A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control
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  An unpublished work subject to trade secret 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 should not be copied, circulated, or distributed to persons not 
employed by GlaxoSmithKline unless specifically authorized.  Unauthorized 
disclosure of this work is expressly prohibited.
Clinical Protocol
207545
 
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CONFIDENTIAL
SUMMARY INFORMATION
Title:
A Bite Force Study Assessing Two Currently Marketed 
Denture Adhesive Products Compared to No-Adhesive 
Control
Protocol Number:
207545
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)
184 Liberty Corner Road, Warren NJ, 07059, United States
Tel:
Product Name:
Super Poligrip® Free & Protefix® denture adhesives
Development Phase:
Not Applicable
Expert Advice Outside of Normal 
Working Hours:
Tel: 
PRIMARY CONTACT
Clinical Study Manager:
 BS
GSKCH
184 Liberty Corner Road, 
Warren NJ, 07059, United States
Tel: 
Key Protocol Authors:
Clinical Research:
 RDH, MS, CCRP
GSKCH
MSC, CSTAT
, PHD
ST GEORGES AVENUE
WEYBRIDGE, SURREY
KT13 0DE, UK
Biostatistician:
  MSc
GSKCH
St. George’s Avenue, 
Weybridge, 
Surrey, KT13 0DE, United Kingdom 
(UK)
 
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Other Protocol Authors:
Clinical Supplies:
GSKCH
St. George’s Avenue, 
Weybridge, Surrey, KT13 0DE, UK
Principal Investigator:
Ana Gossweiler, Odont, DDS, MSD
Study Site Name & Address:
Oral Health Research Institute (OHRI)
415 Lansing Street, Indianapolis, IN 
46202
Study Site Telephone Number:
Study Examiner(s):
, LDH
OHRI
415 Lansing Street, Indianapolis, IN 
46202
Regulatory Agency Identifier Number 
(if applicable):
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 International Conference on 
HarmonisationGood Clinical Practice (ICH GCP)guidelines.
I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described study.
I agree to ensure that all associates, colleagues and employees assisting in the 
conduct of the study are informed about their obligations. Mechanisms are in 
place to ensure site staff receives all appropriate information throughout the 
study.
I agree to conduct this study in full conformance with the laws and regulations 
of the country in which the research is conducted and the Declaration of 
Helsinki.
Investigator Name:
Ana Gossweiler
Investigator Qualifications:
Odont, DDS, MSD
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 207545...................15
1. INTRODUCTION...............................................................23
2. OBJECTIVES AND ENDPOINTS....................................24
3. STUDY PLAN.....................................................................25
3.1. Study Design.......................................................................25
3.2. Subject Restrictions...........................................................28
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..............................................33
4.4. Withdrawal/ Stopping Criteria.........................................34
4.5. Subject Replacement..........................................................34
4.6. Subject and Study Completion..........................................34
5. PRODUCT INFORMATION.............................................35
5.1. Study Product.....................................................................35
 
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5.2. Dose Schedule.....................................................................37
5.3. Dose Modification..............................................................38
5.4. Product Compliance..........................................................38
5.5. Precautions.........................................................................38
5.6. Overdose.............................................................................38
5.7. Rescue Therapy..................................................................38
5.8. Product Assignment...........................................................38
5.8.1 Randomization...................................................................39
5.8.2 Blinding...............................................................................39
5.8.3 Code Breaks........................................................................39
5.9. Packaging and Labelling...................................................40
5.9.1. Accountability of Product.................................................40
5.9.2. Storage of Product............................................................40
6. STUDY ASSESSMENTS AND PROCEDURES..............41
6.1. Visit 1 -Screening Visit......................................................41
6.1.1 Telephone Screening..........................................................41
6.1.2. Informed Consent.............................................................41
6.1.3. Demographics....................................................................41
6.1.4. Medical History and Concomitant Medication...............42
6.1.5. Dental History...................................................................42
6.1.6. Well-Made Denture Assessment.......................................42
6.1.7. OST Examination –Edentulous.......................................42
6.1.8. Denture Bearing Tissue Score..........................................43
6.1.9. Kapur (Olshan Modification) Denture Retention & 
Stability Assessment..........................................................44
6.1.10. Denture cleansing............................................................45
6.1.11. Mandibular Denture Stabilisation.................................45
6.1.12. Bite Force Measurement System....................................45
6.1.13. Bite Force Calibration.....................................................46
6.1.14. Bite Force Measures at Screening..................................46
 
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6.2. Visits 2, 3, 4 & 5..................................................................47
6.2.1. OST Examination -Edentulous........................................47
6.2.2. Denture Adhesive Application to Dentures.....................47
6.2.3. Bite Force Measures during Treatment Visits.................47
6.2.4. Subject Questionnaires.....................................................48
6.2.4. Study Conclusion...............................................................49
7. SAFETY ASSESSMENTS..................................................49
7.1. Definitions of an Adverse Event and Serious Adverse 
Event.................................................................................49
7.1.1. Adverse Events..................................................................49
7.1.2. Serious Adverse Events.....................................................50
7.2. Recording Adverse Events and Serious Adverse Events.51
7.3. Evaluating Adverse Events and Serious Adverse Events52
7.4. Reporting Adverse Events and Serious Adverse Events..53
7.5. Follow-up of Adverse Events and Serious Adverse Events
..........................................................................................54
7.6. Definition of and Procedure for Reporting Medical Device 
Incidents...........................................................................55
7.6.1. Definition of an Incident...................................................55
7.6.2. Reporting of Incidentsand Malfunctions........................56
7.6.3. Follow-up of Incidents......................................................57
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.........................58
8. DATA MANAGEMENT....................................................58
8.1. Source Documents/ Data....................................................58
8.2. Electronic Case Report Form............................................59
8.3. Data Handling....................................................................60
8.3.1. Data Queries......................................................................60
 
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8.4. Processing Patient Reported Outcomes............................60
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES....................................................................61
9.1 Sample Size Determination.................................................61
9.2. General Considerations.....................................................61
9.2.1. Definition of Analysis Populations...................................61
9.2.2. Exclusion of Data from Analysis......................................62
9.2.3. Criteria for Evaluation.....................................................62
9.2.3.1. Criteria for Assessing Efficacy......................................62
9.2.3.2. Criteria for Assessing Tolerability................................63
9.2.4. Handling of Dropouts and Missing Data.........................63
9.3.Statistical Methods and Analytical Plan...........................63
9.3.1. Demographic and Baseline Characteristics.....................63
9.3.2. Primary Analysis...............................................................63
9.3.3. Secondary Analysis...........................................................64
9.3.4. Exploratory Analyses........................................................64
9.3.5. Safety Analysis..................................................................65
10. STUDY GOVERNANCE CONSIDERATIONS.............66
10.1. Posting of Information on Publicly Available Clinical 
Trials Registers................................................................66
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent............................................................66
10.3. Quality Control (Study Monitoring)...............................67
10.4. Quality Assurance............................................................67
10.5. Conditions for Terminating the Study............................67
10.6. Records Retention............................................................68
10.7. Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication................................................69
 
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11. REFERENCES..................................................................70
12. APPENDICES...................................................................72
12.1. Appendix I -Abbreviations.............................................72
12.2. Appendix II –Product Ooze Questionnaire...................74
12.3. Appendix III –Sensory Questionnaire...........................75
12.4. Appendix IV –Denture Removal Questionnaire...........78
12.5. Appendix V -Questionnaire for Site Staff Cleaning the 
Denture.............................................................................81
12.6Appendix VI -Denture Adhesive Application 
Instructions -Positive Control........................................82
12.7.Appendix VII –Denture Adhesive Application 
Instructions......................................................................83
12.8.Appendix VIII –Lower Denture Adhesive Application 
Instructions......................................................................84
 
