Determination
The primary response variable is the change from baseline in the average of the 5 questions in 
the Gum Comfort Questionnaire at 12 weeks.  There are no comparable data available for the 
consideration of the analysis of the responses to the Gum Comfort Questionnaire.  However, (i) 
similar questionnaires have been used and reported and (ii) the nature of the response variables 
using changes from baseline on a 5-point questionnaire allow us to predict the likely 
distributional aspects of such responses.  From this exercise we can assume the standard 
deviation (SD) of the overall mean of gum comfort response can be represented by a Normal 
(0.8, 0.0862) random variable.  
For a large number of simulated studies 100,000 the SD was sampled from this normal (prior) 
distribution. A clinically meaningful treatment effect was defined as -0.5 with adhesive vs no 
adhesive and was introduced into the simulated studies.  With 57 evaluable subjects the power 
to detect such a difference with statistical significance (2-sided) at the 5% level was found to 
be 90%.  This represents the average power to detect a mean difference of -0.5 between 
treatments over a plausible range (prior distribution) for the unknown SD and is often termed 
assurance. 
In order to account for subject drop outs (assumed as 10%), 63 subjects per treatment arm 
should be randomized to ensure 57 subjects per arm are evaluable.  The MITT population will 
be used for the primary analysis, and no correction to the alpha testing level will be made in 
respect of secondary endpoints.
12.2
Statistical Methods and Analytical Plan
Additional details of the proposed statistical analysis will be documented in the statistical 
reporting and analysis plan, which will be written following finalization of the protocol and 
prior to study unblinding/analysis (as appropriate).


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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 actually 
received.

The Modified Intent-To-Treat (Treated or Exposed) population (MITT) will comprise all 
randomized subjects who receive at least one dose of study product and have at least one 
post randomization measure of gum comfort recorded via the questionnaire.  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.

The per protocol (PP) population includes all MITT 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.
12.2.4.1 Prior and Concomitant Medications
Prior medications, concomitant medications and significant non-drug therapies taken during 
treatment will be listed for the safety population. 
12.2.5
Primary Analysis
The primary endpoint is the change from baseline in the mean overall gum comfort 
questionnaire after 12 weeks of study.  The subjects mean change from baseline for the Gum 
Comfort Questionnaire will be compared between groups using analysis of covariance 
(ANCOVA) and test between treatment groups at the 5% level of significance. The model will 
include the baseline value as covariate.  Frequency distributions of the responses by treatment 
group will be provided to detail the whole range of responses.  Within and between group 
estimates of treatment effects will be provided with 95% confidence intervals (CI’s).  The 
direction of the effect is anticipated in the direction of an improved gum comfort OHrQoL in 
favour of the experimental denture adhesive over the no adhesive group.
In the case of the assumptions underlying the model not being supported, a suitable 
transformation or non-parametric procedure will be used.
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The MITT population will be considered primary for this analysis. Analysis of the PP 
population (if applicable) will be secondary.
12.2.6
Secondary Analyses
Analysis of the same primary variable at 1, 4 and 8 weeks will be identical to that of the primary 
variable at 12 weeks.  
Other Questionnaire data at each time of assessment, the OHIP-Edent and GOHAI (including 
any subscales of each) will be analyzed in a similar fashion to the primary variable.
A summary of the Product Sensory Questionnaire at 28 days will be provided for the adhesive 
wearing group.
A summary of the incidence of denture bearing tissue assessments at each time of assessment 
on a scale of 1-4 will be presented.
No correction to the testing level amongst the secondary variables will be made as these are 
considered non definitive and hypothesis generating.
Further details will be given in the Reporting and Analysis Plan which will be finalized prior to 
database lock.
12.2.7
Safety Analysis
All AEs will be coded using MedDRA. AEs will be categorised as oral and non-oral by the 
Clinical Research Director/ Scientist or designee prior to database lock. Treatment-emergent 
adverse event (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. Incidents will be listed.  The safety 
analysis will be performed on the safety population.
12.2.8
Handling of Dropouts and Missing Data 
Missing data will not be replaced or imputed. Dropouts will be included in analyses up to the 
last assessments at the point of discontinuation.
12.2.9
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.


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
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.
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.
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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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 (ICH, Nov 2016) , 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 
information that might influence the evaluation of the benefits and risks of the investigational 
product, GSK CH should be informed immediately. 


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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, 
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.


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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 carbomer and 
carboxymethylcellulose 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.
14
REFERENCES
207545, A bite force study assessing two currently marketed denture adhesive products 
compared to no-adhesive control. GSK Data Held on File; 2017.
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.
Allen F, Locker D. A modified short version of the oral health impact profile for assessing 
health-related quality of life in edentulous adults. International Journal of Prosthodontics. 
2002;15(5).
Atchison KA, Dolan T. Development of the geriatric oral health assessment index. J Dent 
Edu. 1990a;54(11):680-7.
Atchison KA, Dolan TA. Development of the geriatric oral health assessment index. J Dent 
Edu. 1990b;54(11):680-7.
Budtz‐Jørgensen E. Oral mucosal lesions associated with the wearing of removable 
dentures. Journal of Oral Pathology & Medicine. 1981;10(2):65-80.
Coates A. Usage of denture adhesives. Journal of dentistry. 2000;28(2):137-40.


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Felton D, Cooper L, Duqum I, et al. Evidence-based guidelines for the care and maintenance 
of complete dentures: A publication of the american college of prosthodontists. J Am Dent 
Assoc. 2011;142:1S-20S.
Grasso JE. Denture adhesives: Changing attitudes. Journal of the American Dental 
Association. 1996;127(1):90-6.
Hatcher RA, Nelson AL. Contraceptive technology. 19th ed. New York: Ardent Media; 2007.
Henriksen BM, Ambjørnsen E, Axéll TE. Evaluation of a mucosal-plaque index (mps) 
designed to assess oral care in groups of elderly. Special Care in Dentistry. 1999;19(4):154-7. 
doi: 10.1111/j.1754-4505.1999.tb01378.x.
ICH. Topic e6 (r2) guideline for good clinical practice. Nov 2016.
Kapur KK. A clinical evaluation of denture adhesives. J Prosthet Dent. 1967;18(6):550-8.
Locker D, Allen F. What do measures of ‘oral health‐related quality of life’measure? 
Community dentistry and oral epidemiology. 2007;35(6):401-11.
Munoz CA, Gendreau L, Shanga G, et al. A clinical study to evaluate denture adhesive use in 
well‐fitting dentures. J Prosthodont. 2012;21(2):123-9.
Nicolas E, Veyrune Jl, Lassauzay C. A six‐month assessment of oral health‐related quality 
of life of complete denture wearers using denture adhesive: A pilot study. J Prosthodont. 
2010;19(6):443-8.
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.
Polyzois G, Lagouvardos P, Partalis C, et al. Short‐term assessment of the ohip‐14 scale 
on denture wearers using adhesives. J Prosthodont. 2015;24(5):373-80.
 
