A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.
Phase: NA
Conditions: Denture Retention
Sponsor: GlaxoSmithKline

Copyright:  GlaxoSmithKline.  An unpublished work subject to trade secret 
protection.  This work contains confidential and proprietary information of 
GlaxoSmithKline and shouldnot be copied, circulated, or distributed to persons not 
employed by GlaxoSmithKline unless specifically authorized.  Unauthorized 
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Clinical Protocol
206233
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CONFIDENTIAL
SUMMARY INFORMATION
Title:
A Proof of Principle Bite Force Study Using Two New 
Test Adhesives and a Currently Marketed Denture 
Adhesive
Protocol Number:
206233
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)
184 Liberty Corner Road, Warren NJ, 07059, United 
States
Tel: 
Product Name:
Super Poligrip®and two PVA-based experimental 
denture adhesives
Development Phase:
N/A
Expert Advice Outside of Normal 
Working Hours:
Tel: 
Key Protocol Authors:
PRIMARY CONTACT
Clinical Study Manager:
,BS
GSKCH
184 Liberty Corner Road, Warren NJ, 
07059, United States
Tel:
ClinicalResearch:
,PhD, BDS, MFDSRCS, 
MFGDP, FHEA
GSKCH
St. George’s Avenue, Weybridge, Surrey, 
KT13 0DE, United Kingdom (UK)
Biostatistician:
, PhD
inVentiv Health Clinical
 
 
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 India
Clinical Supplies:
GSKCH
St. George’s Avenue, Weybridge, Surrey, 
KT13 0DE, United Kingdom (UK)
Principal Investigator:
Thomas DiLauro, DMD
Study Site Name & Address:
TKL Research, 1255 Broad Street, 
Bloomfield, NJ 07003
Study Site Telephone Number:
Product Name:
Super Poligrip® Free & two PVA-based 
test denture adhesive formulations
IND/EUDRACT No:
N/A
Phase of Study:
N/A
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PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE
I confirm agreement to conduct the study in compliance with the protocol and 
any amendments and according to the current 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 sitestaff 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:
Dr. Thomas DiLauro
Investigator Qualifications:
DMD
Investigator Signature:
Date of Signature/ Agreement:
DD/MMM/YYYY
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Table of Content
SUMMARY INFORMATION...............................................2
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE..............................................................................4
Table of Content......................................................................5
PROCESS FOR AMENDING THE PROTOCOL...............10
PROTOCOL AMENDMENT PAGE....................................11
PROTOCOL SYNOPSIS FOR STUDY 206233...................15
1. INTRODUCTION...............................................................23
2. OBJECTIVES AND ENDPOINTS....................................25
3. STUDY PLAN.....................................................................26
3.1. Study Design.......................................................................26
3.2. Subject Restrictions...........................................................29
3.3. Type and Planned Number of Subjects............................29
3.4. Study Design and Dose Justification.................................29
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA........................................31
4.1. Inclusion Criteria...............................................................31
4.2. Exclusion Criteria..............................................................32
4.3. Screening/ Baseline Failures..............................................34
4.4. Withdrawal/ Stopping Criteria.........................................34
4.5. Subject Replacement..........................................................34
4.6. Subject and Study Completion..........................................35
5. PRODUCT INFORMATION.............................................35
5.1. Study Product.....................................................................35
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5.2. Dose Schedule.....................................................................37
5.3. Dose Modification..............................................................37
5.4. Product Compliance..........................................................37
5.5. Precautions.........................................................................38
5.6. Overdose.............................................................................38
5.7. Rescue Therapy..................................................................38
5.8. Product Assignment...........................................................38
5.8.1 Randomization...................................................................38
5.8.2 Blinding...............................................................................39
5.8.3 Code Breaks........................................................................39
5.9. Packaging and Labelling...................................................39
5.9.1. Accountability of Product.................................................40
5.9.2. Storage of Product............................................................40
6. STUDY ASSESSMENTS AND PROCEDURES..............40
6.1. Visit 1 -Screening Visit......................................................40
6.1.1 Telephone Screening..........................................................40
6.1.2. Informed Consent.............................................................40
6.1.3. Demographics....................................................................41
6.1.4. Medical History and Concomitant Medication...............41
6.1.5. Dental History...................................................................41
6.1.6. Well-Made Denture Assessment.......................................41
6.1.7. OST Examination –Edentulous.......................................42
6.1.8. DentureBearing Tissue Score..........................................42
6.1.9. Kapur (Olshan Modification) Denture Retention & 
Stability Assessment..........................................................43
6.1.10. Denture cleansing............................................................44
6.1.11. Mandibular Denture Stabilisation.................................45
6.1.12. Bite Force Measures prior to and at Screening.............45
6.1.13. Bite Force Calibration.....................................................45
6.1.14. Bite Force Measures at Screening..................................45
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6.2. Visits 2, 3, 4 & 5..................................................................46
6.2.1. OST Examination -Edentulous........................................46
6.2.2. Denture Adhesive Application to Dentures.....................46
6.2.3. Bite Force Measures during Treatment Visits.................46
6.2.4. Subject Questionnaires.....................................................47
6.2.4. Study Conclusion...............................................................48
7. SAFETY ASSESSMENTS..................................................48
7.1. Definitions of an Adverse Event and Serious Adverse 
Event.................................................................................48
7.1.1. Adverse Events..................................................................48
7.1.2. Serious Adverse Events.....................................................49
7.2. Recording Adverse Events and Serious Adverse Events.50
7.3. Evaluating Adverse Events and Serious Adverse Events51
7.4. Reporting Adverse Events and Serious Adverse Events..52
7.5. Follow-up of Adverse Events and Serious Adverse Events
..........................................................................................53
7.6. Definition of and Procedure for Reporting Medical Device 
Incidents...........................................................................54
7.6.1. Definition of an Incident...................................................55
7.6.2. Reporting of Incidents and Malfunctions........................55
7.6.3. Follow-up of Incidents......................................................56
7.7. Collection of Pregnancy Information................................57
7.7.1. Time Period for Collecting of Pregnancy Information...57
7.7.2. Action to be Taken if Pregnancy Occurs.........................57
8. DATA MANAGEMENT....................................................57
8.1. Source Documents/ Data....................................................58
8.2. Electronic Case Report Form............................................58
8.3. Data Handling....................................................................59
8.3.1. Data Queries......................................................................59
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8.4. Processing Patient Reported Outcomes............................59
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES....................................................................60
9.1 Sample Size Determination.................................................60
9.2. General Considerations.....................................................61
9.2.1. Definition of Analysis Populations...................................61
9.2.2. Exclusion of Data from Analysis......................................61
9.2.3. Criteria for Evaluation.....................................................62
9.2.3.1. Criteria for Assessing Efficacy......................................62
9.2.3.2. Criteria for Assessing Tolerability................................62
9.2.4. Handling of Dropouts and Missing Data.........................62
9.3. StatisticalMethods and Analytical Plan...........................62
9.3.1. Demographic and Baseline Characteristics.....................62
9.3.2. Primary Analysis(es).........................................................62
9.3.3. Secondary Analysis(es).....................................................63
9.3.4. Exploratory/ Other Analysis(es).......................................64
9.3.5. Safety Analysis(es).............................................................64
10. STUDY GOVERNANCE CONSIDERATIONS.............64
10.1. Posting of Information on Publicly Available Clinical 
Trials Registers................................................................64
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent............................................................65
10.3. Quality Control (Study Monitoring)...............................65
10.4. Quality Assurance............................................................66
10.5. Conditions for Terminating the Study............................66
10.6. Records Retention............................................................67
10.7. Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication................................................68
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11. REFERENCES..................................................................69
12. APPENDICES...................................................................71
12.1. Appendix I -Abbreviations.............................................71
12.2. Appendix II –Product Ooze Questionnaire...................72
12.3. Appendix III –Sensory Questionnaire...........................73
12.4. Appendix IV –Denture Removal Questionnaire...........76
12.5. Appendix V –Denture Adhesive Application Instructions 
(Super Poligrip®)............................................................78
12.6. Appendix VI –Denture Adhesive Application 
Instructions (Experimental Denture Adhesives with a 
thin nozzle).......................................................................80
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PROCESS FOR AMENDING THE PROTOCOL
Protocol modifications to ongoing studies which could potentially adversely affect the 
safety of subjects or which alter the scope of the investigation, the scientific quality of 
the study, the experimental design, dosages, duration of therapy, assessment 
variables, the number of subjects treated, or subject selection criteria are considered 
major/substantial amendments and must be made only after appropriate consultation 
between an appropriate representative of GSKCH and the investigator.
Details of amendments to the protocols should be recorded on the following page. 
Protocol modifications must be prepared by a representative of GSKCH.  All changes 
must be justified in the Reason for Amendment section of the following Protocol 
Amendment Page. Approval of amendments will be madeby the original protocol 
signatories or their appropriate designees.
All major/substantial protocol modifications must be reviewed and approved by the 
appropriate IRBin accordance with local requirements, before the revised edition can 
be implemented. 
All non-substantial/ minor/ administrative amendments should be submitted to the 
IRBas per country specific requirements. In some countries pre-approval of a minor 
amendment is not required and will just be held on file by the sponsor and 
investigator.
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PROTOCOL AMENDMENT PAGE
Details of all amendments should be recorded in the table below. Affected sections should be listed in the table; the actual 
amendment/ change should be made in the relevant section of the main protocol. 
To highlight the change, the following features will be used: 
To addtext: Use of CAPITAL LETTERS, BOLD AND UNDERLINE
To delete text: Use of Strikethrough e.g. strikethrough
Amendment 
No. & New 
Protocol 
Version No.
Type of Amendment
Reason for Amendment
Other Documents 
Requiring 
Amendment
Section(s) Amended 
PI Amendment 
Agreement
Signature & 
Date
Amendment 
No.:
1
Non-Substantial/Minor    This is Protocol 
amendment 1 (Protocol 
version 5.0) as previous 
amendments (2.0, 3.0 
and 4.0) were made 
prior to Ethics 
submission.
Change of Clinical 
Study Manager details.
To correct 
inconsistencies from 
which point AEs and 
incidents should be 
collected.
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Summary Information.
Schedule of events.
Study Design 
(Synopsis& Section 
3.1).
6.2.3 Bite Force 
Measures during 
Treatment Visits.
7.2 Recording Adverse 
Events and Serious 
Adverse Events.
Signature:
Protocol 
Version 
No.:
5.0
Substantial/ Major           
Date:
 
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Amendment 
No.:
Non-Substantial/Minor    
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Signature:
Protocol 
Version 
No.:
Substantial/ Major           
Date:
 
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SCHEDULE OF EVENTS
Procedure/ Assessment
Screening
Between 1-14 daysof screening
Treatment 1
Between 1-14days
Treatment 2
Between 1-14days
Treatment 3
Between 1-14days
Treatment 4
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Informed Consent
X
Subject Demographics
X
Medical History
X
Dental History
X
Current/Concomitant 
Medications
X
X
X
X
X
Kapur Index Assessmentfor 
well made & fitting dentures
(retention, stability, fit & 
clinical acceptability)
X
Inclusion/Exclusion
X
X
Oral Soft Tissue (OST) 
assessment–Edentulous
X
X1
X1
X1
X1
Denture Bearing Tissue 
Score 
X
Denture Cleansing
X
X
X
X
X
Mandibular Denture 
Stabilization2
X
X
X
X
X
Three Incisal Bite Force 
readings with no adhesive 
X3
X4
X4
X4
X4
Incisal Bite Force with no 
adhesive 
X5
X6
X6
X6
X6
Subject Eligibility/ 
adherence
X
X
Adverse Events/Incident 
Reporting7
X
X
X
X
X
Continued Eligibility
X
X
X
X
Randomization
X
Product Application by site 
staff to maxillary denture
8
X8
X8
X8
X8
Incisal Bite Force 
X9
X9
X9
X9
 
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Measurements9
Subject administered 
questions around product 
ooze at 0.5 hour10
X
X
X
X
Subjects administered 
questions around flavor, 
texture and extrusion of the 
adhesive from the tube
11
X
X
X
X
Removal of denture from 
the mouth by subject
X
X
X
X
Completion of denture 
removal questionnaire
12
X
X
X
X
Remove product from 
denturebefore dismissing 
subject
X
X
X
X
Post treatment OST
X
X
X
X
Adverse Events/Incident 
Reporting
7
X
X
X
X
X
Study Conclusion
X
1 OST on Test Day is for pre-treatment baseline
2Mandibular Denture stabilization with adhesive (if necessary; at the discretion of the Investigator)
3Bite force readings at Screening Visit are “training”
4Bite Force readings on Test Day are “practice”
5Incisal Bite Force at Screening visit is ‘Qualifying’ 
6Incisal Bite Force on Test Day is pre-treatment“baseline”
7Adverse Events and Incidents will be assessed from the OST examinationat screening and pre and post bite force recordings on the Test Days
8Dentures of subjects randomized to a denture adhesive treatment shall be weighed before & after adhesive applicationto ensure correct dose applied
9Incisal Bite Force Measurements at t= 0.5, 1, 3, 6, 9 and 12 hours post adhesive application
10Subjects will complete the Product Ooze Questionnaire immediately following the 0.5 hr bite incisal bite force measure
11Subjects will complete the Sensory including Product Extrusion Questionnaire immediately following the last (12 hr) incisal bite force measure
12Subjects will complete the Denture Removal Questionnaire immediately following upper denture removal by the subject
 