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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 made by the original protocol 
signatories or their appropriate designees.
All major/substantial protocol modifications must be reviewed and 
approved by the appropriate Institutional Review Board (IRB)in 
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    
Change of study personnel 
from Clinical Research.
Error on page 19, 28 
“1 ± -0.05gram“ should read 
“1 ± 0.05gram”
Informed Consent   
Yes 
No
Safety Statement     
Yes 
No
CRF                       
Yes 
No
Protocol Synopsis
Study Design,–   Visit 2,3,4 
Section 3.1 –Visit 
2,3,4 (Page 28)
Signature:
Protocol 
Version 
No.:3.0
Substantial/ Major           
Date:
Amendment 
No.:2
Non-Substantial/Minor    
Change of study personnel 
from Clinical Research.
Clarification from which
pointAEs and incidents 
should be collected.
Informed Consent   
Yes 
No
Safety Statement     
Yes 
No
CRF                       
Yes 
No
Protocol Synopsis
Study Design,(Synopsis), 
Section 3.1
6.1.7 OST Examination –
Edentulous 
6.2.3BiteForce Measures 
during Treatment Visits
7.1.1 Adverse Event
Definition
7.2 Recording Adverse 
Events and Serious 
Adverse Events
Signature:
Protocol 
Version 
No.:4.0
Substantial/ Major           
Date:
 
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Amendment 
No.:3
Non-Substantial/Minor    
Change from the OST 
examiner being blinded to 
being unblinded
Change in procedure for 
denture adhesive removal
Informed Consent   
Yes 
No
Safety Statement     
Yes 
No
CRF                       
Yes 
No
Study Design (synopsis & 
section 3.1)
Sections 3.4, 5.2, 5.8.2, 
6.2.4
Signature:
Protocol 
Version 
No.:5.0
Substantial/ Major           
Date:
Amendment 
No.:4
Non-Substantial/Minor    
Increase in the amount of 
subjects that can be screened.
Informed Consent   
Yes 
No
Safety Statement     
Yes 
No
CRF                       
Yes 
No
Protocol Synopsis, 
Sections 3.3 and 9.1
Signature:
Protocol 
Version 
No.:6.0
Substantial/ Major           
Date:
 
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SCHEDULE OF EVENTS
Procedures
Screening
Treatment 1
Treatment 2
Treatment 3
Visit 1
Visit 2
Visit 3
Visit 4
Informed Consent
X
Between 1-14 days of screening
Between 1-14days
Between 1-14days
Subject Demographics
X
Medical History
X
Dental History
X
Current/Concomitant Medications
X
X
X
X
Kapur Index Assessment for well made & 
fitting dentures (retention, stability, fit & 
clinical acceptability)
X
Inclusion/Exclusion
X
X
OST –Edentulous
X
X1
X1
X1
Denture Bearing Tissue Score 
X
Denture Cleansing
X
X
X
X
Mandibular Denture Stabilization2
X
X
X
X
Three Incisal BFreadings with no adhesive 
X3
X4
X4
X4
Incisal BFwith no adhesive 
X5
X6
X6
X6
Subject Eligibility/ adherence
X
X
Adverse Events/Incident Reporting7
X
X
X
X
Continued Eligibility
X
X
X
Randomization
X
Product Application by site staff to maxillary 
denture
8
X8
X8
X8
Incisal BFMeasurements9
X9
X9
X9
Subject administered questions around 
product ooze at 0.5 hour10
X
X
X
Subjects administered questions around 
flavourandtexture of the adhesive& 
extrusion from tube11
X
X
X
Removal of denture from the mouth by 
subject
X
X
X
Removal of excess adhesive from the mouth 
by the subject facilitated and confirmed by 
X
X
X
 
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Procedures
Screening
Treatment 1
Treatment 2
Treatment 3
Visit 1
Visit 2
Visit 3
Visit 4
site study staff
Subjects administered questions about 
denture comfort and adaptation and ease of  
denture removal12
X
X
X
Removeadhesiveproduct from denture 
before dismissing subject13
X
X
X
Post treatment OST
X
X
X
Adverse Events/Incident Reporting
X7
X
X
X
Study Conclusion
X
1 OST on Test Day is for pre-treatment baseline
2 Mandibular 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 Incidentswillbe 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 application
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 SensoryProduct Questionnaire immediately following the 1 hr. incisal BF measure for flavour & textureand following 
the12 hrincisal bite force measurefor extrusion from the tube
12Subjects will complete the Denture Removal Questionnaire immediately following upper denture removal by the subjectas well as questions around 
denture comfort and adaptation
13Staff complete questionnaire for ease of denture adhesive removal post-12 hour bite force measurement
 
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PROTOCOL SYNOPSIS FOR STUDY 207545
Brief Summary
The objective of this 3-treatment, 3-period, randomized, crossover, bite force (BF) 
study is to compare BFmeasurements over a 12 hour period of a currently marketed 
denture adhesivecream (Protefix®) based on carbomer technology, with a currently 
marketed denture adhesivecream(Super Poligrip®Free, positive control), and a 
negative/no treatment control. A short questionnaire regarding the flavour and texture 
characteristics of each denture adhesive after a single use will also be used to generate 
data for these attributes. 
In this study,a bite force transducer system will be used to measure incisal BFuntil 
dislodgement of maxillary complete dentures.  Subjects in this study will have 
dentures judged to be clinically acceptable and 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
].  BFmeasurements will be taken over 
a 12-hour time period to compare strength of the testadhesive over time against the 
positive and negative (no adhesive) controls. 
This study willconducted at OHRI based in Indiana, USA, and subjects will be 
recruited via the OHRI database.
                                               
®Protefix is a registered trademark of Queisser Pharma GmbH & Co, Flensburg, Germany
®Super Poligrip Free is a registered trademark of GlaxoSmithKline Consumer Healthcare, LLC.
 
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CCI

Objectives and Endpoints
Objectives
Endpoints
Validation:
To compare incisal BF for Super Poligrip
Free denture adhesiveversus no adhesive 
over12 hours
Area over Baseline (AOB) up to12 
hours.
Primary
To compare incisal BF for Protefix 
denture adhesive versus no adhesive over
12 hours
AOBup to12 hours.
Exploratory:
To compare incisal BF for Protefix
denture adhesive versus Super Poligrip 
Free denture adhesive over12 hours.
AOBupto 12 hours.
To compare incisal BF for Super Poligrip 
Free denture adhesive versus no adhesive 
over 9 hours
AOB up to0.5, 1, 3, 6 and 9 hours
To compare incisal BF for Protefix 
denture adhesive versus no adhesive over 
9 hours
AOB up to0.5, 1, 3, 6 and 9 hours
To assess subjects’ preference with 
regards to denture adhesive ooze
Scores from subject-completed 
questionnaireon product ooze, at 0.5 
hoursuse
To assess subject’s preference with 
flavour/after-taste and texture, denture 
comfort and adaptation
Scores from subject-completed 
questionnaire on flavour/after-taste and 
texture, denture comfort and adaptation 
after 1 hour
To assess subjects’ preference with ease 
of denture removal, denture comfort and 
adaptationand ease of extrusion of the 
adhesive from the tube
Scores from subject-completed 
questionnaires on ease of denture 
removal, denture comfort and adaptation 
and ease of extrusion of the adhesive 
from the tubeat 12 hours
To assess clinical staff’s preference for 
ease of denture adhesive removal and 
cleaning
Scores from clinical staff-completed 
questionnaire on ease of denture adhesive 
removal after 12 hours
 
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Study Design
Overall Design
This singlecentre, randomized, crossover study will be a randomized three-treatment, 
three-period, examiner blind [to the examiner performing the BF& oral soft tissue 
(OST) examinations]design in subjects with well-made and moderately well-fitting 
maxillary complete dentures. Written informed consent will be obtained from 
participants before the implementation of any study procedure. 
At the ScreeningVisit (Visit 1), subjectswill be screened for eligibility and ability to 
perform the BF manoeuvresaccording to stated inclusion/exclusion criteria.Dentures 
will be removed from the subject’s mouth and cleaned. An ORAL SOFT TISSUE
(OST)examinationwill be performed before the lower denture (if applicable) is 
secured using Super Poligrip Free denture adhesive. The examiner will record 
triplicate bite force measurementswithout denture adhesive.  These will be referred to 
as “training bites” as the subject becomes accustomed to the equipment.  Four (4) 
further BF measurementswill be made; 2 of these 4 ‘qualifying’ bites must be 
reproducible (±2lb) for a subject to be eligible forthe study.  All 4 of the “qualifying” 
bites must be less than or equal to 9 pounds.Subjects meeting all of the inclusion 
criteria with no exclusions will return for Visit 2. 
On each test day (Visits 2-4),subjects will report to the study site without denture 
adhesive placed in their dentures, and will undergo an OST examination and have 
their dentures cleaned. As described for the screeningvisit, the lower denture will be 
stabilized as needed and the three “training bites” and subsequent 4 pre-treatment 
baseline incisal BFmeasurements will be obtained. Denture adhesive treatment (or no 
treatment as per the randomization schedule) will thenbe applied by a member of 
study staff (ideally the same member of staff throughout the study) as per the 
application instructions,and the dentures will be worn by the subject. Incisal BF
measurements will be made at 0.5, 1, 3, 6, 9 and 12 hours after thedentures are 
placed in the mouth. After 0.5 hours assessment the subjects will be asked to answer a 
short questionnaireabout product ooze (Appendix II). The questions will be 
completed by the subjects themselves and these responseswill then be given to study 
site staff to transcribe to the electronic Case Report Form (eCRF). At the one hour 
time point, subjects will complete another short questionnaire relating to the after-
taste and texture of the assigned denture adhesive(Appendix III). This will be 
completed by the subject in a quiet environment without external influence. Again, 
study staff will transcribe subject responses to the eCRF.
 