GSK Data Held on File; 2014.
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.
US FDA. Guidance for industry: Collection of race and ethnicity data in clinical trials. 2005.
World Medical Association. Declaration of helsinki, 64th general assembly, fortaleza. 2013.
Zarb GA, Hobkirk J, Eckert S, et al. Prosthodontic treatment for edentulous patients-e-book: 
Complete dentures and implant-supported prostheses: Elsevier Health Sciences; 2013.
15
APPENDIX
15.1
ABBREVIATIONS
The following is a list of abbreviations that may be used in the protocol.
Table 15-1
Abbreviation
Abbreviation
Term
AE
adverse event
ANCOVA
analysis of covariance
BDM
biostatistics and data management
CI
confidence interval
CRF
case report form
CCI


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Abbreviation
Term
CTA
clinical trial application
DMS
Data management system
EC
ethics committee
ECG
electro cardiogram
eCRF
Electronic Case Report Form
EDC
Electronic data capture
ePRO
Electronic patient reported outcome
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration (United States)
FRP
Females of Reproduction Potential
GCP
Good Clinical Practice
GOHAI
General Oral Health Assessment Index
GSK CH
GlaxoSmithKline Consumer Healthcare
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IND
investigational new drug 
IRB
institutional review board
IRT
Interactive Response Technology
LSLV
last subject last visit 
MedDRA
medical Dictionary for Regulatory Activities
MITT
modified intent to treat
MSA
mucosal score assessment
N/A
not applicable
OHIP-Edent
Oral Health Impact Profile for Edentulous Patients
OHrQoL
Oral health related quality of life
OST
oral soft tissue
PI
principal investigator
PII
Personally identifiable information
PP
per protocol
PRO
patient reported outcome
SAE
serious adverse event
SRSD
single reference study document
SS
safety statement
SUSAR
suspected unexpected serious adverse reactions
US
United States


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15.2
Application Instructions:

Apply product (thin strips) to clean and dry dentures as:

Upper denture – Apply product in a long continuous strip, not too close to the denture 
edge, as shown in the image above. In the center, apply 2 shorter strips in the middle 
of the denture, as shown in the image above.

Lower Denture - Apply product in a long continuous strip, not too close to the denture 
edge, as shown in the image above.

Rinse your mouth with tap water before inserting dentures. 

Press dentures into place, hold firmly, and bite down for a few seconds to secure hold.

Adhesive should be applied once daily.

For the first time, use a small amount then use more if needed. Too much adhesive can 
cause oozing; apply less next time if this occurs. It may take a few tries to find the right 
amount for your denture.
Removal Instructions:

Swish mouth with water.

Slowly remove denture using a rocking motion.

Remove adhesive residue from denture and mouth with warm water and supplied denture 
brush.

Thoroughly clean your denture in your usual manner and then rinse with water.


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15.3
Example of the Gum-Comfort Questionnaire
Example Only
Please answer the following questions using the rating scale below:
Over the last few weeks (baseline)/Since your last visit to the study site (V2 onwards)…
1)
My gums feel comfortable when wearing my denture(s).
Agree 
Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

2)
I feel my gums are cushioned from the impact of chewing and biting.
Agree 
Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

3)
My gums do not feel sore at the end of the day.
Agree 
Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

4)
My gums are not irritated by trapped food particles under my denture(s).
Agree 
Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

5)
My gums do not feel tired at the end of the day
Agree 
Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly



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15.4
Example of the Oral Health Impact Profile for Edentulous 
Patients (OHIP-Edent) Questionnaire
Example Only
Please answer the following questions using the rating scale below:
Over the last few weeks (baseline)/Since your last visit to the study site…
1) Have you had difficulty chewing any foods because of problems with your teeth, mouth or 
dentures?
Never

Rarely

Occasionally

Often

Very Often

2) Have you had difficulty with food catching in your teeth or dentures?
Never

Rarely

Occasionally

Often

Very Often

3) Have you felt that your dentures have not been fitting properly?
Never

Rarely

Occasionally

Often

Very Often

4) Have you had painful aching in your mouth?
Never

Rarely

Occasionally

Often

Very Often

5) Have you found it uncomfortable to eat any foods because of problems with your teeth, 
mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

6) Have you had sore spots in your mouth?
Never

Rarely

Occasionally

Often

Very Often

7) Have you had uncomfortable dentures?
Never

Rarely

Occasionally

Often

Very Often

8) Have you been worried by dental problems?
Never

Rarely

Occasionally

Often

Very Often

9) Have you been self conscious because of your teeth, mouth or dentures?


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Never

Rarely

Occasionally

Often

Very Often

10) Have you had to avoid eating some foods because of problems with your teeth mouth or 
dentures?
Never

Rarely

Occasionally

Often

Very Often

11) Have you had to interrupt meals because of problems with your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

12) Have you been unable to eat because of problems with your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

13) Have you been upset because of problems with your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

14) Have you been a bit embarrassed because of your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

15) Have you had difficulty with being less tolerant of your spouse or family because of 
problems with your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

16) Have you been a bit irritable with other people because of problems with your teeth, 
mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

17) Have you avoided going out because of problems with your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often

18) Have you been unable to enjoy other people’s company as much because of problems with 
your teeth, mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often



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19) Have you felt that life in general was less satisfying because of problems with your teeth, 
mouth or dentures?
Never

Rarely

Occasionally

Often

Very Often



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15.5
Example of the General Oral Health Assessment Index (GOHAI) 
Questionnaire 
Example Only
Please answer the following questions using the rating scale below:
Over the last few weeks (baseline)/Since your last visit to the study site…
1) How often did you limit the kinds or amounts of food you eat because of problems with 
your teeth or dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

2) How often did you have trouble biting or chewing any kinds of food, such as firm meat or 
apples?
Always

Very Often

Often

Sometimes

Seldom

Never

3) How often were you able to swallow comfortably?
Always

Very Often

Often

Sometimes

Seldom

Never

4) How often have your teeth or dentures prevented you from speaking the way you wanted?
Always

Very Often

Often

Sometimes

Seldom

Never

5) How often were you able to eat anything without feeling discomfort?
Always

Very Often

Often

Sometimes

Seldom

Never

6) How often did you limit contacts with people because of the condition of your teeth or 
dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

7) How often were you pleased or happy with the looks of your teeth and gums, or dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

8) How often did you use medication to relieve pain or discomfort from around your mouth?
Always

Very Often

Often

Sometimes

Seldom

Never



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9) How often were you worried or concerned about the problems with your teeth, gums or 
dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

10) How often did you feel nervous or self-conscious because of problems with your teeth, 
gums or dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

11) How often did you feel uncomfortable eating in front of people because of problems with 
your teeth or dentures?
Always

Very Often

Often

Sometimes

Seldom

Never

12) How often were your teeth or gums sensitive to hot, cold or sweets?
Always

Very Often

Often

Sometimes

Seldom

Never



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15.6
Example of the Product Sensory Questionnaire
Example Only
Using the rating scale below, please answer the following questions about the denture fixative 
product you have been using:
1) I feel the product has a smooth texture on my gums.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

2) I feel the product is gentle on my gums.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

3) I feel the product flavor soothes my gums.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

4) I feel the product flavor cools my gums.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

5) I feel the product is easy to apply.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly

6) I feel less rubbing from my denture throughout the day when using this product.
Agree Strongly 

Agree 
Somewhat

Neither Agree 
or Disagree

Disagree 
Somewhat

Disagree 
Strongly


SAP_001.pdf: 
Carboxymethylcellulose and Carbomer 
209510 
Final Statistical Reporting and Analysis Plan v1.0, 15 Feb 2019 
This document contains confidentiality statements that are not relevant for this publicly available 
version
Property of GSK Consumer Healthcare 
Confidential 
May not be used, divulged, published or otherwise disclosed without the consent of GSK 
Template Version Effective: 15-Jul-2017 
Page 1 of 27 
STATISTICAL REPORTING AND ANALYSIS PLAN 
A randomized, single-blind, efficacy study to evaluate oral health 
and quality of life associated with use of a denture adhesive 
Protocol Number:  209510 
Phase: 
3 


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Document History 
 
Document 
Version Date 
Summary of Changes (New analysis or 
Change in planned analysis) 
Original Analysis Plan 
15 Feb 2019 
Not applicable  
 
Amendments incorporate all revisions to date.   
 
