Clinical trial NCT02752958
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Start date: 2016-05-23; Completion date: 2017-02-03
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Changes in oral health related quality of life will be monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Detailed description:
This will be multicenter, non-comparative design to monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers, using the DHEQ. Changes in DH will be monitored clinically over the 24 week treatment period.

Arms: arm 1: This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Interventions: intervention 1: stannous fluoride
Intervention descriptions: intervention 1: 0.454% w/w (weight per weight) stannous fluoride

Protocol documents:
Prot_000.pdf: 
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  An unpublished work subject to trade secret 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.
The Clinical Protocol
204930
 
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CONFIDENTIAL
SUMMARY INFORMATION
Title:
Study to Investigate the Impact on Oral Health Related 
Quality of Life of Managing Dentine Hypersensitivity 
with a Daily Use Anti-Sensitivity Toothpaste 
Protocol Number:
204930
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)UK
Trading Limited
St Georges Avenue, Weybridge, Surrey, KT13 0DE,
United Kingdom (UK)
Tel: 
Product Name:
Dentifrice containing  0.454% w/w stannous fluoride 
(1100ppm fluoride)
Development Phase:
N/A
Expert Advice Outside of Normal 
Working Hours:
Tel: 
PRIMARY CONTACT
Clinical Study Manager:
 BSC HONS
 BSC, 
MSC
ProtocolAuthors:
Clinical Research:
, MSC
Tel:
Biostatistician:
, B.Sc, M.Sc
Clinical Supplies:
 
Principal Investigator:
Robert Maclure, BSc, BDS
Study Site Name & Address:
SITE 1.IntertekClinical Research 
Services (CRS),
2FrederickStreet,Widnes, Cheshire, 
WA8 6PG
 
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SITE 2. INTERTEK CLINICAL 
RESEARCH SERVICES (CRS),
119 STATION ROAD, ELLESMERE 
PORT, CHESHIRE, CH65 4BW, UK
Study Site Telephone Number:
+ 
Study Examiner:
, BSc, BDS
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE
I confirm agreement to conduct the study in compliance with the protocol and 
any amendments and according to the current ICH GCP guidelines.
I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described study.
I agree to ensure that all associates, colleagues and employees assisting in the 
conduct of the study are informed about their obligations. Mechanisms are in 
place to ensure 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:
Dr Robert Maclure
Investigator Qualifications:
BSc, BDS
Investigator Signature:
Date of Signature/ Agreement:
 
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Table of Content
SUMMARY INFORMATION...............................................2
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE..............................................................................3
Table of Content......................................................................4
PROCESS FOR AMENDING THE PROTOCOL...............8
PROTOCOL AMENDMENT PAGE....................................9
PROTOCOL SYNOPSIS FOR STUDY 204930...................15
1. INTRODUCTION...............................................................19
2. OBJECTIVES AND ENDPOINTS....................................21
3. STUDY PLAN.....................................................................21
3.1. Study Design............................................................................21
3.2. Subject Restrictions................................................................23
3.3. Type and Planned Number of Subjects.................................24
3.4. Study Design and Dose Justification......................................25
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA........................................26
4.1. Inclusion Criteria....................................................................26
4.2. Exclusion Criteria...................................................................28
4.3. Screening/ Baseline Failures...................................................29
4.4. Withdrawal/ Stopping Criteria..............................................30
4.5. Subject Replacement...............................................................32
4.6. Subject and Study Completion...............................................32
5. PRODUCT INFORMATION.............................................32
5.1. Study Product..........................................................................32
5.2. Dose Schedule..........................................................................33
 
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5.3. Dose Modification...................................................................33
5.4. Product Compliance...............................................................33
5.5. Precautions..............................................................................33
5.6. Overdose..................................................................................33
5.7. Rescue Therapy.......................................................................34
5.8. Product Assignment................................................................34
5.8.1 Randomisation..........................................................................34
5.8.2 Blinding.....................................................................................34
5.9. Packaging and Labelling........................................................34
5.9.1. Accountability of Product.......................................................35
5.9.2. Storage of Product..................................................................35
6. STUDY ASSESSMENTS AND PROCEDURES..............35
6.1. Visit 1 -Screening Visit...........................................................35
6.1.1 Telephone Screening................................................................35
6.1.2. Informed Consent...................................................................36
6.1.3. Demographics..........................................................................36
6.1.4. Medical History and Concomitant Medication.....................36
6.1.5. Oral Hard Tissue (OHT) Examination..................................36
6.1.6. Oral Soft Tissue (OST) Examination.....................................36
6.1.7. Eligible Tooth Assessment......................................................37
6.2. Visit 2 to Visit 8.......................................................................38
6.2.1. Dentine Hyersensitivity Experience Questionnaire 
(DHEQ)...................................................................................38
6.2.2 Labelled Magnitude Scales (LMS) Training Exercise...........39
6.2.3. Oral Soft Tissue (OST) Examination.....................................39
6.2.4. Evaporative Air Sensitivity Assessments...............................39
6.2.5. Study Conclusion.....................................................................41
7. SAFETY ASSESSMENTS..................................................41
7.1. Definitions of an Adverse Event and Serious Adverse 
Event......................................................................................41
 
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7.1.1. Adverse Events........................................................................41
7.1.2. Serious Adverse Events...........................................................42
7.2. Recording Adverse Events and Serious Adverse Events......43
7.3. Evaluating Adverse Events and Serious Adverse Events.....44
7.4. Reporting Adverse Events andSerious Adverse Events.......45
7.5. Follow-up of Adverse Events and Serious Adverse Events..46
7.6. Definition of and Procedure for Reporting Medical Device 
Incidents................................................................................47
7.6.1. Definition of an Incident.........................................................48
7.6.2. Reporting of Incidents and Malfunctions..............................48
7.6.3. Follow-up of Incidents............................................................49
7.7. Collection of Pregnancy Information.....................................50
7.7.1. Time Period for Collecting of Pregnancy Information.........50
7.7.2. Action to be Taken if Pregnancy Occurs...............................50
8. DATA MANAGEMENT....................................................51
8.1. Source Documents/ Data.........................................................51
8.2. Electronic Case Report Form.................................................51
8.3. Data Handling.........................................................................52
8.3.1. Data Queries............................................................................52
8.4. Processing Patient Reported Outcomes.................................53
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES....................................................................53
9.1 Sample Size Determination......................................................53
9.2. General Considerations..........................................................53
9.2.1. Definition of Analysis Populations.........................................53
9.2.2. Exclusion of Data from Analysis............................................54
9.2.3. Criteria for Evaluation...........................................................54
9.2.4. Criteria for Assessing Efficacy...............................................55
9.2.5. Criteria for Assessing Tolerability.........................................55
 
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9.2.6. Handling of Dropouts and Missing Data...............................55
9.2.7. Other Issues.............................................................................55
9.3. Statistical Methods and Analytical Plan................................55
9.3.1. Demographic and Baseline Characteristics...........................55
9.3.2. Primary Analysis.....................................................................55
9.3.3. Exploratory Analyses..............................................................57
9.3.4. Safety Analyses........................................................................57
9.3.5. Other Analyses........................................................................58
10. STUDY GOVERNANCE CONSIDERATIONS.............58
10.1. Posting of Information on Publicly Available Clinical 
Trials Registers.....................................................................58
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent.................................................................58
10.3. Quality Control (Study Monitoring)....................................58
10.4. Quality Assurance.................................................................59
10.5. Conditions for Terminating the Study.................................59
10.6. Records Retention.................................................................60
10.7. Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication.....................................................61
11. REFERENCES..................................................................62
12. APPENDICES...................................................................64
12.1. Appendix 1 -Abbreviations..................................................64
12.2. Appendix 2 –DHEQ.............................................................66
12.3. APPENDIX 3-SUBJECT INSTRUCTIONS FOR LMS 
TRAINING EXERCISE......................................................89
12.4. APPENDIX 4 -LMS SUBJECT ASSESSMENT FORM 
(EXAMPLE).........................................................................107
 
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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 IECin accordance with local requirements, before the revised edition can 
be implemented. 
All non-substantial/ minor/ administrative amendments should be submitted to the 
IEC as 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
Amendme
nt No. & 
New 
Protocol 
Version 
No.
Type of Amendment
Reason for 
Amendment
Other 
Documents 
Requiring 
Amendmen
t
Section(s) 
Amended 
PI 
Amendmen
t 
Agreement
Signature 
& Date
Amendme
nt No.:
1
Non-
Substantial/Minor    
This is Protocol 
amendment 1 
(Protocol 
version 4.0) as 
previous 
amendments 
(2.0 and 3.0) 
were made 
prior to Ethics 
submission.
Change the 
orientation of 
the LMS scales 
from horizontal 
to vertical. This 
will allow all 4 
scales of the 
LMS Form to 
fit on one page 
making it 
easier for 
subjects to 
complete the 
scales.
Personnel 
changes
Informed 
Consent   
Yes
No
Safety 
Statement     
Yes
No
CRF                       
Yes
No
Page 2-
Personnel 
changes
6.2.1-
Clarification 
text added
Replace 
Appendix 12.3 
and 12.4
Signature:
Protocol 
Version 
No.:
4
Substantial/ Major         
Date:
 
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Clarification 
textadded
Amendme
nt No.:
2
Non-
Substantial/Minor    
Personnel 
changes-
change to 
Study Manager
Due to 
recruitment 
issues at 
Intertek 
Widnes site, a 
second site is 
being initiated 
at Ellesmere 
Port to recruit 
the remaining 
subject 
numbers. 
Addition of 2nd  
site address
Change of text 
from “single 
centre” to 
“multi-site”
Clarify actions 
to be taken if 
subject is 
prescribed 
antibiotics 
during the 
course of the 
study
Informed 
Consent   
Yes
No
Safety 
Statement     
Yes 
No
CRF                       
Yes
No
Page 2-
Personnel 
changes
Page 3-
Summary 
Information
Page14-Brief 
Summary
Page 14-
Overall Design 
Page 20-
Section 3.1 
Study Design
Page 29-4.4
Withdrawal/
Stopping 
criteria
Signature:
Date:
Protocol 
Version 
No.:
5
Substantial/ Major           
 
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Change of text 
regarding how 
LMS scales 
will be 
measured. 
Change text 
from “left to 
right” to 
“bottom to top”
Clarification of 
additional 
statistical 
analysis that 
will be carried 
out to provide 
endpoint 
summaries by 
site
Page 39
Section 6.2.4.2
Labelled 
Magnitude 
Scales (LMS)
Page 55
Section 9.3.2
Primary 
Analysis
Page 55
Section 9.3.3
Exploratory 
Analysis
Amendme
nt No.:
3
Non-
Substantial/Minor    
Personnel 
changes-
change to 
Study 
Statistician and 
clinical 
supplies lead
Due to moving 
from single site 
to a multisite
study, the 
primary and 
exploratory 
analysis has 
been changed 
from paired t 
test to mixed 
effect ANOVA 
Informed 
Consent   
Yes
No
Safety 
Statement     
Yes 
No
CRF                       
Yes
No
Page 2-
Personnel 
changes
Page 55,56-
Section 9.3.2
Primary 
Analysis
Section 9.3.3
Exploratory 
Analysis
Signature:
Protocol 
Version 
No.:
6
Substantial/ Major           
Date:
 
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foraccounting 
effects by site.
 
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SCHEDULE OF EVENTS
Procedure
Screening
Visit1
Baseline
Visit2 
Week 0
(Day0)
Visit3
Week 4 
(Day28 ±3)
Visit4
Week 8
(Day56 ±3)
Visit5
Week 12 
(Day84±3)
Visit 6
Week 16 
(Day112 ±3)
Visit7
Week 20 
(Day140 ±3)
Visit8
Week 24 
(Day168 ±3)
Informed Consent
X
AcclimatisationPeriod - Minimum 3 weeks – Maximum  6 weeks
Demographics, Medical 
History
X
Current/Concomitant 
Medications
X
X
X
X
X
X
X
X
Inclusion/Exclusion
X
X
Subject Eligibility
X
X
Subject Continuance
X
X
X
X
X
X
X
Oral Soft Tissue (OST) and 
Oral Hard Tissue (OHT) 
Assessment
X
X
X
X
X
X
X
X
Eligible Teeth Assessments 
(Dentition Exclusions, EAR, 
MGI, Tooth Mobility)
X
Qualifying Evaporative Air 
Sensitivity (Y/N)
X
Dispense Acclimatisation 
Toothpaste, Toothbrush, Diary 
and Timer
X
Supervised Brushing with 
Acclimatisation Toothpaste
X
ReturnAcclimatisation 
Toothpaste, Toothbrush and 
Diary 
X
DHEQ completion 1,5
X
X
X
X
X
X
X
LMS5training
X
 
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Procedure
Screening
Visit1
Baseline
Visit2 
Week 0
(Day0)
Visit3
Week 4 
(Day28 ±3)
Visit4
Week 8
(Day56 ±3)
Visit5
Week 12 
(Day84±3)
Visit 6
Week 16 
(Day112 ±3)
Visit7
Week 20 
(Day140 ±3)
Visit8
Week 24 
(Day168 ±3)
Evaporative Air Assessment  
(Schiff Sensitivity Score, 
LMS5)on allEligible Teeth 
from Screening
Acclimatisation Period - Minimum 3 weeks – Maximum  6 weeks
X
Selection of 2 ‘Test Teeth’
X
Evaporative Air Assessment  
(Schiff Sensitivity Score, 
LMS5)on 2 ‘Test Teeth’
X
X
X
X
X
X
Evaporative Air Assessment  
(Schiff Sensitivity Score)on 
Remaining Eligible Teeth from 
Screening
X
X
X
X
X
X
Dispense Study Product 
X2
X
X
X2
X
X
Supervised Brushing 
X
X3
X3
X3
X3
X3
Return Study Productand 
Diary
X
X
X
X
X
X
Compliance checks
X
X
X
X
X
X
X
Adverse Events
X4
X
X
X
X
X
X
X
Incidents
X
X
X
X
X
X
X
Study Conclusion
X
1. To be completed prior to OST examination and any clinical assessments 
2. Dispense a new toothbrush at this visit also
3. Subject instructed to bring all suppliesback to all subsequent visits 
4. After first supervised brushing with acclimatisationproduct
5. To be completed by subjects
 
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PROTOCOL SYNOPSIS FOR STUDY204930
Brief Summary
This single centreMULTI-SITE, non-comparative design study will be used to 
monitorthe impact of long term managementof dentine hypersensitivity(DH) with 
daily useof a sensitivity toothpaste on the quality of lifeof a population of sensitivity 
sufferers.  Changesin oral health related quality of life will be monitored using the 
Dentine Hypersensitivity Experience Questionnaire(DHEQ). The study will be
conducted in subjects in good general health, with pre-existing self-reported and 
clinically diagnosed tooth sensitivity atscreening.
Objectives and Endpoints
Objectives
Endpoints
Primary
To monitor the impact of long term 
management of DHover a 24 week 
period, with twice daily use of a 
sensitivity toothpaste, onthe oral health 
related quality of life in sensitivity 
sufferers, as measured by the DHEQ.
Change from baseline in DHEQ 
endpoints over time.
Exploratory
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, including the number of 
sensitive teeth, as measured by Schiff 
Sensitivity Score to assess examiner 
performance on this measure. 
MeanSchiff Sensitivity Scorefor all 
timepoints.
Change from baseline in Schiff 
sensitivity score (two test teeth) for all 
timepoints.
Changefrom baseline in Schiff 
sensitivity score (all qualifying teeth) for 
all timepoints.  
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, as measured by 
Labelled Magnitude Scales (LMS). 
MeanLMS (of each of 4 VAS scales) 
and change from baseline (for the two 
test teeth) at each time point.
Study Design
Overall Design
A single centreMULTI-SITE, non-comparative design study will be used to monitor
the impact of long term managementof DHwith daily useof a sensitivity toothpaste 
 
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on the quality of lifeof a population of sensitivity sufferers.  Changesin oral health 
related quality of life will be monitored using the DHEQ.  The study will be
conducted in subjects in good general health, with pre-existing self-reported and 
clinically diagnosed tooth sensitivity atscreening.
Visit 1 -Screening Visit
The following assessments will be conducted in the order written:
Written informed consent.
Review of the oral care products the subject is currently usingto confirm they do 
not contain any ingredients intended for treating sensitive teeth. 
Demographics, concomitant medications and medical history.
Oral examination including an oral soft tissue (OST) examination and oral hard 
tissue (OHT) assessments to determine eligible teeth. 
Qualifying evaporative air sensitivity.
Inclusion/exclusion criteria review.
Confirmation of subject eligibility.
Dispensation of acclimatisationtoothpaste, toothbrush, diary and timer.
Supervised brushing with acclimatisation toothpaste.
Adverse Events (AEs) willbe documented from completion of the supervised 
brushing with acclimatisation toothpaste.
Visit 2 -Baseline Visit(Day 0)
The following assessments will be conducted in the order written:
Review of concomitant medications and AEs. 
Return of acclimatisationtoothpaste, toothbrush and diary. 
Review of completed diary to determine usage compliance.
Inclusion/exclusion criteria review. 
Confirmation of subject eligibility and continuance. 
Completion of DHEQ Section 1and Section 2.
LMS Training Exercise
OSTand OHTexaminations.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on all 
eligible teeth from Visit 1.
Selection of two test teeth.
Dispensation of study toothpaste, toothbrushand diary.
Supervised brushing with study treatment.
AEs and Incidents from supervised brushing with study treatment
Visit 3 -Week 4 (Day 28 ± 3)
Visit 4 –Week 8 (Day 56 ± 3)
Visit 5 – Week 12 (Day 84± 3)
Visit 6 – Week 16 (Day 112± 3)
Visit 7 –Week 20  (Day 140 ± 3)
 
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The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpasteand diary. New toothbrush at Week 12.
Review of completed diary to determine usage compliance.
Inclusion/exclusion criteria review. 
Confirmation of subject continuance. 
Completion of DHEQ Section 1 (Q7-9) & Section 2.
OST and OHT examinations.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two test 
teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
Dispensation of study toothpaste and diary (and toothbrush at Visit 5).
Supervised brushing with study treatment.
AEs and Incidents from supervised brushing with study treatment
Visit 8–Week 24  (Day 168± 3)
The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpaste, toothbrush and diary.
Review of completed diary to determine usage compliance.
Confirmation of subject continuance. 
Completion of DHEQ Section 1 (Q7-9) & Section 2.
OST and OHT examination.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two 
selected test teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
AEs and incidents will be recorded for 5 days after last treatment.
Type and Planned Number of Subjects

Sufficient subjects will be screened to ensure approximately 112suitable subjects 
enter the acclimatisationphase. Approximately 75eligible subjects will be allocated 
the study toothpaste in order to ensure that approximately 60 subjects complete the 
study.
 