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Immediately following the last (12 hour) incisal BFmeasurement, subjects will 
remove their upper dentures by themselves and will remove excess adhesive from the 
mouth, facilitated by and removal confirmed by site study staff prior to the final OST 
exam.  Subjects will be asked to answer another short questionnaire (which will be 
administered by the site staff) pertaining to ease of removal of the denture from the 
mouth as well as preferences concerning denture fit and comfort, likes and dislikes
over the 12 hour period(Appendix IV, Questions 1-4) and ease of extrusion of the 
adhesive from the tube (Appendix IV, Question 5). No questionnaire will be 
administered for the negative/no treatment control arm. All subject responses will be 
transcribed by site staff to the eCRF. Following denture removal, and completion of 
the associated questionnaire, site staff will clean the denture before returning to the 
subjectat the end of the treatment phase. Site staff will also be asked to evaluate the 
ease of cleaning the denture adhesive from the denture(Appendix V).
These assessments will be followed by the final post-treatmentOST 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 BF
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
OSTexamination including edentulous maxillary arch
Denture bearing tissue score
Kapur Index assessment
Denture cleansing
Mandibular denture stabilization (with Super Poligrip Free adhesive, if 
deemed to be necessary to ensure accurate BFmeasures; at the discretion of 
the Investigator)
Three incisal BFreadings with no adhesive on upper denture (for training)
Incisal BFwith no adhesive on the upper denture (qualifying)
Inclusion/exclusion criteria (following initial BFmeasures)
Subject eligibility
Adverse events (AEs) and incident reporting(REPORTED assessedfrom the 
END OF THEOST ASSESSMENT)
 
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Visits 2, 3, & 4
The following assessments will be conducted:
Review of current/concomitant medications, adverse events and incidents
OSTexamination including edentulous maxillary arch
Denture cleansing
Mandibular denture stabilization (with Super Poligrip Free adhesive, if 
deemed to be necessary to ensure accurate BFmeasures; at the discretion of 
the Investigator)
Three incisal BFreadings with no adhesive on the upper denture (for practice)
Incisal BFwith no adhesive on the upper denture (pre-treatment “baseline”)
Subject eligibility
Adverse events and incident reporting (assessed pre-BF measurement)
Continued eligibility
Randomisation (Test/Treatment day 1 only)
Weigh maxillary denture prior to adhesive placement.
Product applicationby 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 used), so that 1 ± -0.05gram1 ± 
0.05gram denture adhesive is applied
Dentures of subjects randomized to a denture adhesive shall be weighed 
before & after adhesive application
Upper denture insertion by subject
Incisal BFmeasurements (at 0.5, 1, 3, 6, 9 & 12 hours post adhesive 
application)
Subject evaluation questionnaire (product ooze) 0.5 hours post adhesive 
application (Appendix II)
Subject sensory questionnaire (flavour, after-taste/texture, denture comfort & 
adaptationof the adhesive) immediately following the 1 hour BF measures 
whilst upper denture still retained in the mouth(Appendix III)
Removal of denture from the mouth by the subjectfollowing the 12 hour BF 
measurement
Removal of excess adhesive from the mouth by the subjectfacilitated by and 
confirmed bysite study staff prior to the OST exam
REMOVAL OF EXCESS ADHESIVE FROM THE MOUTH BY THE 
SUBJECT IN THEIR USUAL MANNER WITH, FACILITATED BY
SITE STUDY STAFF TO CONFIRM THE ABSENCE OF ANY 
EXCESS DENTURE ADHESIVE PRIOR TO THE OST EXAM
Subject denture removal questionnaire immediately following the 12 hour 
 
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post adhesive application BFmeasure, completion of subject sensory 
questionnaire and subsequent removal of the upper denture(Appendix IV, 
Questions 1-4)
Subject sensory questionnaire regarding extrusion of the adhesive from the 
tube only after the last (12 hr) BF measure (Appendix IV, Question 5)
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 leavethe clinic site
Post-treatment OSTexamination by a blinded examiner
Dentures cleaned and returned to subject
Site staff evaluate the ease of cleaning the denture adhesive from the denture
(Appendix V)
Adverse events and incident reporting (assessed post BFmeasurement).
There will be at least 24 hours (up to 7 days) between subsequent treatment days to 
allow recovery from the bite force procedures.
Type and Planned Number of Subjects
Approximately 50UP TO 75subjects will be screened to randomize approximately 
45 subjectsto ensure that 42 evaluable subjects complete the study.
A sample size of 42 subjects completing all treatment periods will provide 90%
power to demonstrate study success. Study success is defined as achieving both (a)
study validity (Super Poligrip Free superior to no adhesive) and (b) superiority of the
Protefix product compared to no adhesive (primary objective). The clinically relevant
difference detectable is 2.30 lbs for AOB(0-12 hrs), using two-sided t-tests with a 5%
significance level, assuming a residual standard deviation (square root of within mean
square error) of 2.83 lbs. The estimate of residual standard deviation was obtained as
the higher of the observed variability from two previous bite force studies conducted
at OHRI (GSK studies 
).
Diagnosis and Main Criteria for Inclusion
Healthy male and female subjects, aged between 18 to 85 yearsof age, selected from 
the OHRIvolunteer 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
Reference Product 
Negative 
Control
Product Name 
Protefix® Denture 
Adhesive, Crème Mint 
(Germany marketplace)
Super Poligrip® Free 
Adhesive Cream (USA 
marketplace)
No adhesive
Master
Formulation 
Code (MFC)
N/A
N/A
Dose
5 strips for upper denture, 
as per the application 
instructions
3 dabs for upper denture, as 
per the product label 
application instructions
N/A
Route of 
Administration
Oral topical
Oral topical
N/A
Dosing 
Instructions
applied to clean wet 
denture fit surface in a 
pattern consistent with the 
product label and 
application instructions
applied to clean dry denture 
fit surface in a pattern 
consistent with the product 
label application instructions 
N/A
The Protefix test denture adhesive and the Super Poligrip Free denture adhesive 
cream will be supplied in their respective commercially marketed tube. Samples will 
be overwrapped so as not to potentially bias subject response on the sensory questions 
following BF measures. A study label will be affixed to each sample.
Statistical Methods
Incisal Bite Force (lbs): Area over Baseline (AOB0-12):
AOB over 12 hours for the incisal BF (lbs) (denoted byAOB0-12) is the primary 
efficacy variable. To calculate this variable first the Areaunder the Curve (AUC) is 
calculated from 0 to 12 hours using the trapezoid method;we denote this by AUC0-12. 
AOB0-12is defined as (AUC
0-12)/12 minus baseline BF(lbs). This transformation will 
return the measurement to the same scale as theoriginal observations whilst also 
looking at the average amount of improved forceover time by subtracting the 
 
