A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population
Phase: NA
Conditions: Dentin Sensitivity
Sponsor: HALEON

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Protocol Number: 300026
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CLINICAL PROTOCOL 
A 12-Week, Randomised, Controlled, Examiner-blind,
Clinical Study to Evaluate the Efficacy of a Stannous 
Fluoride Toothpaste for the Relief of Dentine 
Hypersensitivity in a Chinese Population 
Protocol Number: 
300026 
Compound/Product Name: 
Stannous fluoride (SnF2) 
United States (US) Investigational 
New Drug (IND) Number: 
Not Applicable (N/A) 
European Clinical Trials Database 
(EudraCT) Number: 
N/A 
Other Regulatory Agency Identified 
Number: 
N/A 
Phase: 
N/A 
5IJTEPDVNFOUDPOUBJOTDPOGJEFOUJBMJUZTUBUFNFOUTUIBUBSFOPUSFMFWBOUGPSUIJTQVCMJDMZ
BWBJMBCMFWFSTJPO
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Sponsor Information 
 
Sponsor Name & Legal 
Registered Address 
 
GlaxoSmithKline Consumer Healthcare 
(UK) Trading Limited 
St Georges Avenue,  
Weybridge,  
Surrey,  
KT13 0DE,  
United Kingdom (UK) 
Sponsor Contact Details 
 
GlaxoSmithKline Consumer Healthcare 
(GSK CH) 
25/F and 26/F, No.90 QirongRoad, Pudong New 
Area, Shanghai, China 
Tel: 021-2301 9366
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Document History 
 
Document
Version
Summary of Changes 
Original protocol
1.0
N/A
Amendment 1 
2.0 
Minor amendment: 
In section 6.5, clarification on the blinding has been 
added as following: 
unblinding events, only the investigator may learn the 
contents of one or more of the product codes used to 
allocate study product, not the clinical examiners. 
Given the application of IRT within this study, any such 
knowledge will not affect the decision to enroll a 
subject or influence the order in which subjects are 
Amendment 2 
3.0 
Minor amendments: 
1) Sponsor address in China has been updated 
2) Section 5.1 Type and planned number of 
their use would not be 
expected to cause harm to the mother, the 
foetus or baby
clarification 
3) In section 10, the safety email inbox has been 
amended from 
to 
Amendments incorporate all revisions to date, including amendments made at the request of 
country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc.   
 
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Principal Investigator Protocol Agreement Page 
 I confirm agreement to conduct the study in compliance with the protocol and any 
amendments according to the current International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) guidelines. 
 I acknowledge that I am responsible for overall study conduct. I agree to personally 
conduct or supervise the described study. 
 I agree to ensure that all associates, colleagues and employees assisting in the conduct of 
the study are informed about their obligations. Mechanisms are in place to ensure site staff 
receives all appropriate information throughout the study. 
 I agree to conduct this study in full conformance with the laws and regulations of the 
country in which the research is conducted and the Declaration of Helsinki. 
 
Investigator Name: 
Investigator Qualifications: 
 
Investigator Signature: 
 
Date of Signature/Agreement: 
 