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Diagnosis and Main Criteria for Inclusion
Subjects aged 18-55 years of age, with a minimum of20 natural teeth and in good 
general health who suffer from tooth sensitivity.  At Screening, subjects must have a 
minimum of two accessible non adjacent teeth (incisors, canines, or pre-molars) with 
signs of erosion or abrasion or facial/cervical gingival recession (EAR), with a 
modified gingivalindex (MGI) =0 adjacent to the test area and a clinical mobility of 
≤1, and with signs of sensitivity measured by qualifying evaporative air assessment. 
At Baseline subjects must have a minimum of two, non-adjacent accessible teeth 
(incisors, canines or pre-molars), with signs of sensitivity, measured by an 
evaporative air assessment (Schiff Sensitivity Score ≥ 2).
Product Information
Treatment 
Group
Study Product 
Dentifrice containing  0.454% w/w stannous fluoride
(1100ppm fluoride)
Sensodyne Repair and ProtectDaily Repair Toothpaste.
German marketplace
MFC 
Commercial Product 
Route of 
administration
Topical oral use
Dosing 
Instructions 
Subjectswill brush witha full brush head of toothpaste for 1timed 
minute (in their usual manner), twice daily (morning and evening) 
from Visit 2-8
Statistical Methods
Mean values and changes from baseline with 95% confidence intervalswill be plotted 
for all measures of DH (DHEQ, Schiff Sensitivity,and LMS(Intensity, Duration,
Tolerability, Description) over time. Statistical significance ofchanges from baseline 
at each timepointEFFECT OVER TIMEwill be assessedUSING MIXED 
EFFECT ANOVA WITH VISIT AND SITE AS FIXED EFFECT, SUBJECT AS
RANDOM EFFECT.
AEs, incidents and OSTabnormalities will be listed by treatment. 
 
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CCI


1. INTRODUCTION
Dentinal hypersensitivity (DH) is described as ‘pain derived from exposed dentine in 
response to chemical, thermal, tactile, or osmotic stimuli which can’t be explained as 
arising from any other dental defect or pathology’ [Addy, 1985, 2000].  The 
definition was later revised to replace the word ‘pathology’ with ‘disease’ to avoid 
confusion with pain originating from other dental conditions[Canadian Advisory 
Board, 2003].  DH originates from aetiologic factors such as gingival recession, 
erosion and/or abrasion, which result in loss of enamel or cementum and subsequent 
exposure of the underlying dentine with patent dentinal tubules [Orchardson, 1987].  
Brännström’s hydrodynamic theory of DH hypothesizes that the movement of fluid 
within the tubules when a stimulus is applied to the dentine, stimulates the nerve 
processes in the pulpal area of the dentine to transmit a pain impulse[Brannstrom, 
1964; Hall, 2000]. 
Currently there are two approaches to the management of DH;
nerve depolarisation (physiological action);
dentinal tubule occlusion (physical action).
Nerve depolarising agents, such as potassium nitrate, generally require a period of use
(for example, 14 to 28 days) before their benefit is established.  The delivery of
potassium ions to the dentine-pulp junction (odontoblastic layer) via dentinal tubules
is believed to result in depolarisation of the afferent nerve membrane thereby
blocking the pain response[Orchardson, 1975].  The second approach uses tubule
occluding agents which physically block the exposed ends of the dentinal tubules,
thus reducing dentinal fluid movement and pulpal irritation.  Tubule occluding agents
such as strontium salts, stannous salts, bioglasses or silicas serve to seal or block the
dentine tubules,and thereby reduce the effect of external stimuli.  Tubular occlusion
can be favoured over nerve depolarisation primarily due to the more rapid onset of
relief from DH which can be associated with the occlusion approach[Gillam, 2006].
Stannous fluoride has been incorporated into oral hygiene products indicated for the
reduction of DH since the 1960s [Schiff, 2006a].  Itslong-term efficacyhas been 
reported in a number of published studies[Schiff, 2000a, 2000b, 2006b; Sharma, 
2010, 2012; Chaknis, 2011; Du, 2011; Ni, 2011; Parkinson, 2013]with a fewstudies 
reportingshort term efficacy also[He, 2011; Sharma, 2011].  
With the growing acknowledgment of the value of the information gleaned directly 
from the subject, self-reported outcome measures have become increasingly 
important barometers of the benefit of clinical interventions.  These are increasingly 
 
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used in dentistry to capture the psychosocial experiencesof, for example,pain, 
discomfort and malfunctioning [Jokovic, 2002].  Broad, multidimensional quality of 
life measures such as the Oral Health Impact Profile (OHIP) are commonly used
[Slade, 1994, 1997].  Use of the OHIP in a study among patients diagnosed with DH 
attending a group of general practices in Germany reported considerably more 
impaired oral health related quality of life (OHRQoL) than subjectsin the general 
population indicating that DH is significantly associated with impaired OHRQoL
[Bekes, 2009].  Research on OHRQoL commonly usesinstruments like the OHIP that 
are generic for a number of oral health conditions. They cover a broad spectrum of
limitations and dysfunctions and may not detect the nuances of a specific condition.  
The dentine hypersensitivity experience questionnaire (DHEQ)is a validated, 
condition specific measure of OHRQoL in relation to DH [Boiko, 2010; Baker, 2014; 
Robinson, 2015].  It has been shown to have good psychometric properties in both the 
general populationand in a clinical sample of DH sufferers.  In a pooled analysis of 
clinical studies conducted by GSK[GSKCH Study RH02026], the DHEQ has shown 
the significant impact that DH canhave on the everyday lifeof the sufferer (for 
example, 70.4% of sufferers reported “Having sensations in my teeth takes a lot of the 
pleasure out of eating and drinking”).  The data included in thepooled analysis were 
primarily generated from studies of 8 week duration.  Thecurrentstudy will explore 
the impact of long termmanagementof DHby daily useof a sensitivity toothpaste on 
theoral health related quality of lifeof a population of sensitivity sufferers, over six 
months, using the DHEQ.  The long term clinical efficacy of the study product (a 
marketed, sensitivity toothpaste containing 0.454% w/w stannous fluoride) for the 
relief of DH has been previously demonstrated in two, 8 week randomised, controlled 
clinical studies[GSKCH Study RH01685; Parkinson, 2013]. 
 
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2. OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary
To monitor the impact of long term 
management of DHover a 24 week 
period, with twice daily use of a 
sensitivity toothpaste, on the oral health 
related quality of life in sensitivity 
sufferers, as measured by the DHEQ.
Change from baseline in DHEQ 
endpoints over time.
Exploratory
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, including the number of 
sensitive teeth, as measured by Schiff 
Sensitivity Score to assess examiner 
performance on this measure. 
Mean Schiff Sensitivity Score for all 
timepoints.
Change from baseline in Schiff 
sensitivity score (two test teeth) for all 
timepoints.
Change from baseline in Schiff 
sensitivity score (all qualifying teeth) for 
all timepoints.  
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, as measured by 
Labelled Magnitude Scales (LMS). 
At each time point the mean LMS (of 
each of 4 VAS scales) and change from 
baseline (for the two test teeth) and will 
be calculated.
3. STUDY PLAN
3.1. Study Design

Overall Design
This single-centreMULTI-SITE, non-comparative design study will be used to 
monitorthe impact of long term managementof dentine hypersensitivitywith daily 
useof a sensitivity toothpaste on the quality of lifeof a population of sensitivity 
sufferers.  Changesin oral health related quality of life will be monitored using the 
Dentine Hypersensitivity Experience Questionnaire. The study will beconducted in 
subjects in good general health, with pre-existing self-reported and clinically 
diagnosed tooth sensitivity atscreening.
Visit 1 -Screening Visit
 
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The following assessments will be conducted in the order written:
Written informed consent.
Review of the oral care products the subject is currently usingto confirm they do 
not contain any ingredients intended for treating sensitive teeth. 
Demographics, concomitant medications and medical history.
Oral examination including an oral soft tissue (OST) examination and 
assessments to determine eligible teeth. 
Qualifying evaporative air sensitivity.
Inclusion/exclusion criteria review.
Confirmation of subject eligibility.
Dispensation of acclimatisationtoothpaste, toothbrush, diary,and timer.
Supervised brushing with acclimatisation toothpaste.
Adverse Events (AEs) and incidents will be documented from completion of the 
supervised brushing with acclimatisation toothpaste.
Visit 2 -Baseline Visit (Day 0)
The following assessments will be conducted in the order written:
Review of concomitant medications and AEs. 
Return of acclimatisationtoothpaste, toothbrush and diary. 
Review of completed diary to determine usage compliance.
Inclusion/exclusion criteria review. 
Confirmation of subject eligibility and continuance. 
Completion of DHEQ Section 1 and Section 2.
LMS Training Exercise
OST examination.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on all 
eligible teeth from Visit 1.
Selection of two test teeth.
Dispensation of study toothpaste, toothbrushand diary.
Supervised brushing with study treatment.
Incidents from supervised brushing with study treatment 
 
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Visit 3 -Week 4 (Day 28 ± 3)
Visit 4 –Week 8 (Day 56 ± 3)
Visit 5 –Week 12 (Day 84 ± 3)
Visit 6 –Week 16 (Day 112 ± 3)
Visit 7 –Week 20  (Day 140 ± 3)
The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpaste and diary. New toothbrush at Week 12.
Review of completed diary to determine usage compliance.
Confirmation of subject continuance. 
Completion of DHEQ Section 1 (Q7-9) & Section 2.
OST examination.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two test 
teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
Dispensation of study toothpaste and diary(and toothbrush at Visit 5).
Supervised brushing with study treatment.
Incidents from supervised brushing with study treatment
Visit 8 – Week 24  (Day 168± 3) 
The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpaste, toothbrush and diary.
Review of completed diary to determine usage compliance.
Confirmation of subject continuance. 
Completion of DHEQ Section 1 (Q7-9) & Section 2.
OST examination.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two 
selected test teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
AEs and incidents will be recorded for 5 days after last treatment.
3.2. Subject Restrictions

Lifestyle/ Dietary
For the duration of the study (Screening –Week 24):
Eligible subjects will be asked to stop using their regular oral care products from 
Screening for the duration of the study.  Subjects will not be permitted to use any 
other oralcare products (i.e., oral rinses, tongue cleaners, whitening/bleaching 
 
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products) than those provided to them.  Subjects will not be permitted to use any 
dental products, including home remedies, intended for treating sensitive teeth.
Subjects will be permitted to use dental floss for the removal of impacted food 
only.
Subjects will not be permitted to chew gum.
Prior to study visits:(Baseline-Week 24)
In order to standardize oral hygiene practices, subjects will be asked to refrain 
from all oral hygieneprocedures for at least 8 hours, and from eating and 
drinking for at least 4 hours, prior to their scheduled Baselineand Week 4 to 
Week 24 visits. Within fourhours of the visit (but not within one hour of the 
visit), small sips of room-temperature water will be permitted to take medications
and relieve thirst.
Subjects will be requested to refrain from excessive alcohol consumption for 24 
hoursprior to the Baseline and all subsequent visits.  If, in the opinion of the 
Investigator, the subject has consumed an excessive amount of alcohol prior to a 
visit, every effort will be made to reappoint them to the next day.  If this is not 
possible, the subject should be treated as per section 4.4.
Medications and Treatments
For the duration of the study (screening –last visit):
If concomitant medications and traditional herbal ingredients/treatments are used 
during the study, their identity, as well as their dosage and frequency, start and 
stop dates must be recorded in the CRF.  
Should a subject take an analgesic within 8 hoursof a scheduled visit, every 
effort will be made to reappoint them to the next day.  If this is not possible, the 
subject should be treated as per section 4.4.
Subjects who enter the study will be requested to delay having any non-
emergency, elective dental treatment until after study completion (including 
dental prophylaxis).
3.3. Type and Planned Number of Subjects

Approximately 200 subjectswill be screened to ensure approximately 112suitable 
subjects enter the acclimatisationphase. Approximately 75eligible subjects will be 
allocated the study toothpaste in order to ensure that approximately 60 subjects 
complete the study.
Subjects will be recruited by the CRO, primarily from their volunteer database.  
Subjects may also be recruited via advertisements placed in the local press, by use of
leaflets and posters or by word of mouth.
 
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3.4. Study Design and Dose Justification
Thecurrentstudy will explore theimpact of long term managementof DHwith daily 
useof a sensitivity toothpaste on the quality of lifeof a population of sensitivity 
sufferers, using the DHEQ.  Changes in DH will also be monitored clinically over the
24 week treatment period.
A non-comparative, monadic study design has been selected as appropriateto achieve 
the aims of this research.  The inclusion of a controlor comparator treatment is not 
considered necessary to meet the objectives of the study (which is to monitor To 
monitor the impact of long term management of DHover a 24 week period, with 
twice daily use of a sensitivity toothpaste, on the oral health related quality of life in 
sensitivity sufferers, as measured by the DHEQ).  All subjects will use the same 
sensitivity toothpaste(a clinically proven 0.454% w/w stannous fluoride formulation 
[GSKCH Study RH01685; Parkinson, 2013]for the duration of the 24 week study 
period.  
The anti-sensitivity efficacy of toothpastes containing 0.454% w/w stannous fluoride 
has been establishedin a number of published studies[for example Schiff, 2000a, 
2000b, 2006a; Pradeep, 2010; Sharma, 2010; Chaknis, 2011; Du, 2011;Ni, 2011; 
Parkinson, 2013];andwill not be investigated further here.  The study toothpaste 
contains 0.454% stannous fluoride and will be provided in commercial tubes, 
overwrapped to mask its identity.  The dosage regimen of twice daily brushing
(morning and evening) will be the same for all subjects,and has been selectedbased 
on dental health care professionals (DHCP) recommended practice.  
It is anticipated that DH symptoms will decrease over the 24 week study period with 
daily use of a clinically proven, sensitivity toothpaste.  A validated, condition specific
measure of oral health-related quality of life for DH (Dentine Hypersensitivity 
Experience Questionnaire (DHEQ)[Boiko, 2010; Baker, 2014]will be completed by 
the subjects at Baseline and 4, 8, 12, 16, 20 and 24 weeks to monitor the impact of a 
reduction in DH on everyday life.  The DHEQ (48 item) has been shown to have 
good psychometric properties in both thegeneral population,and in DH sufferers
[Boiko, 2010; Baker, 2014].  
An evaporative air stimulus will be administered using a dental air syringe.  Response 
to this stimulus will be evaluated using
Schiff Sensitivity Scale[Schiff, 1994]: This is an examiner assessment of the 
subject’s response to an evaporative air stimulus.  It is scored immediately 
following the stimulus and focuses on a combination of specific, observable, 
physical, behavioural and verbal responses from the subject as a result of the 
 
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stimulation of exposed dentine, rather than solely an oral request from the 
subject to discontinue stimulation and may facilitate discrimination.
Labelled Magnitude Scales (LMS)[Heaton, 2013]: These are completed by 
the subjectfollowing the evaporative stimulus (on a tooth by tooth basis) and 
apply psychophysical procedures (magnitude estimation and cross-modality 
magnitude matching) to condition specific descriptive words relevant to the 
subject’s response. The descriptive words are then aligned along a Visual 
Analogue Scale (VAS) at distancesthat reflect the psychological distances 
between words. These scales have been piloted and validated in a previously 
reporteddentine hypersensitivity trial. 
The selection of two ‘test teeth’to evaluate changes in DH is common practice in 
sensitivity studies [Docimo, 2009].  The sensitivity of the remaining teeth that
qualified following assessments of EAR, MGI and tooth mobility at Screening will 
also be assessed at Baseline and 4, 8, 12, 16, 20 and 24weeks.  
The dosage regimen of twice daily usage (morning and evening) for 1 timed minute 
will be the same for all subjects, and has been selected based on widely recommended 
oral hygiene practice, and typical consumer habit.
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 Safety 
Statement.
Deviations from inclusion and exclusion criteria are not allowed asthey 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 and willingness to participate as evidenced 
 
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by voluntary written informed consent and has received a signed and dated copy of 
the informed consent form.
2. AGE
Aged 18-55 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 of medical history or oral 
examination.
b) Absenceof any condition that would impact on the subject’s safety or 
wellbeing or affect the individual’s ability to understand and follow study 
procedures and requirements.
4. COMPLIANCE 
Understands and is willing, able and likely to comply with all study procedures and 
restrictions.
5. DENTAL HEALTH
At Visit 1 (Screening):
a)Self-reported history of dentinal hypersensitivity (DH) lasting more than six 
months but not more than 10 years.
b)Minimum of 20 natural teeth.
c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), 
preferably in different quadrants, that meet all of the following criteria:
- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion 
(EAR).
- Tooth with MGI score =0 adjacent to the test area (exposed dentine) only 
[Lobene, 1986]and a clinical mobility of ≤1
- Tooth with signs of sensitivity measured by qualifyingevaporative air 
assessment (Y/N response) 
At Visit 2(Baseline):
d)Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-
molars), that meet all of the following criteria:
- with signs of sensitivity, measured by a qualifying evaporative air assessment 
(Schiff Sensitivity Score ≥2)
Note: All teeth which meet the EAR, GI and mobility inclusion criteria and 
none of the dentition exclusion criteria at Screening should be assessed by 
 
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evaporative air stimulus at Baseline.  Test Teethshould not be adjacent to each 
other and preferably in different quadrants.  
4.2. Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria 
apply:
1. PREGNANCY
Women who are known to be pregnant or who are intending to become pregnant over 
the duration of the study. 