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baseline value (AOB). Highervalues of AOB demonstrate a stronger BF over time 
than lower values.
Missing readings will be ignored and interpolation will be made between pre and post
the missing values, if necessary. In the case of more than one missing value or if the
12 hour value is missing, the AOB will be set to missing.
An Analysis of Covariance (ANCOVA) model will be used to analyse AOB
0-12, 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. Pairwise treatment comparisons will be obtained as a
difference in adjusted means, and presented with 95% confidence intervals and
associated p-values.
Violations of normality and homogeneity of variance assumptions will be evaluated
and if found will be overcome using transformations or performing a non-parametric
analysis.
The primary objective is to compare incisal bite force of the test adhesive versus no
adhesive over 12 hours, AOB
0-12. The study validity will first be evaluated by
comparing Super PoligripFree vs no adhesive for AOB0-12. Demonstrating study
validity (p<0.05 for Super PoligripFree vs no adhesive) is a prerequisite to
performing all other treatment comparisons. No further significance testing will be
performed if the initial validation step is not achieved.
AOBfor 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 statistics only 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 dentures for 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. The BF clinical model has been used successfully to 
demonstrate the efficacy of cream denture adhesives to improve denture hold for 12 
hours and as early as one hour after the adhesive application, while also 
demonstrating differences in strength among various adhesive formulations[Chew et 
al. 1984, 1985; Grasso et al. 2004; GSK 
, GSK 
, GSK 
 
and GSK 
]. This study investigates bite force(BF) as a measurement of 
retention of the maxillary denture. 
The objective of this 3-treatment, 3-period, randomized, crossoverBF study is to 
compare BF measurements over a 12-hour period of a currently marketed denture 
adhesive cream based on carbomer technology, with a currently marketed denture 
adhesive cream (positive control), and a no treatment control.The test denture 
adhesive formulation, Protefix
®, marketed by Queisser Pharma, is a carbomer based 
formulation that has shown good adhesive properties in vitro and claims to achieve 
better complete denture hold and food sealing.  Super Poligrip Free, a commercially 
available denture adhesive product marketed by GSKCH globally, will be used as the 
positive control. The third arm will be a ‘no adhesive’ control.A short questionnaire 
regarding the flavour and texture characteristics of each dentureadhesive after a 
single use will also be administered to give an indication of subject satisfaction of 
these attributes. 
In this study, a BFtransducer 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 acceptable and 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 and moderately well-fitting using the design and construction 
criteria used previously (GSK studies 
). BF 
 
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measurements will be taken over a 12-hour time period to compare the strength of the 
Protefix adhesive over time against the positive and negative (no adhesive) controls.
2. OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Validation:
To compare incisal BF for Super Poligrip
Free denture adhesiveversus no adhesive 
over12 hours
AOB up to12 hours.
Primary
To compare incisal BF for Protefix 
denture adhesive versus no adhesive over
12 hours
AOBup to12 hours.
Exploratory:
To compare incisal BF for Protefix
denture adhesive versus Super Poligrip 
Free denture adhesive over12 hours.
AOBupto 12 hours.
To compare incisal BF for Super Poligrip 
Free denture adhesive versus no adhesive 
over 9 hours
AOB up to0.5, 1, 3, 6 and 9 hours
To compare incisal BF for Protefix 
denture adhesive versus no adhesive over 
9 hours
AOB up to 0.5, 1, 3, 6 and 9 hours
To assess subjects’ preference with 
regards to denture adhesive ooze
Scores from subject-completed 
questionnaireon product ooze, at 0.5 
hoursuse
To assess subject’s preference with 
flavour/after-taste and texture, denture 
comfort and adaptation
Scores from subject-completed 
questionnaire on flavour/after-taste and 
texture, denture comfort and adaptation 
after 1 hour
To assess subjects’ preference with ease 
of denture removal, denture comfort and 
adaptationand ease of extrusion of the 
adhesive from the tube
Scores from subject-completed 
questionnaires on ease of denture 
removal, denture comfort and adaptation 
and ease of extrusion of the adhesive 
from the tubeat 12 hours
To assess clinical staff’s preference for 
ease of denture adhesive removal and 
cleaning
Scores from clinical staff-completed 
questionnaireon ease of denture adhesive 
removal after 12 hours
 
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3. STUDY PLAN
3.1. Study Design
Overall Design
This single centre, crossoverstudy will be a randomized threetreatment,three-period,
examiner blind [to the examiner performing the BF& OST examinations]design in 
subjects with well-made and moderately well-fitting maxillary complete dentures. 
Written informed consent will be obtained from participants before the 
implementation of any study procedure. 
At the ScreeningVisit (Visit 1), subjectswill be screened for eligibility and ability to 
perform the BF manoeuvresaccording to stated inclusion/exclusion criteria.Dentures 
will be removed from the subject’s mouth and cleaned. An OST examination will be 
performed before the lower denture (if applicable) is secured using Super Poligrip 
Free denture adhesive. The examiner will record triplicate bite force measurements
without denture adhesive.  These will be referred to as “training bites” as the subject 
becomes accustomed to the equipment.  Four (4) further BF measurementswill be 
made; 2 of these 4 ‘qualifying’ bites must be reproducible (±2lb) for a subject to be 
eligible forthe study.  All 4 of the “qualifying” bites must be less than or equal to 9 
pounds.Subjects meeting all of the inclusion criteria with no exclusions will return 
for Visit 2. 
On each test day (Visits 2-4),subjects will report to the study site without denture 
adhesive placed in their dentures, and will undergo an OST examination and have 
their dentures cleaned. As described for the screening visit, the lower denture will be 
stabilized as needed and the three “training bites” and subsequent 4 pre-treatment 
baseline incisal BFmeasurements will be obtained. 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 will be worn by the subject. Incisal BF 
measurements will be made at 0.5, 1, 3, 6, 9 and 12 hours after the dentures are 
placed in the mouth. After the 0.5 hoursassessment the subjects will be asked to 
answer a short questionnaireabout 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 transcribe to the eCRF. At the one hour time point, subjects will complete 
another short questionnaire relating to the after-taste and texture of the assigned 
denture adhesive(Appendix III). This will be completed bythe subject in a quiet 
environment without external influence. Again, study staff will transcribe subject 
 
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responses to the eCRF.
Immediately following the last (12 hour) incisal BF measurement, subjects will 
remove their upper dentures by themselves and will remove excess adhesive from 
theirmouth, facilitated by site study staff when necessary.  Subjects will be asked to 
answer another short questionnaire (which will be administered by the site staff) 
pertaining to ease of removal of the denture from themouth as well as likes and 
dislikes of the adhesive, preferences concerning denture fit and comfort over the 12-
hour period(Appendix IV, Questions 1-4) and ease of extrusion of adhesive from the 
tube (Appendix IV, Question 5). No questionnaire will be administered for the 
negative/no treatment control arm. All subject responses will be transcribed by site 
staff to the eCRF. Following denture removal, and completion of the associated 
questionnaire, site staff will clean the denture before returning to the subjectat the 
end of the treatment phase. Site staff will also be asked to evaluate the ease of 
cleaning the denture adhesive from the denture(Appendix V).  
These assessments will be followed by the finalpost-treatment OST examination by 
theblinded examiner.  The final OST exam will be conducted only after study
 staff 
have confirmed that excess adhesive is removed from the subject’s mouth.
All procedures will be repeated in a crossover manner. There will be at least 24 hours 
(up to 7 days) between treatment visits to allow recovery from the BFprocedures.
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
OSTexamination including edentulous maxillary arch
Denture bearing tissue score
Kapur Index assessment
Denture cleansing
Mandibular denture stabilization (with Super Poligrip Free adhesive, if 
deemed to be necessary to ensure accurate BF measures; at the discretion of 
the Investigator)
Three incisal BF readings with no adhesive on upper denture (for training)
Incisal BF with no adhesive on the upper denture (qualifying)
 