PPD
PPD
PPD
PPD
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Table of Contents 
Sponsor Information ............................................................................................................2
Document History ...............................................................................................................3
Principal Investigator Protocol Agreement Page ................................................................4
Table of Contents ................................................................................................................5
1 
PROTOCOL SUMMARY ................................................................................................10
1.1 
Synopsis .................................................................................................................10
1.2 
Schedule of Activities ............................................................................................13
2 
INTRODUCTION .............................................................................................................15
2.1 
Study Rationale and Background ..........................................................................15
2.2 
Benefit/Risk Assessment .......................................................................................15
2.3 
Mechanism of Action/Indication ...........................................................................15
3 
STUDY OBJECTIVES AND ENDPOINTS. ...................................................................16
4 
STUDY DESIGN ..............................................................................................................17
4.1 
Overall Design .......................................................................................................17
4.2 
Scientific Rationale for Study Design ...................................................................18
4.3 
Justification for Dose .............................................................................................20
4.4 
End of Study Definition .........................................................................................21
5 
STUDY POPULATION ....................................................................................................21
5.1 
Type and Planned Number of Subjects .................................................................21
5.2 
Inclusion Criteria ...................................................................................................22
5.3 
Exclusion Criteria ..................................................................................................23
5.4 
Randomization Criteria ..........................................................................................25
5.5 
Lifestyle Considerations ........................................................................................25
5.5.1 
Oral Care Restrictions ...........................................................................26
5.5.2 
Dietary and Alcohol Restrictions ..........................................................26
5.5.3 
Covid-19 ................................................................................................26
5.5.4 
Contraception ........................................................................................26
5.6 
Screen Failures.......................................................................................................27
5.7 
 ................................................................27
5.8 
Clinical Assessor Qualifications ............................................................................27
6 
STUDY PRODUCTS ........................................................................................................28
6.1 
Study Product Supplies ..........................................................................................28
6.1.1 
Dosage Form and Packaging .................................................................30
6.1.2 
Product Dispensing ...............................................................................30
6.2 
Administration .......................................................................................................30
6.2.1 
Product Dosing Errors ...........................................................................31
6.2.2 
Overdose ...............................................................................................31
6.3 
Study Product Storage ...........................................................................................31
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6.4 
Study Product Accountability ................................................................................32
6.4.1 
Destruction of Study Product Supplies .................................................32
6.5 
Blinding and Allocation/Randomization ...............................................................33
6.6 
Breaking the Blind .................................................................................................33
6.7 
Compliance ............................................................................................................34
6.8 
Concomitant Medications/Treatments ...................................................................34
7 
DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .........................................................................35
7.1 
Subject Discontinuation/Withdrawal .....................................................................35
7.2 
Lost to Follow up ...................................................................................................36
8 
STUDY PROCEDURES ...................................................................................................36
8.1 
Visit 1/Screening ...................................................................................................36
8.1.1 
Informed Consent ..................................................................................36
8.1.2 
Demographics .......................................................................................37
8.1.3 
Check of the WeChat Application ........................................................37
8.1.4 
DH Screening Questionnaire.................................................................37
8.1.5 
Review of Oral Care Products...............................................................37
8.1.6 
Review of Brushing Habits ...................................................................38
8.1.7 
Medical History and Prior Medication/Treatment ................................38
8.1.8 
Clinical Examinations and Assessments ...............................................38
8.1.9 
Inclusion/Exclusion Criteria .................................................................38
8.1.10 
Subject Eligibility .................................................................................39
8.1.11 
Supervised Brushing with Acclimatization Toothpaste ........................39
8.2 
Study Period ..........................................................................................................39
8.2.1 
Visit 2 (Baseline/Day 1) ........................................................................39
8.2.2 
Visit 3 (Week 6/Day 43 ± 4) and Visit 4 (Week 12/Day 85 ± 4) .........42
8.3 
Study Conclusion ...................................................................................................43
8.4 
Follow-up Visit / Phone Call .................................................................................43
9 
STUDY ASSESSMENTS .................................................................................................43
9.1 
Screening Assessments ..........................................................................................44
9.1.2 
Qualifying Tactile Sensitivity ...............................................................45
9.1.3 
Qualifying Evaporative (Air) Sensitivity ..............................................46
9.2 
Dentine Hypersensitivity Efficacy Assessments ...................................................47
9.2.1 
Tactile Sensitivity Assessment (Yeaple Probe) ....................................47
9.2.2 
Evaporative (Air) Sensitivity Assessments ...........................................48
9.3 
Safety and Other Assessments ...............................................................................48
9.3.1 
Oral Soft Tissue (OST) Examination ....................................................48
9.3.2 
Oral Hard Tissue (OHT) Examination ..................................................48
9.3.3 
Pregnancy ..............................................................................................49
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10 ADVERSE EVENT AND SERIOUS ADVERSE EVENTS ...........................................49
10.1 
Definition of an Adverse Event (AE) ....................................................................49
10.2 
Definition of a Serious Adverse Event (SAE) .......................................................50
10.3 
Time Period and Frequency for Collecting AE and SAE Information ..................51
10.4 
Reporting Procedures.............................................................................................51
10.4.1 
Reporting of an Adverse Event .............................................................52
10.4.2 
Reporting of a Serious Adverse Event ..................................................52
10.5 
Evaluating Adverse Events ....................................................................................53
10.5.1 
Assessment of Intensity ........................................................................53
10.5.2 
Assessment of Causality .......................................................................53
10.6 