2. BREAST-FEEDING
Women who are breast-feeding
3. ALLERGY/ INTOLERANCE
Known or suspected intolerance or hypersensitivity to the study materials (or closely 
related compounds) or any of their stated ingredients.
4. CLINICAL STUDY/ EXPERMENTAL PRODUCT
a) Participation in another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30days of the screening visit.
b) Previous participation in this study.
5. SUBSTANCE ABUSE
Recent history (within the last year) of alcohol or other substance abuse.
6. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family.
7. DISEASE
a) Presence of chronic debilitating disease which, in the opinion of the 
investigator, could affect study outcomes.
b) Any condition which, in the opinion of the investigator, causes xerostomia.
8. GENERAL DENTITION EXCLUSIONS
a) Dental prophylaxis within 4 weeks of Screening.
b) Tongue or lip piercing or presence of dental implants.
c) Desensitizing treatment within 8 weeks of Screening (professional sensitivity 
treatments and non-dentifrice sensitivity treatments).
d) Gross periodontal disease, treatment of periodontal disease (including surgery) 
 
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within 12 months of Screening, scaling or root planning within 3 months of 
Screening.
e) Teeth bleaching within 8 weeks of Screening.
4.3. Screening/ Baseline Failures
Screen failures are defined as subjects who consent to participate in the study butare 
never subsequently provided with study product at the Baseline visit.  In order to
9. SPECIFIC DENTITION EXCLUSIONS FOR TEST TEETH
a) Tooth with evidence of current or recent caries, or reported treatment of decay 
within 12 months of Screening.
b) Tooth with exposed dentine but with deep, defective or facial restorations, 
teeth used as abutments for fixed or removable partial dentures, teeth with full 
crowns or veneers, orthodontic bands or cracked enamel.  Sensitive teeth with 
contributing aetiologies other than erosion, abrasion or recession of exposed 
dentine.
c) Sensitive tooth not expected to respond to treatment with an over-the-counter 
dentifrice in the opinion of the investigator.
10. PRODUCT USE
Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 
weeks of screening (subjects will be required to bring their current oral care products 
to the site in order to verify the absence of known anti-sensitivity ingredients).
11. CONCOMITANT MEDICATION
a)Daily doses of medication/treatments which, in the opinion of the investigator, 
could interfere with the perception of pain.  Examples of such medications 
include analgesics, anticonvulsants, antihistamines that cause marked or 
moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and 
anti-inflammatory drugs.
b)Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.
c)Daily dose of a medication which, in the opinion of the investigator, is causing 
xerostomia.
12. OTHER
Any subject who, in the judgment of the investigator, should not participate in the 
study.
 
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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.
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 timeat the discretion of the investigator for safety, behavioral or 
administrative reasons. Where applicable, if a subject withdraws or is withdrawn 
from the study, all human biological samples collected before they exited the study
will be analysedand reported unless the subject requests otherwise. A subject may 
request for their human biological samples to be destroyed. In these cases, the 
investigator must document this in the site study records and the samples should not 
be used for any further research.
If the reason for removal of a subject from the study is an AE or an abnormal 
laboratory test result, the principal specific event or test will be recorded on the 
electronic case report form (CRF).  If a subject is withdrawn from the study because 
of a product limiting AE, thorough efforts should be clearly made to document the 
outcome. Any AEs ongoing at the final visit will be followed up until resolved, the 
condition stabilizes, is otherwise explained, or the subject is lost to follow-up.
Should a subject take an analgesic medication within 8 hours of a treatment visit, or 
should any other factor, in the opinion of the investigator, be thought to affect study 
outcomes (e.g. excessive alcohol consumption), the following actions must be taken
Baseline visit:every attempt will be made to reschedule the subject, if they 
cannot be reappointed they will be withdrawn from the study. No clinical 
efficacy measures will be performed. 
Week 4, Week 8, Week 12, Week 16, Week 20 visit: every attempt will be
made to reschedule the subject.  If they cannot be reappointed they will 
continue in the studywith all procedures other than clinicalefficacy measures 
completed. The subject will not be withdrawn.
Week 24 visit: every attempt will be made to reschedule the subject, if they 
cannot be reappointed they achieve study conclusion with all procedures other 
than clinicalefficacy measures completed.  Thesubject should not be 
replaced.
 
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SHOULD A SUBJECT TAKE ANTIBIOTIC MEDICATION TWO WEEKS 
PRIOR TO  A TREATMENT VISIT,THE FOLLOWING ACTIONS MUST 
BE TAKEN
BASELINE VISIT: EVERY ATTEMPT WILL BE MADE TO 
RESCHEDULE THE SUBJECT, IF THEYCANNOT BE 
REAPPOINTED THEY WILL BE WITHDRAWN FROM THE STUDY. 
NO CLINICALEFFICACY MEASURES WILL BE PERFORMED.
WEEK 4, WEEK 8, WEEK 12, WEEK 16, WEEK 20 VISIT: EVERY 
ATTEMPT WILL BEMADE TO RESCHEDULE THE SUBJECT 
WITHIN THE 3 DAY VISIT WINDOW. IF THEY CANNOT BE 
REAPPOINTED THEY WILL CONTINUE IN THE STUDY WITH 
ALL PROCEDURES OTHER THAN CLINICAL EFFICACY 
MEASURES COMPLETED. THE SUBJECT WILL NOT BE 
WITHDRAWN.
WEEK 24 VISIT: EVERY ATTEMPT WILL BE MADE TO 
RESCHEDULE THE SUBJECT, IF THEYCANNOT BE 
REAPPOINTED WITHIN THE 3 DAY VISIT WINDOW THEY 
ACHIEVE STUDY CONCLUSION WITH ALL PROCEDURES 
OTHER THAN CLINICAL EFFICACY MEASURES COMPLETED. 
THE SUBJECT SHOULD NOT BE REPLACED.
The following actions must be taken in relation to a subject who fails to attend the 
clinic for a required study visit:
The site must attempt to contact the subject and re-schedule the missed visit as 
soon as possible. 
The site must counsel the subject on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the subject wishes to 
and/or should continue in the study. 
In cases where the subject is deemed ‘lost to follow up’, the investigator or 
designee must make every effort to regain contact with the subject (where 
possible, at least2 telephone calls). The contact attempt should be 
documented in the subject’s record. 
Should the subject continue to be unreachable, only then will he/she be 
considered to have withdrawn from the study with a primary reason of “Lost 
to Follow-up”.
 
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4.5. Subject Replacement
Subjects who withdraw from the study post allocation of study product will not be 
replaced.
4.6. Subject and Study Completion
A completed subject is one who has completed all phases of the study.  The end of the 
study is defined as the date of the last subject’s last visit.
5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Treatment 
Group
Study Product 
Dentifrice containing  0.454% w/w stannous fluoride
(1100ppm fluoride)
Sensodyne Repair and ProtectDaily Repair Toothpaste.
German marketplace
MFC 
Commercial Product 
Route of 
administration
Topical oral use
Dosing 
Instructions 
Subjectswill brush witha full brush head of toothpaste for 1timed 
minute (in their usual manner), twice daily (morning and evening) 
from Visit 2-8
Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Signal®Family Protection toothpaste
containing 1450 ppm fluoride as sodium 
monofluorophosphate (SMFP), (UK 
market place product)
Acclimatisation product -to standardise 
oral hygiene practice prior to Visit 2
Aquafresh Clean Control (Everyday 
Clean) toothbrushes(UK market place 
product)
Toothpaste application by tooth brushing
                                               
®Signal is a registered trademark of Unilever plc.
 
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CCI


Countdown timers
To ensure accurate brushing duration
The subject diary will be supplied by the clinical site.
5.2. Dose Schedule
For both the acclimatisation and study toothpaste, the subjects will apply a full brush 
head of the toothpaste and brush for one timed minute in their usual mannertwice 
daily (morning and evening).
5.3. Dose Modification
No dose modification is permitted in this study.
5.4. Product Compliance
Diaries will be used throughout the study to a) allow the subject to familiarize 
themselves with their completion during the acclimatisationphase and b) promote 
compliance during the treatment phase. Subjects will not be excluded due to missed 
brushings but will be reminded to use the products supplied as per the instructions 
provided and to complete the diary after each product usage to encourage compliance.
Study site staff will review the diaries at the start of each visit for compliance and any 
reports of changes/new medications. 
5.5. Precautions
No special precautions are necessary provided the study is carried out in accordance 
with this protocol.
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 study. Limited quantities of the product will be 
supplied, and closely monitored by the site for each subject.
Overdose per se is not an AE.  However, any clinical sequelae of an overdose should 
be reported as an AE (and serious adverse event (SAE), if appropriate).  For 
reporting, follow the AE and SAE reporting instructions.
 
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5.7. Rescue Therapy
No rescue therapy is required in this study.
5.8. Product Assignment
All eligible subjects at Visit 2 will be provided with the same study product.  
5.8.1 Randomisation
There is no randomisation in this study.  All subjects eligible at Visit 2 will be 
provided with the same study product. 
5.8.2Blinding
The subject is blinded to the identity of the study toothpaste (they will not be aware of 
the brand name of the toothpaste they are using).  The packaging will be overwrapped 
as detailed below.  Neither the study staff nor the sponsor are blinded.
5.9. Packaging and Labelling
The acclimatisation product (Signal FamilyProtectionToothpaste) will be sourced 
from the UK market and supplied in its commercial tube (no overwrapping) with a 
study label affixed. Each subject will receive a sufficient number of tubes to cover 
usage during the acclimatisation phase.
The study toothpaste will be sourced from the Germanmarket.   The tubes will be 
overwrapped in white vinyl to obscure any branding on the commercial tube pack.
Each subject will receive a carton containing sufficient number of tubes to cover 
usage during each 4 week visit. Each tube and carton will have a study label affixed. 
The contents of the label will be in accordance with all applicable regulatory 
requirements(including the device precautionary statement ‘Exclusively For Clinical 
Investigation)’and will be the responsibility of the Clinical Supplies Department, 
GSKCH. Re-dispensing of product will occur at each treatment visit(Visit 3 –
Visit7).  At Visit 2 and 5 a new toothbrush will be dispensed to each subject.
All sundry items will be supplied in their commercial packaging. 
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 not to remove or deface 
any part of the study label.
 
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5.9.1. Accountability of Product
All products supplied are for use only in this clinical study and should not be used for 
any other purpose.
The investigator or designee will maintain a full record of study product 
accountability. A Product Dispensing Log must be kept current and will contain the 
following information:
The identification of the subject to whom the study product was dispensed.
The date(s) and quantity of the study product dispensed to the subject.
The date(s) and quantity of the study product returned by the subject (if 
applicable).
The inventory must be available for inspection by the study monitor during the study. 
At the end of the study, study product supplies will be verified by the monitor.  Study
 
product supplies will then be either collected by the study monitor or returned by the 
investigator or designee to the GSKCH Clinical Supplies Department or designated 
vendor.
5.9.2. Storageof Product
Study product supplies must be stored in compliance with the label requirements in a 
secure place with limited or controlled access.
6. STUDY ASSESSMENTS AND PROCEDURES
This section lists the procedures and parameters of each planned study assessment.  
The exact timing of each assessment is listed in the Schedule of Events section.
Adherence to the study design requirements, including all assessments and 
procedures are essential and required for study conduct.
6.1. Visit 1 -Screening Visit
6.1.1 Telephone Screening
Prior to the screening visit, telephone screening of interested subjects will be 
conducted using a telephone script. This will be conducted by the site recruitment 
staff or designee.  
 
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6.1.2. Informed Consent
The investigator, or designee, must obtain written (signed and dated by the subject) 
informed consent 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 at any time.  
Appropriate forms for documenting a 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 thestudy, 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. The date of consent will be recorded on the CRF.
6.1.3. Demographics
The following demographic parameters will be captured by the Investigator or 
designee and recorded on the CRF: year of birth, gender, ethnicityand race.
6.1.4. Medical History and Concomitant Medication
Medical history will be assessed as related to the inclusion/exclusion criteria by the 
Investigator or medically qualified designee.  Details of any relevant medicalor 
surgical history (within the last year), including allergies or drug sensitivity, will be 
recorded on the CRF.  Any concomitant therapy taken in the 30 daysprior to the 
Screening Visit and throughout the study will also be recorded.
6.1.5. Oral Hard Tissue (OHT) Examination
The dentist will perform a visual examination of the oral hard tissue toconfirm that 
the subject has a minimum of 20 natural teeth and to evaluate thedentition for 
exclusions.
6.1.6.Oral Soft Tissue (OST) Examination
Where possible, this procedure should be conducted by a single trained dental 
examiner.The examination will be accomplished by direct observation and palpation 
withretraction aids as appropriate. The examiner will include examination of the 
LabialMucosa (including lips), Buccal Mucosa, Mucogingival folds, Gingival 
 
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Mucosa, Hard Palate, Soft Palate, Tonsilar Area, Pharyngeal Area, Tongue, 
Sublingual Area,Submandibular Area and Salivary Glands. The results of the 
examination will berecorded in the CRF as either normal or abnormal with details of 
any abnormalities. Abrief description of any abnormality observed by the examiner 
or reported by the subjectat the application site following the administration of the 
acclimatisation or treatmenttoothpastes will be recorded as an AE. 
AnOST examination will be conducted at everystudy visit prior to any clinical 
assessments.While it is preferable to use the same OST examiner throughout the 
study, to facilitate subject flow, OST examinations may be carried out by different
examiners.
6.1.7.Eligible Tooth Assessment
Eligible tooth assessment will include an oral hard tissue examination (visual 
assessment only to evaluate dentition exclusions -see Exclusion Criteria 8and 9);
erosion, abrasionand/or gingival recession; modified gingival index; tooth mobility 
and qualifying evaporative airassessment.Assessments will be carried out by the 
Investigator or medically qualified designee against the inclusion/exclusion criteria 
and recorded in the CRF.
6.1.7.1. Erosion, Abrasion and Recession (EAR) assessment
The presence of cervical erosion, abrasion and/or gingival recession[Addy, 2000]
will be determined on the facial surfaces of individual teeth.Teeth exhibiting EAR 
will be assessed to ensure they do notmeet any of the general dentition exclusion 
criteria and the specific dentition exclusion criteria for test teeth (see Exclusion 
Criteria 8and 9).
6.1.7.2.Modified Gingival Index (MGI)Assessment
The MGI is a non-invasive visual evaluation of gingival health[Lobene, 1986]scored
on a scale of 0-4. MGI will be assessed for the facial gingiva adjacent to the test area
(exposed dentine) only of teeth exhibiting facial cervical erosion, abrasion and/or
recession at the Screening visit.MGI = 0 is required for eligibleteeth.
Score
Description
0
Absence of inflammation
1
mild inflammation; slight change in color, little change in color; little 
change in texture of any portion of the marginal or papillary gingival unit.
2
mild inflammation; criteria as above but involving the entire marginal or 
papillar gingival unit.
 