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Inclusion/exclusion criteria (following initial BF measures)
Subject eligibility
Adverse events and incident reporting (assessed from the OST 
ASSESSMENTstart of the first BF measurement)
Visits 2, 3 & 4
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 (withSuper Poligrip Freeadhesive, if 
deemed to be necessary to ensure accurate BF measures; at the discretion of
the Investigator)
Three incisal BF readings with no adhesive on the upper denture (for practice)
Incisal BF with no adhesive on the upper denture (pre-treatment “baseline”)
Subject eligibility
Adverse events and incident reporting (assessed pre-BF 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 used), so that 1 ± -0.05gram1 ± 
0.05g denture adhesive is applied
Dentures of subjects randomized to a denture adhesive shall be weighed 
before & after adhesive application
Upper denture insertion by subject
Incisal BF measurements (at 0.5, 1, 3, 6, 9 & 12 hours post adhesive 
application)
Subject evaluation questionnaire (product ooze) 0.5 hours post adhesive 
application (Appendix II)
Subject sensory questionnaire (flavour, after-taste/texture, denture comfort & 
adaptation of the adhesive) immediately following the 1 hour BF measures 
whilst upper denture still retained in the mouth (Appendix III)
Removal of denture from the mouth by the subject following the 12 hour BF 
measurement
Removal of excess adhesive from the mouth by the subject IN THEIR 
USUAL MANNERWITH,facilitated bysite study staff to confirm the 
absence of any excess denture adhesive prior to the OSTexam
 
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Subject denture removal questionnaire immediatelyfollowing the 12 hour 
post adhesive application BF measure, completion of subject sensory 
questionnaire and subsequent removal of the upper denture (Appendix IV, 
Questions 1-4)
Subject sensory questionnaire regarding extrusion of the adhesive from the 
tube only after the last (12 hr) BF measure (Appendix IV, Question 5)
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 the clinic site
Post-treatment OSTexamination by a blindedexaminer
Dentures cleaned and returned to subject
Site staff evaluate the ease of cleaning the denture adhesive from the denture 
(Appendix V).
Adverse events and incident reporting (assessed post BF measurement)
There will be at least 24 hours (up to 7 days) between subsequent treatment days to 
allow recovery from the bite force procedures.
3.2. Subject Restrictions
Lifestyle/ Dietary
During the entire study (screening to Last Subject Last Visit [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 ofthe 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 the routineduring 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. 
 
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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 be permitted 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 50UP TO 75subjects will be screened to randomize approximately 
45 subjectsto ensure that 42 evaluable subjects complete the study.
A sample size of 42 subjects completing all treatment periods will provide 90%
power to demonstrate study success. Study success is defined as achieving both (a)
study validity (Super PoligripFree adhesivesuperior to no adhesive) and (b) 
superiority of theProtefix adhesive product compared to no adhesive (primary 
objective). The clinically relevantdifference detectable is 2.30 lbs for AOB(0-12 
hrs), using two-sided t-tests with a 5%significance level, assuming a residual 
standard deviation (square root of within meansquare error) of 2.83 lbs. The estimate 
of residual standard deviation wasobtained asthe higher of the observed variability 
from two previous bite force studies conductedat OHRI (GSK studies  
 and 
).
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 
subject comparison (i.e. a crossover design). A crossover design has been chosen 
because BFmeasurements have high inter-subject variation; the crossover design will 
allow each subject to act as their own control.
Incisal BFuntil 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. 
 
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A screening BFwill be taken to allow subjects to train in how to bite in a consistent 
manner for BFtechnique and to allow the examiner to establish whether subjects 
understand and are able to conduct the necessary manoeuvres. Baseline BFwill be 
taken on each test day to allow the subjects to train and practice the BFtechnique at 
each visit. 
To minimize the possibility of carryover effects from study treatments or procedures, 
a washout period of at least 24 hours has been scheduled between each treatment 
visit.
The study will be blinded with respect to the dental examiner performing the BF
measures and pre and post-treatment OST examinationin order to reduce the risk of 
bias. The OST exam will be conducted after the 12 hour BF reading and after study 
staff haveconfirmedthat all residual denture adhesive has been removed. The 
subjects will not be blinded to the study treatmentssince they will know when they 
do not receive an adhesive treatmentand will be instructed not to disclose their 
treatment to the examiner. To maintain examiner blinding, subjects in the no-adhesive 
group are instructed not to inform the examiner that they did not receive an adhesive
treatment. 
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. Protefix denture adhesive, with a mixture of carbomer and 
carboxymethyl cellulose, is currently marketed in Central and Eastern European
countriesand is the testformulation. The superior performance of Protefix to the no 
adhesive treatment is required for treatment success.  
The dosing regimenwill be consistent with the product application instructionsof 
eachmarketed product. A total of 1±0.05 gram (weighed) of denture adhesive will be 
applied to the maxillary denture in a pattern consistent with the product label and 
application instructions. Use of denture adhesives isonly promoted and
recommended in well-fitting dentures, and therefore only subjects willwell-made and 
moderately 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 allowsinterpretation ofthe 
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 adhesive 
control will allow for variation in BFtechnique over the test period, and enables Area 
 
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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 informed consent form. 
2. AGE
Aged between 18 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
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 
 
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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 BFreadings (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. Insulin dependent diabetics.
d. Taking or have taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, 
Boniva®) for treatment of osteoporosis.
e. A serious chronic disease requiring hospitalization.
f. Any condition not previously mentioned that in the Investigator’s opinion may 
impair the study evaluation.
 
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4. ALLERGY/ INTOLERANCE
Known or suspected intolerance or hypersensitivity to the study materials (or closely 
related compounds) or any of their statedingredients.
5. DENTAL HEALTH / ORAL CONDITIONS
a. Any clinically significant or relevant oral abnormality (e.g. 
temporomandibular joint [TMJ] problems) that, in the opinion of the 
investigator, could affect the subject’s participation in the study.
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. Participation in another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30 days 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.
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 be allowed in this study.
 
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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 
eCRF.  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’srecord. 
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.
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.
 
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5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Test Product 
Reference Product 
Negative 
Control
Product Name 
Protefix® Denture 
Adhesive, Crème Mint 
(Germany marketplace)
Super Poligrip® Free
Adhesive Cream (USA 
marketplace)
No 
adhesive
Master
Formulation 
Code (MFC)
N/A
N/A
Dose
5 stripsfor upper denture, 
as perapplication 
instructions
3 dabs for upper 
denture, as per 
application instructions
N/A
Route of 
Administration
Oral topical
Oral topical
N/A
Dosing 
Instructions
applied to clean wet
denture fit surface in a 
pattern consistent with the 
product label and 
application instructions
applied to clean dry 
denture fit surface in a 
pattern consistent with 
the product label and 
application instructions
N/A
 
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CCI

Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Super PoligripFree Adhesive Cream 
(USA marketplace)
To stabilize the lower denture (apply 2 dabs 
to the lower denture [if required]; to retain
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
Spatulas (Square Tips)
Spreading dental caulk on transducer prong
Small and Large Anti-Static 
Weighing Boats
Weighing and transporting dentures
The site will supply Disposable Barrier Sleeves -to cover the transducer. 
The Protefix test denture adhesive and the Super Poligrip Free denture adhesive 
cream reference product will be supplied in their respective commercially marketed 
tube. Samples will be overwrapped in white opaque vinyl so as not to potentially bias 
subject response on the sensory questions following BF measures. 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. Super Poligrip for lower denture 
stabilisation will be supplied in commercial packaging with a label indicating "For 
Lower Denture Stabilization".
Care should be taken with the supplied study products and their labels so that they are 
maintained in a good condition. It is important that all labels remain intact and legible 
for the duration of the study. Subjects will be instructed to not remove or deface any 
part of the study label while completing the sensory questionnaire following BF 
measures.
The site will provide paper copies of any 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 dentureadhesives will be appliedby the Site Study Staff, per the randomisation 
schedule,to a clean upper completedenture following the pre-treatment baseline BF
measurement in accordance with the product Application Instructions (Appendix VI 
and VII). 
For the positive control, Super PoligripFree denture adhesive, clean and dry upper 
complete denture will be weighed and masses recorded prior to and immediately 
following denture adhesive application. 
For the test adhesive, clean and wetupper complete dentures will be weighed and 
their masses recorded before and afteradhesive application. 
For all products, a total of 1±0.05 gram(weighed) of denture adhesive will be applied 
to the maxillary denture in a pattern consistent with the product label and application 
instructions (AppendixVI & VII). 
For all subjects in all arms: SuperPoligrip 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(Appendix VIII).
The masses of the adhesives used will be calculated as the difference in the recorded 
masses pre-and post-adhesive application. These masses will be for information use 
only and are not required for the analysis of the study results. 
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 examinersremain blind. The denture will then be returned to the subject who 
should reposition the 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. 
As stabilisation of the lower denture is necessary for accurate BFmeasurements to be 
performed, reapplication of denture adhesive (to the lower denture only) may be 
performed up to a maximum of 2 timeson any given test dayprovided that; (1) the 
investigator deems it necessary for BF measurements (2) the subject has been 
compliant with the protocol and has not actively washed the adhesive out. 
 