Follow-up of AEs and SAEs..................................................................................54
10.7 
Withdrawal Due to an Adverse Event ...................................................................55
10.8 
Regulatory Reporting Requirements for SAEs......................................................55
10.9 
Pregnancy ..............................................................................................................55
10.9.1 
Time Period for Collecting Pregnancy Information..............................55
10.9.2 
Action to be Taken if Pregnancy Occurs ..............................................55
11 DATA MANAGEMENT ..................................................................................................56
11.1 
Case Report Form ..................................................................................................56
11.2 
Data Handling ........................................................................................................57
11.2.1 
Data Queries ..........................................................................................57
12 STATISTICAL CONSIDERATIONS AND DATA ANALYSES ..................................57
12.1 
Sample Size Determination ...................................................................................57
12.2 
Populations for Analysis ........................................................................................58
12.2.1 
Definitions of Analysis Populations .....................................................58
12.2.2 
Exclusion of Data from Analysis ..........................................................58
12.3 
Statistical Analyses ................................................................................................58
12.3.1 
Primary Analysis ...................................................................................59
12.3.2 
Secondary Analyses ..............................................................................59
12.3.3 
Safety Analyses .....................................................................................60
12.3.4 
Demographic and Baseline Characteristics ...........................................61
12.3.5 
Study Product Compliance and Use of Other Therapies ......................61
12.3.6 
Handling of Dropouts and Missing Data ..............................................61
12.3.7 
Interim Analysis ....................................................................................62
13 STUDY GOVERNANCE CONSIDERATIONS..............................................................62
13.1 
Quality Control ......................................................................................................62
13.2 
Quality Assurance ..................................................................................................62
13.3 
Regulatory and Ethical Considerations .................................................................63
13.3.1 
Institutional Review Board ...................................................................63
13.3.2 
Ethical Conduct of the Study ................................................................63
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13.3.3 
Subject Information and Consent ..........................................................63
13.3.4 
Subject Recruitment ..............................................................................64
13.3.5 
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP ...............................................................................................64
13.4 
Posting of Information on Publicly Available Clinical Trial Registers .................64
13.5 
Provision of Study Results to Investigators ...........................................................64
13.6 
Records Retention ..................................................................................................65
13.7 
Conditions for Terminating the Study ...................................................................65
14 REFERENCES ..................................................................................................................66
15 APPENDICES ...................................................................................................................69
15.1 
ABBREVIATIONS ...............................................................................................69
15.2 
Screening questionnaire .........................................................................................71
15.3 
Video Compliance Check-list ................................................................................73
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List of in text tables 
Table 1-1 
Schedule of Activities ...........................................................................13
Table 3-1 
Study Objectives and Endpoints ...........................................................16
Table 4-1 
Eligibility Checks for Test Tooth Selection ..........................................20
Table 6-1 
Study Product Supplies .........................................................................28
Table 6-2 
Acclimatization Product ........................................................................29
Table 6-3 
Sundry Items .........................................................................................29
Table 15-1 
Abbreviations ........................................................................................69
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1 
PROTOCOL SUMMARY  
1.1 
Synopsis 
Short Title: 
Randomized Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride 
Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population. 
Background and Rationale: 
The sponsor markets 0.454% weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the 
relief of dentine hypersensitivity (DH) globally; clinical efficacy is supported by two 8-week 
DH studies conducted outside China. Chinese Ministry of Health (MoH) guidelines require two
clinical studies to support the efficacy of a functional toothpaste; at least one of these studies 
(for each claimed benefit) must be conducted on a local Chinese population (Ministry of Health 
China, 2010). Thus, a clinical study conducted in the Chinese population is required to support 
long-term DH relief claims for 0.454% w/w stannous fluoride (SnF2) toothpastes in China.
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to an evaporative (air) 
stimulus (as measured by Schiff sensitivity score), 
compared to a negative control toothpaste, after 12 weeks 
twice daily use. 
Change from Baseline in Schiff 
sensitivity score at Week 12. 
Secondary
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to a tactile stimulus (as 
measured by tactile threshold), compared to a negative 
control toothpaste, after 12 weeks twice daily use. 
Change from Baseline in tactile 
threshold (grams [g]) at Week 
12. 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to an evaporative (air) 
stimulus (as measured by Visual Analogue Scale [VAS]), 
compared to a negative control toothpaste, after 12 weeks 
twice daily use. 
Change from Baseline in VAS
(millimeters [mm]) at Week 
12. 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to evaporative (air) and tactile 
stimuli (as measured by Schiff sensitivity score/VAS and 
tactile threshold, respectively), compared to a negative 
control toothpaste, after 6 weeks twice daily use. 
Change from Baseline in Schiff 
sensitivity score, tactile 
threshold (g) and VAS (mm) at 
Week 6.  
To determine the clinical efficacy of a 5.0% w/w calcium 
sodium phosphosilicate (CSPS) toothpaste (positive 
control) in reducing DH to evaporative (air) and tactile 
stimuli (as measured by Schiff sensitivity score/VAS and 
tactile threshold, respectively), compared to a negative 
control toothpaste, after 6 and 12 weeks twice daily use. 
Change from Baseline in Schiff 
sensitivity score and tactile 
threshold (g) and VAS (mm) at 
Week 6 and Week 12. 
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Safety
To evaluate the safety and oral tolerability of the study 
toothpastes when used twice daily for 12 weeks. 
Treatment emergent adverse 
events (TEAEs) 
Study Design: 
This will be a single centre, 12-week, randomized, controlled, examiner-blind, 3 treatment arm, 
parallel group design, stratified (by maximum Baseline Schiff sensitivity score of the two
2
toothpaste for the relief of DH in a Chinese population.  
Randomized subjects will be requested to brush their teeth twice daily (morning and evening) 
with their assigned study toothpaste for the duration of the 12-week study period. DH will be 
assessed at Screening, Baseline (Day 1), Week 6 and Week 12 using three clinical measures (an 
evaporative (air) stimulus with Schiff sensitivity score; a tactile stimulus with tactile threshold 
[g]; an evaporative (air) stimulus with VAS [mm]). Safety and oral tolerability of the study 
products will be monitored over the 12-week usage period by review of reported adverse events
(AEs). 
A 5.0% w/w CSPS toothpaste with clinically proven longer term DH efficacy in the Chinese 
population will be included in the study as a positive control. The clinical efficacy of both anti-
sensitivity toothpastes (test and positive control) will be compared with that of a regular fluoride 
toothpaste (negative control), with no known anti-sensitivity properties. 
Study Products: 
Product 
Description 
Test Toothpaste 
Reference Toothpaste 
(Positive Control) 
Reference Toothpaste 
(Negative Control) 
Product Name 
0.454% w/w SnF2 
toothpaste 
(Sensodyne Sensitivity & 
Gum*) 
5.0% w/w CSPS 
toothpaste 
(Sensodyne Repair & 
Protect*) 
Regular fluoride 
toothpaste
(Crest Cavity Protection 
Fresh Lime*)
Master 
Formulation Code 
 