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3
moderate inflammation; glazing, redness, edema, and/or hypertrophy of 
the marginal or papillary gingival unit.
4
severe inflammation; marked redness, edema and/or hypertrophy of the 
marginal or papillary gingival unit, spontaneous bleeding, congestion, or 
ulceration.
6.1.7.3.Tooth MobilityAssessment
The clinical mobility assessment will only be performed on teeth exhibiting facial 
cervical erosion, abrasion and/or recession and that have a MGI = 0. Clinicalmobility 
will be classified in the following way (based on a modification to the MillerIndex) 
[Laster, 1975]and the degree of mobility will be recorded. A clinical mobilityof ≤1 
is required for eligibleteeth.
Degree 0
No movement or mobility of the crown of the tooth < 0.2mm in a 
horizontal direction.
Degree 1
Mobility of the crown of the tooth 0.2 –1mm in a horizontal direction
Degree 2
Mobility of the crown of the tooth exceeding 1mm in a horizontal 
direction
Degree 3
Mobility of the crown of the tooth in a vertical direction as well.
6.1.7.4. Qualifying Evaporative air Sensitivity
The screening dentist will assess sensitivity by a simple air blast on the facial surface 
of all teeth that meet the EAR, MGI and mobility criteria. This assessment is made by 
directing a one second application of air from a standard dental syringe perpendicular 
to the tooth surface approximately 1-2 mm coronal to the free gingival margin and 
from a distance of approximately 1cm. Following the air blast, the dentist will ask the 
subject if they experienced sensitivity. In order to qualify, the subject should confirm 
they experienced sensitivity and a simple “yes/no” response will be recorded.
6.2. Visit 2 toVisit 8
6.2.1. Dentine Hyersensitivity Experience Questionnaire (DHEQ)
TheDHEQ (Appendix 2) will be completed by the subjects at Visit 2 (Baseline) and 
Visits3 -8(Week 24), prior to any clinical assessments (including OST assessment).  
Section 1 asks questions about “your sensitive teeth and the impact it has on your 
everyday life”. Section 2 asks questions about “the ways in which the sensations in 
your teeth affect you in your daily life”, and is grouped into domains as follows.
Restrictions (Section 2, Q1-4)
Adaptation (Section 2, Q5-16)
 
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Social Impact (Section 2, Q17-21)
Emotional Impact(Section 2, Q22-29) 
Identity (Section 2, Q30-34)
Visit
DHEQ questions to beanswered by subjects
Visit 2
Section 1:
All questions, Q1-9 
Section 2:
All questions, Q1-39
Visit 3-8
Section 1:
Q7-9
Section 2:
All questions Q1-39
THE SITE WILLCHECK AND CROSS REFERENCE THE SUBJECT’S 
RESPONSE TO DHEQ SECTION 1 QUESTION 2, AT VISIT2 (BASELINE), 
WITH THE INCLUSION CRITERIA 5(A) BEFORE THE SUBJECT LEAVES 
THE STUDY SITE, AND CLARIFY ANY DISCREPANCY WITH THE 
SUBJECT IF NECESSARY.
6.2.2Labelled Magnitude Scales (LMS) Training Exercise
At Baseline(Visit 2), eligible subjects will be given instructions on how to use the 
LMS and asked to complete the LMS training exercise. The investigator or designee 
will determinewhether or not the subject understands how to use the LMS. 
Investigator instructionsfor administrating and interpreting the LMS training exercise 
can be found inAppendix 3. Subject instructions for completing the LMS training 
exercise can also befound in Appendix 3. The data from this exercise are for training 
purposesonly andwill not be recorded in the CRF. 
6.2.3. Oral Soft Tissue (OST) Examination
Complete as described in Section 6.1.6.
6.2.4. EvaporativeAir Sensitivity Assessments 
This assessment will be conducted by a single examiner for all subjects at each visit 
by directing a maximum onesecondapplication of airfrom adental air syringe to the 
exposed dentinesurface from a distance of approximately 1 cm. The examiner should 
takeappropriate measures to isolate the test tooth surface in order to prevent stimulus
exposure to adjacent tooth or surrounding soft tissue.
At Baseline, the examiner will assess the evaporative airsensitivity of all clinically
eligible teeth identified at Screening (teeth that qualified on EAR, MGI and tooth 
mobility criteria, and had none of the dentition exclusions),using the Schiff 
 
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Sensitivity Scale and LMS (Appendix 4).  Two test teeth will be selected according to 
specific eligibilitycriteria in an individual subject. 
At Week 4, 8, 12, 16, 20 and 24 visits the examiner will first assess the evaporative 
airsensitivity of the two identified test teeth from the Baseline visit using the Schiff 
Sensitivity Scale and LMS.  The examiner will then assess the evaporative air
sensitivityof the remaining Eligible Teeth from Screening(teeth that qualified on 
EAR, MGI and tooth mobility criteria, and had none of the dentition exclusions),
using the Schiff Sensitivity Scale. 
6.2.4.1. Schiff Sensitivity Scale
This is an examiner based index[Schiff, 1994], scored immediately following 
administration of the evaporative airstimulus.  This scale focuses on a combination of 
specific, observable, physical, behavioural and verbal responses from the subject as a 
result of the stimulation of exposed dentine, rather than solely an oral request from 
the subject to discontinue stimulation and may facilitate discrimination. The 
examiner will indicate the subject’s response to the evaporative air stimulus, after the 
stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows.  
0
Subject does not respond to air stimulation
1
Subject responds to air stimulus but does not request 
discontinuation of stimulus
2
Subject responds to air stimulus and requests discontinuation or 
moves from stimulus
3
Subject responds to stimulus, considers stimulus to be painful, 
and requests discontinuation of the stimulus
6.2.4.2. Labelled Magnitude Scales (LMS) 
The LMS score should be completed after the Schiff Sensitivity score assessment to 
avoid examiner bias.  The examiner should not use the subjects response to the LMS 
to guide their Schiff assessment score. These are completed by the subject 
immediately following the evaporative stimulus and apply psychophysical procedures 
(magnitude estimation and cross-modality magnitude matching) to condition specific 
descriptive words relevant to the subject’s response[Gracely, 1978]. The descriptive 
words are then aligned along a VAS at distances that reflect the psychological 
distances between words. These scales have been piloted and validated in a 
previously reported dentine hypersensitivity trial[Heaton, 2013]. Subjects will use 
LMS (see Appendix 3and 4)to rate the intensity, duration,tolerability and 
descriptive quality of their response to the evaporative air stimulus,after the 
 
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stimulation of each individual tooth, using 100 millimetre (mm) LMS. Thestudy staff 
will measure the line segment marked-off in mm from left to rightBOTTOM TO 
TOPalongthe line and record this measurement.
6.2.5. 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 
Conclusionpage of the CRF by selecting one of the options below.
Subject did not meet study criteria
Adverse Event
Lost to Follow Up
Protocol Violation
Withdrawal of Consent
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 unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease (new or 
exacerbated) temporally associated with the use of an investigational or 
washout product.
Events meeting AE definition include:
Any abnormal laboratory test results (if applicable) or other safety 
assessments, including those that worsen from baseline, and felt to be 
clinically significant in the medical and scientific judgment of the investigator.
Exacerbation of a chronic or intermittent pre-existing condition including 
either an increase in frequency and/or intensity of the condition.
New condition(s) detected or diagnosed after study product administration 
 
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even though it may have been present prior to the start of the study.
Signs, symptoms, or the clinical sequelae of a suspected interaction.
Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
study product or a concomitant medication (overdose per se will not be 
reported as an AE/SAE).
Events NOT meeting definition of an AE include:
Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, 
unless judged by the investigator to be more severe than expected for the 
subject’s condition. 
The disease/disorder/ condition being studied or expected progression, signs, 
or symptoms of the disease/disorder being studied, unless more severe than 
expected for the subject’s condition.. 
Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition 
that leads to the procedure is an AE.
Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.
7.1.2. Serious Adverse Events
Serious Adverse Event is defined as any untoward medical occurrence that, at 
any dose:
A. Results in death
B. Is life-threatening
NOTE: The term 
'life-threatening
' in the definition of 
'serious
' refers to an 
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 overnightstay) 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 
serious.
 
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Hospitalization for elective treatment of a pre-existing condition that didnot 
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 ofrelatively 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. RecordingAdverse Eventsand Serious Adverse Events
Recording of adverse events and serious adverse events:
The investigator or site staff will be responsible for detecting, documenting 
and reporting events that meet the definition of an AE or SAE. 
The investigator or site staff will then record all relevant information 
regarding an AE/SAE in the CRF.
There may be instances when copies of medical records for certain cases are 
requested by GSK.  In this instance, all subject identifiers, with the exception 
of the subject number, will be blinded on the copies of the medical records 
prior to submission of to GSK.
The investigator will attempt to establish a diagnosis of the event based on 
signs, symptoms, and/or other clinical information.  In such cases, the 
diagnosis will be documented as the AE/SAE and not the individual 
 
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signs/symptoms. Clinical AEs will be described by diagnosis and not by 
symptoms when possible (e.g., upper respiratory tract infection, seasonal 
allergy, etc. instead of runny nose).
AEs will be collected from the start of the investigational product 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-up contact.  
Medical conditions reported prior to the time period for reporting AEs/SAEs 
should be recorded as part of the subject’s medical history.
7.3. Evaluating Adverse Eventsand Serious Adverse Events
Assessment of Intensity:
The investigator or designee will make an assessment of intensity for each AE and 
SAE reported during the study and will assign it to one of the following categories:
Mild:  An event that is easily tolerated by the subject, causing minimal 
discomfort and not interfering with everyday activities.
Moderate:  An event that is sufficiently discomforting to interfere with normal 
everyday activities
Severe:  An event that prevents normal everyday activities. -an AE that is 
assessed as severe will not be confused with an SAE. Severity is a category 
utilized for rating the intensity of an event; and both AEs and SAEs can be 
assessed as severe.
Note: An event is defined as ‘serious’ when it meets at least one of the pre-defined 
outcomes as described in the definition of an SAE.
Assessment of Causality:
The investigator is obligated to assess the relationship between study product 
and the occurrence of each AE/SAE.
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.
Alternativecauses, 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.
 
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The investigator will also consult the Investigator Brochure (IB) and/or 
Product Information, for marketed products, in the determination of his/her 
assessment.
For each AE/SAE the investigator must document in the medical notes 
(source document) or CRF that he/she has reviewed the AE/SAE and has 
provided anassessment 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 forevery event prior to the initial transmission of the SAE data 
to GSK.
The investigator may change his/her opinion of causality in light of follow-up 
information, amending the SAE data collection tool accordingly.
The causality assessment is one of the criteria used when determining 
regulatory reporting requirements.
7.4. Reporting Adverse Eventsand Serious Adverse Events
AE Reporting to GSKCH:
AEs will be recorded in the AE section of the CRF. 
Medical conditions recorded by the subject on a diary
 card or similar 
document that meet the definition of an AE must also be recorded in the AE 
section of the CRF, if not previously well-characterized by the investigator in 
the subject’s medical history. 
AEs elicited by the investigator in a standard manner at the study visits should 
also be recorded in the AE section of the CRF.  The investigator or designee 
must ask the subject the following question during each visit including any 
follow-up visits:  “Have you felt unwell, experienced any symptoms or taken 
any medication (since your last visit) (today) (since your last dose) (since the 
last session)?”
The medically qualified investigator should review adverse events in a timely 
manner; this review should be documented in writing in the source document 
or in the CRF. 
After the study is completed at a given site, and the site has received their 
study data on Compact Discs (CDs), the electronic data collection tool will be 
removed from the internet to prevent the entry of new data or changes to 
existing data.
SAE Reporting to GSKCH:
A paper copy of theSAE form provided in the investigator study master file should 
 
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be completed as fully as possible. 
It is essential to enter the following information: 
Protocol and subject identifiers
Subject’s demography
Description of events, with diagnosis if available
Investigator opinion of relationship to study product (see section 8.3)
Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and 
GSKCH assessment of the SAE report:
Date of onset of AE 
Date AE stopped,if relevant
Study product start date
Study product end date if relevant
Action taken on study product
Outcome if known
TheSAE form, completed as fully as possible, and SAE fax cover sheet must be 
faxed or e-mailed to the appropriate GSKCH Study Manager as soon as possible, but 
not later than 24 hoursafter study site personnel learn of the event. The GSKCH 
Study Manager should be notified of the situation by telephone or email.
Fax Serious Adverse Events to:
UK: 
The GSKCH Study Manager will be responsible for forwarding the SAE form to the 
Case Management Group, Global Clinical Safety and Phamacovigilance, the Medical 
Director responsible for the study and other GSKCH personnel as appropriate via 
email.
The initial report will be followed up with more information as relevant, or as 
requested by the GSKCH study manager.
7.5. Follow-up of Adverse Eventsand Serious Adverse Events
Follow-up of AEs and SAEs:
After the initial report, the investigator is required to proactively follow up 
with each subject and provide further information on the subject’s condition.
All AEs/SAEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the subject is lost to follow-up.  
 
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The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations as may be indicated or as 
requested by GSK to elucidate as fully as possible the nature and/or causality 
of the AE or SAE.
Investigators are not obliged to actively seek AEs or SAEs in former subjects.  
However, if the investigator learns of any SAE, including the death, at any 
time after a subject has been discharged from the study, and considers the 
event reasonably related tothe 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, IECand 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 or IEC, 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 
device in this study is the study toothpaste.  GSKCH medical device incidents, 
 
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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 lead to the death of a 
patient or user or of other persons or to a serious deterioration in their state of 
health.
7.6.2. Reporting of Incidents and Malfunctions
Incident Reporting to GSKCH:
All incidents must be reported to GSKCH within 24 hours (or sooner if 
possible) of the investigator or designee becoming aware of the situation.
Any medical device incident occurring during the study will be documented in 
the subject
's medical records, in accordance with the investigator
's normal 
clinical practice, and on the appropriate Incident Report Form.  In addition, 
for incidents fulfilling the definition of an AE or an SAE, the appropriate AE 
CRF page or SAE form will be completed and reported as per the AE and 
SAE reporting sections.
The Incident Report Form will be completed as thoroughly as possible and 
signed by the investigator before transmittal to GSKCH.  It is very important 
that the investigator describes any corrective or remedial actions taken to 
prevent recurrence of the incident.
The completed Incident Report Form should be faxed or emailed to the 
appropriate GSKCH Study Manager as soon as possible, but not later than 
24 hoursafter study site personnel learn of the event. If there is an SAE, the 
completed SAE pages should be sent together with this report form.  
However, if a copy of the SAE report is sent with this form, this does not 
replace the procedure to report an SAE.  The original Incident Report Form 
will remain with the subject’s records.
The GSKCH Study Manager should be notified of the situation by telephone 
or email.
Fax the Incident Report Forms to:
UK: 
The GSKCH Study Manager will be responsible for forwarding the Incident 
ReportForm to the Case Management Group, Global Clinical Safety and 
Pharmacovigilance, the Medical Director responsible for the study and other 
 
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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 of Malfunctions to GSKCH:
The investigator will follow the following directions regarding device failure 
(malfunction):
Notify GSKCH immediately.
Schedule the subject to return to the site promptly to return the failed device.
Record any incidents on the CRF and Incident Report Form following 
instructions given in the section above.
Return the failed device to the sponsor as soon as possible, including 
documentation of the details of the failure.
7.6.3. Follow-up of Incidents
Follow-up of Incidents:
During the study:
All incidents will be followed until resolution of the event, until the condition 
stabilizes, until the condition is otherwise explained, or until the subject is lost 
to follow-up. This applies to all subjects, including those withdrawn 
prematurely. The investigator is responsible for ensuring that follow-up 
includes any supplemental investigations as may be indicated to elucidate as 
completely as practical the nature of the incident.
New or updatedinformation 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 
 
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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 IEC.
7.7. Collection of Pregnancy Information
7.7.1. Time Period for Collectingof Pregnancy Information
Collection of Pregnancy Information:
Pregnancy information will be collected on all pregnancies reported following 
administration of any investigational product. Information on pregnancy 
identified during the screening phase and prior to investigational product 
administration does not need to be collected.
7.7.2. Action to be Taken ifPregnancy 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 beno 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 
 
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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 
negatives, microfilm or magnetic media, x-rays, subject files and records kept at the 
pharmacy, at the laboratory and at the medico-technical departments involved in the 
clinical study) which contain the source of data recorded in the CRF should be 
specified in the Source Document Designation Form.  In some cases the CRF can be 
used as a source document.
Each subject will be assigned and identified by a unique Screening Number. Any 
reference made to an individual subject within the study must be done using the 
unique Screening Number.
8.2. Electronic Case Report Form
A CRF is a printed, optical, or electronic document designed to record all of the 
protocol required information to be reported to the sponsor on each trial subject.
For each subject who has given informed consent/assent and has been screened, CRF 
must be completed and signed by the Principal Investigator (or authorized designee) 
to certify that the data are complete and correct.  
Management of clinical data will be performed in accordance with applicable 
GSKCH standards and data cleaning procedures to ensure the integrity of the data e.g. 
removing errors and inconsistencies in the data. 
 
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In order to protect the privacy of subjects, no Personally Identifiable Information 
(PII) (including the subject
's name or initials or birth date) is to be recorded in the 
CRF or as part of the query text.
Adverse events and concomitant medications terms (if applicable) will be coded 
using MedDRA (Medical Dictionary for Regulatory Activities) and an internal 
validated medication dictionary, GSKDrug.  
Subject data will be entered into GSKCH defined CRFs and transmitted electronically 
to GSKCH in a validated (21 CFR Part 11 compliant) web-based electronic data 
capture system (InFormTM).
All CRF pages should be completed during a subject assessment when the CRF has 
been designated as the source.  Data that is sourced elsewhere should be entered into 
the CRF in an agreed upon timeframe between the Investigator and Sponsor.  
The CRFs (including queries, query responses and audit trails) will be retained by 
GSKCH. Site data archived compact discs (CD(s)) prepared by a third party will be 
sent to the investigator to maintain as the investigator copy following the 
decommissioning of the study.
8.3. Data Handling
Documentation of all data management activities should allow step-by-step 
retrospective assessment of data quality and study performance. Any changes or 
corrections to data will be performed in the Electronic Data Capture (EDC) System, 
and it will include rationale for changes. The EDC system has an audit trail, which 
will provide a complete record of the changes and corrections endorsed by the 
Investigator.
8.3.1. Data Queries
Programmed edit checks will be generated automatically, as the data is being entered 
into the system. Data Management will also run reports and listings on the CRF data, 
in addition to the queries already programmed and generated by the system, to raise 
manual queries as needed for site clarification or correction. The Clinical Dictionary 
Development and Management Group will raise queries as needed on safety data to 
code the terms (Adverse Events and Drugs) are reported appropriately. 
The study monitor at the study site will review the CRFs in accordance with the 
monitoring plan, and any queries will be generated in the EDC System to the 
Investigator or designee, enabling the errors to be addressed in parallel with Data 
 
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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, andentered into the sponsor’s clinical 
data management system (DMS) by the study site representative. In instances where 
the PRO data is entered into the DMS by GSKCH, the PROs will be anonymised, and 
forwarded to GSKCH for entry, as agreed and documented ahead of the study 
starting. PROs that are source will be retained by the investigator and certified copies 
will be sent to GSKCH. 
In order to protect the privacy of subjects, no Personally Identifiable Information 
(PII) (including the subject
's name or initials or birth date) is to be recorded on all 
PRO’s that will be forwarded to GSKCH.
In this study the DHEQ is a PRO.  The DHEQ will be completed by the subjects as 
described in section 6.2.1.  A member of the study site staff will enter the data into 
the CRF.
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES
9.1 Sample Size Determination
The sample size is based on DHEQ total Score, restrictions, adaptation, social impact, 
emotional impact and identity, from a previous study[GSKCH Study RH01897].
A sample size of 60 subjects will have at least 90% power todetect significant 
changes to week 24 for each of the DHEQ variables, with a significance level (alpha) 
of 0.05 using a two-sided one-sample t-test. No adjustments for multiple testing have 
been used. Approximately 75eligiblesubjects will be allocated the study toothpaste
in order to ensure that approximately 60subjectscomplete the study.  Sixtysubjects 
will provide reasonable precision on estimates of DHEQ response and clinical DH 
assessments.  
9.2.General Considerations
9.2.1.Definition of Analysis Populations
The Safety population will consist of all subjects who received the study toothpaste.
 