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PROTOCOL SYNOPSIS FOR STUDY 206233
Brief Summary
The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle 
bite force study is to compare bite force measurements over a 12 hour period across 
two newly formulated (test) cream denture adhesives based on a new polymer
technology, with a currently marketed cream denture adhesive (positive control), and 
a negative/no treatment control. Thetest products comprise 2 new denture adhesive 
formulations that are based on a new water insoluble and heat-resistant polyvinyl 
acetate (PVA) polymer based formulationwith a new solvent system to try to achieve 
better complete denturehold and food sealing. Super Poligrip®Free, a commercially 
available denture adhesive product marketed by GSKCH in the United States (US), 
will be used as the positive control. A short questionnaire regarding the flavor and 
texture characteristics of each denture adhesive after a single use will also be 
administered to give anindication of subject satisfaction of these attributes.
In this study, a bite force transducer system will be used to measure incisal bite force 
until dislodgement of maxillary complete dentures.  Subjects in this study will have 
dentures judged to be clinically acceptable/moderately well fitting using the Kapur 
criteria that was modified by Olshan et al.in 1992. Dentures will also be judged to 
be well made using the design and construction criteria used previously [GSK studies 
].  Bite force measurements will be taken over a 12-
hour time periodto compare treatments. 
This study is planned to be conducted at TKL Research based in Bloomfield, New 
Jersey, USA,and subjects will be recruited via the TKLdatabase.
                                               
®Super Poligrip Free is a registered trademark of GlaxoSmithKline Consumer Healthcare, LLC.
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Objectives and Endpoints
Objectives
Endpoints
Primary
To compare incisal bite force for test 
adhesive 1 versus no adhesive after 12 
hours.
Area Over Baseline (AOB)at 12 hours.
To compare incisal bite force for test 
adhesive 2 versus no adhesive after 12 
hours.
AOB at 12 hours.
Secondary
To compare incisal bite force for test 
adhesive 1 versus Super Poligrip
®Free 
after 12 hours.
AOB at 12 hours.
To compare incisal bite force for test 
adhesive 2 versus Super Poligrip
®Free 
after 12 hours.
AOB at 12 hours.
To compare incisal bite force between 
test adhesives 1 & 2 after 12 hours.
AOB at 12 hours.
Other
To compare incisal bite force for test 
adhesive 1 versus no adhesive over 9 
hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 2 versus no adhesive over 9 
hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 1 versus Super Poligrip
®Free 
over 9 hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 2 versus Super Poligrip
®Free 
over 9 hours.
AOB at 0.5, 1, 3, 6 and 9 hours
To assess subjects’ preference with 
regards to denture adhesive ooze, flavor/ 
after-taste, texture and assess ease of 
removal
Scores from subject-completed 
questionnaires on product ooze, at 0.5 
hours, and flavour/ after-taste, texture and 
ease of removal after 12 hours’ use
To assess the ease of extrusion of the 
product from the tube by the subjects 
post bite force phase
Scores from subject-completed 
questionnaire on product extrusion after 
12 hours’ use
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Study Design

Overall Design
Thissingle centre, randomized, crossover, proof-of-principle study will be a 
randomized four period, four treatment, examiner blind [to the examiner performing 
the bite force & oral soft tissue (OST) examinations]design in subjects with well 
made and moderately well-fitting maxillary complete dentures. Informed consent will 
be obtained from participants before the implementation of any study procedure. 
At the Screening Visit, subjects will be screened for eligibility and ability to perform 
the bite force manoeuvre according to stated inclusion/exclusion criteria. On the test 
day visit, subjects will report to the study site without adhesive placed in their 
dentures. Dentures will be removed and cleaned. An OSTexamination will be 
performed before the lower denture (if applicable) is secured using Super Poligrip®
Flavour Free denture adhesive, whilst the upper denture is removed, and the pre-
treatment baseline incisal bite force measurements will be obtained (both practice 
bites and qualifying test bite). To maintain blinding, subjects must not disclose to the 
examiner if they are wearing adhesive or no adhesive. Subjects meeting all the 
inclusion criteria with no exclusions will then be randomized at Visit 2. 
On each test day (Visits 2-5) subjects will undergo an OST examination and have 
their dentures cleaned. Denture adhesive treatment (or no treatment as per the 
randomization schedule) will then be applied by a member of study staff (ideally the 
same member of staff throughout the study) as per the application instructions,and 
the dentures worn by the subject. Incisal bite force measurements will be made at 0.5, 
1, 3, 6, 9 and 12 hours after the dentures are placed in the mouth. After 0.5 hours 
assessment the subjects will be asked to complete questionsabout product ooze 
(Appendix II). The questions will be completed by the subjects themselves and these 
responses will then be given to study site staff to transfer to the eCRF. 
Immediately following the last (12 hour) incisal bite force measurement, subjects will 
be asked to complete a short questionnaire relating to the after-tasteand texture of the 
denture adhesive when randomized to one of the denture adhesive treatment periods 
(Appendix III). Thiswill be completed by the subject themselves in a quiet
environment without external influence. 
Immediately following subsequent upper denture removal by the subjects themselves, 
subjects will be asked to answer another short questionnaire (which will be 
administered by the site staff; Appendix IV) pertaining to ease of removal of the 
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denture when undertaking the treatment phases of the study, but not the negative no 
treatment control arm. The subjects will remove their dentures by themselves under 
supervision by site staff.Following denture removal, and completion of the 
associated questionnaire, site staff will clean the denture before returning to the 
patient at the end of the study. 
These assessments will be followed by the final post-treatment OST examination.
These procedures will be repeated in a crossover manner. There will be at least 24 
hours (up to 14days) between treatment visits to allow recovery from the bite force 
procedures.
Visit 1 -Screening Visit
The following assessments will be conducted:
Written informed consent.
Demographics, medical history, current/concomitant medications, and dental 
history.
Criteria for well-made dentures
Inclusion/exclusion criteria
Oral soft tissue examination including edentulous maxillary arch
Denture bearing tissue score
Kapur Index assessment
Denture cleansing
Mandibular denture stabilization (with adhesive, if deemed to be necessary to 
ensure accurate bite force measures; at the discretion of the Investigator)
Three incisal bite force readings with no adhesive on upper denture (for 
training)
Incisal bite force with no adhesive on the upper denture (qualifying)
Inclusion/exclusion criteria (following initial bite force measures)
Subject eligibility
Adverse events and incident reporting (assessed from the OST 
EXAMINATION AT SCREENINGstart of the first bite force 
measurement)
Visits 2, 3, 4 & 5
The following assessments will be conducted:
Review of current/concomitant medications, adverse events and incidents
Oral soft tissue examination including edentulous maxillary arch
Denture cleansing
Mandibular denture stabilization (with adhesive, if deemed to be necessary to 
ensure accurate bite force measures; at the discretion of the Investigator)
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Three incisal bite force readings with no adhesive on the upper denture (for 
practice)
Incisal bite force with no adhesive on the upper denture (pre-treatment 
“baseline”)
Subject eligibility
Adverse events and incident reporting (assessed pre bite force measurement)
Continued eligibility
Randomisation (Test/Treatment day 1 only)
Weigh maxillary denture prior to adhesive placement.
Product application by site staff to maxillary denture (or no adhesive for the 
no adhesive negative control)
Weigh maxillary denture immediately following adhesive placement (record 
weight difference i.e. weight of adhesive usedto ensure correctdose applied)
Dentures of subjects randomized to a denture adhesive shall be weighed 
before & after adhesive application
Upper denture insertion by subject
Incisal bite force measurements (at 0.5hours prior to product ooze 
questionnaire (Appendix II), followed by1, 3, 6, 9 & 12 hours post adhesive 
application)
Subject evaluation questionnaire (product ooze) 0.5 hourspost adhesive 
application (Appendix II)
Subject sensory questionnaire (flavour, texture and extrusion of the adhesive 
from the tube; Appendix III) immediately following the last (12 hr) bite force 
measure whilst upper denture still retained in the mouth
Removal of denture from the mouth by the subject
Denture adhesive retention questionnaire completed by Examiner/ site staff
Removal of excessadhesive from the mouth by the subject facilitated by site 
study staff as and where necessary
Subject denture removal questionnaire (Appendix IV) immediately following 
12 hour post adhesive application bite force measure, completion of subject 
sensory questionnaire and subsequent removal of the upper denture
Study Staff to check denture removal questionnaire completion to ensure that 
any AEs which have been noted in the questionnaire free text is reviewed and 
captured in the eCRF before the subjects leave
Post-treatment oral soft tissue examination by a blinded examiner
Dentures cleaned and returned to subject
Adverse events and incident reporting (assessed post bite force measurement)
There will be at least 24 hours (up to 14days) between subsequent treatment days to 
allow recovery from the bite force procedures.
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Type and Planned Number of Subjects
Approximately 25subjects will be screened to randomize approximately 21subjects 
to ensure that approximately 18evaluable subjects complete the study.
Diagnosis and Main Criteria for Inclusion
Healthy male and female subjects, aged between 18 to 85 yearsof age, selected from 
the TKLResearch volunteer database. Subjects must have a completely edentulous 
maxilla restored with well to moderately well fitting and well made conventional full 
maxillary denture and a maxillary incisal bite force (without adhesive) that is less 
than or equal to 9 pounds (lbs), at the Screening Visit.
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Product Information
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Test Product 1 Test Product 2
Reference 
Product 
Negative 
Control
Product 
Name 
Test adhesive 1
with a thin 
nozzle
Test adhesive 2
withathin 
nozzle
Super 
Poligrip® Free 
Adhesive 
Cream(USA 
marketplace)
No adhesive
Product 
Formulation 
Code (MFC)
N/A
Dose
Continuous 
strips applied 
to upper 
denture as per 
the application 
instructions
Continuous 
strips applied 
to upper 
denture as per 
the application 
instructions
3 dabs for 
upper denture
as per the 
product label 
application 
instructions
N/A
Route of 
Administrat
ion
Oral topical
Oral topical
Oral topical
N/A
Dosing 
Instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the application 
instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the application 
instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the product 
label 
application 
instructions
N/A
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Statistical Methods
The Area Over Baseline (AOB) over 12 hours for the incisal bite force (lbs) (denoted 
by AOB0-12) is the primary efficacy variable. To calculate this variable first the Area 
Under the Curve (AUC) is calculated from 0 to 12 hours (AUC
0-12) using the 
trapezoid method. AOB
0-12will be calculatedas (AUC
0-12)/12 minus baseline bite 
force (lbs). An Analysis of Covariance (ANCOVA) model will be used to analyse 
AOB0-12, with treatment and period as fixed effects; the covariates in this model are 
the subject level baseline and period level baseline minus subject level baseline. 
Subject will be included as a random effect.
If statistical significance is not obtainedfor at least onetest adhesive vs no adhesive
then the study validity will be evaluated by comparing Super Poligrip®Free vs no 
adhesive.
AOB for 0.5, 1, 3, 6 and 9 hours will be defined and analysed in a similar manner as 
AOB0-12.
Subject questionnaire and denture adhesive weight data will be summarized using 
summary statisticsonly and no formal statistical analyses will be performed.
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1. INTRODUCTION
Denture adhesives or fixatives have been used by edentulous patients to improve the 
retention and stability of denturesfor many years. 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 & Fenton 2013). 
There are a number of recognized methods which have been used to demonstrate the 
effectiveness of a denture adhesive. These include the Kapur Index (Kapur et al. 
1967) and bite force until denture dislodgement (Howell et al. 1948) to measure 
denture retention and stability, denture dislodgement (Tarbet et al. 1980) to measure 
denture movement in function, and masticatory performance (Kapur et al. 1967) an 
indicator of chewing efficiency. This study investigates bite force as a measurement 
of retention of the maxillary denture. 
The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle 
bite force study is to compare bite force measurements over a 12 hour period across 
two newly formulated (test) cream denture adhesives based on a new polymer
technology, with a currently marketed cream denture adhesive (positive control), and 
a negative/no treatment control. Thetest products comprise 2 new denture adhesive 
formulations that are based on a new water insoluble and heat-resistant polyvinyl 
acetate (PVA) polymer based formulation with a new solvent system to try to achieve 
better complete denturehold and food sealing. Super Poligrip®Free, a commercially 
available denture adhesive product marketed by GSKCH in the United States (US), 
will be used as the positive control. A short questionnaire regarding the flavor and 
texture characteristics of each denture adhesive after a single use will also be 
administered to give anindication of subject satisfaction of these attributes.
In this study, a bite force transducer system will be used to measure incisal bite force 
until denture dislodgement of maxillary complete dentures. Subjects in this study will 
have dentures judged to be clinically and acceptable/moderately well fitting using the 
Kapur criteria that was modified by Olshan et al. in 1992. Dentures will also be 
judged to be well made using the design and construction criteria used previously 
(GSK studies 
). Bite force measurements will be 
taken over a 12-hour time period to compare the strength of the two test adhesives 
over time against the positive control adhesive over time with the aim of 
demonstrating a statistically significant difference, and to compare the three denture 
                                               