 
Not applicable (N/A)
Fluoride Content 
1100 parts per million 
(ppm) fluoride as SnF2 
1150 ppm fluoride as 
sodium fluoride (NaF) 
 1150 ppm fluoride as 
NaF 
* Chinese commercial product      
Type and Planned Number of Subjects: 
Male and female subjects aged 18-70 years (inclusive), in good general and oral health, with no 
clinically relevant abnormalities in medical history, or upon oral examination, that could impact 
subject safety or well-being, or the outcomes of the study. Female subjects who are pregnant,
or intending to become pregnant during the study, or breast-feeding, will not be included. 
Eligible subjects will have a minimum of 20 natural teeth, a self-reported history of tooth 
sensitivity and at least two teeth with clinical examiner-
 and 
; in 
addition, the selected test teeth must demonstrate a consistent response to the evaporative (air) 
stimulus at the Screening and Baseline visits (i.e., Schiff sensitivity score = 2 at Screening and
Baseline, or Schiff sensitivity score = 3 at Screening and Baseline; Table 4-1). 
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Sufficient subjects will be screened to randomize approximately 240 subjects to study treatment 
to ensure approximately 235 subjects complete the study (approximately 94 each for test 
toothpaste and negative control, and 47 for positive control), allowing for approximately 2%
dropouts after randomization, as observed in previous clinical studies conducted in China.
Statistical Analysis Summary: 
A modified Intent-To-Treat (mITT) population will be used for the efficacy analyses (all 
randomized subjects who complete at least one use of study product and have at least one post 
Baseline clinical efficacy assessment). 
Schiff sensitivity score, tactile threshold (g) and VAS (mm) will be derived as the average score 
or value, respectively, of the 2 test teeth (identified at Baseline). Change from Baseline will be
derived for the individual teeth first before calculating the average change of the 2 test teeth.
Significance testing will be conducted at the two-sided 5% significance level. 
Change from Baseline in Schiff sensitivity score will be analysed using a Mixed Model with 
Repeated Measures (MMRM) with study product, visit and study product x visit interaction as 
fixed effects and Baseline Schiff sensitivity score as a covariate. Subject will be included as a 
repeated measure with unstructured covariance matrix. Kenward Rogers degrees of freedom 
approach will be applied.  
For the primary endpoint (change from Baseline in Schiff sensitivity score at Week 12), the 
difference between least square means for the test toothpaste compared to the negative control
at Week 12 from the MMRM will be presented along with the two-sided p-value and 95% 
confidence intervals (CIs) to test the primary hypothesis of the study.  
Change from Baseline in tactile threshold (g) will be analysed using the same MMRM as the 
primary endpoint but with Baseline tactile threshold as a covariate, rather than Baseline Schiff 
sensitivity score. In addition, the maximum Baseline Schiff sensitivity score across test teeth (2 
or 3) will be fitted as a fixed effect. The difference between least square means for the test 
toothpaste compared to the negative control at Week 12 from the MMRM will be presented,
along with the two-sided p-value and 95% CIs.   
Change from Baseline in VAS (mm) will be analysed using the same MMRM as for the change
from Baseline in tactile threshold (g) but with Baseline VAS (mm) as a covariate, rather than 
the Baseline tactile threshold (g). The difference between least square means for the test 
toothpaste vs. negative control at Week 12 will be presented, along with the two-sided p-value 
and 95% CIs.  
For the other secondary endpoints, the differences between least square mean change from 
Baseline from the respective MMRM (test toothpaste vs. negative control at Week 6, positive 
vs. negative control at Weeks 6 and 12) will be presented with two-sided p-values and 95% CIs.
The assumption of normality and homogeneity of variance in each MMRM will be investigated. 
In case of violation of these assumptions, a suitable non-parametric test (adjusted for the 
randomisation stratification) will be performed to assess the change from Baseline comparisons 
(test toothpaste vs. negative control and positive control vs. negative control at Week 6 and 
Week 12) and results will be provided to support the MMRM results; the non-parametric results
will be considered to supersede the MMRM results under the observation of strong violations 
of the above assumptions. 
 