 
 


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Table of Contents 
Document History ............................................................................................................... 2 
Table of Contents ................................................................................................................ 3 
List of Tables ....................................................................................................................... 5 
Abbreviations.............................................................................................................................. 6 
1 
Summary of Key Protocol Information ............................................................................... 7 
1.1 
Study Design ............................................................................................................ 7 
1.2 
Study Objectives ...................................................................................................... 9 
1.3 
Treatments ............................................................................................................. 10 
1.4 
Sample Size Calculation ........................................................................................ 10 
2 
Planned Analyses ............................................................................................................... 11 
2.1 
Interim Analysis ..................................................................................................... 11 
2.2 
Final Analyses ....................................................................................................... 11 
3 
Considerations for Data Analyses and Data Handling Conventions ................................. 11 
3.1 
Baseline Definition ................................................................................................ 11 
3.2 
Subgroups/Stratifications ....................................................................................... 11 
3.3 
Centres Pools ......................................................................................................... 11 
3.4 
Timepoints and Visit Windows ............................................................................. 11 
4 
Data Analysis ..................................................................................................................... 12 
4.1 
Populations for Analysis ........................................................................................ 12 
4.1.1 
Subject Disposition ............................................................................... 12 
4.1.2 
Protocol Deviations ............................................................................... 12 
4.1.3 
Analysis Populations ............................................................................. 14 
4.2 
Subject Demographics and Other Baseline Characteristics ................................... 14 
4.2.1 
Demographic Characteristics ................................................................ 14 
4.2.2 
General Medical History ....................................................................... 15 
4.2.3 
Characteristics of Study Population ...................................................... 15 
4.3 
Treatments (Study Product, Rescue Medication, other Concomitant 
Therapies, Compliance) ......................................................................................... 15 
4.3.1 
Product Compliance .............................................................................. 15 
4.3.2 
Prior and Concomitant Medication ....................................................... 16 
4.4 
Analysis of Efficacy .............................................................................................. 16 
4.4.1 
Primary Efficacy Endpoint .................................................................... 16 
4.4.2 
Primary Efficacy Endpoint Definition .................................................. 16 


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4.4.3 
Handling of Missing Values/Censoring/Discontinuations .................... 18 
4.5 
Analysis of Secondary Objectives ......................................................................... 22 
4.5.1 
Efficacy (Secondary) ............................................................................. 22 
4.5.2 
Pharmacokinetic (Secondary) ............................................................... 25 
4.6 
Analysis of Safety .................................................................................................. 25 
4.6.1 
Adverse Events and Serious Adverse Events ........................................ 25 
4.6.2 
Other Safety Variables .......................................................................... 26 
4.7  
 Other Analysis ...................................................................................................... 26 
5 
Changes to the Protocol Defined Statistical Analysis Plan ............................................... 27 
Attachment 1: List of Data Displays ........................................................................................ 27 


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List of Tables 
Table 1-1 
Schedule of Activities ............................................................................. 8 
Table 1-2 
Investigational/Study Product Supplies ................................................. 10 
Table 4-1 
The Functional Domains of the OHIP-Edent Questionnaire ................ 23 
Table 4-2 
The Functional Domains of the GOHAI Questionnaire ....................... 24 
Table 5-1 
Changes to Protocol Defined Analysis Plan ......................................... 27 
 
 
 


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Abbreviations  
Abbreviation 
Term 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
BDRM 
Blinded Data Review Meeting 
CI 
Confidence Interval 
GOHAI 
General Oral Health Assessment Index 
MSA 
Mucosal Score Assessment 
MITT 
Modified Intent To Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
OST 
Oral Soft tissue 
OHrQoL 
Oral Health Related Quality of Life 
OHIP-Edent 
Oral Health Impact Profile-Edentulous 
PP 
Per Protocol 
PT 
Preferred Term 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SOC 
System Organ Class 
SE 
Standard Error 
TEAE 
Treatment emergent adverse event 
 
 


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The purpose of this Statistical Reporting and Analysis Plan is to describe the planned analyses 
and outputs to be included in the Clinical Study Report for 209510. 
1 
Summary of Key Protocol Information 
Whilst the effectiveness of denture adhesives to increase the retention of dentures and to help 
prevent food ingress under dentures is well established, the overall impact of denture adhesive 
use on the gum health of users the oral health related quality of life (OHrQoL) has been less 
well investigated. This study will therefore evaluate whether usage of an experimental denture 
adhesive is able to impact the overall gum health and the OHrQoL of subjects through 12 weeks 
usage. The hypothesis being investigated is that usage of the experimental adhesive will lead to 
improvement in the gum-health and to improve the OHrQoL of subjects who wear full dentures 
compared to the usage of no adhesive.  
1.1 
Study Design 
This will be a single center, controlled, single-blind (to the safety assessor and the examiner 
determining the Mucosal Score Assessment (MSA) score), randomized, two-treatment, parallel 
design in healthy subjects with a full conventional, acrylic denture in either or both dental 
arches, with a treatment period of 12 weeks, to assess the clinical effectiveness of an 
experimental denture adhesive in the improvement of denture-bearing tissue irritation related 
measures, and the subject’s oral health related quality of life. The control arm will have subjects 
use no denture adhesive which is representative of a significant number of denture wearers who 
currently do not use an adhesive. The test experimental adhesive will be applied once per day 
in accordance with typical usage instructions. Efficacy and safety will be assessed at Baseline, 
and after 1, 4, 8 and 12 weeks treatment to monitor clinical efficacy and safety. 
This study will be considered successful if a statistically significant difference between the 
mean scores from the Gum Comfort questionnaire is observed between subjects using the 
experimental denture adhesive compared to subjects using no adhesive, in favor of the 
experimental adhesive after 12 weeks use.  
The schedule of activities in Table 1-1 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. 
 