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The intention to treat (ITT) population will be defined as all subjects who received 
the study toothpasteand have at least one post-baseline DHEQ/clinicalassessment.
The per-protocol (PP) population will be defined asall subjects whoreceived the 
study toothpaste andhave at least one post-baseline DHEQ/clinicalefficacy 
assessment and have no protocol violations deemed to affect DHEQ/clinical efficacy 
assessmentsduring the study. Further details will be provided in the statistical 
analysis plan (SAP).
Violations deemed to affect DHEQ/clinical efficacy assessments will be identified 
between the Biostatistician and Medical Director or designeepre analysis.
Analysis of the DHEQ and clinical efficacy measures (Schiff, LMS) will be 
performed ontheITT population. Analysis on the PP population will also be 
performed if there is more than 10% difference in the number of subjects betweenthe 
ITT and PP populations.
9.2.2.Exclusion of Data from Analysis
Any of the following will be considered a protocol violation which maywarrant 
exclusion of data or the subject from efficacy analysis:
Violation of inclusion or exclusion criteria that are deemed to affect efficacy.
Medical history which is deemed to affect efficacy.
Use of prohibited treatment or medication before or during the study, which is 
felt to affect the assessment of efficacy. 
Treatment non-compliance
Assessments outside the scheduled time windows
Protocol deviations captured in CRF.
Any other reason identified likely to affect efficacy
Protocol violations which warrant exclusion from efficacy analysis will be identified 
between the statistician and medical director or designee ahead of database lock.
9.2.3.Criteria for Evaluation
DHEQmeasures captured in the study will be used evaluate changes in oral health 
related in quality of life over time. OST abnormalities, incidents and AEs reported in
the study will be used for safety evaluations of the study treatments.
 
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9.2.4.Criteria for Assessing Efficacy
There are no formal success criteria in this study however it is expected that 
statistically significant changes from baseline will be observed for the DHEQ 
measures, in particular the Total score.  
9.2.5.Criteria for Assessing Tolerability
Safety will be assessed with respect to AEs, Incidentsand OST abnormalities (oral 
tolerability).
9.2.6.Handling of Dropouts and Missing Data
No data will be imputed in the case of dropouts or missing data.
9.2.7.Other Issues
An interim analysis is not planned for this study.
9.3. Statistical Methods and Analytical Plan
More details of the proposed statistical analysis will be documented in the statistical 
analysis plan(SAP), which will be written following finalisation of the protocol and 
prior to study unblinding.
Selected raw data will be listed as defined in the SAP.
9.3.1.Demographic and Baseline Characteristics
Descriptive statistics (number of subjects, mean, standard deviation, 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
The following DHEQ endpoints will be analysed:
Section 1, questions 7, 8 and 9 as separate questions
Total Score (34 item total from Section 2 questions 1 to 34)
Domains:
1. Restrictions (4 item total from Section 2 questions 1 to 4)
            2. Adaptation (12 item total from Section 2 questions 5 to 16)
            3. Social Impact (5 item total from Section 2 questions 17 to 21)
            4. Emotional Impact (8 item total from Section 2 questions 22 to 29)
            5. Identity (5 item total from Section 2 questions 30 to 34)
Global Oral Health Rating (response to Section 2 question 35)
 
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Effect on Life Overall (4 item total from Section 2 questions 36 to 39)
ABOVE DHEQ ENDPOINTS WILL BEANALYSED USING MIXEDEFFECT 
ANOVA WITH VISIT AND SITEAS FIXED EFFECT, SUBJECT AS 
RANDOM EFFECT. ADJUSTED MEANS WILL BE COMPUTED FOR 
EACH VISIT. USING THIS MODEL THEPOST BASELINE VISITS WILL 
BE COMPARED TO THE BASELINE VISIT AND DIFFERENCE OF THEIR 
EFFECT WILL BE COMPUTED ALONG WITH P-VALUES AND 95% 
CONFIDENCE INTERVALS.
THE VISIT BY SITE INTERACTION WILL BE INVESTIGATED BY 
INCLUDEINGTHE VISIT BY SITE INTERACTION TERM.
IF THE VISIT BY SITE INTERACTION TERM IS NOT SIGNIFICANT AT 
THE 10% LEVEL OF SIGNIFICANCE THEN THIS TERM WILL BE 
REMOVED FROM THE MODEL. 
IF THE VISIT BY SITE INTERACTION TERM IS SIGNIFICANT AT 10% 
LEVEL OF SIGNIFICANCE THEN THE INTERACTION WILL BE 
INCLUDED IN THEMODEL AND ALL MODEL ESTIMATES (ADJUSTED 
MEANS, 95% CI’S ANF P-VALUES) FOR WITHIN AND BETWEEN VISITS 
WILL BE REPORTED SEPARATELY FOREACH SITE BASED ON THE 
RESULTS FROM VISIT BY SITE INTERACTION.
Each of the DHEQ endpoints will be summarised by time point(Baseline, Week 4, 8, 
12, 16, 20 and 24)together with changes from baseline.
Standard summary measures together with the changes from baseline,95% CIs and p-
values of changes from baselinewill be presented.A plot of means of raw scores 
over time (mean standard errors)will also be presented for all measures.
PRESENTATIONS OF ENDPOINT SUMMARIESWILL ALSO BE 
PERFORMED BY SITE.NO INFERENCES WITHIN SITE WILL BE 
PROVIDED.
P-values will be provided to test for non-zero changes from baseline in all measures.  
Due to the exploratory nature of the study no correctionofFORmultiple testing will 
be performed.
THE ASSUMPTION OF NORMALITY AND HOMOGENEITY OF 
VARIANCE IN THE ANCOVA MODEL WILL BE INVESTIGATED. 
VIOLATION OF THESE ASSUMPTIONS MAY BE OVERCOME USING 
SUITABLE TRANSFORMATION OR PERFORMING A NON-
PARAMETRIC TEST (E.G., THE WILCOXON SIGNED-RANK TEST).
 
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9.3.3.ExploratoryAnalyses
The following exploratory analyses will be conducted.
At each time point the mean Schiff Sensitivity Score (for the two test teeth and all 
qualifying teeth) and mean LMS scores[each of 4 scales(description, tolerability, 
description, intensity]as well as the change from baseline will be calculated.  
THEMEAN SCHIFF SENSITIVITY (TWO TEST TEETH), MEAN SCHIFF 
SENSITIVITY (ALL QUALIFYING TEETH)AND MEAN LMS SCORE 
WILL BE ANALYSED USING THE SAME MODEL MENTIONED AT 
PRIMARYANALYSIS AND SIMILARSTATISTICS WILL BE PROVIDED. 
THEVISIT BY SITE INTERACTION WILL ALSO BE INVESTIGATEDAS 
PER THE PROCEDURE MENTIONED AT PRIMARY ANALYSIS.
Standard summary measures together with the changes from baseline, 95% CIs and p-
valuesof changes from baselinewill be presented. A plot of means of raw scores over 
time (mean standard errors)will also be presented for all measuresVARIABLES.
Due to the exploratory nature of the study no correction of FOR multiple testing will 
be performed.
The percentage of teeth that are sensitive (Schiff sensitivity score >0 of all qualifying 
teeth from screening (termed 
'the qualifying teeth
') will be summarised for each 
timepoint and also plotted over time. 
PRESENTATIONS OF ENDPOINT SUMMARIESWILL ALSO BE 
PERFORMED BY SITE.NO INFERENCES WITHIN SITE WILL BE 
PROVIDED.
THE ASSUMPTION OF NORMALITY AND HOMOGENEITY OF 
VARIANCE IN THE ANCOVA MODEL WILL BE INVESTIGATED. 
VIOLATION OF THESE ASSUMPTIONS MAY BE OVERCOME USING 
SUITABLE TRANSFORMATION OR PERFORMING A NON-
PARAMETRIC TEST (E.G., THE WILCOXON SIGNED-RANK TEST).
9.3.4.Safety Analyses
AEs, incidents and OSTabnormalities will be listed by treatmentand reviewed.
 
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9.3.5.Other Analyses
No further analysesare planned.
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 enrolmentof subjects 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.
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 IEC for 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 IEC)
GSK will provide full details of the above procedures, either verbally, in 
writing, or both.
10.3.Quality Control (Study Monitoring)
In accordance with applicable regulations including GCP, and GSK procedures, GSK 
or designee (i.e. third party vendor) monitors will contact the site prior to the start of 
 
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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 thetime 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 aninspection.
10.5.Conditions for Terminating the Study
Upon completion or premature discontinuation of the study, the GSKCH monitor will 
conduct site closure activities with the investigator or site staff, as appropriate, in 
accordance with applicable regulations including GCP, and GSKCH Standard 
Operating Procedures.
 
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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 the investigator terminates or suspends a trial without prior agreement of 
GSKCH, the investigator site should promptly inform the sponsor and the 
IEC, and should provide the sponsor and the IEC a detailed written 
explanation of the termination or suspension.
If the GSKCH terminates or suspends a trial, the investigator should promptly 
inform the IECand provide the IECa detailed written explanation of the 
termination or suspension. 
If the IECterminates or suspends its approval/favorable opinion of a trial, the 
investigator should promptly notify the GSKCH and provide GSKCH with a 
detailed written explanation of the termination or suspension.
10.6.Records Retention
Following closure of the study, the investigator must maintain all site study records 
(except for those required by local regulations to be maintained elsewhere), in a safe 
and secure location.  
The records (study/ site master file) must be maintained to allow easy and timely 
retrieval, when needed (e.g., for a GSK audit or regulatory inspection) and must be 
available for review in conjunction with assessment of the facility, supporting 
systems, and relevant site staff.
Where permitted by local laws/regulations or institutional policy, some or all of these 
records can be maintained in a format other than hard copy (e.g., microfiche, scanned, 
electronic); however, caution needs to be exercised before such action is taken. 
The investigator must ensure that all reproductions are legible and are a true and 
accurate copy of the original and meet accessibility and retrieval standards, including 
re-generating a hard copy, if required.  Furthermore, the investigator must ensure 
 
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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 institutional requirements.  
No study document should be destroy
ed without a prior written agreement between 
GSKCH and the investigator. The investigator must notify GSK of any changes in the 
archival arrangements, including, but not limited to, archival at an off-site facility or 
transfer of ownership of the records in the event the investigator is no longer 
associated with the site.
10.7.Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials Registers 
and Publication
Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the clinical study report.  The investigator will be 
provided reasonable access to statistical tables, figures, and relevant reports and will 
have the opportunity to 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.
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.
 
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A manuscript will be progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge.
11. REFERENCES
Addy M., Dentine Hypersensitivity: definition, prevalence, distribution and aetiology. 
In Tooth Wear and Sensitivity; 2000; pp 239–248.
Addy M., Mostafa P., Absi E., Adams D., Cervical dentin hypersensitivity. Etiology 
and management with particular reference to dentifrice. In Rowe NH, ed. Proceedings 
of Symposium on Hypersensitive Dentin. Origin and Management. University of 
Michigan, Ann Arbor, MI,; 1985; pp 146–167.
Baker S. R., Gibson B. J., Sufi F., Barlow A., Robinson P. G., The Dentine 
Hypersensitivity Experience Questionnaire: A longitudinal validation study. J. Clin. 
Periodontol.2014, 41, 52–59.
Bekes K., John M. T., Schaller H. G., Hirsch C., Oral health-related quality of life in 
patients seeking care for dentin hypersensitivity. J. Oral Rehabil.2009, 36, 45–51.
Boiko O. V., Baker S. R., Gibson B. J., Locker D., Sufi F., Barlow A. P. S., Robinson 
P. G., Construction and validation of the quality of life measure for dentine 
hypersensitivity (DHEQ). J. Clin. Periodontol.2010, 37, 973–980.
Brannstrom M., Astrom A., A Study on the Mechanism of Pain Elicited From the 
Dentin. J. Dent. Res.1964, 43, 619–625.
Canadian Advisory Board, Consensus-Based Recommendations for the Diagnosis 
and Management. Joournal Can. Dent. Assoc.2003, 69, 221–226.
Chaknis P., Panagakos F. ., DeVizio W., Sowinski J., Petrone D., ProskinH., Silica 
as compared to a denti frice conta ining 0 . 454 % stannous fluoride , sodium 
hexametaphosphate and zinc lactate and to a dentifrice containing 0 . 243 % NaF on 
dentin hypersensitivity reduction: An 8 -week study. Am. J. Dent.2011, 24, 14A –
20A.
Docimo R., Montesani L., Maturo P., Costacurta M., Bartolino M., Zhang Y. P., 
DeVizio W., Delgado E., Cummins D., Dibart S., et al., Comparing the efficacy in 
reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, 
calcium carbonate, and 1450 ppm fluoride to a benchmark commercial desensitizing 
toothpaste containing 2% potassium ion: An eight-week clinical study . J. Clin. Dent.
2009, 20, 137–143.
Du M., Jiang H., Tai B., He T., Chang J., Sun L., De-sensitizing effect of a stannous 
containing sodium fluoride novel dentifrice. J Dent Res2011, 90, Poster Session.
Gillam D., Orchardson R., Advances in the treatment of root dentine sensitivity: 
mechanisms and treatment principles. Endo Top.2006, 13, 13–33.
 
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Gracely R. H., McGrath P., Dubner R., Ratio scales of sensory and affective verbal 
pain descriptors. Pain1978, 5, 5–18.
GSKCH Study RH01685, GSKCH Clinical Study Report, RH01685.
GSKCH Study RH01897, GSKCH Clinical Study Report, RH01897.
GSKCH Study RH02026, GSKCH Clinical Study Report, RH02026.
Hall R. ., Embery G., Shellis R. ., Biological and structural features of enamel and 
dentin: current concepts relevant to erosion and dentin hypersensitivity. In Tooth 
Wear and Sensitivity; Addy, M., Embery, G., Edgar, W. ., Orchardson, R., Eds.; 
Martin Dunitz Ltd, London, 2000; pp 3–19.
He T., Barker M. L., Qaqish J., Sharma N., Fast onset sensitivity relief of a 0.454% 
stannous fluoride dentifrice. J. Clin. Dent.2011, 22, 46–50.
Heaton L., Barlow A., Coldwell S., Development of labeled magnitude scales for the 
assessment of pain of dentin hypersensitivity. J. Orofac. Pain2013, 27, 72–87.
Jokovic a, Locker D., Stephens M., Kenny D., Tompson B., Guyatt G., Validity and 
reliability of a questionnaire for measuring child oral-health-related quality of life. J. 
Dent. Res.2002, 81, 459–463.
Laster L., Laudenbach K. W., Stoller N. H., An evaluation of clinical tooth mobility 
measurements. J. Periodontol.1975, 46, 603—607.
Lobene R. R., Weatherford T., Ross N. M., Lamm R. A., Menaker L., A modified
gingival index for use in clinical trials. Clin. Prev. Dent.1986, 8, 3–6.
Ni L., He T., Chang J., Cheng R., Sun L., De-sensitizing effect of a Stannous 
containing sodium fluoride toothpaste. J Dent Res2011, 90.
Orchardson R., Changes in extracellular fluid composition which excite axons. J. 
Physiol.1975, 245, 14P—16P.
Orchardson R., Collins W. J. ., Clinical features of hypersensitive teeth. Br. Dent. J.
1987, 162, 253–256.
Parkinson C., Hughes N., Jeffery P., Jain R., Kennedy L., Qaqish J., Gallob J. T., S 
M., The efficacy of an experimental dentifrice containing 0.454% w/w stannous 
fluoride in providing relief fropm the pain of dentin hypersensitivity: An 8-week 
clinical study. Am. J. Dent.2013, 26, 25A –31A.
Pradeep a R., Sharma A., Comparison of clinical efficacy of a dentifrice containing 
calcium sodium phosphosilicate to a dentifrice containing potassium nitrate and to a 
placebo on dentinal hypersensitivity: a randomized clinical trial. J. Periodontol.2010, 
81, 1167–1173.
 