 
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1.2 
Schedule of Activities 
The schedule of activities table provides an overview of the subject visits and study procedures.  
The investigator may schedule visits (unplanned visits) in addition to those listed on the 
schedule of activities, to conduct evaluations or assessments required to protect the well-being 
of the subject. 
Table 1-1 
Schedule of Activities 
 
Procedure/Assessment 
Screening 
Acclimatization Period (14-28 Days)
Study Visits
Visit 1 
Visit 2 
Baseline 
(Day 1)  
Visit 3 
Week 6 
(Day 43±4)
Visit 4 
Week 12 
(Day 85±4) 
Informed consent1 
X 
 
 
Demographics 
X 
 
 
Confirm WeChat application 
mobile phone2 
X 
 
 
DH screening questionnaire 
X 
 
 
Confirm absence of anti-sensitivity ingredients & DH 
claims from subject s own oral care products  
X 
 
 
specifically their rinsing habits  
X 
 
 
Medical history and prior/current 
medication/treatment review 
X 
 
 
Changes in health and medications/treatments 
 
X 
X 
X
Compliance checks 
- Check returned study supplies, review diary & 
evaluate compliance with twice daily use.  
- Check compliance with Lifestyle Guidelines/ 
Medication requirements.   
 
X 
X 
X
Check brushing videos to confirm compliance with 
acclimatisation toothpaste usage instructions 
 
X 
 
 
Oral soft tissue (OST) examination 
X 
X 
X 
X
Oral hard tissue (OHT) examination  
X 
 
 
X
Eligible teeth assessments (dentition exclusions, 
Erosion/Abrasion/Recession [EAR], Modified 
Gingival Index [MGI], clinical mobility) 
X 
 
 
 
Qualifying tactile sensitivity assessment  
(tactile threshold (g)) for all eligible teeth 3,4 
X 
X 
 
 
Qualifying evaporative (air) sensitivity assessments  
(Schiff sensitivity score, VAS) for all eligible teeth 
with a tactile threshold 
20g 3,4 
X 
X 
 
 
Identify all eligible teeth which qualify for Baseline 
sensitivity assessments:  
- No dentition exclusions 
- Presence of EAR 
- MGI = 0 adjacent to the test area only 
- Clinical mobility = 0  
- Tactile threshold 
 
- 
 2 
X 
 
 
 
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Footnotes: 
1. 
Study information will be communicated to the subjects by the investigator, or designee, and by interactive video.
After signing the ICF, subjects will be asked to complete a knowledge check (a quiz).  
Subjects will also be shown a list of the ingredients contained in the test products to confirm they have no known 
allergies or hypersensitivity to any of the ingredients. 
2. 
Send study information video (at Screening) and brushing instruction video (at Baseline) to subjects using WeChat.
3. 
Qualifying tactile threshold (g) and Schiff sensitivity scores can be recorded on paper source documents for later 
transcription into the electronic case report form (eCRF).  
4. 
Prior to clinical examinations and assessments, subjects will be shown or reminded how to complete a VAS. 
Evaporative (air) assessments follow the tactile assessments, with minimum 5 minutes between last tactile assessment 
and first evaporative (air) assessment (to allow tooth recovery).  
 
Visits 1 and 2: maximum force for tactile assessments = 20g 
 
Visits 3 and-4: maximum force for tactile assessments = 80g 
The clinical examiner should communicate their Schiff sensitivity score to the scribe (non-verbally) before the subject
completes the VAS. Examiner and subject should be blinded to 
 scores.  
VAS is a qualifying assessment at Baseline ONLY. 
5. 
Test teeth must only be selected from eligible teeth (no dentition exclusions, presence of EAR, MGI = 0 adjacent to 
the test area only
Screening and Baseline
.  
Test teeth must have the same Schiff sensitivity score at Screening and Baseline (i.e., Schiff sensitivity score = 
2 at Screening and Baseline, or Schiff sensitivity score = 3 at Screening and Baseline) 
6. 
Return study supplies to subject after supervised brushing. 
7. 
Subjects randomized to test toothpaste only: Dispensing staff will show the subject the location of their two test 
teeth prior to supervised brushing. 
8. 
Record AEs from signing of the informed consent form (ICF) until 5 days after last use of study product (or the last 
study procedure). 
Select two test teeth 5 
 
X 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
Subject eligibility 
X 
X 
 
 
Subject continuance 
 
 
X 
X
Dispense acclimatisation toothpaste, toothbrush, 
rinsing cups, timer and diary 
X 
 
 
 
Supervised brushing with acclimatisation toothpaste 6 
X 
 
 
 
Return to site with acclimatisation toothpaste, 
toothbrush and completed diary 
 
X 
 
 
Stratification and randomisation  
 
X 
 
 
Dispense study toothpaste, toothbrush, rinsing cups 
and diary 
 
X 
 
 
Dispense toothbrush only 
 
 
X 
 
Supervised brushing with study toothpaste and 
reminder of product usage instructions 6,7 
 
X 
X 
 
Return to site with study toothpaste, toothbrush and 
completed diary 
 
 
X 
X
Tactile sensitivity assessment (tactile threshold): Two 
test teeth only 5 
 
 
X 
X
Evaporative (air) sensitivity assessment (Schiff 
sensitivity score, VAS): Two test teeth only 5 
 
 
X 
X
Study conclusion 
 
 
 