 


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Table 1-1 
Schedule of Activities 
Procedure/Assessment 
Visit 1 
Screening 
/ Baseline 
Day1 
Visit 2 
Day 
7±1 
Visit 3 
Day 
28±3 
Visit 4 
Day 
56±3 
Visit 5 
Day 
84±3 
Informed consent 
X 
Review inclusion/exclusion criteria 
X 
X 
X 
X 
X 
Demographics 
X 
 
 
 
 
Medical history 
X 
 
 
 
 
Dental history 
X 
 
 
 
 
Current/concomitant medications 
X 
X 
X 
X 
X 
Urine pregnancy test4 
X 
X 
X 
X 
X 
Clean dentures 
X 
 
 
 
X 
Well-made assessment of dentures 
X 
 
 
 
 
Denture bearing tissue score 
X 
 
 
 
 
Denture retention and stability assessment 
X 
 
 
 
 
OST examination edentulous 
X 
X 
X 
X 
X 
Subject eligibility 
X 
 
 
 
 
Mucosal score assessment 
X 
X 
X 
X 
X 
Subject-completed questionnaires (Gum-Comfort, 
GOHAI and OHIP-Edent) 
X 
X 
X 
X 
X 
Randomization 
X 
 
 
 
 
Dispense treatment, application instructions, diary 
(with diary completion instructions) and brushes3 
X 
 
X 
X 
 
Treatment usage demonstration1 
X 
X 
X 
X 
 
Subject returns treatment, diary and brush5 
X 
X 
X 
X 
Review of subject compliance (diaries and returned 
product) 
X 
X 
X 
X 
Return of treatment and brush to subjects1 
X 
 
 
 
Return of diary to subjects 
X 
X 
X 
 
Subject removes dentures. All traces of adhesive 
from mouth confirmed absent by second examiner2 
 
X 
 
X 
 
X 
 
X 
Subject-completed sensory questionnaire1 
 
X 
 
 
Adverse events and Incidents 
X 
X 
X 
X 
X 
Subject continuance 
X 
X 
X 
 
Study conclusion 
 
 
 
X 
Abbreviations: OST = Oral Soft Tissue, OHIP-Edent = Oral Health Impact Profile-Edentulous, GOHAI = General 
Oral Health Assessment Index 
Any serious adverse event, adverse event or incident assessed as related to study participation that occurs 
subsequent to the signing of informed consent will be recorded. 


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1 for subjects randomized to the adhesive group only. 
2 the second (unblinded) examiner shall not be the examiner performing the MSA/OST assessment. 
3 brushes, treatment and application instructions dispensed to subjects randomized to the denture adhesive 
group only. Diary and application instructions will be dispensed only once at V1 unless subject requires a new 
copy of the instructions due to loss/spoilage. 
4 for females of childbearing potential only. 
5 subjects randomized to no-treatment use return only their diary. 
1.2 
Study Objectives 
The study objectives are as follows: 
Objectives 
Endpoints 
Primary Objective 
Primary Endpoint 
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 12 weeks of product use. 
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 12 weeks (overall 
mean score). 
Secondary Objectives 
Secondary Endpoints 
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 and 8 weeks of product 
use. 
Change from baseline in mean scores of 
subject responses to the Gum Comfort 
questionnaire after 1, 4 and 8 weeks 
(overall mean score). 
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
mucosal benefits compared to the use of no 
adhesive after 1, 4 , 8 and 12 weeks of 
product use. 
Change from baseline in mean scores of 
subject responses to the individual 
questions on the Gum Comfort questionnaire 
after 1, 4, 8 and 12 weeks. 
To compare the ability of an experimental 
denture adhesive to reduce denture-bearing 
mucosal irritation compared to the use of no 
adhesive after 1, 4, 8 and 12 weeks of 
product use. 
Change from baseline in examiner derived 
scores from the mucosal assessment after 1, 4, 8 
and 12 weeks. 
To compare the ability of an experimental 
denture adhesive to provide self-perceived 
oral health related quality-of-life benefits 
compared to the use of no adhesive after 1, 
4, 8 and 12 weeks of product use. 
Change from baseline in mean scores of 
subject responses to the OHIP-Edent and 
GOHAI questionnaires after 1, 4, 8 and 
12 weeks (overall mean scores and 
average domain scores). 
To assess the sensory attributes of an 
experimental denture adhesive. 
Mean scores of subject responses to the sensory 
questionnaire after 28 days. 
Safety 
Safety Endpoints 
To assess the tolerability of an experimental 
denture adhesive. 
Treatment emergent adverse events. 
 


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1.3 
Treatments 
The following study products will be supplied: 
Table 1-2 
Investigational/Study Product Supplies 
 
Test Product 
Negative 
Control 
Product Name 
Experimental Denture Adhesive 
No Adhesive 
Pack Design 
Denture adhesive tube fitted with a precision nozzle 
N/A 
Dispensing Details 
New tubes of denture adhesive will be dispensed at each 
study visit 
N/A 
Product Master 
Formulation Code (MFC) 
 
 
N/A 
 
Dose/Application 
A sufficient quantity of denture adhesive to be applied to 
the maxillary and/or mandibular dentures once per day in 
the pattern described in the application instructions. 
 
N/A 
Route of Administration 
Applied to denture which is placed in mouth 
N/A 
Usage Instructions 
As per the Product Application Instructions (Section 15.2 
of the protocol) 
N/A 
Return Requirements 
All used/unused samples to be returned to GSK CH 
N/A 
 
1.4 
Sample Size Calculation 
The primary response variable is the change from baseline in the average of the 5 questions in 
The Gum Comfort Questionnaire at 12 weeks. There are no comparable data available for the 
consideration of the analysis of the responses to the Gum Comfort Questionnaire. However, 
similar questionnaires have been used and reported and the nature of the response variables 
using changes from baseline on a 5-point questionnaire allow us to predict the likely 
distributional aspects of such responses. From this exercise we can assume the standard 
deviation (SD) of the overall mean of gum comfort response can be represented by a Normal 
(0.8, 0.0862) random variable. 
For a large number of simulated studies 100,000 the SD was sampled from this normal (prior) 
distribution. A clinically meaningful treatment effect was defined as -0.5 with adhesive vs no 
adhesive and was introduced into the simulated studies. With 57 evaluable subjects the power 
to detect such a difference with statistical significance (2-sided) at the 5% level was found to 
be 90%. This represents the average power to detect a mean difference of -0.5 between 
treatments over a plausible range (prior distribution) for the unknown SD and is often termed 
assurance. 
 
 
CCI


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In order to account for subject drop outs (assumed as 10%), 63 subjects per treatment arm 
should be randomized to ensure 57 subjects per arm are evaluable. The Modified Intent-to-Treat 
(MITT) population will be used for the primary analysis, and no correction to the alpha testing 
level will be made in respect of secondary endpoints. 
2 
Planned Analyses 
2.1 
Interim Analysis 
No interim analysis is planned. 
2.2 
Final Analyses 
The final planned analyses will be performed after the completion of the following sequential 
steps:    
1. All subjects have completed the study as defined in the protocol. 
2. All required database cleaning activities have been completed and database has been 
locked. 
3. All criteria for unblinding the randomization codes have been met and the randomization 
codes have been distributed. 
3 
Considerations for Data Analyses and Data Handling 
Conventions 
3.1 
Baseline Definition 
For all endpoints the baseline value will be the corresponding pre-treatment assessment at 
Screening/Baseline (Visit 1).  
Unless otherwise stated, if baseline data are missing no derivation will be performed and will 
be set to missing. 
3.2 
Subgroups/Stratifications 
No subgroups or stratification factors are defined in this study. 
3.3 
Centres Pools 
Since this is a single center study, pooling of centers is not applicable. 
3.4 
Timepoints and Visit Windows 
The timepoints and visits for this study are defined in the Section 1.1. Any deviation from the 
study schedule may be reviewed on case-by-case basis at the Blinded Data Review Meeting 