®Super Poligrip Free is a registered trademark of GlaxoSmithKline Consumer Healthcare, LLC.
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adhesives to bite force readings (Area over the Baseline) taken without the use of 
adhesive. 
Studies using bite force as a clinical model have routinely utilized a sample size of 
35-50 subjects with clinically poor (Kapur et al. 1967) maxillary dentures. In this 
population, the bite force clinical model has been used successfully to demonstrate 
that cream denture adhesives improve denture hold for 12 hours and to also 
demonstrate differences in strength among various adhesive formulations. The dental 
literature also contains a number of studies that indicate benefits for other brands or 
formulationsof denture adhesive in well fitting dentures (Chew et al. 1984, 1985, 
Grasso et al. 2004). 
Previous GSK studies (
) with sample 
sizes of 22-45 subjects have demonstrated that statistically significant increases in 
bite force can be achieved with well-fitting and well-made dentures one hour after the 
application of denture adhesives and denture powders. GSK only promotes the use of 
denture adhesives in well-fitting dentures. Hence in this study, subjects with 
moderately well-fitting dentures will be the test population. 
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2. OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary
To compare incisal bite force for test 
adhesive 1 versus no adhesive after 12 
hours.
AOB at 12 hours.
To compare incisal bite force for test 
adhesive 2 versus no adhesive after 12 
hours.
AOB at 12 hours.
Secondary
To compare incisal bite force for test 
adhesive 1 versus Super Poligrip
®Free 
after 12 hours.
AOB at 12 hours.
To compare incisal bite force for test 
adhesive 2 versus Super Poligrip
®Free 
after 12 hours.
AOB at 12 hours.
To compare incisal bite force between 
test adhesives 1 & 2 after 12 hours.
AOB at 12 hours.
Other
To compare incisal bite force fortest 
adhesive 1 versus no adhesive over 9 
hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 2 versus no adhesive over 9 
hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 1 versus Super Poligrip®Free 
over 9 hours.
AOB at 0.5, 1, 3, 6 and 9 hours.
To compare incisal bite force for test 
adhesive 2 versus Super Poligrip
®Free 
over 9 hours.
AOB at 0.5, 1, 3, 6 and 9 hours
To assess subjects’ preference with 
regards to denture adhesive ooze, flavor/ 
after-taste, texture and assess ease of 
removal
Scores from subject-completed 
questionnaires on product ooze, at 0.5 
hours, and flavour/ after-taste, texture and 
ease of removal after 12 hours’ use
To assess the ease of extrusion of the 
product from the tube by the subjects 
post bite force phase
Scores from subject-completed 
questionnaire on product extrusion after 
12 hours’ use
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3. STUDY PLAN
3.1. Study Design
Overall Design
This single centre, randomized, crossover, proof-of-principle study will be a 
randomized four treatment, examiner blind [to the examiner performing the bite force 
& oral soft tissue (OST) examinations] design in subjects with well made and 
moderately well-fitting maxillary complete dentures. Informed consent will be 
obtainedfrom participants before the implementation of any study procedure. 
At the Screening Visit, subjects will be screened for eligibility and ability to perform 
the bite force manoeuvre according to stated inclusion/exclusion criteria. On the test 
day visit, subjects will report to the study site without adhesive placed in their 
dentures. Dentures will be removed and cleaned. An OST examination will be 
performed before the lower denture (if applicable) is secured using Super Poligrip
®
Flavour Free denture adhesive, whilst the upper denture is removed, and the pre-
treatment baseline incisal bite force measurements will be obtained (both practice 
bites and qualifying test bite). To maintain blinding, subjects must not disclose to the 
examiner if they are wearing adhesive or no adhesive. Subjects meeting all the 
inclusion criteria with no exclusions will then be randomized at Visit 2. 
On each test day (Visits 2-5) subjects will undergo an OST examination and have 
their dentures cleaned. Denture adhesive treatment (or no treatment as per the 
randomization schedule) will then be applied by a member of study staff (ideally the 
same member of staff throughout the study) as per the application instructions, and 
the dentures worn by the subject. Incisal bite force measurements will be made at 0.5, 
1, 3, 6, 9 and 12 hours after the dentures are placed in the mouth. After 0.5 hours 
assessment the subjects will be asked to complete questions about product ooze 
(Appendix II). The questions will be completed by the subjects themselves and these 
responses will then be given to study site staff to transfer to the eCRF. 
Immediately following the last (12 hour) incisal bite force measurement, subjects will 
be asked to complete a short questionnaire relating to the after-tasteand texture of the 
denture adhesive (Appendix III). This will be completed by the subject themselves in 
a quiet environment without external influence. 
Immediately following subsequent upper denture removal by the subjects themselves, 
subjects will be asked to answer another short questionnaire (which will be 
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administered by the site staff; Appendix IV) pertaining to ease of removal of the 
denture when undertaking the treatment phases of the study, but not the negative no 
treatment control arm. The subjects will remove their dentures by themselves under 
supervision by site staff. Following denture removal, and completion of the 
associated questionnaire, site staff will clean the denture before returning to the 
patient at the end of the study. 
These assessments will be followed by the final post-treatment OST examination.
These procedures will be repeated in a crossover manner. There will be at least 24 
hours (up to 14days) between treatment visits to allow recovery from the bite force 
procedures.
Visit 1 -Screening Visit
The following assessments will be conductedin the order written:
Written informed consent.
Demographics, medical history, current/concomitant medications, and dental 
history.
Criteria for well made dentures
Inclusion/exclusion criteria
Oral soft tissue examination including edentulous maxillary arch
Denture bearing tissue score
Kapur Index assessment
Denture cleansing
Mandibular denture stabilization (with adhesive, if deemed to be necessary to 
ensure accurate bite force measures; atthe discretion of the Investigator)
Three incisal bite force readings with no adhesive on upper denture (for 
training)
Incisal bite force with no adhesive on the upper denture (qualifying)
Inclusion/exclusion criteria (following initial bite force measures)
Subject eligibility
Adverse events and incident reporting (assessed from the OST 
EXAMINATION AT SCREENINGstart of the first bite force 
measurement)
Visits 2, 3, 4 & 5
The following assessments will be conducted:
Review of current/concomitant medications, adverse events and incidents
Oral soft tissue examination including edentulous maxillary arch
Denture cleansing
Mandibular denture stabilization (with adhesive, if deemed to be necessary to 
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ensure accurate bite force measures; at the discretion of theInvestigator)
Three incisal bite force readings with no adhesive on the upper denture (for 
practice)
Incisal bite force with no adhesive on the upper denture (pre-treatment 
“baseline”)
Subject eligibility
Adverse events and incident reporting (assessed pre bite force measurement)
Continued eligibility
Randomisation (Test/Treatment day 1 only)
Weigh maxillary denture prior to adhesive placement
Product application by site staff to maxillary denture (or no adhesive for the 
no adhesive negative control)
Weigh maxillary denture immediately following adhesive placement (record 
weight difference i.e. weight of adhesive usedto ensure correct dose applied)
Dentures of subjects randomized to a denture adhesive shall be weighed 
before & after adhesive application
Upper denture insertion by subject
Incisal bite force measurements (at 0.5hours prior to product ooze 
questionnaire (Appendix II), followed by1, 3, 6, 9 & 12 hours post adhesive 
application)
Subject evaluation questionnaire (product ooze) 0.5 hourspost adhesive 
application (Appendix II)
Subject sensory questionnaire (flavour, texture and extrusion of the adhesive 
from the tube; Appendix III) immediately following the last (12 hr) bite force 
measure whilst upper denture still retained in the mouth
Removal of denture from the mouth by the subject
Denture adhesive retention questionnaire completed by Examiner/ site staff
Removal of excess adhesive from the mouth by the subject facilitated by site 
study staff as and where necessary
Subject denture removal questionnaire (Appendix IV) immediately following 
12 hour post adhesive application bite force measure, completion of subject 
sensory questionnaire and subsequent removal of the upper denture
Study Staff to check denture removal questionnaire completion to ensure that 
any potential AEs whichmayhave been noted in the questionnaire free text is 
reviewed and capturedin the eCRF before the subjectleaves the site
Post-treatment OSTby a blinded examiner
Dentures cleaned and returned to subject
Adverse events and incident reporting (assessed post bite force measurement)
There will be at least 24 hours (up to 14days) between subsequent treatment days to 
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allow recovery from the bite force procedures.
3.2. Subject Restrictions
Lifestyle/ Dietary
During the entire study (screening to LSLV):
Subjects will be instructed to report to the clinic on the treatmentvisit days 
without the presence of denture adhesive in either their maxillary or 
mandibular denture.
Subjects will be required to remain on site for the duration of the treatment
visit day. Standardized meals will be provided.
On the test days, subjects’ intake of hot & cold liquids will be restricted.
Smoking, including e-cigarettes and the use of chewing tobacco or other 
tobacco products are prohibited for the duration of screening and on each test 
day.
If subjects were using denture adhesives to stabilize their dentures, then they 
can continue using the denture adhesives during the washout periods between 
treatment visitsonly, but they cannot change it during the course of the study.
Subjects should not consume any food or liquid an hour before the treatment
visit. Subjects can consume small sips of water for medications. 
Subjects are not permitted to chew gum throughout the study. 
Medications and Treatments
During the entire study (screening to LSLV):
The details of current and concomitant medications will be collected and 
subjects will be allowed to participate if these medications are judged to be 
non-interfering by the investigator. 
Subjects will not bepermitted to have any dental/denture work performed 
during the time that they are in the study, unless discussed and permitted by 
the examiner. This is to assure that the denture fit will not be altered during 
the study.  
3.3. Type and Planned Number of Subjects
Approximately 25subjects will be screened to randomizeapproximately21subjects 
to ensure that approximately 18evaluable subjects complete the study.
3.4. Study Design and Dose Justification
Dentures are unique to each individual. Therefore, the most efficient approach to 
evaluating their performance with different adhesives or ‘no adhesive’ is a within 
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subject comparison (i.e. a crossover design). A crossover design has been chosen 
because bite force measurements have high inter-subject variation; the crossover 
design will allow each subject to act as their own control. 
Incisal bite forceuntil denture dislodgementis a measure of maxillary denture 
retention and is a recognized objective test method that has been used to demonstrate 
the efficacy of denture adhesives. 
A screening bite force will be taken to allow subjects to train in how to bite in a 
consistent manner for bite force technique and to allow the examiner to establish 
whether subjects understand and are able to conduct the necessary manoeuvres. 
Baseline bite force will be taken on each test day to allow the subjects to train and 
practice the bite force technique at each visit. 
To minimize the possibility of carryover effects from study treatments or procedures, 
a washout period ofat least 24 hours has been scheduled between each treatment 
visit. 
The study will be blinded with respect to the dental examiner performing the bite 
force measures and OST examination in order to reduce the risk of bias. The subjects 
will not be blinded to the study treatments and will be instructed not to disclose their 
treatment to the examiner. 
Super Poligrip®Free has been selected as the positive control adhesive in this study 
as it is a currently marketed and a representative denture adhesive of the denture 
adhesive market. The test adhesives in this study are experimental formulations –
inclusion of these test adhesives will enable assessment of difference against a 
currently marketed, representative denture adhesive to assess whetherthese adhesives 
are suitable candidates to progress for further investigation. 
The dosing regimenwill be consistent with the product application instructions in the 
case of the marketed positive control, and consistent with product design and 
consumer habit for the experimental test adhesives. Denture adhesives are only 
promoted and recommended in well-fitting dentures, and therefore only well-fitting 
dentures are permitted for inclusion in this study. 
A no adhesive negative control arm has been chosen to provide a continual reference 
point of no adhesive use over the 12 hour period. This should allow interpretation of 
the results of this study with previous work, and is representative of a significant 
number of denture wearers who currently do not use an adhesive. Use of the no 
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adhesive control will allow for variation in bite force technique over the test period, 
and enables Area over Baseline (AOB) comparison of the positive and negative 
controls over the 12 hour period. 
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA
Specific information regarding warnings, precautions, contraindications, adverse 
events, and other pertinent information on the GSK investigational product or other 
study treatment that may impact subject eligibility is provided in the product label.
Deviations from inclusion and exclusion criteria are not allowed because they can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability or 
subject safety. Therefore, adherence to the criteria as specified in the protocol is 
essential.
4.1. Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria 
apply:

1. CONSENT
Demonstrates understanding of the study procedures, restrictions and willingness to 
participate as evidenced by voluntary written informed consent and has received a 
signed and dated copy of the informedconsent form. 
2. AGE
Aged between18 to 85 years.
3. GENERAL HEALTH
Good general and mental health with, in the opinion of the investigator or medically 
qualified designee:
a.No clinically significant and relevant abnormalities in medical history or upon 
oral examination.
b.Absence of any condition that could affect the subject’s safety or wellbeing or 
their ability to understand and follow study procedures and requirements.
4. DIAGNOSIS
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a. Completely edentulous maxillary arch restored with a conventional full 
acrylic based upper complete denture.
b. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous 
arch may be restored with a stable complete, partial or implant supported 
denture. 
c. Maxillary dentures must be considered to be moderately well-fitting at the 
screening visit (Kapur Index, Olshan Modification: retention score >2, 
stability score >2).
d. Maxillary dentures and mandibular dentures, if present, must be considered to 
be well-made based on design and construction criteria specified in the 
protocol.
e. The qualifying maxillary incisal bite force readings (without adhesive) must 
be less than or equal to 9 pounds at the Screening Visit and subsequent visit 
pre-treatment baseline bites.
f. At least 2 of the 4 qualifying bite readings at the Screening Visit must be 
reproducible (+2lb). At subsequent visits the bite force readings must be 
within +2lb for 1 of the 3 practice bites and the pre-treatment baseline bite. 
5. COMPLIANCE
Understands and is willing, able and likely to comply with all study procedures and 
restrictions.
4.2. Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria 
apply:
1. PREGNANCY
A woman who isknown to be pregnant or who isintending to become pregnant (self 
reported) over the duration of the study.
2. BREAST-FEEDING
A woman who isbreast-feeding.
3. CONCURRENT MEDICATION/ MEDICAL HISTORY
a. Implanted with a cardiac pacemaker.
b. Daily doses of medication that might interfere with the ability to perform the 
study according to protocol (as determined by the Investigator).
c. Taking or have taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, 
Boniva®) for treatment of osteoporosis.
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d. A serious chronic disease requiring hospitalization..
e. Any condition not previously mentioned that in the Investigator’s opinion may 
impair the study evaluation.
4. ALLERGY/ INTOLERANCE
Known or suspected intolerance or hypersensitivity to the study materials (or closely 
related compounds) or any of their stated ingredients.
5. DENTAL HEALTH / ORAL CONDITIONS
a. Any clinically significant or relevant oral abnormality (e.g. temporo-
mandibular joint [TMJ] problems) that, in the opinion of the investigator, 
could affect the subject’s participation in the study.
b. Any subject clinically identified as having an incisal bite relation which could 
affect the bite force measurements.
c. Severe dry mouth that may affect denture retention in the opinion of the 
Investigator. 
d. OST examination findings such as stomatitis, open sores, lesions, redness or 
swellingthat, in the opinion of the investigator, could affect the subject’s 
participation in the study. 
6. CLINICAL STUDY/ EXPERMENTAL PRODUCT
a. Participationin another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30days of the screening visit.
b. Previous participation in this study.
7. SUBSTANCE ABUSE
Recent history (within the last year) of alcohol or other substance abuse.
8. LIFESTYLE
A subject who isunwilling to refrain from smoking, including e-cigarettes and the use 
of chewing tobacco or other tobacco products for the duration of screening and each 
treatmentday (12-14 hours).
9. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family.
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4.3. Screening/ Baseline Failures
Screen failures are defined as subjects who consent to participate in the study but are 
never subsequently randomized.  In order to ensure transparent reporting of screen 
failure subjects, a minimal set of screen failure information is required including 
Demography, Screen Failure details, Eligibility Criteria, and any Serious Adverse 
Events. Re-screening of subjects will not beallowed in this study.
4.4. Withdrawal/ Stopping Criteria
A subject may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioural or 
administrative reasons.
If the reason for removal of a subject from the study is an AE or an abnormal 
laboratory test result, the principal specific event or test will be recorded on the 
electronic case report form (CRF).  If a subject is withdrawn from the study because 
of a product limiting AE, thorough efforts should be clearly made to document the 
outcome. Any AEs ongoing at the final visit will be followed up until resolved, the 
condition stabilizes, is otherwise explained, or the subject is lost to follow-up.
The following actions must be taken in relation to a subject who fails to attend the 
clinic for a required study visit:
The site must attempt to contact the subject and re-schedule the missed visit as 
soon as possible. 
The site must 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. 
In cases where the subject is deemed ‘lost to follow up’, the investigator or 
designee must make every effort to regain contact with the subject (where 
possible, at least2 telephone calls). The contact attempt should be 
documented in the subject’s record. 
Should the subject continue to be unreachable, only then will he/she be 
considered to have withdrawn from the study with a primary reason of “Lost 
to Follow-up”.
4.5. Subject Replacement
Subjects who withdraw from the study post-randomization will not be replaced.
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4.6. Subject and Study Completion
A completed subject is one who has completed all phases of the study including the 
follow-up visit.
The end of the study is defined as the date of the last subject’s last visit.
5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Test Product 1 Test Product 2
Reference 
Product 
Negative 
Control
Product 
Name 
Test adhesive 1
with a thin 
nozzle
Test adhesive 2
with a thin 
nozzle
Super 
Poligrip® Free 
Adhesive 
Cream(USA 
marketplace)
No adhesive
Product 
Formulation 
Code (MFC)
N/A
Dose
Continuous 
strips applied 
to upper 
denture as per 
the application 
instructions
Continuous 
strips applied 
to upper 
denture as per 
the application 
instructions
3 dabs for 
upper denture 
as per the 
product label 
application 
instructions
N/A
Route of 
Administrat
ion
Oral topical
Oral topical
Oral topical
N/A
Dosing 
Instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the application 
instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the application 
instructions
applied to clean 
dry denture fit 
surface in a 
pattern 
consistent with 
the product 
label 
application 
instructions
N/A
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Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Super Poligrip® Free Adhesive Cream
(USA marketplace)
To stabilize the lower denture (apply 2 
dabs to the lower denture [if required]; 
sufficient to retain the lower denture) as 
per the product label instructions
Oral B
®Denture brushes
Standard brush to brush dentures
Polident®Dentu Crème Denture 
Cleansing Paste (USA)
Cleaning of dentures (adhesive removal)
Reprosil medium body impression 
material and mixer tips
Ancillary supplies to aid with study 
conduct
Nitrile Finger Cots
Covering transducer prongs
Kimtech Wipes
Assorted use
Small and Large Anti-Static Weighing 
Boats
Weighing and transporting dentures
Spatulas (Square Tips)
Spreading dental caulk on transducer 
prong
Nitrile Gloves(these may be supplied by 
the clinical site)
Covering hands
The site willsupply Disposable Barrier Sleeves -to cover the transducer. 
Alltest denture adhesivetubes, and the positive control adhesive, will be 
overwrapped and then labelled. The Super Poligrip®Free Denture Adhesive Cream 
will be supplied in its commercial tube. Samples will be overwrapped so as not to 
potentially bias subject response on the ‘extrudability’ question following bite force 
measures (question 6; Appendix III). A study label will be affixed to each tube.
All sundry items will be supplied in commercial packaging to be distributed by site 
staff as required throughout the study duration. 
Care should be taken with the supplied study 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 during the ‘extrudability’ question followingbite force 
measures (question 6; Appendix III). 
The site will provide paper copies ofany study instructions and questionnaires. 
                                               
®Oral B is a registered trademark of Procter & Gamble.
®Polident Dentu Crème is a registered trademark of GlaxoSmithKline Consumer Healthcare, LLC.
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5.2. Dose Schedule
The dentureadhesiveswill be appliedby the Site Study Staffto a clean and dryupper 
completedenture following the pre-treatment baseline bite force measurement in 
accordance with the product Application Instructions (Appendix V & VI). 
For adhesive test arms: A total of 1+0.05 gram (weighed) of denture adhesive will be 
applied to the dry maxillary denture in a pattern consistent with the product labeland 
application instructions (Appendix V & VI). For all subjects in all arms: Super 
Poligrip® Free denture adhesive cream will be applied to the dry mandibular denture 
(if applicable) in a pattern consistent with the instructions on the product label. 
Clean and dry upper complete dentures will be weighed and their masses recorded 
prior to and immediately following adhesive application for all products. The masses 
of the adhesives used will be calculated as the difference in the recorded masses pre-
and post-adhesive application.
All application of denture adhesive should be made in an area not accessible by the 
examiner performing the bite force and OST (safety) assessment in order to ensure 
that the examiners remain blind. The denture will then be returned to the subject who 
should repositionthe denture in their mouth. For subjects on the “no adhesive” 
treatment visit, the denture should be cleaned and dried as above, and then refitted by 
the subject, no weighing of the denture is necessary. 
Asstabilisation of the lower denture is necessaryfor accurate Bite Force 
measurements to be performed, reapplication of denture adhesive (to the lower 
denture only) may be performed up to a maximum of 2 times is acceptable on any 
given test dayprovided that; (1) the investigator deems it necessary for Bite Force
measurements (2) the subject has been compliant with the protocol and has not 
actively washed the adhesive out. 
5.3. Dose Modification
No dose modification is permitted in this study.
5.4. Product Compliance
The adhesive will be applied to dentures by one member of the study staff therefore 
excellent compliance is anticipated. 
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5.5. Precautions
No precautions will be necessary as product will be applied professionally as per 
marketed product label and the test denture adhesive application instructions
(Appendix V & VI). 
5.6.Overdose
An overdose is a deliberate or inadvertent administration of a product at a dose higher 
than specified in the protocol.
Overdose is not likely to occur in this studyas product will be applied by a single 
member of staff.  Limited quantities of the product will be supplied, and closely 
monitored by the site for each subject.
Overdose per se is not an AE.  However, any clinical sequelae of an overdose should 
be reported as an AE (and serious adverse event (SAE), if appropriate).  For 
reporting, follow the AE and SAEreporting instructions.
5.7. Rescue Therapy
No rescue therapy is required in this study.
5.8. Product Assignment
Subjects will be assigned to a specificstudyproduct order. Subjects will use each of 
the study products using this pre-determined randomised schedule. The 
randomization schedule will be generated by the Biostatistics Department, GSKCH, 
prior to the start of the study, using a validated internal procedure.
5.8.1Randomization
A unique screening number will identify each subject screened for study 
participation.  Screening numbers will be assigned in ascending numerical order as 
each subject signs their consent form.  Subjects who meet all inclusion and exclusion 
criteria will be randomized according to the randomization schedule.  Randomization 
numbers will be assigned in ascending numerical order as each subject is determined 
to be fully eligible.
The randomization schedule will indicate the treatment order sequence; one of the
fourtreatmentsto be used for each of the fourtreatment periods. Thisrandomisation 
will use a Williams Square layout and be provided by the BiostatisticsDepartment, 
GSKCH. The study site will receive two randomization schedules, one with treatment 
de-codes and one without. Theschedule without the treatment decodes will be used to 
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dispense study treatments to the subjects and the schedulewith treatment decodes will 
be provided in a sealed envelope and will be available foremergency use only.
5.8.2Blinding
The examiner, the study statistician and other employees of the Sponsor who may 
influence study outcomes are blinded to the product allocation of subjects. All study 
staff other than the member of Site Study Staffapplying treatment will be blinded. 
The treatments will be applied and the denture will be fitted to the subject’s mouth in 
a secluded area to preserve the blinding. The subject will be instructed not to disclose 
to the examiner whether or not treatment was applied.Access to aspects of the eCRF 
that are considered at risk of unblinding will be restricted where required in order to 
maintain study blinding. 
5.8.3Code Breaks
The blind must only be broken in an emergency where it is essential to know which 
product a subject received in order to give the appropriate medical care.  Wherever 
possible the Investigator (or designee) must contact the Sponsor prior to breaking the 
blind.  The investigator must document the reason for breaking the code and sign and 
date the appropriate document.
At the end of the study, this sealed randomization envelope with treatment decodes 
will be returned to the study sponsor.
5.9. Packaging and Labelling
The contents of the label will be in accordance with all applicable regulatory 
requirements and will be the responsibility of the Clinical Supplies Department, 
GSKCH.
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.
Each study label will contain, but not be limited to, protocol number, product code 
letter (for treatment products only), directions for storage, emergency contact 
telephone number and “For Clinical Trial Use Only”. In addition, the USA device 
warning “Caution: Investigational Device –Limited by Federal (or United States) 
Law to Investigational Use” will also be included on all labels.
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5.9.1. Accountability of Product
All products supplied are for use only in this clinical study and should not be used for 
any other purpose.
The investigator or designee will maintain a full record of study product 
accountability. A Product Dispensing Log must be kept current and will contain the 
following information:
The identification of the subject to whom the study product was dispensed.
The date(s) and quantity of the study product dispensed to the subject.
The date(s) and quantity of the study product returned by the subject (if 
applicable).
The inventory must be available for inspection by the study monitor during the study. 
At the end of the study, study product supplies will be verified by the monitor.  Study
 