X
Monitor adverse events (AEs) 8 
X 
 
X 
X 
X
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2 
INTRODUCTION 
(Addy, 1985; Canadian Advisory Board on Dentin 
Hypersensitivity, 2003). The primary aetiological factors associated with the onset of DH 
include gingival recession and/or enamel loss (e.g., through dental erosion or abrasion), both
result in exposure of dentine with patent dentinal tubules (Orchardson, 2000). The 
hydrodynamic theory of DH hypothesises that an external stimulus (e.g., a temperature/osmotic 
differential) applied to exposed dentine disrupts the movement of fluid within dentinal tubules
(Brännström, 1962). This disruption may stimulate nerve processes in the pulpal area of the 
dentine including irritation of odontoblasts, pulpal neurons, and even subodontoblastic blood 
vessels (Hall, 2000), resulting in the characteristic short, sharp pain of DH. 
Currently there are two approaches to the management of DH: nerve depolarisation or dentine
tubule occlusion. Nerve depolarising agents, typically potassium salts, generally require a 
period of use (e.g., 14 to 28 days) before their benefit is established. The delivery of potassium 
ions to the dentine-pulp junction (odontoblastic layer) via exposed dentine tubules is believed 
to result in depolarisation of the afferent nerve membrane thereby interrupting the pain response
(Orchardson, 2000). The second approach uses occluding agents which act to physically block 
or narrow the exposed end of dentinal tubules (by the precipitation of insoluble materials onto 
the dentine surface and/or within dentinal tubules), thus reducing disruption to dentinal fluid 
movement in response to an external stimulus (Pashley, 1986).   
Stannous fluoride (SnF2) has been incorporated into oral hygiene products indicated for the 
reduction of DH since the 1990s (Schiff, 2006); it provides relief from DH by the occlusion of 
the dentine tubules through chemical precipitation of stannous oxides and hydroxides. Proctor 
and Gamble (P&G), Colgate and the sponsor market 0.454% SnF2 toothpastes indicated for DH 
relief, with published evidence demonstrating longitudinal clinical efficacy (Ni, 2010; 
Parkinson, 2011; Makin, 2013).   
2.1 
Study Rationale and Background 
The longer-term clinical efficacy of sponsor  0.454% SnF2 toothpastes is currently supported 
by two 8-week DH studies conducted outside China (Parkinson et al, 2013; Parkinson et al, 
2015). The Chinese MoH guidelines (Ministry of Health China, 2010) require two clinical 
studies to support the efficacy of a functional toothpaste, with at least one of these studies (for 
each claimed benefit) to be conducted in a local Chinese population. Thus, a clinical study in 
the Chinese population which meets the additional requirements described above is required to 
support longer-term DH relief claims for 
 0.454% SnF2 toothpastes in China.   
2.2 
Benefit/Risk Assessment  
Study products are commercially available daily use toothpastes which contain only ingredients 
with a history of safe use in oral healthcare products. Summary safety information for the 
acclimatization and study products will be provided on the product labels. 
2.3 
Mechanism of Action/Indication 
Occlusion agents act to physically block or narrow dentinal tubules where they open on to the 
surface of exposed dentine, thereby preventing or reducing disruption to the movement of fluid 
within the tubule in response to an external stimulus (Addy, 2002). SnF2 is one of the most 
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commonly employed tubule-occluding agents included in anti-sensitivity toothpastes. The 
stannous (tin [II]) ion reacts with water and phosphate minerals found in saliva and dentine
tubule fluid to form insoluble deposits (a 
layer) over the surface of the dentine
(Parkinson 2011; Parkinson 2013) 
3 
STUDY OBJECTIVES AND ENDPOINTS. 
Table 3-1 
Study Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to an evaporative (air) 
stimulus (as measured by Schiff sensitivity score), 
compared to a negative control toothpaste, after 12 weeks 
twice daily use. 
Change from Baseline in Schiff 
sensitivity score at Week 12. 
Secondary
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to a tactile stimulus (as 
measured by tactile threshold), compared to a negative 
control toothpaste, after 12 weeks twice daily use. 
Change from Baseline in tactile 
threshold (grams [g]) at Week 
12. 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to an evaporative (air) 
stimulus (as measured by Visual Analogue Scale [VAS]), 
compared to a negative control toothpaste, after 12 weeks 
twice daily use. 
Change from Baseline in VAS 
(millimeters [mm]) at Week 
12. 
To determine the clinical efficacy of a 0.454% w/w SnF2 
toothpaste in reducing DH to evaporative (air) and tactile 
stimuli (as measured by Schiff sensitivity score/VAS and 
tactile threshold, respectively), compared to a negative 
control toothpaste, after 6 weeks twice daily use. 
Change from Baseline in Schiff 
sensitivity score, tactile 
threshold (g) and VAS (mm) at 
Week 6.  
To determine the clinical efficacy of a 5.0% w/w calcium 
sodium phosphosilicate (CSPS) toothpaste (positive 
control) in reducing DH to evaporative (air) and tactile 
stimuli (as measured by Schiff sensitivity score/VAS and 
tactile threshold, respectively), compared to a negative 
control toothpaste, after 6 and 12 weeks twice daily use. 
Change from Baseline in Schiff 
sensitivity score and tactile 
threshold (g) and VAS (mm) at 
Week 6 and Week 12. 
Safety
To evaluate the safety and oral tolerability of the study 
toothpastes when used twice daily for 12 weeks. 
Treatment emergent adverse 
events (TEAEs) 
The study will be considered successful if the 0.454% SnF2 toothpaste demonstrates statistically 
significant, superior anti-hypersensitivity efficacy, compared to negative control, as measured 
by Schiff sensitivity score at Week 12. 
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4 
STUDY DESIGN  
4.1 
Overall Design 
This will be a single centre, 12-week, randomised, controlled, examiner-blind, 3-treatment arm, 
parallel group design, stratified (by maximum Baseline Schiff sensitivity score of the 2 selected 
test teeth) clinical study investigating the clinical efficacy of a 0.454% SnF2 toothpaste for the 
relief of DH in a Chinese population. A 5.0% CSPS toothpaste with clinically proven longer-
term DH efficacy in the Chinese population will be included in the study as a positive control. 
The clinical efficacy of both anti-sensitivity toothpastes will be compared with that of a regular 
fluoride toothpaste (negative control), with no known anti-sensitivity properties. 
Two stimuli will be employed to evaluate the DH efficacy of the test toothpaste. A tactile 
stimulus will be administered using a constant pressure probe (Yeaple Probe (Polson, 1980)); 
subject response to the stimulus determines the tactile threshold in grams (g). An evaporative 
(air) stimulus will be administered using a dental air syringe; subject response to the stimulus 
will be evaluated by a dental examiner using the Schiff sensitivity scale (Schiff, 1994) and a 
subject-completed VAS (mm). DH will be assessed at Screening, Baseline (Day 1), Week 6 and 
Week 12. 
 At Baseline, tactile sensitivity will be assessed for all eligible teeth identified at 
Screening (i.e. no dentition exclusions, presence of EAR, MGI = 0 adjacent to the test 
area only, clinical 
sitivity 
(air) sensitivity (with Schiff sensitivity 
score and VAS) for all eligible teeth identified at Screening with Baseline tactile 
.  
On completion of the Baseline assessments, two test teeth will be selected for continued 
assessment of tactile and evaporative (air) sensitivity at subsequent visits. Each test tooth must 
comply with the following selection criteria: 
 No dentition exclusions, presence of EAR, MGI = 0 adjacent to the test area only and 
clinical mobility = 0  
 