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(BDRM) to determine whether any data should be excluded from the Per-Protocol (PP) 
population.   
4 
Data Analysis 
Data analysis will be performed by Syneos Health. The statistical analysis software used will 
be SAS (Studio) version 9.4 or higher.   
Prior to database closure a BDRM will be conducted, during which various aspects of the trial 
will be discussed and agreed.   
Unless otherwise described, all listings will be produced for all randomized subjects.   
4.1 
Populations for Analysis 
4.1.1 
Subject Disposition 
Screen failures are defined as subjects who consent to participate in the clinical study but are 
not subsequently randomized. An enrolled subject is a subject who has signed informed consent 
and is eligible to proceed beyond screening.  The number of subjects screened, enrolled and 
randomized will be presented in Table 14.1.1. 
Table 14.1.1 will also display the number and percentage of screen failure subjects (subjects 
not randomized) with reasons why subjects are not randomized. Percentages for screen failure 
subjects will be based on the total number of subjects screened.  
Subject disposition will also be summarized as the number and percentage of subjects in each 
of the defined analysis populations, who complete the study and who discontinue the study 
broken down by reason for discontinuation. The summary will be presented by study product 
group and overall. The percentages are based on the study product specific total number of 
subjects randomized. 
Subject disposition including demographic data (age, sex, race and ethnicity), screening date, 
study product start date, the subject status (completer, Yes/No), study completion/withdrawal 
date, duration (in days) in the study (defined as [(date of completion or withdrawal – screening 
date) + 1] and the primary reason for withdrawal will be listed (Listing 16.2.1.1). 
Subject disposition information will be listed for non-randomized subjects (Listing 16.2.1.2), 
displaying subject number, demographic information (age, sex, race and ethnicity), screening 
date, reason for screen failure and any further details of reason for screen failure. 
4.1.2 
Protocol Deviations 
Protocol deviations will be tracked by the study team throughout the conduct of the study. Data 
will be reviewed prior to unblinding and closure of the database to ensure all important 
deviations are captured and categorised. Subjects with important protocol deviations liable to 
influence the efficacy outcomes will be excluded from the PP population. Subjects may also be 


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identified as having important protocol deviations not leading to exclusion from the PP 
population. 
Important deviations of the protocol procedures may include, but will not necessarily be limited 
to:  
• Violation of inclusion or exclusion criteria at screening 
• Non-compliance with study product use 
• Use of prohibited treatment or medication before or during the study 
• Violation of visit windows 
The specific details of important protocol deviations and how these will be assessed will be 
specified in the Blind Data Review Plan and subjects with important protocol deviations will 
be identified at the BDRM. 
The number and percentage of subjects with at least one important protocol deviation, important 
protocol deviations not leading to exclusion from PP population with reasons for deviations and 
subjects with important protocol deviations leading to exclusion from the PP population with 
reasons for deviations will be summarised by study product group (Table 14.1.2) and listed 
(Listing 16.2.2.1).  
All protocol deviations captured on the case report form will be listed in Listing 16.2.2.2. The 
listing will present date of deviation, deviation type and deviation description.     
 
 


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4.1.3 
Analysis Populations 
The analysis populations defined for this study are as follows:   
Population 
Definition / Criteria 
Analyses Evaluated 
Safety 
All randomized subjects who receive at least 
one dose of study product. 
This population will be based on the product 
the subject actually received. 
Safety 
 
Modified Intent-
To-Treat 
(MITT) 
(Treated or 
exposed) 
All randomized subjects who receive at least 
one dose of study product and have at least 
one post randomization measure of gum 
comfort recorded via the questionnaire.  
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. 
Efficacy 
 
Per Protocol 
(PP) 
All subjects in MITT population who comply 
with all study procedures and restrictions that 
may affect the interpretation of the primary 
response. 
Deviations will be determined and applied 
prior to unblinding and consist of variations in 
criteria likely to affect the interpretation of the 
efficacy parameters. 
Efficacy 
 
NOTES :  
Please refer to Attachment 1: List of Data Displays which details the population to be used for 
each displays being generated. 
Subjects excluded from any of the analysis populations will be listed in Listing 16.2.3.1.  
The primary population for assessment of efficacy will be the MITT Population. PP population 
analysis will be performed only if 10% of MITT population is excluded from PP population. 
4.2 
Subject Demographics and Other Baseline Characteristics 
4.2.1 
Demographic Characteristics 
Descriptive statistics (n, mean, SD, median, minimum and maximum for continuous variables, 
frequency count [n] and percentage [%] of subjects for categorical variables) will be presented 
for demographic variables by study product and overall. These variables include age, gender, 
race and ethnicity and will be presented for the Safety population (Table 14.1.3.1), the MITT 
population (Table 14.1.3.2) and the PP Population (Table 14.1.3.3) if applicable. 


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Demographic information will be listed (Listing 16.2.4.1) for all randomized subjects. 
4.2.2 
General Medical History 
Medical history data will be listed (Listing 16.2.4.2) with start date and end date or ongoing at 
the start of the study.  
4.2.3 
Characteristics of Study Population 
Table 14.1.4.1 summarises the baseline characteristic data collected on the denture information 
(descriptive statisticis of duration of denture use), denture history (descriptive statistics of 
current age of denture), criteria for well-made denture (frequency counts and percentages of all 
responses to each question), evaluation of well fit denture (frequency counts and percentages 
of each response under retention and stability and descriptive statistics for sum score retention 
and stability) and denture bearing tissue evaluation (frequency counts and percentages of 
responses to ridge shape, tissue resiliency and boarder tissue attachment) eCRF pages for the 
subjects in the Safety population. 
The baseline characteristic table described above will be repeated for the MITT population 
(Table 14.1.4.2).  
Denture information and history details (Listing 16.2.4.3), criteria for well-made denture 
(Listing 16.2.4.4), evaluation of well-fit denture (Listing 16.2.4.5) and denture bearing tissue 
evaluation information (Listing 16.2.4.6) will be listed as collected on the respective eCRF 
pages.  
4.3 
Treatments (Study Product, Rescue Medication, other 
Concomitant Therapies, Compliance) 
Randomization details will be listed, including the planned study product, the actual study 
product the subject was randomized to and the randomization date (Listing 16.1.7). 
4.3.1 
Product Compliance  
Product compliance of the experimental adhesive group will be recorded as number of missed 
product uses since last visit and number of additional product uses since last visit.  
Compliance to experimental adhesive use will also be calculated as a percentage at each visit: 
Compliance = (actual number of uses / expected number of uses) X 100  
Where: 
Expected number of product uses = number of days between the two visits 
Actual number of uses = expected number – missed product uses + additional product uses 
The number of missed product uses, additional product uses and percentage compliance will be 
summarized using descriptive statistics (n, missing, mean, SD, median, minimum and 
maximum) at Weeks 1, 4, 8 and 12.  In addition at Week 12, the number and percentage of 
subjects <80%, between 80% - 120% and >120% compliance will be presented.  Compliance 