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5.3. Dose Modification
No dose modification is permitted in this study.
5.4. Product Compliance
The adhesive will be applied to dentures by a singlemember of the study staff 
therefore excellent compliance is anticipated. 
5.5.Precautions
No precautions will be necessary as the denture adhesive productswill be applied 
professionally as per marketed product label and the test denture adhesive application 
instructions(AppendicesVI -VII). 
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 subject 
evaluation of the adhesive product extrusion will be closely monitored.
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 SAE reporting 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 apre-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.
 
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5.8.1 Randomization
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 
threetreatments to be used for each of the threetreatment periods. This randomisation 
will use a Williams Square layout and be provided by the Biostatistics Department, 
GSKCH. The study site will receive two randomization schedules, one with treatment 
de-codes and one without. The schedule without the treatment decodes will be used to 
dispense study treatments to the subjects and the schedule with treatment decodes will 
be provided in a sealed envelope and will be available for emergency use only.
5.8.2 Blinding
The examinerwill beblinded to the product allocation of subjects. All study staff 
other than the member of Site Study Staffapplying treatment, THE PRINCIPAL 
INVESTIGATOR, THE OST ASSESSORSand the eCRF recorder 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.  Further, study staff will 
confirm that all residual denture adhesive is removed prior to the final (post-12 hour 
bite force reading) OSTexam by the examiner.  Examiner’s access to aspects of the 
eCRF that are considered at risk of unblinding will be restricted in order to maintain 
study blinding. 
5.8.3 Code 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.
 
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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.
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. Storage of Product
Study product supplies must be stored in compliance with the label requirements in a 
secure place with limited or controlled access.
 
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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 (signedand dated by the subject) 
informed from each subject participating in this study after adequate explanation of 
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 new information becomes 
available that may affect the subject’s willingness to participate in the study, each 
ongoing subject should receive a copy of this new information and be re-consented 
into the study. 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 United States Food and Drug Administration (FDA)
guidelines (Guidance for Industry: Collection of Race and Ethnicity Data in Clinical 
Trials, 2006, FDA) the ethnicity of subjects will be captured as the information may 
 
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be useful in evaluating potential differencesin the safety and efficacy of the treatment 
products among population subgroups.
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 recorded in the eCRF.  Any 
concomitant therapy taken in the 30 days prior to the Screening Visit and throughout 
the study will also be recorded in the CRF.
6.1.5. Dental History
The Investigator, or medically qualified designee, will take a dental history from each 
subject and recordin the CRF.  Dental history will include information of all 
prostheses in the mouth, maxillary and mandibular, as well as information regarding 
the age of the dentures, and how long the subject has worn dentures.  Documentation 
of prosthetic teeth material will also be recorded by the Investigator in the CRF.
6.1.6. Well-Made Denture Assessment
The examiner will examine each subject’s denture in the maxilla and mandible (if 
present) to determineif he/she considers it to be well made i.e.:
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, colour 
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 gingival mucosa (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 
 
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abnormalities will also be recorded.  Adverse events and incident reporting will be 
REPORTEDassessedfrom the first OST examination at screening.and following 
the first BF measurement.
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 maxillary denture 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.   
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   *
 
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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 score and 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
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
 
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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/exclusion criteria (section 4). 
6.1.10. Denture cleansing
Dentures will be removed from the mouth by the subject. Prior to application of the
assigned denture adhesive, denture cleansing will 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. Immediately following the 12 hrs BF
measurement and following the removal of the upper denture from the mouth by the
subject, site staff will clean denture adhesive from the denture, as described,prior to 
returning thedenture to the subject. Site staff will evaluate the ease of cleaning the 
dentureadhesive from the denture on a 1 to 5 scale (1 = Not at all easy, 2 = slightly 
easy, 3 =moderately easy, 4 = Very easy, and 5 = extremely easy.
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) will be fully stabilized by the investigator using Super Poligrip 
Free Denture Adhesive Cream. This will be completed, when necessary, for all 
screening, practice, training and test bite force measurements.
6.1.12. Bite Force Measurement System
A bite force transducer system will be supplied by GSKCH and used to measure 
incisal bite force needed to dislodge the maxillary denture.  The transducer system is 
composed of two plates embedded with a strain gauge that measures displacement of 
the upper denture during biting.  
 
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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.  ACertificate of Calibration (validfor 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) will instruct the subjects 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 material in 
order to facilitate anterior denture tooth placement on the bite force transducer.  The 
examiner willinstruct 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 
 
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“qualifying” bites must be less than or equal to 9 pounds.These BF readings 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 will be performed as 
previously described(Section 6.1.10). Denture adhesive will be applied to the
denturesby a suitably qualified member of site staff (blinded to the investigator 
collecting efficacy measures) as per the Denture Adhesive Application Instructions 
(Appendix VI& VII). Upper dentures shall be weighed before and after adhesive 
application, and weights (including weight of adhesive used) recorded in the eCRF. 
Weight differences should be calculated to ensure so that 1 ± 0.05gramdenture 
adhesive is applied.
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. 
On each treatmentday, 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 Day pre-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. Additional bite force measures will take 
place at 0.5hour(immediately prior to completion of product ooze questionnaire) 
followed by 1, 3, 6, 9 and 12 hours after application of each test adhesive (or no 
treatment as per the randomization schedule). 
 
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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
Subjectquestionnaires will only be completed during treatment visits whensubjects 
are assigned to adhesive.  To ensure that the examiner is blinded to the assignment of 
denture adhesive treatment, the examiner will not have access to these questionnaires 
and should not have knowledge of who is completing the questionnaires. 
A questionnaire pertaining to product ooze will be completed by the subjects 
immediately after the 0.5 hrBFmeasurement (Appendix II). Furthermore, a 
questionnaire regarding sensory attributes aroundflavour, texture, denture fit and 
comfort will be completed immediately after the onehour BF measurement, whilst 
the upper denture is still retained in the mouth (Appendix III).Immediately following 
the last (12 hour) incisal BF measurement,subjects will answer another short 
questionnaire pertaining to ease of removal of thedenture from the mouth as well as 
likes and dislikes of the adhesive over the 12 hourperiod (Appendix IV, Questions 1-
4). Completion of this questionnaire after the 12hrs BF measurement will also 
involve the subject extruding some denture adhesiveonto paper prior to answering 
the question regarding ease of product extrusion fromthe tube (Appendix IV, 
Question 5). This final “denture questionnaire” must bereviewed by Study Staff 
immediately following completion whilst the subject is stillpresent, in order to ensure 
that any potential AEs that may be included in the free textof questions are 
investigated by Study Staff and transcribed to the eCRF.
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 assigned tothe ‘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 4; Appendix IV). 
 
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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) Lost to 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 
or washout product, whether or not considered related to the investigational or 
washout product.
NOTE: An AE can therefore be any unfavourable 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.
Adverse events and incident reporting(assessed from the END start of the 
END OF THE OST ASSESSMENTfirst BF measurementat screening)
Events meeting AE definition include:
Any abnormal laboratory test results (if applicable) or other safety 
assessments, including those that worsen from baseline, and felt to be 
clinically significant in the medical and scientific judgment of the 
investigator.
 