 at Screening and Baseline  
 
 at Screening and Baseline 
 
 
 Test teeth must have the same Schiff sensitivity score at Screening and Baseline
Schiff sensitivity score = 2 at Screening and Baseline, OR  
Schiff sensitivity score = 3 at Screening and Baseline 
Qualifying subjects will be stratified according to the maximum Baseline Schiff sensitivity 
score of their two test teeth and randomised to one of the 3 study toothpastes. Randomised 
subjects will brush their teeth twice daily (morning and evening) with their assigned study 
toothpaste for the duration of the 12-week treatment period.  
Safety and oral tolerability of the study products will be monitored throughout the study by 
review of subject- and examiner-reported AEs.  
 At Screening, tactile sensitivity will be assessed for all eligible teeth identified by oral 
examination (i.e. no dentition exclusions, presence of EAR, MGI = 0 adjacent to the 
test area only, clinical mobility = 0), followed by evaporative (air) sensitivity (with 
Schiff sensitivity score and VAS) for eligible teeth with tactile thr
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4.2 
Scientific Rationale for Study Design 
A randomised, controlled, examiner-blind, parallel group design is a recognised approach for 
investigating the clinical efficacy of a product for the relief of DH (Holland, 1997).  
The longer-term clinical efficacy of 
 0.454% SnF2 toothpastes is currently 
supported by two 8-week DH studies conducted outside China (Parkinson et al, 2013; Parkinson 
et al, 2015). Longer-term DH studies evaluating an alternative occlusion technology (CSPS) in 
China employed a longer treatment period (Hall et al, 2017 11 weeks; 
 In
order to establish longitudinal performance for the test toothpaste, with greater opportunity for 
its clinical benefits to be observed, a 12 week treatment period will be employed here (Murray, 
1994; Irwin, 1997). To comply with Chinese MoH guidelines for the testing of functional 
(desensitising) toothpastes, a single interim assessment timepoint will be included after 6 
Sensitivity levels are to be examined and recorded at the baseline, mid-trial 
and end-trial stages
Ministry of Health (China), 2010).  
In line with published recommendations for the design and conduct of DH studies (Holland, 
1997) and the requirements of the  Chinese MoH guidelines for the testing of functional 
(desensitising) toothpastes (Ministry of Health (China), 2010), two independent stimuli will be 
employed (tactile and thermal (evaporative air) stimuli) to evaluate the efficacy of the 0.454% 
SnF2 toothpaste. To avoid inter-assessor variability, the same clinical examiner should be 
responsible for the administration of a given stimulus (tactile or evaporative (air)) and the 
conduct of the associated examiner-assessed DH measure from Screening until the end of the 
study. DH will be assessed at Screening, Baseline (pre-treatment) and following 6 and 12 weeks
of treatment. 
The age range over which an individual can experience DH is wide (early teens to 70s) (Fischer 
et al, 1992), with peak incidence known to occur between the ages of 20-40 years (Flynn et al, 
1985). The fall in prevalence observed in later decades reflects age-related changes in the 
dentine and pulp of the tooth which act to reduce both 
response to external triggers of DH (Pashley, 2008; Seltzer and Bender, 1975). The dental pain 
experienced by much older members of the population is less likely to be diagnosed as DH 
(Rees, 2000), thus an age range of 18-70 years has been selected for this study to target 
individuals with tooth sensitivity due to DH. 
While there is no published evidence to indicate that gender impacts the pathophysiology of
DH, a national DH survey conducted in rural China in 2009 reported a greater proportion of 
females with DH compared to males (female 35.8%; male 23.4%) (Liang, 2017). To ensure the 
current study population is representative of the Chinese population being studied, the study 
site will aim to recruit a female:male ratio of approximately 3:2. 
According to ICH guidelines (ICH E6 (R2) Good clinical practice | European Medicines 
Agency (europa.eu), for a study to be classed as double blind, the subject, investigator, clinical 
examiners, monitors, data analysts, and staff involved in determining subject eligibility/
assessing compliance should be blinded to the treatment a subject receives. However, given it 
will not be possible to ensure identical appearance, flavour and packaging for the three 
commercial toothpastes to be evaluated in this study, the study is 
In line with the Chinese MOH guidelines (Ministry of Health (China), 2010) for the testing of 
functional (desensitising) toothpastes, a regular fluoride toothpaste with no known (or claimed) 
anti-sensitivity efficacy will be included as the negative control (Crest Cavity Protection Fresh 
Lime; China commercial product). In addition, a 5.0% CSPS toothpaste (Sensodyne Repair &