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Schiff T., Dotson M., Cohen S., Efficacy of a dentifrice containing potassium nitrate, 
soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal 
hypersensitivity: a twelve-week study. J. Clin. Dent.1994, 5, 87–92.
Schiff T., Zhang Y., DeVizio W., Stewart B., Chaknis P., Petrone M., Volpe A., 
Proskin H., A randomized clinical trial of the desensitizing efficacy of three 
dentifrices. Compend. Contin. Educ. Dent.2000a, 27, 4–10.
Schiff T., Bonta Y., Proskin H., DeVizio W., Petrone M., Volpe A., Desensitizing 
efficacyof a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous 
fluoride. Am. J. Dent.2000b, 13, 111–115.
Schiff T., He T., Sagel L., Baker R., Efficacy and safety of a novel stabilized 
stannous flouride and sodium hexametaphosphate dentifrice for dental 
hypersensitivity. J. Contemp. Dent. Pract.2006a, 7, 1–10.
Schiff T., He T., Sagel L., Baker R., Efficacy and Safety of a Novel Stabilized 
Stannous Fluoride and Sodium Hexametaphosphate. J. Contemp Dent. Pract. Pract.
2006b, 7, 1–10.
Sharma N., Roy S., Kakar A., Greenspan D. C., Scott R., A clinical study comparing 
oral formulations containing 7.5% calcium sodium phosphosilicate (novamin??), 5% 
potassium nitrate, and 0.4% stannous fluoride for the management of dentin 
hypersensitivity. J. Clin. Dent.2010, 21, 88–92.
Sharma N., Roy S., Kakar A., Greenspan D., Scott R., Instant Sensitivity Relief of a 
Stannous containing Sodium Fluoride Dentifrice. J. Dent. Res.2011, 90, Oral 
Presentation.
Sharma S., Shetty N. J., Uppoor A., Evaluation of the clinical efficacy of potassium 
nitrate desensitizing mouthwash and a toothpaste in the treatment of dentinal 
hypersensitivity. J. Clin. Exp. Dent.2012, 4, 28–33.
Slade G., Spencer A., Development and evaluation of the Oral Health Impact Profile. 
Community Dent Heal.1994, 11(1), 3–11.
Slade G. D., Derivation and validation of a short-form oral health impact profile. 
Community Dent. Oral Epidemiol.1997, 25, 284–290.
Dentine Hypersensitivity: Developing a Person-Centred Approach to Oral Health; 
Robinson, P. G.,Ed.; Elsevier Inc.: London, 2015. 
12. APPENDICES
12.1. Appendix 1 -Abbreviations
Abbreviations
 
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AE 
Adverse Event
CD
Compact Disc
CRF
Case Report Form
DH
Dentine Hypersensitivity
DHEQ
Dentine Hypersensitivity Experience Questionnaire
EAR
Erosion, Abrasion, Recession
EDC
Electronic Data Capture
GCP
Good Clinical Practice
GSKCH
GlaxoSmithKline Consumer Healthcare
ICH
International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
ITT
Intention toTreat
OHT
Oral Hard Tissue
OST
Oral Soft Tissue
PII
Personally Identifiable Information
LMS
Labelled Magnitude Scales
PP
Per Protocol
ppm
Parts per million
PRO
Patient Reported Outcome
SAE
Serious Adverse Event
 
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12.2. Appendix 2–DHEQ
Example
 
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12.3. Appendix 3 –Instructions for LMS Training Exercise
Subjects will be given instructions for using the LMS andasked to complete the LMS 
training exercise form.  The investigator or designee should read the instructions 
aloud while the subject reads along.  Subjects will be permitted to ask questions.  
However, most questions should be answered by rereading the appropriate section of 
the instructions.  The investigator, or designee, will then determine whether the 
subject understands how to use the LMS based on the line scale training exercise 
answers and the criteria below.
Interpretation of the Line Scale Training Exercise
The objective of this exercise is NOTto determine whether the subject can get the 
exact answers, but to determine whether they understand the concept.  Therefore, the 
following general criteria are suggested:
Are markings only on the verbal descriptors?  If so, provide feedback that they 
are to use the entire scale, including areas between the descriptors.
Are subjects marking on the same place on all the scales for one stimulus 
(particularly if the LMS measures are all presented on one page?)  If so, make 
sure subjects understand what each scale is meant to measure (intensity, 
duration, ability to tolerate, and description) and that stimuli will likely 
produce different marks on each scale.  
The stimuli are presented generally in increasing intensity.  Are subjects 
indicating an increasing intensity across stimuli?
Are subjects marking their ratings with an “X” on the scale?  If not (subjects 
are circling descriptors, making unclear marks, etc.), provide feedback on the 
use of the correct mark.
If subjects appear unable to complete each of the LMS scales (intensity, duration, 
tolerability and description) with the appropriate response (s), the investigator/ 
designee should talk them through the grading of the first two LMS scenarios, if 
required.  If the marks are generally correctly ordered, but far from their true 
positions, the investigator/ designee should try to get the subject to verbalize why 
they placed the marks as they did.  However, the investigator/ designee should be 
careful not to pressure the subject to change their responses.  One approach would be 
for the investigator/ designee to start with an item that the subject did well, ask about 
that and then continue by asking about an item where they did less well.
If subjects are not ableto provide proper responses to the stimuli questions across all 
four figure scales, it is unlikely they will provide appropriate responses on the clinical 
response LMS scales.  These subjects should be disqualified.
 
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Subject Instructions for LMS Training Exercise (Example)
“The purpose of this exercise is to introduce you to the scales you will be using.  
There are no right or wrong answers.  
Please read each item carefully. Then try to remember or imagine what each sensation 
feels like.  If you haven’t had exactly the experience described, try to think of 
something similar.
The scales you will be using each have words that can be used to describe different 
feelings or sensations people have in their mouths.  As you think about each 
sensation, you should think about the word that best describes what that sensation 
feels like.  Then, if appropriate, you can “fine tune” your rating by marking the line 
betweenthat word and the next word up or down the scale.  
FOR EACH ITEM PLEASE INDICATE HOW YOU WOULD RATE THE 
FEELING DESCRIBED BY PLACING AN ”X” ON THE LINE.  YOU MAY 
MARK ANYWHEREALONG THE LINE.
Please turn to the next page for the first example in this exercise.
 
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Let’s start with this example.
The touch of a pill on your tongue.
Have you ever experiencedthis feeling or sensation before?  
(Please circle one):  Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
    NOT TO SCALE
Please turn to the next page.
STABBING
DIM 
DULL
SHARP
NO PAIN
STABBING
DIM 
DULL
SHARP
NO PAIN
DIM 
DULL
SHARP
NO PAIN
 
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Still thinking aboutthe touch of a pill on your tongue, pleaserate the DURATION
of this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
 
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Still thinking aboutthe touch of a pill on your tongue, pleaserate how much you 
are able to TOLERATEwith this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
       NOT TO SCALE
Please turn to the next page.
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
 
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Finally, thinking about thethe touch of a pill on your tongue, please give a rating 
that DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
 
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Let’s try this example.
The pain from biting your tongue.  
Have you ever experienced this feeling or sensation before?  
(Please circle one):  Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
       NOT TO SCALE
Please turn to the next page.
Still thinking aboutthepain from biting your tongue, pleaserate the DURATION
of this feeling or sensation.
STABBING
DIM 
DULL
SHARP
NO PAIN
STABBING
DIM 
DULL
SHARP
NO PAIN
DIM 
DULL
SHARP
NO PAIN
 
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Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
    NOT TO SCALE
Please turn to the next page.
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
 
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Still thinking aboutthepain from biting your tongue, pleaserate how much you are 
able to TOLERATEwith this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
           NOT TO SCALE
Please turn to the next page.
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
 
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Finally, thinking about thethepain from biting your tongue, please give a rating 
that DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
    NOT TO SCALE
Please turn to the next page.
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
 
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Let’s try one last example.
The pain of a persistent toothache.
Have you ever experienced this feeling or sensationbefore?  
(Please circle one): Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
           NOT TO SCALE
Please turn to the next page.
STABBING
DIM 
DULL
SHARP
NO PAIN
STABBING
DIM 
DULL
SHARP
NO PAIN
DIM 
DULL
SHARP
NO PAIN
 
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Still thinking aboutthepain of a persistenttoothache, pleaserate the DURATION
of this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
        NOT TO SCALE
Please turn to the next page.
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
 
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Still thinking aboutthepain of a persistent toothache, pleaserate how much you 
are able to TOLERATEwith this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
             
  NOT TO SCALE
Please turn to the next page.
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
 
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Finally, thinking aboutthepain of a persistent toothache, please give a rating that 
DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
        
NOT TO SCALE
You have finished the practice exercise, and you are now ready to take part in 
the main part of the study.  
If you have any questions about this exercise, please let a member of the study 
staff know.  
If you feel that you understand how to use these scales, please see a member of 
the study staff, who will start you on the main part of the study.
Thank you for your time!
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
TWINGE 
ACHE
NO PAIN
THROBBING
SHOOTING
 
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12.3. APPENDIX 3-SUBJECT INSTRUCTIONS FOR LMS 
TRAINING EXERCISE
Subjects will be given instructions for using the LMS and asked to complete the LMS 
training exercise form.  The investigator or designee should read the instructions 
aloud while the subject reads along.  Subjects will be permitted to ask questions.  
However, most questions should beanswered by rereading the appropriate section of 
the instructions.  The investigator, or designee, will then determine whether the 
subject understands how to use the LMS based on the line scale training exercise 
answers and the criteria below.
Interpretation of the Line Scale Training Exercise
The objective of this exercise is NOT to determine whether the subject can get the 
exact answers, but to determine whether they understand the concept.  Therefore, the 
following general criteria are suggested:
Are markings only on the verbal descriptors?  If so, provide feedback that they 
are to use the entire scale, including areas between the descriptors.
Are subjects marking on the same place on all the scales for one stimulus 
(particularly if the LMS measures are all presented on one page?)  If so, make 
sure subjects understand what each scale is meant to measure (intensity, 
duration, ability to tolerate, and description) and that stimuli will likely 
produce different marks on each scale.  
The stimuli are presented generally in increasing intensity.  Are subjects 
indicating an increasing intensity across stimuli?
Are subjects marking their ratings with an “X” on the scale?  If not (subjects 
are circling descriptors, making unclear marks, etc.), provide feedback on the 
use of the correct mark.
If subjects appear unable to complete each of the LMS scales (intensity, duration, 
tolerability and description) with the appropriate response (s), the investigator/ 
designee should talk them through the grading of the first two LMS scenarios, if 
required.  If the marks are generally correctly ordered, but far from their true 
positions, the investigator/ designee should try to get the subject to verbalize why 
they placed the marks as they did.  However, the investigator/ designee should be 
careful not to pressure the subject to change their responses.  One approach would be 
for the investigator/ designee to start with an item that the subject did well, ask about 
that and then continue by asking about an item where they did less well.
If subjects are not able to provide proper responses to the stimuli questions across all 
four figure scales, it is unlikely they will provide appropriate responses on the clinical 
response LMS scales.  These subjects should be disqualified.
 
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Subject Instructions for LMS Training Exercise (Example)
The purpose of this exercise is to introduce you to the scales you will be using.  There 
are no right or wrong answers.
Please read each item carefully. Then try to remember or imagine what each sensation 
feels like.  If you haven’t had exactly the experience described, try to think of 
something similar.
The scales you will be using each have words that can be used to describe different 
feelings or sensations people have in their mouths.  As you think about each 
sensation, you should think about the word that best describes what that sensation 
feels like.  Then, if appropriate, you can “fine tune” your rating by marking the line 
betweenthat word and the next word up or down the scale.
FOR EACH ITEM PLEASE INDICATE HOW YOU WOULD RATE THE 
FEELING DESCRIBED BY PLACING AN ”X” ON THE LINE.  YOU MAY 
MARK ANYWHEREALONG THE LINE.
Please turn to the next page for the first example in this exercise.
 
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Let’s start with this example.
The touch of a pill on your tongue.
Have you ever experienced this feeling or sensation before?  
(Please circle one):  Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthe touch of a pill on your tongue, pleaserate the DURATION
of this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthe touch of a pill on your tongue, pleaserate how much you 
are able to TOLERATEthis feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Finally, thinking about the touch of a pill on your tongue, please give a rating that 
DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below withan “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn tothe next page
 
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Let’s try this example.
The pain from biting yourtongue.
Have you ever experienced this feeling or sensation before?  
(Please circle one):  Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthepain from biting your tongue, pleaserate the DURATION
of this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthepain from biting your tongue, pleaserate how much you are 
able to TOLERATEthis feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Finally, thinking about thepain from biting your tongue, please give a rating that 
DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Let’s try one last example.
The pain from persistent toothache.
Have you ever experienced this feeling or sensation before?  
(Please circle one):  Yes / No
First please rate the INTENSITYof this feeling or sensation. 
Mark the scale below with an “X” to indicate the best description of that feeling or
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthepain of a persistent toothache, pleaserate the DURATION
of this feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page.
 
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Still thinking aboutthepain of a persistent toothache, pleaserate how much you 
are able to TOLERATEthis feeling or sensation.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
Please turn to the next page
 
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Finally, thinking aboutthepain of a persistent toothache, please give a rating that 
DESCRIBESthe kind of feeling or sensation this is.
Mark the scale below with an “X” to indicate the best description of that feeling or 
sensation.  Remember, you can mark anywhereon the line, including between the 
descriptive words.
NOT TO SCALE
You have finished the practice exercise, and you are now ready to take part in
the main part of the study.  
If you have any questions about this exercise, please let a member of the study 
staff know.  
If you feel that you understand how to use these scales, please see a member of 
the study staff, who will start you on the main part of the study.
Thank you for your time!
 
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12.4. APPENDIX 4 -LMS SUBJECT ASSESSMENT FORM (EXAMPLE)
TOLERABILITY
Labelled Magnitude Scales
TOLERABLE
UNCOMFORTABLE
UNNERVING
UNBEARABLE
NO PAIN
INTENSITY
DURATION
DIM
DULL
SHARP
STABBING
NO PAIN
TEMPORARY
QUICK
LINGERING
CHRONIC
NO PAIN
Screening No. S___ ___ ___ ___
Protocol:  204930 
Visit No: ____ Date: __ __/ __ __/ __ __
Score:
Scorer initials (site staff):
mm
mm
mm
Tooth No:
mm
TWINGE
ACHE
THROBBING
SHOOTING
NO PAIN
DESCRIPTION
P
lease rate the INTENSITY/DURA
TION/TOLERABILITY/DESCRIPTION of this feeling or sensation.
Mark the scales below with an “X” to indicate the best description of that feeling or sensation. 
Remember, you can mark anywhere on the line, including 
between the descriptive words.
Final v1.0 16 Oct 15
NOT TO SCALE
 
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SIGNATURE PAGE 
 
  
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
09-Sep-2016 15:29:05
 
Biostatistics Approval
12-Sep-2016 05:12:42
Approved
09-Sep-2016 05:32:57
Approved
Clinical Operations Approval
Clinical Protocol 204930
08-Sep-2016 17:03:11
 
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PPD
PPD
PPD
PPD

SAP_001.pdf: 
CONFIDENTIAL
STATISTICAL ANALYSIS PLAN FOR PROTOCOL 204930
Study to Investigate the Impact on Oral Health RelatedQuality of 
Life of Managing Dentine Hypersensitivityby a Daily Use Anti-
Sensitivity Toothpaste
BIOSTATISTICS DEPARTMENT
GLAXOSMITHKLINE CONSUMER HEALTHCARE
 INDIA
 (Statistician)
 
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PPD
PPD
PPD


Table of Contents
Glossary.....................................................................................4
1
Introduction.....................................................................5
2
Objectives.........................................................................5
3
Study Design.....................................................................5
4
Sample Size Determination............................................7
5
Data Considerations.........................................................8
5.1 Analysis Populations......................................................8
5.2 Subgroups/Stratification...............................................9
5.3 Criteria for Evaluation.....................................................9
5.3.1 Criteria for Assessing Efficacy.......................................9
5.3.2 Criteria for Assessing Tolerability.................................9
6
Demographics and Baseline Characteristics..................9
6.1 Subject Disposition........................................................9
6.2 Demographics and Baseline Characteristics................10
7
Treatment Compliance and Concomitant Medications10
7.1 Treatment Compliance..................................................10
7.2 Concomitant Medications.............................................11
7.3 Medical History.............................................................11
8
Efficacy Analysis..............................................................11
8.1 Primary Analysis...........................................................11
8.2 Exploratory Analyses....................................................12
9
Safety Analysis.................................................................13
10 Interim Analysis...............................................................14
11 Topline Summary Tables................................................15
Appendix 1 Study Schedule......................................................16
 
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Appendix 2 List of Tables, Figures & Listings.......................18
Appendix3 Templates for Tables, Figures & Listings............21
 
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Glossary
AE
Adverse Event
AM
Ante Meridiem (Morning)
ANCOVA
Analysis of Covariance
CI
Confidence Interval
cm
Centimetre
CRO
Clinical Research Organisation
DH
Dentine hypersensitivity
DHEQ
Dentine Hypersensitivity Evaluation Questionnaire
eCRF
electronic Case Report Form
EAR
Erosion, Abrasion, Recession
g
Grams
GI
Gingival Index
GSKCH
GlaxoSmithKline Consumer Healthcare
ITT
Intention-to-Treat
LMS
LabelledMagnitude Scale
mm
Millimetre
MGI
Modified Gingival Index
OST
Oral Soft Tissue 
PP
Per Protocol
ppm
Parts Per Million
SAP
Statistical Analysis Plan
TPI
Turesky Modification of the Quigley-Hein Plaque Index
UK
United Kingdom
VAS
Visual Analogue Scale
w/w
Weight/Weight Ratio
 
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1
Introduction
This document describes the statistical methods and data presentations to be used in 
the summary and analysis of the final data from Protocol 204930.The statistical 
analysis plan (SAP) will be finalisedand approved prior to database lock.This is a 
non comparative study.
2
Objectives
Primary
To monitor the impact of long term 
management of DH over a 24 week 
period, with twice daily use of a 
sensitivity toothpaste, on the oral health 
related quality of life in sensitivity 
sufferers, as measured by the DHEQ. 
Change from baseline in DHEQ 
endpoints over time.
Exploratory
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, including the number of 
sensitive teeth, as measured by Schiff 
Sensitivity Score to assess examiner 
performance on this measure. 
Mean Schiff Sensitivity Score for all 
timepoints.
Change from baseline in Schiff 
sensitivity score (two test teeth) for all 
timepoints.
Change from baseline in Schiff 
sensitivity score (all qualifying teeth) for 
all timepoints.  
To evaluate changes in dentine 
hypersensitivity over the 24 week 
treatment period, as measured by 
Labelled Magnitude Scales (LMS). 
At each time point the mean LMS (of 
each of 4 VAS scales) and change from 
baseline (for the two test teeth) and will 
be calculated.
3
Study Design
Overall Design
This multi-site, non-comparative design study will be used to monitor the impact of 
long term management of DH with daily use of a sensitivity toothpaste on the quality 
of life of a populationof sensitivity sufferers.  Changesin oral health related quality 
of life will be monitored using the DHEQ.   The study will be conducted in subjects 
in good general health, with pre-existing self-reported and clinically diagnosed tooth 
sensitivity at screening.
Visit 1 -Screening Visit
 
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The following assessments will be conducted in the order written:
Written informed consent.
Review of the oral care products the subject is currently using to confirm they do 
not contain any ingredients intended for treating sensitive teeth. 
Demographics, concomitant medications and medical history.
Oral examination including an oral soft tissue (OST) examination and oral hard 
tissue (OHT) assessments to determine eligible teeth. 
Qualifying evaporative air sensitivity.
Inclusion/exclusion criteria review.
Confirmation of subject eligibility.
Dispensation of acclimatisation toothpaste, toothbrush, diary and timer.
Supervised brushing with acclimatisation toothpaste.
Adverse Events (AEs) will be documented from completion of the supervised 
brushing with acclimatisation toothpaste.
Visit 2 -Baseline Visit (Day 0)
The following assessments will be conducted in the order written:
Review of concomitant medications and AEs. 
Return of acclimatisation toothpaste, toothbrush and diary. 
Review of completed diary to determine usage compliance.
Inclusion/exclusion criteria review. 
Confirmation of subject eligibility and continuance. 
Completion of DHEQ Section 1 and Section 2.
LMS Training Exercise
OST and OHT examinations.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on all 
eligible teeth from Visit 1.
Selection of two test teeth.
Dispensation of study toothpaste, toothbrush and diary.
Supervised brushing with study treatment.
AEs and Incidents from supervised brushing with study treatment
Visit 3 -Week 4 (Day 28 ± 3)
Visit 4 –Week 8 (Day 56 ± 3)
Visit 5 –Week 12 (Day 84 ± 3)
Visit 6 –Week 16 (Day 112 ± 3)
Visit 7 –Week 20  (Day 140 ± 3)
The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpaste and diary. New toothbrush at Week 12.
Review of completed diary to determine usage compliance.
 