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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 AEinclude:
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 
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 appropriate in 
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 
 
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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 disability means a substantial disruption of a person’s ability 
to conduct normal life functions.
This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may 
interfere 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 in deciding 
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, 
blood dyscrasias or convulsions that do not result in hospitalization or 
development of drug dependency or drug abuse or reports of 
spontaneous abortion.
7.2. Recording Adverse Events and Serious Adverse Events
Recording of adverse events and seriousadverse events:
The investigator or site staff will be responsible for detecting, documenting 
and reporting events that meet the definition of an AE or SAE. 
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 submissionto 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 as the AE/SAE and not the individual 
signs/symptoms. Clinical AEs will be described by diagnosis and not by 
 
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symptoms when possible (e.g., upper respiratory tract infection, seasonal 
allergy, etc. instead of runny nose).
AEs will be collected from the beginning of theScreening Visit(assessed 
from the start of theEND OF THE OST ASSESSMENTfirst BF 
measurement)and 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-upcontact.  
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 Events and 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.
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 
 
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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 Events and 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 subjectthe 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 
existing data.
SAE Reporting to GSKCH:
A paper copy of the SAE form provided in the investigator study master file should 
be completed asfully as possible. 
It is essential to enter the following information: 
Protocol and subject identifiers
Subject’s demography
Description of events, with diagnosis if available
 
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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
Actiontaken on 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 fax or email to: 
Fax the Incident Report Forms to:
US: 
The GSKCH Study Managerwill be responsible for forwarding the SAE form to the 
Case Management Group, Global Clinical Safety and Pharmacovigilance, 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 Events and 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, 
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 obligedto actively seek AEs or SAEs in former subjects.  
However, if the investigator learns of any SAE, including the death, at any 
 
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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 safety information (e.g., summary of listing of SAEs) from 
GSKCH will file it with the Investigator Brochure (or safety statement) and 
will notify the IRB , if appropriate 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.
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 ledto the death of a 
patient or useror of other persons or to a serious deterioration in their state of 
health.
 
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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 fax or 
email to: 
Fax the Incident Report Forms to:
US:
or
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.
Reporting ofMalfunctions 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.
 
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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 the originally 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 information relating 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.
7.7. Collection of Pregnancy Information
7.7.1. Time Period for Collecting of Pregnancy Information
Collection of Pregnancy Information:
Pregnancy information will be collected on all pregnancies reported following 
administration of any investigational product. Information on pregnancy 
 
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identified during the screening phase and prior to investigational product 
administration does not need to be collected.
7.7.2. Action to be Taken if Pregnancy Occurs
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 following the 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 to the 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.
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 
 
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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 datae.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 querytext.
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.  Datathat is sourced elsewhere should be entered into 
the CRF in an agreed upon timeframe between the Investigator and Sponsor.  
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.
 
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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 recordof 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 theterms (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 System to 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 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 50UP TO 75subjects will be screened to randomize approximately 
45 subjectsto ensure that 42 evaluable subjects complete the study.
A sample size of 42 subjects completing all treatment periods will provide 90%
power to demonstrate study success. Study success is defined as achieving both (a)
study validity (Super PoligripFreesuperior to no adhesive) and (b) superiority of the
Protefix product compared to no adhesive (primary objective). The clinically relevant
difference detectable is 2.30 lbs for AOB
0-12, using two-sided t-tests with a 5%
significance level, assuming aresidual standard deviation (square root of within mean
square error) of 2.83 lbs. The estimate of residual standard deviation was obtained as
the higher of the observed variability from two previous bite force studies conducted
at OHRI (GSK studies 
).
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 intention-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 
 
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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 evaluablein 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, 
which it 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 Clinical Research
Director/Scientist or designee, ahead of breaking the study blind. Further details of 
methodology foridentifying data to be included in PP analysis will be provided in the 
SAP.
9.2.3. Criteria for Evaluation
9.2.3.1.Criteria for Assessing Efficacy
Efficacy will primarily be assessed by AOB over 12 hours for the incisal bite force 
(lbs) (denoted by AOB
0-12).
The primary objective is to compare incisal bite force of the test adhesive versus no 
adhesive over 12 hours, AOB
0-12.  The study validity will first be evaluated by 
comparing Super Poligrip Free vs no adhesivefor AOB
0-12.Demonstrating study 
validity (p<0.05 for Super Poligrip Free vs no adhesive) is a prerequisite to 
performing all other treatment comparisons.  No further significance testing will be 
performed if the initial validation step is not achieved.
 
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Therefore, study success is defined as achieving both (a)study validity (Super 
Poligrip Free superior to no adhesive) and (b) superiority of theProtefix product 
compared to no adhesive (primary objective).
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 AOB0-12, linear interpolation will be used in the case of missing 
values. If more than one of the assessments during the 12 hour period is missingor if 
the 12 hour value is missing, the AOB0-12will be set to missing.The same missing 
data handling rule will be applied to the calculation of AOB over 0.5, 1, 3, 6 and 9 
hours.
9.3. Statistical Methods and Analytical Plan
More details of the proposed statistical analysis will be documented in the statistical 
analysis plan, which will be written followingfinalisationof the protocol and prior to 
studyunblinding.
9.3.1. Demographic and Baseline Characteristics
Descriptive statistics (number of subjects, mean, standard deviation (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
Incisal Bite Force (lbs): AOB0-12Super Poligrip versus no adhesive
The AOB over 12 hours for the incisal BF (lbs) (denoted byAOB0-12) is the primary 
efficacy variable. To calculate this variable first the AUC is calculated from 0 to 12 
hours using the trapezoid method;we denote this by AUC0-12. AOB
0-12is defined as 
(AUC
0-12)/12 minus baseline BF(lbs). This transformation will return the 
measurement to the same scale as theoriginal observations whilst also looking at the 
average amount of improved forceover time by subtracting the baseline value 
 
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(AOB). Highervalues of AOB demonstrate a stronger BF over time than lower 
values.
Missing readings will be ignored and interpolation will be made between pre and post
the missing values, if necessary. In the case of more than one missing value or if the
12 hour value is missing, the AOB will be set to missing.
An ANCOVA model will be used to analyse AOB0-12, withtreatment and period as 
fixed effects; the covariates in this model are the subject levelbaseline and period 
level baselineminus subject level baseline. Subject will beincluded as a random 
effect. Pairwise treatment comparisons will be obtained as adifference in adjusted 
means, and presented with 95% confidence intervals(CI)andassociated p-values.
Violations of normality and homogeneity of variance assumptions will be evaluated
and if found will be overcome using transformations or performing a non-parametric
analysis.
The primary objective is to compare incisal bite force of the test adhesive versus no
adhesive over 12hours, AOB0-12. The study validity will first be evaluated by
comparing Super Poligrip Free vs no adhesive for AOB0-12. Demonstrating study
validity (p<0.05 for Super Poligrip Free vs no adhesive) is a prerequisite to
performing all other treatment comparisons. No further significance testing will be
performed if the initial validation step is not achieved.
9.3.3. Secondary Analysis
There are no secondary efficacy variables.
9.3.4. Exploratory Analyses
Incisal Bite Force (lbs): AOB0-12)Protefix versus Super Poligrip 
From the ANCOVA model described above, the treatment difference for Protefix 
adhesive versus Super Poligripin AOB0-12will be provided along with 95% 
confidence intervals and p-values. This test will be conducted at the two sided 5% 
significance level. If non-parametric analysis is performed for the primary efficacy 
variable then this secondary comparison will be performed in a similar way as the 
primary comparisons.
All significance tests will be conducted atthe two sided 5% significance level. The 
assumption of normality and homogeneityof variance will be investigated. Violation 
 
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of these assumptions may be overcomeusing suitable transformationsor performing 
a non-parametric tests (e.g.the WilcoxonSign Ranktest).
Incisal Bite Force (lbs): AOB
0-0.5, AOB0-1, AOB0-3, AOB0-6, AOB0-9
AOB for 0.5, 1, 3, 6 and 9 hours will be defined and analysed in a similar manner as
AOB0-12.From each ANCOVA model, treatment differences between the three 
groups will be provided along with 95% CIsand p-values. In the event that the model 
assumptions are violated, a transformation or non-parametric analysis will be 
performed.
Subjective Questionnaires
The following questionnaire data will be summarized usingsummary statistics only 
and no formal statistical analyses will be performed:
product ooze
flavour/after-taste and texture, denture comfort and adaptation
ease of denture removal, denture comfort and adaptationand ease of extrusion 
of the adhesive from the tube
clinical staff’s preference for ease of denture adhesive removal and cleaning
Denture Adhesive Weight
Denture adhesive weight data (difference between denture weight before and after 
adhesive application) will be summarized usingsummary statistics.
9.3.5. SafetyAnalysis
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 MedDRA. AEs will be categorized as oral and non-oral 
by the clinical researchdirector 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 ofthe safety analyses.
 