product supplies will then be either collected by the study monitor or returned by the 
investigator or designee to the GSKCH Clinical Supplies Department or designated 
vendor.
5.9.2. Storageof Product
Study product supplies must be stored in compliance with the label requirements in a 
secure place with limited or controlled access.
6. STUDY ASSESSMENTS AND PROCEDURES
This section lists the procedures and parameters of each planned study assessment.  
The exact timing of each assessment is listed in the Schedule of Events section.
Adherence to the study design requirements, including all assessments and 
procedures are essential and required for study conduct.
6.1. Visit 1 -Screening Visit
6.1.1 Telephone Screening
Prior to the screening visit, telephone screening of interested subjects maybe 
conducted using a telephone script. This will be conducted by the site recruitment 
staff or designee.  
6.1.2. Informed Consent
The investigator, or designee, must obtain written (signed and dated by the subject) 
informed from each subject participating in this study after adequate explanation of 
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the aims, methods, objectives, and potential hazards of the study. 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 any time. Appropriate forms for documenting 
written consent will be provided by the investigator or by GSKCH.  The investigator, 
or designee, should sign and date the consent form to confirm that the consent process 
was completed correctly.  The subject will be provided with a copy of their signed 
and dated consent form and any other written information which they should be 
instructed to retain.
If, during a subject’s participation in the study, any newinformation 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. Subjects should be provided with a copy of the signed and dated 
amended consent form.
6.1.3. Demographics
The Investigator, or designee, will record each subject
's year of birth, gender and 
race.In accordance with FDA guidelines (Guidance for Industry: Collection of Race 
and Ethnicity Data in Clinical Trials, 2005, FDA) the ethnicity of subjects will also be 
captured. 
6.1.4. Medical History and Concomitant Medication
For each subject, the medical history will be taken and reviewed by the Investigator 
or medically qualified designee.Details of any relevant medical or surgical history, 
including allergies or drug sensitivity, will be recordedin the CRF.  Any concomitant 
therapy taken in the 30 days prior to the Screening Visit and throughout the study will 
also be recordedin theCRF.
6.1.5. DentalHistory
The Investigator, or medically qualified designee, will take a dental history from each 
subject and recorded in the CRF.  Dental history will include information of all 
prostheses in the mouth, maxillary and mandibulary, as well as information regarding 
the age of the dentures,andhow long the subject has worn dentures.  Documentation 
of prosthetic teeth material will also be recorded by the Investigatorin the CRF.
6.1.6. Well-Made Denture Assessment
The examiner will examineeach subject’s denture in the maxilla and mandible (if 
present) to determine if he/she considers it to be well made i.e.:
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Denture(s) has adequate vertical dimension, freeway space, horizontal 
occlusal relationships and border extension
Denture(s) has acceptable contour and finish
Denture(s) has acceptable porosity, tissue surfaces, polished surfaces, color 
and thickness.
For each denture, maxillary and mandibular, if present, the examiner will identify 
from what material it is made and indicate acceptable or unacceptable on the CRF.
6.1.7. OSTExamination –Edentulous
The OST Exam-Edentulous will include the maxillary mucogingival fold, maxillary 
edentulous gingival mucosa, maxillary hard palate, mandibular mucogingival fold, 
mandibular edentulous gingivalmucosa (if applicable), gingival mucosa (if 
applicable), labial mucosa (including lips), buccal mucosa, tongue, sublingual area, 
soft palate, 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.  Adverse eventswill be assessed from the first 
OST examination at screening. 
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.
6.1.8. Denture Bearing Tissue Score
The denture bearing tissue score (Kapur 1967) will be assessed by the investigator 
and recorded for the maxillarydenture only on the appropriate CRF.  There are no 
eligibility requirements associated with this measure in this bite force trial.
* Note, for completeness, 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.   
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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   *
6.1.9. Kapur (Olshan Modification) Denture Retention & Stability 
Assessment
At the screening visit, the examiner will determine the subject’s denture retention and 
stability scoreand it will be recorded in the CRF.  
Retention Criteria
With gloved hands, the examiner will attempt to unseat the maxillary complete
denture by applying an opposing vertical force at the canine/lateral incisor region of 
the denture.  The examiner will score retentionas 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
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0= No retention-when the denture is seated in place, it displaces itself 
Stability Criteria
With gloved hands, the examiner will attempt to rock the seated dentures by placing 
alternate horizontal force at the cuspid and contralateral molar regions of the 
maxillary complete dentures.  The examiner will score denturestabilityas 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
Following completion of informed consent (section 6.1.2), medical history/ 
concomitant medication (section 6.1.4), dental history (section 6.1.5), well-made 
denture assessment (section 6.1.6), OST examination (section 6.1.7) and Kapur index/ 
assessment (section 6.1.9), subject inclusion/ exclusion will be determined as per the 
inclusion/ exclusioncriteria (section 4). 
6.1.10. Denture cleansing
Dentures should be removed from the mouthby the subject. Denture cleansing should 
be performed by suitably qualified site staff. Enough denture cleansing paste will be 
applied to the supplied denture brush. Holding the upper (and lower where necessary) 
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 prior to 
denture adhesive application. 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. 
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6.1.11. Mandibular Denture Stabilisation
Prior to all bite force measures, if deemed necessary at the discretion of the 
Investigator in order to ensure accuracy of bite force measures, any lower denture 
(partial or complete) willbe fully stabilized by the investigator using the positive 
control denture adhesive (Super Poligrip® Free Adhesive Cream). This will be 
completed, when necessary, for all screening, practice, training and test bite force 
measurements.
6.1.12. Bite Force Measures prior to and at Screening
A bite force transducer system will be supplied by GSKCH and used to measure 
incisal bite force needed to dislodgethe maxillary denture.  The transducer system is 
composed of two plates embedded with a strain gauge that measures displacement of 
the upper denture during biting.  
Each subject will have their bite force assessments with the same examiner. In this 
way inter-examiner variability will be minimized.Bite force data will be recorded on 
the appropriate CRF page.
6.1.13. Bite Force Calibration
The bite force device will be calibrated using appropriate software or through the 
application of incremental forces to the transducer by GSKCH’s external vendor 
Specialty Measurements Incorporated (SMI), in agreement with GSK staff and the 
investigator prior to commencing the study.  A Certificate of Calibration (which lasts 
for 12 months) will be provided before the start of the study and filed within the site’s 
Regulatory Binder and the Study Master File.
6.1.14. Bite Force Measures at Screening
At Screening, subjects will have any denture adhesive on their denture removed. A 
member of site staff (trained in bite force procedures)willinstruct thesubjects in the 
execution of the bite force procedure participation.The subject will be instructed to 
sit and hold his/her head in a natural position so that the occlusal plane is parallel to 
the floor.  The examiner will stand or sit in front of the subject holding the bite force 
transducer parallel to the floor at a comfortable level for the subject.  In order to 
facilitate insertion the examiner may angle the bite force plates for certain subjects as 
necessary.  The examiner will prevent cross contamination by placing a clean finger 
cot over the bite force plates for each subject in addition to a clean infection control 
sleeve over the transducer hand piece. The examiner will insert the bite force plates 
into the subject’s mouth, which may be customized using impression materialin 
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order to facilitate anterior denture tooth placement on the bite force transducer.  The 
examiner will instruct the subject to swallow, and then ensure that the muscles of 
mastication are relaxed.  The examiner will signal the subject to bite until he/she feels 
movement on the maxillary denture at which time he/she will be instructed to release 
the bite plate.  If, in the opinion of the examiner, the subject will be unable to 
successfully complete the required bite force system training tasks, the subject will be 
withdrawn from the study.
During the Screening Visit, the examiner will record a triplicate bite force 
measurement at pre-treatment baseline without denture adhesive.  These will be 
referred to as “training bites” on the CRF as the subject becomes accustomed to the 
equipment.  Four (4) further bites will be made; 2 of these 4 ‘qualifying’ bites must 
be reproducible (±2lb) for a subject to be eligible to the study.  All 4 of the 
“qualifying” bites must be less than or equal to 9 pounds.These will form the subject 
eligibility/ adherence for continuation in the study. 
6.2. Visits2, 3, 4 & 5
6.2.1. OSTExamination -Edentulous
Full OST edentulous assessments will be performed by the investigator twiceduring 
each of the Test Days; at pre-treatment baseline and also at the end of each of the 
Test/TreatmentVisits. OST examinations will be performed as previously outlined in 
Section 6.1.7. 
6.2.2. Denture Adhesive Application to Dentures
Prior to denture adhesive application, Denture Cleansing (Section 6.1.10) will be 
performed as previously described. Denture adhesivewill be applied to the dentures
by a suitably qualified member of site staff (blinded to the investigator collecting 
efficacy measures) as per the Denture Adhesive Application Instructions (Appendix 
V & VI). Upper dentures shall be weighed before and after adhesive application, and 
weights (including weight of adhesive used) recorded in the eCRFto ensure correct 
dose applied (1+0.05 grams). The specific tube used for denture adhesive application 
will be retained for use to assess product extrusion (Appendix III, question 6) to 
prevent the risk of cross-infection. 
6.2.3. Bite Force Measures during TreatmentVisits
Prior to Bite Force measures during each of the treatment visits, Denture Cleansing 
(Section 6.1.10)and Mandibular Denture Stabilisation (Section 6.1.11) will be 
performed as previously described. 
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On eachtreatmentday, the examiner will record triplicate bite force measurements
without denture adhesive.  These three measurements will be referred to as “practice 
bites”, where the goal is to have the subject re-familiarize themselves with the 
system.  The 4
thbite of the series will be captured as the Test Daypre-treatment 
baseline bite force.  Test Day bite force readings must be within (±2 lb) for 1 of the 3 
“practice bites” and the pre-treatment baseline bite.  In addition, only subjects whose 
test day pre-treatment baseline bite force is less than or equal to 9 pounds will be 
eligible to proceed.  If a subject does not meet these criteria at any test day visit they 
will be discontinued entirely from the study. Additionalbite force measures will take 
place 0.5(immediately prior to completion of product ooze questionnaire) followed 
by1, 3, 6, 9 and 12 hoursafter application of each test adhesive (or no treatment as 
per the randomization schedule). 
At each post-adhesive time-point, the subject will swallow and then bite on the 
transducer until the maxillary denture dislodges.  No post adhesive application bite 
force measurements will be made earlier than the specified time and not later than 5 
minutes after the specified time.  Bite force data will be recorded on the appropriate 
CRF.Incidents will be assessed pre-and post-bite force recordings on each of the 
treatment days.  
6.2.4. Subject Questionnaires
These questionnaires will only be completed by the subjects during treatment visits 
where subjects are assigned to adhesive. 
A questionnaire pertaining to product ooze will be completed by the subjects 
immediately after the 0.5 hrs bite force measurement (Appendix II). Furthermore, a 
questionnaire regarding sensory attributes around flavour and texture will be 
completed immediately after completion of the 12 hrs bite force measurement whilst 
the upper denture is still retained in the mouth (Appendix III). Completion of this 
questionnaire will also involve the subject extruding some denture adhesive onto 
paper prior to answering the question regarding ease of product extrusion (question 6; 
Appendix III). A third and final denture removal questionnaire will be completed 
immediately following the 12 hrs bite force measurement, following completion of 
the sensory questionnaire and removal of the upper denture from the mouth by the 
subject (Appendix IV). This final “denture removal questionnaire”(Appendix IV) 
must be reviewed by Study Staff immediately following completion whilst the subject 
is still present, in order to ensure that any potential AEs that may be includedin the 
free text (question 3; Appendix IV)are investigated by Study Staff and captured in 
the eCRF. 
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All questionnaires will be completed by the subjects according to the study schedule
(i.e. when undertaking the treatment, but not the no-treatment negative controlstudy 
arms)in a quiet environment without external influence. Subjects will not be issued a 
questionnaire when completing the ‘no adhesive’ negative control treatment arm. The 
study Investigator(s) (in particular all site study staff involved in the collection of bite 
force and OST data) will remain blinded to the distribution and completion of all 
questionnaires. All questionnaire data will be captured in the eCRF, and will be 
monitored on site in order to ensure that all patient reported outcomes are captured in 
the database, paying particular attention to the free text about denture adhesive likes 
& dislikes (question 2; Appendix IV). 
6.2.4. Study Conclusion
Subjects will be evaluated to determine if they completed all study procedures or if 
they were discontinued from the study early.  If the subject discontinued at any point 
during the study, the primary reason for withdrawal should be recorded on the Study 
Conclusion CRF by selecting one of the options below.
a) Subject did not meet study criteria
b) Adverse Event/ SAE or Incident
c) Lostto Follow Up
d) Protocol Violation
e) Withdrawal of Consent
f) Other
7. SAFETY ASSESSMENTS
7.1. Definitions of an Adverse Event and Serious Adverse Event 
7.1.1. Adverse Events
The investigator or site staff will be responsible for detecting, documenting and 
reporting events that meet the definition of an AE or SAE.
Adverse Event Definition:
An AE is any untoward medical occurrence in a patient or clinical 
investigation subject, temporally associated with the use of an investigational 
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or washout product, whether or not considered related to the investigational or 
washout product.
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 an investigational or 
washout product.
Events meeting AE definition include:
Any abnormal laboratory test results (if applicable) or other safety 
assessments, including those that worsen from baseline, and felt tobe 
clinically significant in the medical and scientific judgment of the 
investigator.
Exacerbation of a chronic or intermittent pre-existing condition including 
either an increase in frequency and/or intensity of the condition.
New condition(s) detected or diagnosed after study product administration 
even though it may have been present prior to the start of the study.
Signs, symptoms, or the clinical sequelae of a suspected 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).
Events NOT meeting definition of an AE include:
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/ condition 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): the condition 
that leads to the procedure is an AE.
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.
7.1.2. Serious Adverse Events
Serious Adverse Event is defined as any untoward medical occurrence that, at 
any dose:
A. Results in death
B. Is life-threatening
NOTE: The term 
'life-threatening
' in the definition of 
'serious
' refers to an 
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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.
C. Requires hospitalization or prolongation of existing hospitalization
NOTE: 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 appropriatein 
the physician’s office or out-patient 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.
D. Results in disability/incapacity
NOTE: The term disabilitymeans 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 or prevent everyday life functions but do not constitute a substantial 
disruption.
E. Is a congenital anomaly/birth defect
F. Other Situations
Medical or scientific judgment should be exercised indeciding 
whether 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 should also be 