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Inclusion/exclusion criteria review. 
Confirmation of subject continuance.
Completion of DHEQ Section 1 (Q7-9) & Section 2.
OST and OHT examinations.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two test 
teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
Dispensation of study toothpaste and diary (and toothbrush at Visit 5).
Supervised brushing with study treatment.
AEs and Incidents from supervised brushing with study treatment
Visit 8 – Week 24  (Day 168 ± 3) 
The following assessments will be conducted in the order written:
Review of concomitant medications, AEs and incidents. 
Return of study toothpaste, toothbrush and diary.
Review of completed diary to determine usage compliance.
Confirmation of subject continuance. 
Completion ofDHEQ Section 1 (Q7-9) & Section 2.
OST and OHT examination.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale, LMS) on two 
selected test teeth.
Evaporative air sensitivity assessment (Schiff Sensitivity Scale) on remaining 
eligible teeth from Visit 1.
AEs and incidents will be recorded for 5 days after last treatment. 
The study product is:
Dentifrice containing  0.454% w/w stannous fluoride(1100ppm fluoride)
Sensodyne Repair and ProtectDaily Repair Toothpaste. German marketplace
4
Sample Size Determination
The sample size is based on DHEQ total Score, restrictions, adaptation, social impact, 
emotional impact and identity, from a previous study [GSKCH Study RH01897]. 
A sample size of 60 subjects will have at least 90% power to detect significant 
changes to week 24 for each of the DHEQ variables, with a significance level (alpha) 
of 0.05 using a two-sided one-sample t-test. No adjustments for multiple testing have 
been used. Approximately 75 eligible subjects will be allocated the study toothpaste 
in order to ensure that approximately 60 subjects complete the study.  Sixty subjects 
 
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will provide reasonable precision on estimates of DHEQ response and clinical DH 
assessments.  
5
Data Considerations
5.1
Analysis Populations
The Safety population will consist of all subjects who received the study toothpaste.
The intention to treat (ITT) population will be defined as all subjects who received 
the study toothpasteand have at least one post-baseline clinicalassessment.
The per-protocol (PP) population will be defined asall subjects whoreceived the 
study toothpaste andhave at least one post-baseline clinicalassessment and have no 
protocol violations deemed to affect clinical assessmentsduring the study. 
The following will be considered a protocol violation which maywarrant exclusion 
from the PP analysis:
Violation of inclusion or exclusion criteria that are deemed to affect efficacy.
Medical history which is deemed to affect efficacy.
Use of amedication before or during the study, which is felt to affect the 
assessment of efficacy.  The time points affectedwill be determinedprior to 
database lock.
Not receiving any studytreatment.
The following will be included in the review of protocol violations but will be 
reviewed ona case-by-case basis to determine whether the data should be excluded 
from a PP analysis:
Non compliance with assigned treatment regimen.  Treatment compliance will 
be reviewed on a case-by-case basis prior to database lock to determine the
time points from which subject data will be excluded.More details will be 
given in the Blinded Review Specification Document.
Assessments outside the time window of the designated time windows Visit 3 
-Week 4 (Day 28 ± 3), Visit 4 –Week 8 (Day 56 ± 3), Visit 5 –Week 12 
(Day 84 ± 3), Visit 6 –Week 16 (Day 112 ± 3), Visit 7 –Week 20 (Day 140 ± 
3)and Week 24 (Day 168 ± 3)willbe reviewed on a case-by-case basis prior 
 
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to database lock to determine thetime points from which subject data will be 
excluded.  For theanalysis, assessments will be assigned to the nominal visit, 
irrespective of whether the assessment took place within the visit window.
Protocol violations which warrant exclusion from efficacy analysiswill be identified 
between the statistician and ClinicalResearch Directoror designee, before database 
lock.Further details will be provided in the Data Review Specifications document.
Analysis of all quality of life or hypersensitivity endpointswill be performed onthe
ITT population. Analysis on the PP population will also be performed if there is more 
than 10% difference in the number of subjects for the ITT and PP populations.
5.2
Subgroups/Stratification
No subgroup or stratified analyses are planned.
5.3 Criteria for Evaluation
DHEQ measures capturedin the study will be used evaluate changes in oral health 
related in quality of life over time. OST abnormalities, incidents and AEs reported in 
the study will be used for safety evaluations of the study treatments.
5.3.1 Criteria for Assessing Efficacy
There are no formal success criteria in this study however it is expected that 
statistically significant changes from baseline will be observed for the DHEQ 
measures, in particular the Total score.  
5.3.2 Criteria for Assessing Tolerability
Safety will be assessed with respect to AEs, Incidents and OST abnormalities (oral 
tolerability).
6
Demographics and Baseline Characteristics
6.1
Subject Disposition
The subject disposition summary will include the number of screened subjects and 
screen failures overall.The number and percentage of subjects, in the Safety, ITTand 
PPpopulations will be presented. The percentages will be based upon the total 
number of subjects in the Safety population.
 
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The number and percentage of subjects completing the study and not completing the 
study, including a breakdown of the reasons for not completing the study, will be 
presented. The percentages are based upon the total number of subjects in the Safety 
population.
A separate summary table of protocol violations leading to exclusion from PP 
analyses will be produced indicating the number and percentage of subjects with each 
violation. Percentages will be based on the ITT population.
6.2
Demographicsand Baseline Characteristics
Descriptivestatistics (number of subjects, mean, standard deviation, median, 
minimum and maximum for continuous variables, and frequency and percentage for 
categorical variables) will be provided for demographic on baseline dataon the 
Safety,ITT and PP populations.
7
Treatment Compliance and Concomitant Medications
7.1
Treatment Compliance
Diaries will be used throughout the study to a) allow the subject to familiarize 
themselves with their completion during the acclimatisationphase and b) promote 
compliance during the treatment phase. Subjects will not be withdrawn from the 
study due to missed brushings but will be reminded to use the products supplied as 
per the instructions provided and to complete the diary after each product usage to 
encourage compliance.
Study site staff will review the diaries at the start of each visit for compliance and any 
reports of changes/new medications. 
To ensure that subjects understand the dose of toothpasteto be used, staff will 
demonstrate what is meant by a ‘full ribbon’ (i.e. covering the length of the 
toothbrush head), and brushing will be supervised at all assessmentvisits (at the end 
of the visit procedures). 
Subjects will receive a product use diary.  This will outline the brushing instructions 
and will be used to record each brushing occasion during the study.  Subjects will be 
provided with a newdiary at screening, baseline, Week 4, Week 8, Week 12, Week 
16andWeek20which they will return to the site at the subsequent visit.  The number 
of missed or extra brushings will be recorded in the eCRFand may lead to exclusion 
from the PP population.
 
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Subjects will also be asked to bring all tubes of toothpaste toeach study visit for a 
visual compliance check of product usage.  
7.2
Concomitant Medications
Concomitant medications used during the study will be databasedbut no formal 
listing of these data will be produced. These data will be reviewed for potential 
exclusions from the PP population.
7.3
Medical History
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.  Any concomitant therapy 
taken in the 30 days prior to the Screening Visit and throughout the study will also be 
recorded.
8
Efficacy Analysis
8.1
Primary Analysis
The null hypothesis for the primary analysiswill be:
H0= There isno difference from baseline in DHEQ endpoints over time.
The alternative hypothesis will be: 
H1= There is statistically significance difference from baseline in DHEQ endpoints 
over time.
The following DHEQ endpoints will be analysed:
Section 1, questions 7, 8 and 9 as separate questions
Total Score (34 item total from Section 2 questions 1 to 34)
Domains:
1. Restrictions (4 item total from Section 2 questions 1 to 4)
            2. Adaptation (12 item total from Section 2 questions 5 to 16)
            3. Social Impact (5 item total from Section 2 questions 17 to 21)
            4. Emotional Impact (8 item total from Section 2 questions 22 to 29)
            5. Identity (5 item total from Section 2 questions 30 to 34)
Global Oral Health Rating (response to Section 2 question 35)
Effect on Life Overall (4 item total from Section 2 questions 36 to 39)
 
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Above DHEQ endpoints will be analysed using mixed effect ANOVA with Visit and 
site as fixed effect, subject as random effect. Adjusted Means will be computed for 
each visit. Using this model, the post baseline visit will be compared to the baseline 
visit and difference of their effect will be computed along with P-values and 95% 
confidence interval. 
The visit by site interaction will be investigated by including the visit by site 
interaction term. If the visit by site interaction term is not significant at the 10% level 
of significance then this term will be removed from the model.
If the visit site interaction term is significant at 10% level of significance then the 
interaction will be included in the model and all model estimates (Adjusted Means, 
95% CIs and P-values) for within and between visits will be reported separately for 
each site and based on results from visit by site interaction. 
Each of the DHEQendpoints will be summarised by time point (Baseline, Week 4, 8, 
12, 16, 20 and 24).
Standard summary measures, 95% CIs and p-values will be presented.A plot of 
means of raw scores over time (mean standard errors)will also be presented for all 
measures.
Due to the exploratory nature of the study no correction of multiple testing will be 
performed.
Summary statistics (N, Percentage)will be provided for section 1 (Q1-Q6) and 
section 2 (Q1 -Q39)of DHEQ questionnaire.
The assumption of normality and homogeneity of variance in the ANOVAmodel will 
be investigated. Violation of these assumptions may be overcome using suitable 
transformation or performing a non-parametric test (e.g., the Wilcoxon signed-rank 
test).
8.2
Exploratory Analyses
The followingexploratory analyses will be conducted.
At each time point the mean Schiff Sensitivity Score (for the two test teeth and all 
qualifying teeth) and mean LMS scores [each of 4 scales (description, tolerability, 
description, intensity] as well as the changefrom baseline will be calculated. 
 
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The above each endpoint will be analysed using mixed effect ANOVA with visit and 
site as fixed effect, subject as random effect. Adjusted Means will be computed for 
each visit. Using this model, the post baseline visitwill be compared to the baseline 
visit and difference of their effect will be computed along with P-values and 95% 
confidence interval. 
The visit by site interaction will be investigated by including the visit by site 
interaction term. If the visit by site interaction term is not significant at the 10% level 
of significance then this term will be removed from the model.
If the visit site interaction term is significant at 10% level of significance then the 
interaction will be included in the model and allmodel estimates (Adjusted Means, 
95% CIs and P-values) for within and between visits will be reported separately for 
each site and based on results from visit by site interaction. 
Standard summary measures, 95% CIs and p-values will be presented. A plot of 
means of raw scores over time (mean standard errors)will also be presented for all 
measures.
The assumption of normality and homogeneity of variance in the ANOVAmodel will 
be investigated. Violation of these assumptions may be overcome using suitable 
transformation or performing a non-parametric test (e.g., the Wilcoxon signed-rank 
test).
The percentage of teeth that are sensitive (Schiff sensitivity score >0 of all qualifying 
teeth from screening (termed 
'the qualifying teeth
') will be summarisedfor each 
timepoint and also plotted over time. 
9
Safety Analysis
The safety profile of the study dentifrice willbe assessed with respect to adverse 
events (AEs).  Oral soft tissue (OST) abnormalities are included as AEs if they appear 
or worsen after the initial assessment.
All safety data will be reported for the Safety population as per actual treatment 
received.  All subjects screened will be included in the list of AEs.
All AEs will be reviewed by the ClinicalResearch Directoror Designee prior to 
database freeze and will be coded using the Medical Dictionary for Regulatory 
 
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Activities (MedDRA). During this review stage, AEs will be further categorized as 
oral or non-oral.
AEs will be regarded as treatment emergentif they occur on or after the startdate and 
time of the first treatment application. All other AEs prior to this will be considered 
non-treatment emergent.
The following summary tables and listings will be presented by treatment group.
Table of treatment emergent AEs by Oral/Non-Oral  and Preferred Term
Table of  treatment emergent AEs by SOC and Preferred Term
Table of Treatment emergent treatment related AEs by Oral/Non-Oral and 
Preferred Term
Listing of all AEs (including Non-treatment emergent from All Subjects).
Listing of serious AEs.(if there are none a null listing will be produced, if 
there are >5 treatment emergent SAEs a table will be produced by SOC and 
PT)
Listing of incidents (if there are none a null listing will be produced) 
Table of Non Serious treatment emergent AEs by SOC and Preferred Term. 
(only produced if there are > 5 SAEs)
10
Interim Analysis
No interim analysis is planned for this study.
 
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11
Topline Summary Tables
The following tables and figures will be provided for top-line report.
FigureNo.
Title
Figure 9.1.2.1
DHEQ Total Score over Time
Intent  to Treat Population
Figure 9.1.3.1
DHEQ Domainsover Time
Intent  to Treat Population
(Note Restrictions, Social Impact, 
Identity, 
Adaptation, EmotionalImpact)
* Validated datasetswill be sufficient for the topline report.  
Table 
No./ 
Datasets
Title 
Table 9.1.1
Subject Disposition 
All Screened Subjects
Table 9.3.1.1
Summary and Statistical Analysis of Dentine 
Hypersensitivity Experience Questionnaire [DHEQ 
Section 1]
Intent to Treat Population
Table 9.3.1.2
Summary and Statistical Analysis of Dentine
Hypersensitivity Experience Questionnaire [DHEQ 
Section 2 -All Domains]
Intent to Treat Population
Table 9.4.1
Treatment Emergent Adverse Events by Oral/non-
Oral and preferred termSafety Population
Table 9.4.3
Treatment Emergent Treatment Related Adverse 
Events by Oral/non-Oral and preferred termSafety 
Population
Table 9.4.5
Listing of all AEs (including Non-treatment emergent 
from All Subjects).
Datasets*
ADSL.sas7bdt, ADAE.sas7bdt, ADDHEQ.sas7bdt 
STAT1_TOP.sas7bdt and STAT2_TOP.sas7bdt
 
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Appendix 1 Study Schedule 
Procedure
Screening
Visit1
Baseline
Visit2 
Week 0
(Day0)
Visit3
Week 4 (Day28 
±3)
Visit4
Week 8
(Day56 ±3)
Visit5
Week 12 
(Day84 ±3)
Visit 6
Week 16 
(Day112 ±3)
Visit7
Week 20 
(Day140 ±3)
Visit8
Week 24 
(Day168 ±3)
Informed Consent
X
Acclimatisation Period - Minimum 3 weeks – Maximum  6 weeks
Demographics, Medical History
X
Current/Concomitant Medications
X
X
X
X
X
X
X
X
Inclusion/Exclusion
X
X
Subject Eligibility
X
X
Subject Continuance
X
X
X
X
X
X
X
Oral Soft Tissue (OST) and Oral 
Hard Tissue (OHT) Assessment
X
X
X
X
X
X
X
X
Eligible Teeth Assessments 
(Dentition Exclusions, EAR, MGI, 
Tooth Mobility)
X
Qualifying Evaporative Air 
Sensitivity (Y/N)
X
Dispense Acclimatisation 
Toothpaste, Toothbrush, Diary and 
Timer
X
Supervised Brushing with 
Acclimatisation Toothpaste
X
Return Acclimatisation Toothpaste, 
Toothbrush and Diary 
X
DHEQ completion 
1,5
X
X
X
X
X
X
X
LMS5training
X
Evaporative Air Assessment  (Schiff 
Sensitivity Score, LMS5)on all 
Eligible Teeth from Screening
Acclimatisation Period 
X
Selection of 2 ‘Test Teeth’
X
Evaporative Air Assessment  (Schiff 
Sensitivity Score, LMS5)on 2 ‘Test 
Teeth’
X
X
X
X
X
X
 