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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 enrolmentofsubjects begins.
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 testdenture adhesive (Protefix) 
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/favourableopinion from the IRBfor the 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 protocol are 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.
 
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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:
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 regulatory requirements, 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 orsite staff, as appropriate, in 
accordance with applicable regulations including GCP, and GSKCH Standard 
Operating Procedures.
 
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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: 
If theinvestigator 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 suspends its approval/favourableopinion 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 formatother 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 
 
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there is an acceptable back-up of these reproductions and that an acceptable quality 
control process exists for making these reproductions.
The investigator must assure that the subject’s anonymity will be maintained.  On 
CRFs or other documents submitted to 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 10 years). 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 
that site for the study, as dictated by any institutional requirements or local laws or 
regulations, GSK standards/procedures, and/or institutionalrequirements.  
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 review the 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.
 
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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.
11. REFERENCES
Chew CL, Philips RW, Boone ME, Swartz ML. Denture stabilization withadhesives: 
A kinesiographic study. Compend Contin Educ Dent 1984;
4(supple); S32-8.
Chew CL, Boone ME, Swartz ML, Phillips RW. Denture adhesives: their effectson 
denture retention and stability.  J Dent1985; 13(2):152-159.
Collection of Race and Ethnicity in Clinical Trials (October 2016) 
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-
gen/documents/document/ucm126396.pdf
Grasso JE, Denture adhesives. Dent Clin North Am 2004;48(3):721-733.
GSKCH
 
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 Practice CPMP/ICH/135/95 17th July 1996.
Kapur KK: A clinical evaluation of denture adhesive. J Prosthet Dent1967;18:550-
558.
 
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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.
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, 
2013.
 
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12. APPENDICES
12.1. Appendix I-Abbreviations
AE 
Adverse Event
ANCOVA
Analysis of Covariance
AOB
Area over baseline
ATRT
As per treatment
AUC
Area under the Curve
BF
Bite Force
CD
Compact Disc
CI
Confidence Interval
CRF
Case Report Form
DMS
Data management system
EDC
Electronic Data Capture
FDA
Food and Drug Administration
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
lb
Pound
LSLV
Last Subject Last Visit
MedDRA
Medical Dictionary for Regulatory Activities
MFC
Master Formulation Code
NSR
non-significant risk
OST
Oral soft tissue
PII
Personally Identifiable Information
PP
Per Protocol
PRO
Patient Reported Outcome
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Standard deviation
SMI
Specialty Measurements Incorporated
TMJ
temporomandibular joint
US
United States of America
 
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Trademark Information
Trademarks of the GlaxoSmithKline group of companies:
POLIGRIP
Protefix is a registered trademark of Queisser Pharma GmbH & Co, Flensburg, 
Germany
 
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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 atthe no adhesive 
treatment visit.
Questions tobe completed by the subjectimmediately after the 0.5 hour bite 
force reading.  
Please mark/ tick only ONEresponse per question. 
1. Did any excess denture adhesive OOZE out from underneath the denture 
after inserting in the mouth? 
No
Yes
IF YES, proceed to answer Question 2
2. If you didexperience excess denture adhesive oozing out, how long after 
inserting your denture did this happen? 
Immediately Less than 10 
minutes 
10 to 20 
minutes
20 to 30 
minutes
More than 
30 minutes 
0
1
2
3
4
 
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12.3. Appendix III–Sensory Questionnaire
Please note that this questionnaire is only completed for subjects on treatment
visits when they have a denture adhesive applied and NOT atthe no adhesive 
treatment visit.
To be completed by the subject immediately following the 1 hour bite force 
measures(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 
slightly
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 TASTE of 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 would you describe the TEXTURE of the denture adhesive? 
Not at all
Slightly
Moderately
Very
Extremely
Smooth
Oily
Gritty
Soft
1 
2
3
4
5
5. How much did you feel the adhesive was providing a CUSHIONING 
EFFECT on your gums?
Not 
cushioning 
at all
A slight 
amount of 
cushioning
A moderate 
amount of 
cushioning
A lot of 
cushioning
Extremely 
cushioning
1 
2 
3 
4 
5
 
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6. How well did you feel the adhesive ADAPTS to the unique shape of your 
gums?
Doesn’t 
adapt at all
Adapts 
slightly
Adapts 
moderately 
well
Adapts very 
well
Adapts 
extremely 
well
1 
2 
3 
4 
5
7. How much did you AGREEor DISAGREEwith the following statements 
about the adhesive?
Extremely 
disagree
Very much 
disagree
Moderately 
disagree
Neither 
agree nor 
disagree
Moderately 
agree
Very much 
agree
Extremely 
agree
7a. Provides a 
feeling of 
COMFORT 
when wearing the 
denture
1 
2 
3 
4 
5 
6 
7
7b.The adhesive 
provides 
COVERAGE 
over my gums
1 
2 
3 
4 
5 
6 
7
 
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12.4. Appendix IV–Denture Removal Questionnaire
To be administered immediately after 12 hourbite forcemeasures and denture 
removal.
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 
ADHESIVE from the mouth? 
Not at all 
easy
Slightly 
easy
Moderately 
easy
Very easy
Extremely 
easy 
1
2
3
4
5
 
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3. How much did you AGREE or DISAGREE with the following statements 
about the adhesive?
Extremely 
disagree
Very much 
disagree
Moderately 
disagree
Neither 
agree nor 
disagree
Moderately 
agree
Very much 
agree
Extremely 
agree
3a. Provides a 
feeling of 
COMFORT 
when wearing the 
denture
1 
2 
3 
4 
5 
6 
7
3b.The adhesive 
provides 
COVERAGE 
over my gums
1 
2 
3 
4 
5 
6 
7
4. Please describe below what you LIKED or DISLIKED about the denture
adhesive.
LIKED
DISLIKED
 
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For the following question subjects willbe given a tube of the adhesive 
product and asked to squeeze the adhesive on to a piece of paper as per 
the strips that appear on the product application 
5. 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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12.5. Appendix V -Questionnaire for Site Staff Cleaning the 
Denture 
This question is addressed to the site staff whoclean the dentures after the 12 
hour measurement, beforereturning denture to the patient at the end of the 
treatment phase. 
1. How EASY was it to REMOVE ANY RESIDUAL DENTURE 
ADHESIVE from the denture?
Not at all 
easy
Slightly 
easy
Moderately 
easy
Very easy
Extremely 
easy 
1
2
3
4
5
 
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12.6 Appendix VI -Denture Adhesive Application Instructions-
Positive Control
ApplyTo Maxillary (Upper) Dentures(Super Poligrip®Free 
Adhesive):
1. Clean and dry dentures.
2. Apply product in short strips as shown in the diagrams, not too close to the 
denture edges (3 strips should be applied to the upper denture).Atotal of 
1±0.05gram(weighed) of denture adhesive will be applied to the upper 
denture.
3. Have subjects rinse their mouth with tap water before inserting denture. 
4. Have subjects press dentures into place, hold firmly, and bite down for a few 
seconds to secure hold.
 
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12.7.Appendix VII–Denture Adhesive Application Instructions 
Test Adhesive
Apply To Maxillary Dentures:
Clean dentures.
Applyproduct(thin strips)to wetdentures as shown in the diagram, not 
too close to the denture edges (5 thin strips to the upper denture).A total 
of 1±0.05 grams (weighed) of denture adhesive will be applied to the 
upper denture.
Have subjects rinse their mouth with tap water before inserting dentures. 
Have subjects press dentures into place, hold firmly, and bite down for a 
few seconds to secure hold.
 
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12.8.Appendix VIII–Lower Denture Adhesive Application 
Instructions 
Application of Super Poligrip®Free Adhesive Cream to Lower 
Dentures (Where Necessary): 
5. Clean and dry dentures.
6. Apply product in short strips as shown in the diagrams, not too close to the 
denture edges (2 strips on the lower denturein the posterior regions, a third 
strip may be applied in the anterior region as needed).
7. Have subjects rinse their mouth with water before inserting dentures. 
8. Have subjects press dentures into place, hold firmly, and bite down for a few 
seconds to secure hold.
 
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Biostatistics Approval
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15-Mar-2017 10:42:07
Clinical Operations Approval
Approved
207545 Clinical Protocol
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