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data will be summarised and listed for the experimental adhesive group only in Table 14.2.1.1 
(Safety population) Table 14.2.1.2 (MITT population) and Listing 16.2.5.1. 
4.3.2 
Prior and Concomitant Medication 
Prior or concomitant medication taken by or administered to a subject will be recorded in the 
case report form. The prior and concomitant medications will be coded using an internal 
validated medication dictionary, GSK Drug. 
Prior medication will be listed by subject, with drug name, GSK drug synonym, dose, dose 
form, frequency, route, start date, study day relative to randomization date/first use of study 
product administration and end date (Listing 16.2.5.2). Prior medications are defined as those 
which stopped before the date of randomization/first use of the study product. If the stop date 
is unknown or incomplete and the medication cannot be considered as stopped prior to the 
randomization date/first use of study product then the medication will be considered as a 
concomitant medication.  
Concomitant medications and significant non-drug therapy will be listed similarly (Listing 
16.2.5.3) with either ongoing or end date displayed. Concomitant medications are defined as 
medications that are ongoing or started on or after the randomization date/first use of the study 
product.  
For the assignment of prior and concomitant medications, the randomization date will be used 
for subjects randomized to the No Adhesive group and the date of first use of study product will 
be used for the subjects randomized to the Experimental Adhesive Group. 
Unknown dates will not be imputed, however if the start or stop date is unknown, then it will 
be assumed to be concomitant medication unless the partial start date or stop date indicates 
differently. 
4.4 
Analysis of Efficacy  
4.4.1 
Primary Efficacy Endpoint 
4.4.2 
Primary Efficacy Endpoint Definition 
The primary endpoint is the change from baseline in the mean overall gum comfort 
questionnaire score after 12 weeks of study.  
The gum-comfort questionnaire is comprised of 5 questions that record the subject-perceived 
comfort of their denture-bearing tissues. The questions have 5 possible responses (Agree 
Strongly, Agree Somewhat, Neither Agree or Disagree, Disagree Somewhat, Disagree 
Strongly) and are scored on a 0 (Agree Strongly) to 4 (Disagree Strongly) scale for all questions. 
The score from all 5 questions will be summed as the overall gum comfort score at each time 
point, which will have a range score of 0-20 where a low score is more favorable. See section 
4.4.4.1 on how to deal with missing scores. 


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4.4.2.1 
Statistical Hypothesis, Model, and Method of Analysis 
Descriptive statistics (n, missing, mean, SD, SE, median, minimum and maximum) of the 
primary variable observed value will be provided (Table 14.2.2.1) at Baseline, Weeks 1, 4, 8 
and 12, along with the change from baseline statistics at Weeks 1, 4, 8 and 12 by product group 
for the MITT population and (Table 14.2.2.4) for PP population. 
Frequency distributions of the overall gum comfort score by product group will be provided 
displaying the complete range of responses from 0 – 20 at each week (Table 14.2.2.2) for MITT 
population. 
The primary analysis is a comparison of the mean change from baseline in overall gum comfort 
score between Experimental Adhesive and No Adhesive at Week 12 for subjects eligible for 
the MITT population. 
The null hypothesis for the primary endpoint is that the mean change from baseline in overall 
gum comfort score is equal between the 2 groups. 
H0: µ1 = µ2 
The alternative hypothesis is that the mean change from baseline in overall gum comfort score 
is not equal between the 2 groups. 
H1: µ1 ≠ µ2 
The change from baseline in overall gum comfort score at Week 12 will be analysed using  
analysis of covariance (ANCOVA) with study product as a fixed effect and baseline overall 
gum comfort score as a covariate. Adjusted means and their SEs, 95% confidence intervals (CI), 
within treatment p-values for each product group will be displayed with product group 
difference, SE, 95% confidence interval of the difference and the between-treatment p-value in 
Table 14.2.2.3 for MITT population and in Table 14.2.2.5 for PP population.  All statistical tests 
of hypotheses will be two-sided and will employ a level of significance of α = 0.05. 
This study will be considered successful if a statistically significant difference between the 
adjusted mean scores of the two product groups is observed to be in favor of the Experimental 
Adhesive. 
The assumptions of the ANCOVA model i.e. normality of residual and equality of variances 
will be investigated. If the assumptions of the underlying model are violated, data 
transformations will be investigated and if suitable transformations cannot be found, an 
appropriate non-parametric test will be performed (e.g. Mann-Whitney U test). 
All Gum Comfort Questionnaire responses with the overall and change from baseline scores 
will be listed (Listing 16.2.6.1).  
4.4.2.2 
Supportive Analyses 
If there is more than 10% difference in the overall number of subjects between PP and MITT 
populations, a summary of the primary efficacy variable will be presented for all subjects in the 


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PP population (Table 14.2.2.4) and the same ANCOVA model applied to the primary analysis 
will be performed on the PP population (Table 14.2.2.5). 
Secondary efficacy variables are defined in Section 4.5. 
4.4.3 
Handling of Missing Values/Censoring/Discontinuations 
Subjects who withdraw from the study prematurely will be included in the statistical analyses 
up to the point of discontinuation. 
4.4.3.1 
Handling of Missing Values in Questionnaire Data 
For any overall questionnaire score (with the exception of product sensory questionnaire) or 
functional domain score (where applicable), if there are ≤ 20% of missing values/scores that are 
required for the derivation of the overall or functional domain score, the missing score will be 
imputed pro-rated. If there is > 20% of missing values, the score will be set to missing. 
 This ≤20% imputation rule will therefore be dependent on the number of questions per 
functional domain or overall score. For example: 
 
Number of Questions within 
Domain or Overall Score 
Number of Scores Missing 
Impute or Set to Missing 
1 to 4 
≥ 1  
Set to missing 
5 to 9 
1  
Impute  
≥ 1 
Set to missing 
10 to 15 
1  
Impute  
2 
Impute  
≥ 2 
Set to missing 
16 to 19 
1 
Impute 
2 
Impute 
3 
Impute 
≥ 4 
Set to missing 
Scores will be imputed using the following calculation: 
Imputation score = s*n/(n-m) 
Where: 
s = total value of scores available 
n = number of questions within the overall score or domain 
m = number of missing values 
Imputation examples are provided for a couple of the questionnaires below 
Gum-Comfort Questionnaire 
Gum-comfort questionnaire comprises of 5 questions; if 1 of the scores out of the 5 questions 
is missing, the overall gum comfort score will be derived as: 


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Question 
Response 
1) My gums feel comfortable when wearing my denture(s) 
1 
2) I feel my gums are cushioned from the impact of chewing and biting 
2 
3) My gums do not feel sore at the end of the day 
3 
4) My gums are not irritated by trapped food particles under my denture(s) 
3 
5) My gums do not feel tired at the end of the day 
missing 
Rating scale: [0] - Agree Strongly, [1] - Agree Somewhat, [2]- Neither Agree or Disagree, [3]- Disagree Somewhat, [4]- Disagree 
Strongly 
Imputation of Overall score for above example:  (1+2+3+3)*5/4 =11.25 
OHIP-Edent Questionnaire 
OHIP-Edent Questionnaire comprises of 19 questions grouped into 6 functional domains (see 
section 4.5.1.4 for further details): 
Domain 
Question 
Number of 
Questions 
within Domain 
Response 
Total 
Score 
Functional limitations 
1-3 
3 
 
missing 
1) Have you had difficulty chewing any 
foods because of problems with your 
teeth, mouth or dentures? 
 
 
1 
 
2) Have you had difficulty with food 
catching in your teeth or dentures? 
 