considered serious.
Examples of such events are invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, 
blooddyscrasias or convulsions that do not result in hospitalization or 
development of drug dependency or drug abuse or reports of 
spontaneous abortion.
7.2. RecordingAdverse Eventsand Serious Adverse Events
Recording of adverse events and serious adverse events:
The investigator or site staff will be responsible for detecting, documenting 
and reporting events that meet the definition of an AE or SAE. 
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The investigator or site staff will then record all relevant information 
regarding an AE/SAE in the CRF.
There may be instances when copies of medical records for certain cases are 
requested by GSK.  In this instance, all subject identifiers, with the exception 
of the subject number, will be blinded on the copies of the medical records 
prior to submission of to GSK.
The investigator will attempt to establish a diagnosis of the event based on 
signs, symptoms, and/or other clinical information.  In such cases, the 
diagnosis will be documented asthe AE/SAE and not the individual 
signs/symptoms. Clinical AEs will be described by diagnosis and not by 
symptoms when possible (e.g., upper respiratory tract infection, seasonal 
allergy, etc. instead of runny nose).
AEs will be collected from the OST EXAMINATION AT SCREENING
beginning of the Screening Visitand until 5 days following last administration 
of the study product.
SAEs will be collected over the same time period as stated above for AEs.  
However, any SAEs assessed as relatedto study participation (e.g., 
investigational product, protocol mandated procedures, invasive tests, or 
change in existing therapy) or related to a GSK concomitant medication will 
be recorded from the time a subject consents to participate in the study up to 
and including any follow-up contact.  
Medical conditions reported prior to the time period for reporting AEs/SAEs 
should be recorded as part of the subject’s medical history.
7.3. Evaluating Adverse Eventsand Serious Adverse Events
Assessment of Intensity:
The investigator or designee will make an assessment of intensity for each AE and 
SAE 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
Severe:  An event that prevents normal everyday activities. -an AE that is 
assessed as severe will not be confused with an SAE. Severity is a category 
utilized for rating the intensity of an event; and both AEs and SAEs can be 
assessed as severe.
Note: An event is defined as ‘serious’ when it meets at least one of the pre-defined 
outcomes as described in the definition of an SAE.
Assessment of Causality:
The investigator is obligated to assess the relationship between study product 
and the occurrence of each AE/SAE.
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A "reasonable possibility" is meant to convey that there are facts/evidence or 
arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
The investigator will use clinical judgment to determine the relationship.
Alternative causes, such as natural history of the underlying diseases, 
concomitant therapy, other risk factors, and the temporal relationship of the 
event to the study product will be considered and investigated.
The investigator will also consult the Investigator Brochure (IB) and/or 
Product Information, for marketed products, in the determination of his/her 
assessment.
For each AE/SAE the investigator must document in the medical notes 
(source document) or CRF that he/she has reviewed the AE/SAE and has 
provided an assessment of causality.
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.
The investigator may change his/her opinion of causality in light of follow-up 
information, amending the SAE data collection tool accordingly.
The causality assessment is one of the criteria used when determining 
regulatory reporting requirements.
7.4. Reporting Adverse Eventsand Serious Adverse Events
AE Reporting to GSKCH:
AEs will be recorded in the AE section of the CRF. 
Medical conditions recorded by the subject on a diary
 card or similar 
document that meet the definition of an AE must also be recorded in the AE 
section of the CRF, if not previously well-characterized by the investigator in 
the subject’s medical history. 
AEs elicited by the investigator in a standard manner at the study visits should 
also be recorded in the AE section of the CRF.  The investigator or designee 
must ask the subject the following question during each visit including any 
follow-up visits:  “Have you felt unwell, experienced any symptoms or taken 
any medication (since your last visit) (today) (since your last dose) (since the 
last session)?”
The medically qualified investigator should review adverse events in a timely 
manner; this review should be documented in writing in the source document 
or in the CRF. 
After the study is completed at a given site, and the site has received their 
study data on Compact Discs (CDs), the electronic data collection tool will be 
removed from the internet to prevent the entry of new data or changes to 
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existing data.
SAE Reporting to GSKCH:
A paper copy of the SAE form provided in the investigator study master file should 
be completed as fullyas possible. 
It is essential to enter the following information: 
Protocol and subject identifiers
Subject’s demography
Description of events, with diagnosis if available
Investigator opinion of relationship to study product (see section 8.3)
Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and 
GSKCH 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 takenon study product
Outcome if known
The SAE form, completed as fully as possible, and SAE fax cover sheet must be 
faxed or e-mailed to the appropriate GSKCH Study Manager as soon as possible, but 
not later than 24 hoursafter study site personnel learn of the event. The GSKCH 
Study Manager should be notified of the situation by telephone or email.
Fax Serious Adverse Events to:
US: 
The GSKCH Study Manager will be responsible for forwarding the SAE form to the 
Case Management Group, Global Clinical Safety and Phamacovigilance, the Medical 
Director responsible for the study and other GSKCH personnel as appropriate via 
email.
The initial report will be followed up with more information as relevant, or as 
requested by the GSKCH study manager.
7.5. Follow-up of Adverse Eventsand Serious Adverse Events
Follow-up of AEs and SAEs:
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/SAEs will be followed until resolution, until the condition stabilizes, 
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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 to elucidate as fully as possible the nature and/or causality 
of the AE or SAE.
Investigators are not obliged to actively seek AEs or SAEs in former subjects.  
However, if the investigator learns of any SAE, including the death, at any 
time after a subject has been discharged from the study, and considers the 
event reasonably related to the investigational product or study participation, 
the investigator will promptly notify GSKCH.
The investigator will submit any updated SAE data to GSK within the 
designated reporting time frames.
Regulatory and ethics reporting requirements for SAEs:
The investigator will promptly report all SAEs to GSKCH within the 
designated reporting timeframes (within 24 hours of learning of the event).  
GSKCH 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 GSKCH is essential so that legal obligations and ethical 
responsibilities towards the safety of subjects are met.
GSKCH will comply with country specific regulatory requirements relating to 
safety reporting to the regulatory authority, IRBand investigators.
Investigator safety reports are prepared according to GSKCH policy and are 
forwarded to investigators as necessary.  An investigator safety report is 
prepared for a SAE(s) that is both attributable to investigational product and 
unexpected.  The purpose of the report is to fulfill specific regulatory and 
GCP requirements, regarding the product under investigation.
An investigator who receives an investigator safety report describing a SAE(s) 
or other specific safetyinformation (e.g., summary of listing of SAEs) from 
GSKCH will file it with the Investigator Brochure (or safety statement) and 
will notify the IRB , ifappropriate according to local requirements.
7.6. Definition of and Procedure for Reporting Medical Device 
Incidents
Medical devices are being provided by GSKCH for use in this study; the medical 
devicesin this study are the denture adhesives, the denture cleaning brushesand 
denture cleansing paste. GSKCH medical device incidents, including those resulting 
from malfunctions of the device, must be detected, documented, and reported by the 
investigator on the CRF throughout the study.
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7.6.1. Definition of an Incident
Definition of an Incident:
Any malfunction or deterioration in the characteristics and/or performance of 
a device, as well as any inadequacy in the labelling or the instructions for use 
which, directly or indirectly, might lead to or might have lead to the death of a 
patient or user or of other persons or to a serious deterioration in their state of 
health.
7.6.2. Reporting of Incidents and Malfunctions
Incident Reporting to GSKCH:
All incidents must be reported to GSKCH 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, 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 or an SAE, the appropriate AE 
CRF page or 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 GSKCH.  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 faxed or emailed to the 
appropriate GSKCH Study Manager as soon as possible, but not later than 
24 hoursafter study site personnel learn of the event. If there is an SAE, the 
completed SAE pages 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 remain with the subject’s records.
The GSKCH Study Manager should be notified of the situation by telephone 
or email.
Fax the Incident Report Forms to:
US: 
The GSKCH Study Manager will be responsible for forwarding the Incident 
Report Form to the Case Management Group, Global Clinical Safety and 
Pharmacovigilance, the Medical Director responsible for the study and other 
GSKCH personnel as appropriate.
The initial report will be followed up with more information as relevant, or as 
requested by the GSKCH study manager.
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Reporting of Malfunctions to GSKCH:
The investigator will follow the following directions regarding device failure 
(malfunction):
Notify GSKCH immediately.
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.
7.6.3. Follow-up of Incidents
Follow-up of Incidents:
During the study:
All incidents will be followed until resolution of the event, until the condition 
stabilizes, until the condition is otherwise explained, or until the subject is lost 
to follow-up. This applies to all subjects, including those withdrawn 
prematurely. The investigator is responsible for ensuring that follow-up 
includes any supplemental investigations as may be indicated to elucidate as 
completely as practical the nature of the incident.
New or updated information will be recorded on theoriginally completed 
form with all changes signed and dated by
 the investigator.
After the study:
Investigators are not obligated to actively seek reports of incidents in former 
subjects.  However, if the investigator learns of any incident at any time after 
a subject has been discharged from the study, and such incident is reasonably 
related to a GSKCH medical device provided for the study, the investigator 
will promptly notify GSKCH.
Regulatory and Ethics Reporting Requirements for Incidents:
The investigator will promptly report all incidents occurring with any GSKCH 
medical device provided for use in the study within 24 hours. GSKCH has a 
legal responsibility to notify appropriate regulatory bodies and other entities 
about certain safety informationrelating to medical devices being used in 
clinical studies. Prompt notification of incidents by the investigator to 
GSKCH is essential in order to meet legal obligations and ethical 
responsibility towards the safety of subjects.
The investigator, or responsible person according to local requirements, will 
comply with the applicable local regulatory requirements relating to the 
reporting of incidents to the IRB.
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7.7. Collection of Pregnancy Information
7.7.1. Time Period for Collectingof Pregnancy Information
Collection of Pregnancy Information:
Pregnancy information will be collected on all pregnancies reported following 
administration of any investigational product. Information on pregnancy 
identified during the screening phase and prior to investigational product 
administration does not need to be collected.
7.7.2. Action to be Taken ifPregnancyOccurs
Action to be Taken:
The investigator will collect pregnancy information on any subject who 
becomes pregnant while participating in the study after administration of the 
investigational product. The investigator will record pregnancy information on 
the appropriate form and submit it to GSKCH within 2 weeks of learning of 
the subject becoming pregnant. 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 to GSKCH. Generally, follow-up will be no 
longer than 6 to 8 weeks followingthe estimated delivery date. Any 
termination of the pregnancy will be reported.
While pregnancy itself is not considered to be an AE, any pregnancy 
complication or elective termination for medical reasons will be recorded as 
an AE or SAE.
A spontaneous abortion is always considered to be an SAE and will be 
reported as such. An SAE occurring in association with a pregnancy, brought 
to the investigator’s attention after the subject completed the study and 
considered by the investigator as possibly related tothe investigational 
product, must be promptly forwarded to GSK.
While the investigator is not obliged to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous 
reporting.
For non-medicinal or licensed products with no pregnancy warning on the 
label, use the following text: “There is no requirement for the subject to be 
withdrawn from the study as a result of the pregnancy.  However if they are 
withdrawn, this should be recorded in the appropriate section of the CRF.”
8. DATA MANAGEMENT
For this study subject data will be entered into an electronic case report form, using a 
GSKCH validated data system.
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8.1. Source Documents/ Data
The source documents (e.g. hospital records, clinical and office charts, laboratory 
notes, memoranda, subjects’ diaries or 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 the Source Document Designation Form.  In some cases the CRF can be 
used as a source document.
Each subject will be assigned and identified by a unique Screening Number. Any 
reference made to an individual subject within the study must be done using the 
unique Screening Number.
8.2. Electronic Case Report Form
A CRF is a printed, optical, or electronic document designed to record all of the 
protocol required information to be reported to the sponsor on each trial subject.
For each subject who has given informed consent/assent and has been screened, CRF 
must be completed and signed by the Principal Investigator (or authorized designee) 
to certify that the data are complete and correct.  
Management of clinical data will be performed in accordance with applicable 
GSKCH standards and data cleaning procedures to ensure the integrity of the data e.g. 
removing errors and inconsistencies in the data. 
In order to protect the privacy of subjects, no Personally Identifiable Information 
(PII) (including the subject
's name or initials or birth date) is to be recorded in the 
CRF or as part of the query text.
Adverse events and concomitant medications terms (if applicable) will be coded 
using MedDRA (Medical Dictionary for Regulatory Activities) and an internal 
validated medication dictionary, GSKDrug.  
Subject data will be entered into GSKCH defined CRFs and transmitted electronically 
to GSKCH in a validated (21 CFR Part 11 compliant) web-based electronic data 
capture system (InForm
TM).
All CRF pages should be completed during a subject assessment when the CRF has 
been designated as the source.  Data that is sourced elsewhere should be entered into 
the CRF in an agreed upon timeframe between the Investigator and Sponsor.  
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The CRFs (including queries, query responses and audit trails)will be retained by 
GSKCH. Site data archived compact discs (CD(s)) prepared by a third party will be 
sent to the investigator to maintain as the investigator copy following the 
decommissioning of the study.
8.3. 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.
8.3.1. Data Queries
Programmed edit checks will be generated automatically, as the data is being entered 
into the system. Data Management will also run reports and listings on the CRF data, 
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 (Adverse Events and Drugs) are reported appropriately. 
The study monitor at the study site will review the CRFs in accordance with the 
monitoring plan, and any queries will be generated in the EDC Systemto the 
Investigator or designee, enabling the errors to be addressed in parallel with Data 
Management review. Monitor can also run reports and listings on the CRFs, to raise 
manual queries as needed for site clarification or correction
8.4. Processing Patient Reported Outcomes
Patient reported outcome (PRO) data are collected directly from the subject PRO 
measures e.g. diary cards, questionnaires etc, and entered into the sponsor’s clinical 
data management system (DMS) by the study site representative. In instances where 
the PRO data is entered into the DMS by GSKCH, the PROs will be anonymised, and 
forwarded to GSKCH for entry, as agreed and documented ahead of the study
 