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Procedure
Screening
Visit1
Baseline
Visit2 
Week 0
(Day0)
Visit3
Week 4 (Day28 
±3)
Visit4
Week 8
(Day56 ±3)
Visit5
Week 12 
(Day84 ±3)
Visit 6
Week 16 
(Day112 ±3)
Visit7
Week 20 
(Day140 ±3)
Visit8
Week 24 
(Day168 ±3)
Evaporative Air Assessment  (Schiff 
Sensitivity Score)on Remaining 
Eligible Teeth from Screening
X
X
X
X
X
X
Dispense Study Product 
X2
X
X
X2
X
X
Supervised Brushing 
X
X3
X3
X3
X3
X3
Return Study Product and Diary
X
X
X
X
X
X
Compliance checks 
X
X
X
X
X
X
X
Adverse Events
X4
X
X
X
X
X
X
X
Incidents
X
X
X
X
X
X
X
Study Conclusion
X
1. To be completed prior to OST examination and any clinical assessments 
2. Dispense a new toothbrush at this visit also
3. Subject instructed to bring all supplies back to all subsequent visits 
4. After first supervised brushing with acclimatisation product
5. To be completed by subjects
 
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Appendix 2List of Tables, Figures & Listings
Table No. 
Title
Specification
Table 9.1.1
Subject Disposition 
Standard
All Screened Subjects
Table 9.2.1.1
Demographic Characteristics 
Appendix3
Safety Population
Table 9.2.1.2
Demographic Characteristics 
Table 9.2.1.1
Intent to Treat Population
Table 9.2.1.3
Table 9.2.1.2 on PP as required.
Table 9.2.1.1
Table 9.3.1.1 Summary Statistics of Individual Dental
Hypersensitivity Experience Questionnaire
(DHEQ) Questions (Section 1, Question 1 to 
6)by Site andOverall─ITTPopulation
Appendix3
Table 9.3.1.2 Summary Statistics of Individual Dental
Hypersensitivity Experience Questionnaire
(DHEQ) Questions (Section2, Question 1 to 
39) by Site and Overall─ITTPopulation
Table 9.3.1.1
Table 9.3.1.3
Summary and Statistical Analysis of Dentine 
Hypersensitivity Experience Questionnaire 
[DHEQ Section 1, Question 7 to 9]
Intent to Treat Population
Appendix3
Table 9.3.1.4
Summary and Statistical Analysis of Dentine 
Hypersensitivity Experience Questionnaire 
[DHEQ Section 2 -All Domains]
Intent to Treat Population
Table 9.3.1.1
Table 
9.3.1.5/6
9.3.1.3/4 on PP as required.
Table 9.3.2.1
Summary Statistics of Evaporative (Air) 
Sensitivity (Schiff Sensitivity Score) By Site 
and Overall
Intent to Treat Population
Appendix3
Table 9.3.2.2
Summary and Statistical Analysis of Measures 
of Dentinal Hypersensitivity (Schiff Sensitivity 
Score) Over Time
Intent to treat Population
Appendix3
 
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Table No. 
Title
Specification
Table 9.3.3.1
Summary of Measures of Dentinal 
Hypersensitivity (LMS) by Site and Overall
Intent to treat Population
Table 9.3.2.1
Table 9.3.3.2
Summary and Statistical Analysis of Measures 
of Dentinal Hypersensitivity (LMS) Over Time
Intent to treat Population
Table 9.3.2.2
Table 9.3.4.1 Summary of Percentage Qualifying TeethOver 
TimeIntent totreat Population
Appendix3
Table 9.4.1
Treatment Emergent Adverse Eventsby 
Oral/non-Oral and preferred term
Safety Population
Standard
Table 9.4.2
Treatment emergent AEs by SOC and 
Preferred TermSafety Population
Standard
Table 9.4.3
Treatment Emergent Treatment Related 
Adverse Eventsby Oral/non-Oral and 
preferred termSafety Population
Standard
Table 9.4.4
Listing of serious AEs. (if there are none a null 
listing will be produced, if there are >5 
treatment emergent SAEs a table will be 
produced by SOC and PT)
Standard
Table 9.4.5
Listing of all AEs (including Non-treatment 
emergent from All Subjects).
Standard
Table 9.4.6
Table of Non Serious treatment emergent AEs 
by SOC and Preferred Term. (only produced if 
there are > 5 SAEs)
Standard
Listing 2.1
Listing of Oral Soft Tissue Abnormalities
Standard
Listing 2.2
Listing of Incidents
Standard
Listing 2.3
Listing of Randomisation Details
Standard
FIGURES
Figure 9.1.1
DHEQ Section 1 Question 7/8/9–Over Time
Intent  to Treat Population
Appendix 3
Figure 9.1.2
DHEQ Section 1 Question 7/8/9 Over Timeby 
Site-Intent  to Treat Population
Figure 9.1.1
Figure 9.2.1
DHEQ Total Score over Time
Intent  to Treat Population
Figure 9.1.1
Figure 9.2.2
DHEQ Total Score over Timeby Site
Intent  to Treat Population
Figure 9.1.1
 
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Table No. 
Title
Specification
Figure 9.3.1
DHEQ Domainsover Time
Intent  to Treat Population
(Note Restrictions, Social Impact, Identity, 
Adaptation, EmotionalImpact)
Figure 9.1.1
Figure 9.3.2
DHEQ Domainsover Timeby Site
Intent  to Treat Population
(NoteRestrictions, Social Impact, Identity, 
Adaptation, EmotionalImpact)
Figure 9.1.1
Figure 9.4.1
DHEQ Global Health rating and Effect on Life  
Over Time
Intent  to Treat Population
Figure 9.1.1
Figure 9.4.2
DHEQ Global Health rating and Effect on Life  
over Timeby Site
Intent  to Treat Population
Figure 9.1.1
Figure 9.5.1
DHEQ Effect on Life OverallLife  Over Time
Intent  to Treat Population
Figure 9.1.1
Figure 9.5.2
DHEQ Effect on Life OverallLife  Over Time
by Site
Intent  to Treat Population
Figure 9.1.1
Figure 9.6.1
Schiff SensitivityScore Over Time
Intent  to Treat Population
Appendix3 
Figure 9.6.2
Schiff Sensitivity Score Over Timeby Site
Intent  to Treat Population
Figure 9.6.1
Figure 9.7.1
% Qualifying TeethSensitive (Schiff 
SensitivityScore >0) Over Time
Intent  to Treat Population
Appendix3
Figure 9.7.2
% Qualifying TeethSensitive (Schiff 
Sensitivity Score >0) Over Timeby Site
Intent  to Treat Population
Figure 9.7.1
Figure 9.8.1
Labelled Magnitude Scales (Mean Two Test 
Teeth) Over Time
Intent  to Treat Population
Appendix 3 
Figure 9.8.2
Labelled Magnitude Scales (Mean Two Test 
Teeth) Over Timeby Site
Intent  to Treat Population
Figure 9.8.1
 
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Appendix3Templates for Tables,Figures & Listings
DHEQ
11Measures are summarized from this questionnaire.
Section 1 Q7: Intensity of Sensations (VAS 0-10cm), Section 1 Q8: How Bothersome are 
Sensations (VAS 0-10cm), Section 1 Q9: Ability to Tolerate Sensations (VAS 0-10cm), Total 
Score (34 item total from Section 2 questions 1 to 34), Restrictions (4 item total from Section 2 
questions 1 to 4), Adaptation (12 item total from Section 2 questions 5 to 16), Social Impact (5 
item total from Section 2 questions 17 to 21), Emotional Impact (8 item total from Section 2 
questions 22 to 29), Identity (5 item total from Section 2 questions 30 to 34), Global Oral Health 
Rating (response to Section 2 question 35), Effect on Life Overall (4 item total from Section 2 
questions 36 to 39)
Please add footnote reference to the Study Product at the end of each output:
Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride) Sensodyne Repair and 
Protect Daily Repair Toothpaste 
 
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C
C
I
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Protocol: 204930                                                                          Program Run Date: DDMMMYYYY
Table 9.2.1.1
Demographic Characteristics
Safety Population
Study Population: Safety (N=xxx)
SITE 1
(N=xx)
SITE 2
(N=xx)
Overall
(N=xx)
SEX  N (%)
     MALE
     FEMALE
RACE N (%)
       XX (XX.X)
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     AFRICAN AMERICAN/AFRICAN HERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     AMERICAN INDIAN OR ALASKAN NATIVE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     ASIAN -CENTRAL/SOUTH ASIAN HERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     ASIAN -EAST ASIAN HERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     ASIAN -SOUTH EAST ASIAN HERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     WHITE -ARABIC/NORTH AFRICANHERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     WHITE -WHITE/CAUCASIAN/EUROPEAN HERITAGE
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
ETHNICITY N (%)
     HISPANIC OR LATINO
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
     NOT HISPANIC OR LATINO
        XX (XX.X)
        XX (XX.X)
        XX (XX.X)
AGE (YEARS)
     N
        XX
        XX
        XX
     MEAN
        XX.X
        XX.X
        XX.X
     SD
        XX.XX
        XX.XX
        XX.XX
     MEDIAN
        XX.X 
        XX.X 
        XX.X 
     MINIMUM
        XX
        XX
        XX
     MAXIMUM
        XX
        XX
        XX
                                                                                                
                                                                                      (Page X of Y)
 
 
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Protocol: 204930                                                                          Program Run Date: DDMMMYYYY
Table 9.3.1.1
Summary of Individual Dental Hypersensitivity Experience Questionnaire (DHEQ) Questions 
[DHEQ Section 1, Question 1 to 6]By Site and Overall
Study Population: ITT (N=XX)
SITE 1
SITE 2
OVERALL
(N=XX)
(N=XX)
(N=XX)
Q 1: WHICH OF THE FOLLOWING BEST DESCRIBES ANY SENSATIONS YOU MAY HAVE 
FELT IN YOUR TEETH? N (%)
BASELINE
           ITCHY
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
           ACHING
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
           SHOOTING
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
           PIERCING
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
           ...
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
           MISSING
     XX
     XX
     XX
Q 2: HOW LONG HAVE YOU BEEN EXPERIENCING ANY SENSATIONS IN YOUR TEETH? N 
(%)
BASELINE
        LESS THAN 6 MONTHS (1)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        MORE THAN SIX MONTHS BUT LESS THAN A YEAR (2)    
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        MORE THAN A YEAR BUT LESS THAN FIVE
        YEARS (3)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        MORE THAN FIVE YEARS BUT LESS  THAN 20 YEARS (4)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        MORE THAN 20 YEARS (5)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
       NONE (0)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
       MISSING
     XX
     XX
    XX
 
Programming Note: 1) XX.X % = XX/N *100 i.e. N is number of subjects.  2) Please populate same summary for the remaining questions.  
 
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Table 9.3.1.3
Summary and Statistical Analysis ofDentine Hypersensitivity Experience Questionnaire
[DHEQ Section 1, Question 7 to 10]
Study Population: ITT (N=XX)
Q7. ON THE SCALE OF 1 TO 10 HOW INTENSE ARE THE SENSATIONS?
WEEK 4
WEEK 8
BASELINE
BASELINE 
[1]
VALUES
CFB
BASELINE
[1]
VALUES
CFB
N
XX
XX
XX
XX
XX
XX
XX
MISSING 
XX
XX
XX
XX
XX
XX
XX
MEAN
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
SD
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
SE
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
MEDIAN
X.X
X.X
X.X
X.X
X.X
X.X
X.X
MINIMUM
XX
XX
XX
XX
XX
XX
XX
MAXIMUM
XX
XX
XX
XX
XX
XX
XX
ADJUSTED MEAN [2]
XX.XX
XX.XX
95 % CIS [2]
[X.XX, X.XX]
[X.XX, X.XX]
P-VALUES [2]
0.XXXX
0.XXXX
WEEK COMPARISON
DIFFERENCE [2,3]
95% CIS [2]
P-VALUES [2]
WEEK 0 VS. WEEK 4
XX.XX
[X.XX, X.XX]
0.XXXX
WEEK 0 VS. WEEK 8
XX.XX
[X.XX, X.XX]
0.XXXX
[1] Baseline only includes those subjects who have a corresponding post-baseline assessment. Baseline = Day 0.
[2]From mixed effect ANOVA model with visit and site as fixed effect, subject as random effect.
[2] Difference is first named week minus second named weeksuch that a positive difference favors the first named week.
CFB= Change From Baseline;
 
Programming note: Same tables will populated for-‘Week 12’,‘Week 16 ’, ‘Week 20’ and ‘Week 24’. Please repeat tables for the Q8 and Q9.  
 
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Protocol: 207238                                                                     Program Run Date: DDMMMYYYY
Table 9.3.2.1
Summary Statistics of Evaporative (Air) Sensitivity (Schiff Sensitivity Score)By Site and Overall
Intent to Treat Population
Study Population: Intent to TreatPopulation (N=XXX)
TWO TEST TEETH
SITE 1
(N=XX)
SITE 2
(N=XX)
OVERALL
(N=XX)
BASELINE 
   N (NON-MISSING)
   MEAN
XXX
XXX
XXX
   SD
X.XXX
X.XXX
X.XXX
   SE
X.XXX
X.XXX
X.XXX
   MEDIAN
XX.X
XX.X
XX.X
   MINIMUM
XX.X
XX.X
XX.X
   MAXIMUM
XX.X
XX.X
XX.X
WEEK 4
   N (NON-MISSING)
XXX
XXX
XXX
   MEAN
X.XXX
X.XXX
X.XXX
   SD
X.XXX
X.XXX
X.XXX
   SE
XX.X
XX.X
XX.X
   MEDIAN
XX.X
XX.X
XX.X
   MINIMUM
XX.X
XX.X
XX.X
   MAXIMUM
WEEK 8....
 
Programmer note: Please repeat same table for all qualifying teeth.
 
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Protocol: 204930                                                                              Program Run Date: DDMMMYYYY
Table 9.3.2.2
Summary and Statistical Analysis of Measures of Dentinal Hypersensitivity (Schiff Sensitivity Score) Over Time
Study Population: ITT (N=XX)
TWO TEST TEETH
WEEK 4
WEEK 8
BASELINE
BASELINE 
[1]
VALUES
CFB[1]
BASELINE
[1]
VALUES
CFB[1]
N
XX
XX
XX
XX
XX
XX
XX
MISSING 
XX
XX
XX
XX
XX
XX
XX
MEAN
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
SD
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
SE
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
MEDIAN
X.X
X.X
X.X
X.X
X.X
X.X
X.X
MINIMUM
XX
XX
XX
XX
XX
XX
XX
MAXIMUM
XX
XX
XX
XX
XX
XX
XX
ADJUSTED MEAN [2]
XX.XX
XX.XX
95 % CIS [2]
[X.XX, X.XX]
[X.XX, X.XX]
P-VALUES [2]
0.XXXX
0.XXXX
WEEK COMPARISON
DIFFERENCE [2,3]
95% CIS [2]
P-VALUES [2]
WEEK 0 VS. WEEK 4
XX.XX
[X.XX, X.XX]
0.XXXX
WEEK 0 VS. WEEK 8
XX.XX
[X.XX, X.XX]
0.XXXX
[1] Baseline only includes those subjects who have a corresponding post-baseline assessment. Baseline = Day 0.
[2]From mixed effect ANOVA model with visit and site as fixed effect, subject as random effect.
[2] Difference is first named week minus second named weeksuch that a positive difference favors the first named week.
CFB= Change From Baseline;
 
Programming note: The same table will populated for-‘Week 12’‘Week 16 ’, ‘Week 20’ and ‘Week 24’. Please repeat the same summary for 
Qualifying Teeth.
 
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Protocol: 204930                                                                              Program Run Date: DDMMMYYYY
Table 9.3.4.1
Summary of % Qualifying TeethSensitiveoverTime
Study Population: ITT (N=XX)
% OF QUALIFYING TEETH SENSITIVE
BASELINE
WEEK 4
WEEK 8
WEEK 12
WEEK 16
WEEK 20
WEEK 24
N
XX
XX
XX
XX
XX
XX
XX
MEAN
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
SD
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
SE
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
X.XXX
MEDIAN
X.X
X.X
X.X
X.X
X.X
X.X
X.X
MINIMUM
XX
XX
XX
XX
XX
XX
XX
MAXIMUM
XX
XX
XX
XX
XX
XX
XX
PROPORTION OF 
QUALIFYING 
TEETH 
SENSITIVE
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
X.XX
Footnote: % Qualifying TeethSensitivewill be calculatingfollows:
Percentage Qualifying Teeth sensitive =(Schiff sensitivity score >0 for qualifying teeth /All qualifying teeth from 
screening)*100
 
 
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Protocol: 204930                                                                               Program Run Date: DDMMMYYYY
Figure 9.1
DHEQ Section 1 Question 7/8/9 –Over Time
Intent to Treat Population
Values are mean ± SE
Q7: On a scale of 1-10 how intense are the sensations?
Q8: On a scale of 1-10 how bothered are you by any sensations?
Q9: On a scale of 1-10 how well can you tolerate sensations?
 
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Protocol: 204930                                                                               Program Run Date: DDMMMYYYY
Figure 9.6.1
Schiff Sensitivity Score overTime
Intent to Treat Population
 
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Figure 9.7.1
% Qualifying Teeth Sensitive over Time
Intent to Treat Population
Percentage QualifyingTeeth sensitive =(Schiff sensitivity score >0 for qualifyingteeth /All qualifying teeth from screening)*100
 
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Protocol: 204930                                                                               Program Run Date: DDMMMYYYY
Figure 9.8.1
Labelled Magnitude Scales over Time
Intent to Treat Population
LMS range 0-100mm
 
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