 
2 
 
3) Have you felt that your dentures have 
not been fitting properly? 
 
 
missing 
 
 
 
 
 
 
Physical pain 
4-7 
4 
 
missing 
4) Have you had painful aching in your 
mouth? 
 
 
missing 
 
5) Have you found it uncomfortable to eat 
any foods because of problems with your 
teeth, mouth or dentures? 
 
 
1 
 
6) Have you had sore spots in your 
mouth? 
 
 
3 
 
7) Have you had uncomfortable 
dentures? 
 
 
2 
 
 
 
 
 
 
Psychological discomfort 
8-9 
2 
 
3 
8) Have you been worried by dental 
problems? 
 
 
1 
 
9) Have you been self-conscious because 
of your teeth, mouth or dentures? 
 
 
2 
 
 
 
 
 
 


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Physical disability 
10-12 
3 
 
4 
10) Have you had to avoid eating some 
foods because of problems with your 
teeth mouth or dentures? 
 
 
1 
 
11) Have you had to interrupt meals 
because of problems with your teeth, 
mouth or dentures? 
 
 
3 
 
12) Have you been unable to eat because 
of problems with your teeth, mouth or 
dentures? 
 
 
0 
 
 
 
 
 
 
Psychological disability 
13-14 
2 
 
4 
13) Have you been upset because of 
problems with your teeth, mouth or 
dentures? 
 
 
1 
 
14) Have you been a bit embarrassed 
because of your teeth, mouth or 
dentures? 
 
 
3 
 
 
 
 
 
 
Social disability 
15-19 
5 
 
8.75 
15) Have you had difficulty with being less 
tolerant of your spouse or family because 
of problems with your teeth, mouth or 
dentures? 
 
 
1 
 
16) Have you been a bit irritable with 
other people because of problems with 
your teeth, mouth or dentures? 
 
 
missing 
 
17) Have you avoided going out because 
of problems with your teeth, mouth or 
dentures? 
 
 
2 
 
18) Have you been unable to enjoy other 
people’s company as much because of 
problems with your teeth, mouth or 
dentures? 
 
 
2 
 
19) Have you felt that life in general was 
less satisfying because of problems with 
your teeth, mouth or dentures? 
 
 
2 
 
 
 
 
 
 
Overall OHIP-Edent score 
1-19 
19 
27 
32.06 
Rating Scale: [0] Never [1] Rarely [2] Occasionally [3] Often [4] Very Often 
For the overall OHIP-Edent score is calculated as: 
27*19/16 = 32.06 
Where 16 (19-3) is the denominator due to the 3 missing scores in questions 3, 4 and 16. 


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Product Sensory Questionnaire 
There will be no imputation of the product sensory score which comprises of 6 questions (see 
section 4.5.1.6 for further details).  If one of more of the question scores is missing, then the 
product sensory score will be set to missing.   
4.5 
Analysis of Secondary Objectives 
No correction to the testing level amongst the secondary variables will be made as these are 
considered non definitive and hypothesis generating. All analyses will be conducted on the 
MITT population only. 
4.5.1 
Efficacy (Secondary) 
4.5.1.1 
Overall Gum Comfort Score at Weeks 1, 4 and 8  
Change from baseline in overall gum comfort questionnaire scores at Weeks 1, 4 and 8 (overall 
mean score) will be evaluated using the same model as used for primary efficacy analysis on 
the MITT population (Table 14.2.2.1).  
4.5.1.2 
Gum Comfort Questionnaire Individual Questions Scores 
Summary of Individual Gum Comfort question scores will be presented (n, missing, mean, SD, 
SE, median, minimum and maximum) at Weeks 1, 4, 8 and 12 in Table 14.2.3.1. Individual 
Gum Comfort question scores will be statistical analyzed using the same model as used for 
primary efficacy analyses in Table 14.2.3.2. 
4.5.1.3 
Mucosal Score Assessment (MSA) 
The MSA will be made on the denture bearing tissues using the scale described by Henriksen 
et al and summarized in Table 9-3 of the Protocol. The MSA score at each assessment is measure 
on a scale of 1 (normal appearance) up to 4 (severe inflammation). 
A summary table of descriptive statistics (n, missing, mean, SD, SE, median, minimum and 
maximum) of the observed and change from baseline MSA values will be presented at each 
week (Table 14.2.4.1) for subjects in the MITT population. 
Wilcoxon rank sum test will be used to compare the between-product group medians of change 
from baseline MSA values at each week and the Wilcoxon signed-rank test will be used to 
compare the within-product group medians of change from baseline MSA values at each week 
for subjects in MITT population. P-values for both tests will be reported along with median 
change from baseline values. (Table 14.2.4.2) 
All MSA responses and change from baseline scores will be listed (Listing 16.2.6.2). 


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4.5.1.4 
OHIP-Edent Questionnaire  
This questionnaire comprises 19 questions grouped into 6 functional domains as provided in 
Table 4-1. The questions have 5 possible responses ranging from 0 (Never) to 4 (Very Often) 
scale for all questions and thus a low score is more favorable and the overall score range is 0-
76 where 0 is the best possible score. 
Table 4-1 
The Functional Domains of the OHIP-Edent Questionnaire 
Domain 
Questions 
Score range 
Functional limitations 
1-3 
0-12 
Physical pain 
4-7 
0-16 
Psychological discomfort 
8-9 
0-8 
Physical disability 
10-12 
0-12 
Psychological disability 
13-14 
0-8 
Social disability 
15-19 
0-20 
Summary tables of descriptive statistics (n, missing, mean, SD, SE, median, minimum and 
maximum) of the observed and change from baseline overall OHIP-Edent score will be 
presented (Table 14.2.5.1) at each week and for OHIP-Edent functional domain scores over 
time (Table 14.2.5.3) for subjects in the MITT population. 
The change from baseline in overall OHIP-Edent score at Weeks 1, 4, 8 and 12 will be analyzed 
using ANCOVA with study product as a fixed effect and baseline overall OHIP-Edent score as 
a covariate. Adjusted means and their SEs, 95% CI, within treatment p-values for each product 
group will be displayed with product group difference, SE, 95% CI of the difference and the 
between-treatment p-value in (Table 14.2.5.2).  All statistical tests of hypotheses will be two-
sided and will employ a level of significance of α = 0.05. Similar model will be used to analyze 
change from baseline OHIP-Edent functional domain scores at weeks 1, 4, 8 and 12 (Table 
14.2.5.4).   
As with the primary efficacy analysis, the model assumptions will be checked and suitable 
transformations or alternative non-parametric method will be performed if these are not met. 
All OHIP-Edent responses for each question will be listed (Listing 16.2.6.3) by functional 
domain including the functional domain score, change from baseline domain score and overall 
OHIP-Edent observed and change from baseline values. 
4.5.1.5 
GOHAI Questionnaire  
This questionnaire is comprised of 12 questions with 6 possible responses to each question 
(always, very often, often, sometimes, seldom and never). The responses are scored on a 0 
(always) to 5 (never) scale for all questions except 3, 5 and 7 where the scoring is reversed, and 
thus the overall GOHAI scores can range from 0-60, where 60 is the best possible score.  
The questions are grouped into 3 domains as detailed in Table 4-2. 