starting. PROs that are source will be retained by
 the investigator and certified copies 
will be sent to GSKCH. 
In order to protect the privacy of subjects, no Personally Identifiable Information 
(PII) (including the subject
's name or initials or birth date) is to be recorded on all 
PRO’s that will be forwarded to GSKCH.
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All PRO source data should be reviewed by the Study Staff/Study Monitor (as 
appropriate) in order to ensure that any potential AEs reported on these documents 
are represented in the DMS. 
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES
9.1 Sample Size Determination
Approximately 25subjects will be screened to randomize approximately 21subjects
to ensure that approximately 18evaluable subjects complete the study.
A sample size of approximately 18subjects completing all treatment periods will 
provide approximately81% power to detect a difference of 2.01lbs in at least oneof 
the two test products from no adhesive, using two-sided t-tests with family wise 
significance level of 5% based on the Dunnett’s adjustment, assuming a residual 
standard deviation of 1.929lbs. The estimate of SD isobtained from the study 
203114. This was the larger SD among two similar earlier studies: RH02625 and 
203114. The delta of 2.01 was obtained from the study RH02443. In that study this 
was the observed difference between Super Poligrip and no adhesive. This was the 
lowest observed delta for Super Poligrip vs no adhesive among the studies RH02446, 
RH02443 and 203114.As such the expected performance of the test products is 
completely unknownbut we would like at least one testproduct to perform like Super 
Poligrip or better.
Power calculations were performed for 2 alternative hypotheses:
1. One of the treatment means is 2.01 lbs more than the mean for no adhesive; 
the other treatment mean is 1 lb more than the mean for no adhesive
2. One treatment meanis 2.01 lbs more than the mean for no adhesive; the other 
treatment mean is the same as the mean for no adhesive.
The power was approximately 81% for both the cases.
The results are based on 100000 simulations.
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9.2.General Considerations
9.2.1.Definition of Analysis Populations
All analyses of safety will be made on the safety population which will be defined as 
all subjects who are randomized and received treatment at least once during the study.  
The safety population will be analyzed as per treatment received(ATRT variable).
Efficacy analyses will be based on the intent-to-treat (ITT) population which will be 
defined as all randomized subjects with at least one post baseline assessment of 
efficacy.  This will be the primary population for the efficacy analysis which will be 
performed as per the randomized treatment. 
The Per Protocol (PP) population will be a subset of the ITT population.Subjects 
with a protocol violation that is deemed to affect efficacy assessments in all study 
periods will be excluded from the PP population.Subjects with a protocol violation 
that is deemed to affect efficacy assessments in some (but not all) study periods will 
be part of the PP population, but their data will be excluded from the period(s) 
affected by the protocol violation for a PP analysis.  An analysis on the PP population 
will be performed for the primary efficacy variable if there is more than 10% 
difference in the number of subjects evaluable in any of the treatment groups for the 
ITT and PP populations.  A decision on whether a PP analysis will be performed will 
be made prior to study unblinding.
9.2.2.Exclusion of Data from Analysis
No data will be excluded from the safety or ITT populations.
The following will be considered violations that may lead to the exclusion of data for
PP analysis:
Violation of inclusion or exclusion criteria at screening that may affect 
efficacy
Violation of pre-treatment baseline bite force continuance criteria
Treatment administration errors
Use of prohibited treatment or medication before or during the study, 
whichit is felt will affect the assessment of efficacy
Other reasons for protocol violations may be provided in the Statistical Analysis Plan
(SAP). Violations will be identified between the Biostatistician and Medical Director
or designee, ahead of breaking the study blind. Further details of methodology for
identifying data to be included in PP analysis will be provided in the SAP.
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9.2.3.Criteria for Evaluation
9.2.3.1.Criteria for Assessing Efficacy
Efficacy will primarily be assessed by AreaOver Baseline (AOB) over 12 hours for 
the incisal bite force (lbs) (denoted by AOB
0-12). The differencewill be estimated for 
each of the test products compared to no adhesive.
Success would be achieved if any of the test productswas statistically significantly 
better than no adhesive.The observed differences for the treatment means willalso be 
considered.
9.2.3.2.Criteria for Assessing Tolerability
The assessment for safety will be based on the OST examination and adverse events
(AEs) and incidents reported by subjects following application of denture adhesives.
9.2.4.Handling of Dropouts and Missing Data
For calculation of AOB, linear interpolation will be used in the case of missing
values. If more than one of the assessments during the 12 hour period is missing,
AOB will be set to missing.
9.3. Statistical Methods and Analytical Plan
More details of the proposed statistical analysis will be documented in thestatistical 
analysis plan, which will be written following finalisation of the protocol and prior to 
study unblinding.
Selected raw data will be listed as defined in the SAP.
9.3.1.Demographic and Baseline Characteristics
Descriptive statistics (number of subjects, mean, SD, median, minimum and
maximum for continuous variables, and frequency and percentage for categorical
variables) will be provided for demographic and baseline data.
9.3.2.Primary Analysis(es)
Incisal Bite Force (lbs): Area over Baseline (AOB
0-12)
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The Area Over Baseline (AOB) over 12 hours for the incisal bite force (lbs) (denoted 
by AOB0-12) is the primary efficacy variable.
To calculate this variable first the Area Under the Curve (AUC) is calculated from 0 
to 12 hours (AUC
0-12) using the trapezoidal method. AOB
0-12will be calculatedas 
(AUC
0-12)/12 minus baseline bite force (lbs). This transformation will return the 
measurement to thesame scale as the original observations whilst also looking at the 
average amount of improved force over timeby subtractingthe baseline value(AOB: 
Area Over Baseline). Higher values of AOB demonstrate a stronger bite force over 
timethan lower values.
Missing readings will be ignored and interpolation will be made between pre and post 
the missing values, if necessary. Inthe case of more than one missing value or if the 
12 hour value ismissing, the AOBwill beset to missing. 
An analysis of covariance (ANCOVA) model will be used with AOB valuesas the 
response, with fixed effect factors for treatment group, period andsubject-level 
baseline, period level baseline minus subject-level baseline ascovariates. Subject will 
be included as a random effect. 
From the above model, treatment differences between groups, (each of the two
adhesives versus no adhesive), 95% confidenceintervals and p-values, will be 
provided. The confidence intervals and p-values will be adjusted using the Dunnett’s 
methodso that the overall confidence level forthe two confidence intervals is 
maintained at 95% and the two treatment comparisons can be performed with an 
overall 5% significance level. The assumption of normality and homogeneityof 
variance will be investigated. Violation of these assumptions may be overcomeusing 
suitable transformation or performing a non-parametric test (e.g.the WilcoxonSign 
Rank test).
9.3.3.Secondary Analysis(es)
Incisal Bite Force (lbs): Area over Baseline (AOB0-0.5, AOB0-1, AOB0-3, AOB0-6, 
AOB0-9, AOB0-12)
From the ANCOVA model described above, treatment difference for each of the two 
test adhesives versus Super Poligrip
®Free will be provided along with 95% 
confidence intervals and p-values. All tests will be conducted at the two sided 5% 
significance level. If non-parametric analysis is performed for the primary efficacy 
variable then these secondary comparisons will be performed in a similar way as the 
primary comparisons.
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Furthersecondary efficacy variables will be bite force AOBs over 0.5, 1, 3, 6 and 9 
hours respectively. Each of thesesecondary efficacy variableswill be analysed using 
a similar ANCOVA model as described above for the primary efficacy variable.  
From this model, treatment difference between each test adhesive versus Super 
Poligrip®Free, the treatment difference between each test adhesive versus no 
adhesive, 95% confidenceintervals and p-values, will be provided. All significance 
tests will be conducted atthe two sided 5% significance level. The assumption of 
normality and homogeneityof variance will be investigated. Violation of these 
assumptions may be overcomeusing suitable transformationsor performing a non-
parametric tests(e.g.the WilcoxonSign Ranktest).
9.3.4.Exploratory/ OtherAnalysis(es)
For eachANCOVA model described above for eachsecondary efficacy variable, 
treatment difference between the two test adhesives will be provided along with 95% 
confidence intervals and p-values. All tests will be conducted at the two sided 5% 
significance level. If non-parametric analyses are performed for asecondary efficacy 
variablethen this correspondingexploratory comparison will be performed in a 
similar way as the associatedsecondary comparisons for thatsecondary endpoint.
The data from the questionnaires and the denture adhesive weights will be listed and 
tabulatedusing descriptive statistics.
9.3.5.SafetyAnalysis(es)
Safety will be assessed based on any oral AEs (this includes those that are identified 
as Treatment Emergent OST abnormalities and spontaneously reported oral AEs). All 
AEs will be coded using the Medical Dictionary for Regulatory Activities
(MedDRA). AEs will be categorized as oral and non-oral by the clinical research
director or designee prior to database lock. AEs will be deemed to be TE if they occur 
after the first supervised use of the randomized treatment.No formal statistical 
analyses of AEs will be performed. A list of incidents will also be included as part of 
the safety analyses. 
10. STUDY GOVERNANCE CONSIDERATIONS
10.1.Posting of Information on Publicly Available Clinical Trials 
Registers
Study information from this protocol will be posted on publicly available clinical trial 
registers before enrollment of subjects begins.
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10.2.Regulatory and Ethical Considerations, Including the Informed 
Consent
The study will be conducted in accordance with all applicable regulatory 
requirements, and with GSK policy.
As per the regulatory determination for this study, the experimental denture adhesive 
is categorized as a non-significant risk medical device, and therefore a non-significant 
risk (NSR) application will be required as part of the IRB submission to conduct this 
study in the US.
The study will also be conducted in accordance with ICH Good Clinical Practice 
(GCP), all applicable subject privacy requirements, and the guiding principles of the 
current version of the Declaration of Helsinki.  This includes, but is not limited to, the 
following:
Before initiating a trial, the investigator/institution should have written and 
dated approval/favorable opinion from the IRBforthe trial protocol 
(including amendments), written informed consent form, consent form 
updates, subject recruitment procedures (e.g., advertisements), investigator 
brochure/ safety statement(including any updates) and any other written 
information to be provided to subjects. A letter or certificate of approval will 
be sent by the investigator to the sponsor prior to initiation of the study, and 
also when subsequent amendments to the protocolare made.
Signed informed consent  to be obtained for each subject before participation 
in the study (and for amendments as applicable)
Investigator reporting requirements (e.g. reporting of AEs/SAEs/protocol 
deviations to IRB)
GSK will provide full details of the above procedures, either verbally, in 
writing, or both.
10.3.Quality Control (Study Monitoring)
In accordance with applicable regulations including GCP, and GSK procedures, GSK 
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 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 or designee will monitor the study and site activity to verify that the:
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Data are authentic, accurate, and complete.
Safety and rights of subjects are being protected.
Study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements.
The extent and nature of monitoring will be described in a written monitoring plan on 
file at GSKCH. 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.
10.4.Quality Assurance
To ensure compliance with GCP and all applicable regulatoryrequirements, GSK 
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 sponsor will be available to help investigators prepare for an inspection.
10.5.Conditions for Terminating the Study
Upon completion or premature discontinuation of the study, the GSKCH monitor will 
conduct site closure activities with the investigator or site staff, as appropriate, in 
accordance with applicable regulations including GCP, and GSKCH Standard 
Operating Procedures.
Both GSKCH and the Investigator reserve the right to temporarily suspend or 
prematurely discontinue this study at any time for reasons including, but not limited 
to, safety or ethical issues or severe non-compliance. For multicenter studies (if 
applicable), this can occur at one or more or at all sites.  
If the trial is prematurely terminated or suspended for any reason, the investigator site 
should promptly inform the trial subjects and should assure appropriate therapy/ 
follow-up for the subjects. Where required by the applicable regulatory requirements, 
GSKCH should inform the regulatory authority(ies). 
In addition: 
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If the investigator terminates or suspends a trial without prior agreement of 
GSKCH, the investigator site should promptly inform the sponsor and the 
IRB, and should provide the sponsor and the IRB a detailed written 
explanation of the termination or suspension.
If the GSKCH terminates or suspends a trial, the investigator should promptly 
inform the IRBand provide the IRBa detailed written explanation of the 
termination or suspension. 
If the IRBterminates or suspendsits approval/favorable opinion of a trial, the 
investigator should promptly notify the GSKCH and provide GSKCH with a 
detailed written explanation of the termination or suspension.
10.6.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 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 submittedto GSKCH, 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 GSKCH, e.g. subjects’ written consent forms, should be maintained by the 
investigator in strict confidence.
GSK will inform the investigator of the time period for retaining these records to 
comply with all applicable regulatory requirements (GSKCH recommends that 
documents be kept for 10years). The investigator is also required to keep subject 
identification codes on file for at least 15 years after completion or discontinuation of 
the study. The minimum retention time will meet the strictest standard applicable to 
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that site for the study, as dictated by any institutional requirements or local laws or 
regulations, GSK standards/procedures, and/or institutional requirements.  
No study document should be destroy
ed without a prior written agreement between 
GSKCH and the investigator. The investigator must notify GSK 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.
10.7.Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials Registers 
and Publication
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 reviewthe complete study results at a GSK site or other 
mutually-agreeable location.
GSK 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 Policy.
A manuscript will be progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge.
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11.REFERENCES
Chew CL, Philips RW, Boone ME, Swartz ML. Denture stabilization with
adhesives: A kinesiographic study. Compend Contin Educ Dent 1984;
4(supple)S32-8.
Chew CL, Boone ME, Swartz ML, Phillips RW. Denture adhesives: their effects
on denture retention and stability.  J Dent1985; 13(2):152-159.
FDAGuidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials, 
2005.
Grasso JE, Denture adhesives. Dent Clin North Am 2004;48(3):721-733.
GSKCH Clinical Study Report L3510566 (2010). A Study of Denture Adhesives
in Well-Fitting Dentures. Data held on file.
GSKCH
 