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Table 4-2 
The Functional Domains of the GOHAI Questionnaire 
Table  
Questions 
Score range 
Meaning 
Functional 
1-4 
0-20 
Subject’s ability to eat, speak and swallow 
Psychosocial 
6,7,9-11 
0-25 
Subject’s concerns, relationships and 
appearance 
Pain/Discomfort 
5,8,12 
0-15 
Subject’s discomfort during chewing, 
sensitivity to hot/cold/sweets and use of 
medications to manage oral pain. 
Summary tables of descriptive statistics (n, missing, mean, SD, SE, median, minimum and 
maximum) of the observed and change from baseline overall GOHAI score will be presented 
(Table 14.2.6.1) at each week for subjects in the MITT population. 
The change from baseline in overall GOHAI score at Weeks 1, 4, 8 and 12 will be analyzed 
using ANCOVA with study product as a fixed effect and baseline overall GOHAI score as a 
covariate. Adjusted means and their SEs, 95% CI, within treatment p-values for each product 
group will be displayed with product group difference, SE, 95% CI of the difference and the 
between-treatment p-value in Table 14.2.6.2.  All statistical tests of hypotheses will be two-
sided and will employ a level of significance of α = 0.05.  
As with the primary efficacy analysis, the model assumptions will be checked and suitable 
transformations or alternative non-parametric method will be performed if these are not met. 
A summary table for the GOHAI 3 functional domains will be presented individually and their 
respective questions (Table 14.2.6.3). Similar model used to analyze overall GOHAI score will 
be used to analyze the change from baseline GOHAI functional domain scores at weeks 1, 4, 8 
and 12 (Table 14.2.6.4).   
All GOHAI responses for each question will be listed (Listing 16.2.6.4) by functional domain 
including the functional domain score, change from baseline functional domain score and 
overall GOHAI observed and change from baseline scores. 
4.5.1.6 
Sensory Questionnaire  
The sensory questionnaire will be completed by subjects at Week 4 (Day 28/Visit 3) only.  
This questionnaire comprises 6 questions that inform on the sensory attributes of the adhesive, 
and thus will only be administered to subjects randomized to the experimental adhesive group.  
The questionnaire allows for 5 possible responses (Agree Strongly, Agree Somewhat, Neither 
Agree or Disagree, Disagree Somewhat, Disagree Strongly) and are scored on a 0 (Agree 
Strongly) to 4 (Disagree Strongly) scale for all questions.  Thus the range of the overall sensory 
questionnaire score is 0-24 where a low score is more favorable. 
 
A summary table of descriptive statistics (n, missing, mean, SD, SE, median, minimum and 
maximum) of the overall sensory questionnaire score and individual questions at Week 4 will 
be provided for the experimental adhesive group in Table 14.2.7 


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Listing 16.2.6.5 will display all the sensory questionnaire responses to each question including 
the overall score. 
4.5.2 
Pharmacokinetic (Secondary) 
Not Applicable  
4.6 
Analysis of Safety 
The safety analysis will be performed on the safety population. 
4.6.1 
Adverse Events and Serious Adverse Events 
All Adverse Events (AEs) will be reviewed by the Clinical Research Scientist or Designee prior 
to database lock and will be coded to a system organ class (SOC) and preferred term (PT) using 
the Medical Dictionary for Regulatory Activities (MedDRA).  
AEs will be classified by the dental examiner as either oral or non-oral on the AE page of the 
eCRF. 
Treatment emergent adverse events (TEAEs) are defined as new AEs that occur on or after the 
first study product use/date of randomization. AEs events with an onset date/time prior to the 
first study product use/date of randomization will be considered as non-treatment emergent.  
For the assignment of TEAEs, the randomization date will be used for subjects randomized to 
the No Adhesive group and the date of first use of study product will be used for the subjects 
randomized to the Experimental Adhesive Group. 
AEs will be summarized by the number and percentage of subjects with an AE, an AE in each 
SOC and each PT. The following summary tables (by product group for subjects in the Safety 
Population) and listings (for all Randomized Subjects) will be presented:  
• Table of treatment-emergent AEs by SOC and TPT (Table 14.3.1.1). Summary of the 
number and percentage of subjects with at least one AE, total number of AEs, number and 
percentage of AEs within each SOC and PT will be displayed. 
• Table of treatment-emergent AEs by Oral/Non-Oral and PT (Table 14.3.1.2.) 
• Table of treatment related treatment-emergent AES by Oral/Non-Oral and PT (Table 
14.3.1.3) 
• Listing of all AEs (Listing 16.2.7.1.1 for all randomized subjects; Listing 16.2.7.1.2 for 
non-randomized subjects) 
• Listing of deaths (Listing 14.3.2.1) 
• Listing of non-fatal Serious Adverse Events (Listing 14.3.2.2) 
• Listing of treatment-emergent AEs leading to study or drug discontinuation (Listing 
14.3.2.3) 
• Listing of treatment-emergent AEs classified as oral (Listing 14.3.2.4) 
In the event that there is nothing to report, a null table or listing will be produced.   


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4.6.2 
Other Safety Variables 
Medical Device Incidents 
Medical devices are being provided by GSK CH for use in this study; the medical devices in 
this study are the test denture adhesive, the denture brush, and the denture cleansing paste. 
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. 
All Incidents will be listed in Listing 16.2.7.2. 
Oral Soft Tissue Examination 
Summary of oral soft tissue (OST) examination results (frequency counts and percentages) will 
be tabulated in Table 14.3.1 at each visit and listed in Listing 16.2.9.1. 
4.7  
 
Other Analysis 
In addition to what was planned in the protocol, Cronbach’s coefficient alpha will be calculated 
at Week 1, 4, 8 and 12 for OHIP-Edent domains (Table 14.2.5.5) and GOHAI domains (Table 
14.2.6.5).   
Cronbach's coefficient alpha is a measure of internal consistency, that is, how closely related a 
set of items are as a group. It is considered to be a measure of scale reliability which can be 
used to support the use of combined domain scales. 
Cronbach’s Coefficient will be calculated as: 
 
A coefficient of 0.7 and above shows that the internal consistency/reliability between the 
domain is at least acceptable.   


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5 
Changes to the Protocol Defined Statistical Analysis Plan 
Any changes from the originally planned statistical analysis specified in the protocol are 
outlined in Table 5-1. 
Table 5-1 
Changes to Protocol Defined Analysis Plan 
Table  
Reporting & Analysis Plan 
 
Statistical Analysis section 
Statistical Analysis Plan 
Rationale for Changes 
Section 12.2.1 Definition of 
Analysis Population 
The per protocol (PP) population 
includes all MITT 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. 
Section 4.1.3 Analysis 
Population 
PP population includes all 
subjects in MITT population 
who comply with all study 
procedures and restrictions 
that may affect the 
interpretation of the primary 
response. Deviations will be 
determined and applied prior 
to unblinding and consist of 
variations in criteria likely to 
affect the interpretation of the 
efficacy parameters. 
To provide clarification of the 
definition. 
Details were not included 
Section 4.7 Other Analysis 
Cronbach coefficient alpha 
will be derived for OHIP-
EDENT domains and GOHAI 
domains. 
Cronbach's coefficient alpha 
is a measure of internal 
consistency, that is, how 
closely related a set of items 
are as a group. It is 
considered to be a measure 
of scale reliability which can 
be used to support the use of 
combined domain scales. 
 
 
Attachment 1: List of Data Displays 
GSKCH_209510_TFL
_V1.0_15Feb2019.xls