 
GSKCH
 
GSKCH
 
Howell AH, Manly RS: An electronic strain gauge for measuring oral forces. J Dent 
Res1948;27:705-712
ICH Topic 6 Guideline for Good Clinical PracticeCPMP/ICH/135/95 17th July 1996.
Kapur KK: A clinical evaluation of denture adhesive. J Prosthet Dent1967;18:550-
558.
Olshan AM, Ross NM, Mankodi S, Melita S. A modified Kapur scale for evaluating 
denture retention and stability: methodology study.  Am J Dent1992; 5(2):88-90.
Tarbet WJ, Boone M, Schmidt NF: Effect of a denture adhesive on complete denture 
dislodgement during mastication. J Prosthet Dent1980;44:374-378.
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World Medical Association Declaration of Helsinki, 59th General Assembly, Seoul 
2008.
Zarb GA, Fenton AH: Prosthodontic treatment for edentulous patients: complete 
dentures and implant-supported prostheses, St. Louis, Missouri, Elsevier/Mosby
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12. APPENDICES
12.1. Appendix I-Abbreviations
Abbreviations
AE 
Adverse Event
AOB
Area over baseline
CD
Compact Disc
CRF
Case Report Form
EDC
Electronic Data Capture
GCP
Good Clinical Practice
GSKCH
GlaxoSmithKline Consumer Healthcare
Hr
Hour
ICH
International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ITT
Intention to Treat
OST
Oral soft tissue
PII
Personally Identifiable Information
PP
Per Protocol
PRO
Patient Reported Outcome
PVA
Polyvinylacetate
SAE
Serious Adverse Event
US
United States of America
Trademark Information
Trademarks of the GlaxoSmithKline group of companies:
POLIGRIP
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12.2. Appendix II–Product Ooze Questionnaire
Please note that this questionnaire is only completed for subjects on treatment 
visits when they have a denture adhesive applied and NOT on the no adhesive 
treatment visit.
Question 1 to be completed by the subject immediatelyafter the 0.5 hour bite 
force reading.  
Please mark/ tick only ONEresponse per question. 
1. How long after inserting your denture did you experience denture 
adhesive OOZING out of your UPPERDENTURE? 
Immediately 
Less than 
approximately 
10 minutes 
Approximately 
10 to 20 
minutes
Approximately 
20 to 30 
minutes
No ooze 
experienced
1
2
3
4
5
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12.3. Appendix III–SensoryQuestionnaire
Please note that this questionnaire is only completed for subjects on treatment 
visits when they have a denture adhesive applied and NOT on the no adhesive 
treatment visit.
To be completed by the subjectimmediately following the last (12 hr) bite force 
measure (whilst upper denture still retained in the mouth).Questions relate to 
the UPPER DENTURE only.
Please mark/ tick only ONEresponse per question. 
1. How would you rate your OVERALL OPINION of the denture 
adhesive?
Dislike 
extremely
Dislike 
moderately
Dislike 
slightly
Neither like 
nor dislike
Like 
slightly
Like
moderately
Like 
extremely
1 
2 
3 
4 
5 
6 
7
2. How much did you LIKE/ DISLIKE the TASTE  of the denture 
adhesive?
Dislike 
extremely
Dislike 
moderately
Dislike 
slightky
Neither like 
nor dislike
Like 
slightly
Like 
moderately
Like 
extremely
1 
2 
3 
4 
5 
6 
7
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3. How would you describe the STRENGTH of the TASTEof the denture  
adhesive?
No flavour 
at all
Barely 
detectable
Weak
Moderate 
Strong
Very strong
Strongest 
flavour 
imaginable
1 
2 
3 
4 
5 
6 
7
4. How much did you LIKE/ DISLIKEthe FEELof the adhesive in the 
mouth?
Dislike 
extremely
Dislike very 
much
Dislike 
moderately
Neither like 
nor dislike
Like 
moderately
Like very 
much
Like 
extremely
1 
2 
3 
4 
5 
6 
7
5. How would youdescribe the TEXTURE ofthe denture adhesive?
Not at all
Slightly
Moderately
Very
Extremely
Smooth
Oily
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Gritty
1 
2
3
4
5
For the following question subjects to be given a tube of the test product  
and asked to squeeze the adhesive on to a piece of paper as per the strips 
that appear on the product application 
6. How EASY was it to SQUEEZE OUT the adhesive from the tube?
Not at all 
easy
Slightly 
easy
Moderately 
easy
Very easy
Extremely 
easy 
1
2
3
4
5
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12.4. Appendix IV–Denture RemovalQuestionnaire
Please note that this questionnaire is only completed for subjects on treatment 
visits when they have a denture adhesive applied and NOT on the no adhesive 
treatment visit.
To be completed by the subjectimmediately after denture removal.
Please mark/ tick only ONEresponse per question. 
1. How EASY was it to REMOVE the denture from the mouth?
Not at all 
easy
Slightly 
easy
Moderately 
easy
Very easy
Extremely 
easy 
1
2
3
4
5
2. How EASY was it to REMOVE ANY RESIDUAL DENTURE 
ADHESIVEfrom the mouth?
Not at all 
easy
Slightly 
easy
Moderately 
easy
Very easy
Extremely 
easy 
1
2
3
4
5
3. Please describe below what you LIKED or DISLIKED about the denture 
adhesive.
LIKED
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DISLIKED
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12.5. Appendix V–Denture Adhesive Application Instructions 
(Super Poligrip®)
Super Poligrip®(Reference Product)
APPLYING TO UPPER (AND WHERE NECESSARY LOWER) DENTURES:
1. Clean and dry dentures.
2. Pre-dispense sufficient denture adhesive to remove any potential separation in 
order to ensure product uniformity prior to application to the denture. 
3. Apply product in strips, not too close to the denture edges (3 strips should be 
applied to the upper denture and 2 on the lower denturewhere necessary)as 
indicatedin the images. 
4. Maxillary dentures should be weighed before and after adhesive application to 
ensure correct dose applied (1+0.05 gram).
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5. Where necessary, denture adhesive application to the lower denture should be 
sufficient to fully retain the lowerdenture in order to ensure accuracy of 
maxillary denture dislodgement bite force measures; please note that thelower 
dentureimages are for illustrative purposes only.
6. Have subjects rinse their mouth with water before inserting dentures. 
7. Have subjects press dentures into place, hold firmly, and bite down for a few 
seconds to secure hold.
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12.6. Appendix VI–Denture Adhesive Application Instructions 
(Experimental Denture Adhesives with a thin nozzle)
Experimental Denture Adhesives with Precision Applicator 
(Test Products)
  
APPLYING TO UPPER DENTURES:
1. Clean and dry upper dentures.
2. Pre-dispense sufficient denture adhesive to remove any potential separation in 
order to ensure product uniformity prior to application to the denture. 
3. Apply product in long continuous strips as shown in the image, not too close 
to the denture edge (3 strips should be applied to the upper denture).
4. Maxillary dentures should be weighed before and after adhesive application to 
ensure correct dose applied (1+0.05 gram).
5. Havesubjects rinse their mouth with water beforeinserting the upper denture
6. Have subjects press upper denture into place, hold firmly, and bite down for a 
few seconds to secure hold
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23-Feb-2017 07:00:52
 
Approved
23-Feb-2017 14:35:38
Biostatistics Approval
22-Feb-2017 09:38:16
Approved
Clinical Operations Approval
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22-Feb-2017 06:26:52
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