Protect; China commercial product) with proven DH efficacy in the Chinese population (in 
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clinical studies that satisfied current (at time of writing) Chinese MoH guidelines: sponsor 
clinical studies  Hall et al, 2017 and
 will be included in the study as a positive control 
(i.e., as a benchmark of performance in the Chinese population 
). Given 
the primary objective is to demonstrate statistical superiority for the test toothpaste compared 
to negative control in change from Baseline in Schiff sensitivity score at Week 12, qualifying 
subjects will be randomised to study treatment using a 2:2:1 allocation ratio (Test: Negative 
Control: Positive Control).  
Subjects using anti-sensitivity products as part of their normal oral hygiene routine will be 
excluded (their own oral hygiene products will be checked for presence of known anti-
sensitivity ingredients at Screening); if they are continuing to experience DH, they are unlikely 
to respond to use of a sensitivity toothpaste in the current study. 
Subjects will be asked to describe their typical daily oral care regimen at Screening. To help 
maintain study product in the oral cavity for the duration of each timed brushing, any subject
who habitually rinses with water during toothbrushing (self-reported) will be excluded from the 
study. Similarly, at Baseline, following review of the brushing videos, any subjects who rinsed 
during brushing with the acclimatisation toothpaste will be excluded. 
Clinical trials evaluating pain-related 
(Addy, 1985; 
West, 1997); such effects are frequently observed in DH studies. A study conducted to evaluate 
the natural history of the DH condition also 
,
characterised by an improvement in sensitivity simply as a result of study participation (Leight, 
2008). Analyses of sponsor data from earlier DH efficacy studies indicate (i) subjects with a 
(sponsor 
clinical study: 216953) and (ii) subjects with different qualifying Schiff sensitivity scores at 
Screening and Baseline for one or both test teeth may also 
 (sponsor clinical study: 216954) . 
To help minimise the potential impact of such effects: 
 An acclimatisation period (2-4 weeks) will precede the Baseline visits. During this 
period, study subjects will brush twice daily with the regular fluoride toothpaste and 
toothbrush provided (in place of their normal oral hygiene products) and record each 
timed brushing occasion in a diary. The acclimatisation period will also help standardise
oral hygiene practice across the study population prior to treatment.  
 Subjects will complete a Screening Questionnaire (Appendix 15.2) at Visit 1; those who 
report experiencing DH symptoms only several times a month
e study.  
 Each selected test tooth must have the same qualifying Schiff sensitivity score at the 
Screening and Baseline visits (i.e., Schiff sensitivity score = 2 at Screening and Baseline, 
or Schiff sensitivity score = 3 at Screening and Baseline). 
On completion of the Baseline assessments, the clinical examiner will select two test teeth from 
those that qualified at Screening (Visit 1) and Baseline (Visit 2) for assessment of tactile and 
evaporative (air) sensitivity at all subsequent visits (Table 4-1)
to evaluate changes in DH is common practice in sensitivity studies (Schiff, 1994). Qualifying
subjects will be stratified according to the maximum Schiff sensitivity score of their two 
selected test teeth to ensure treatment groups are balanced for DH severity. 
DH is an episodic condition; symptoms are known to vary spontaneously (West, 2008, West et 
al., 2013). Baseline clinical values that would support enrolment may represent random highs 
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that could be followed by regression to the mean, leaving the subject or selected test tooth 
without the condition under investigation during the treatment period. To help minimise the 
potential for this to occur on the current study, randomised subjects will be required to 
demonstrate consistency in DH response at both the Screening and Baseline visits.
 Randomised subjects must have a minimum of two eligible teeth (no dentition 
exclusions, presence of EAR, MGI = 0 adjacent to the test area only, clinical mobility = 
0) with a tactile 
 and a 
and
Baseline. 
 Test teeth can only be selected from eligible teeth identified at Screening (no dentition 
exclusions, presence of EAR, MGI = 0 adjacent to the test area only, clinical mobility 
= 0), with a tactile 
 a 
and Baseline 
. 
 Test teeth must have the same Schiff sensitivity score at Screening and Baseline.
Table 4-1 
Eligibility Checks for Test Tooth Selection 
Screening Assessments (Visit 1) 
Baseline Assessments (Visit 2)
Dentition 
Exclusions EAR
MGI*
Clinical 
Mobility
Tactile 
Threshold 
Schiff 
Sensitivity 
Score
Eligible 
Tooth 
Tactile 
Threshold 
Schiff 
Sensitivity 
Score
VAS
Test 
Tooth
None 
Yes 
0 
0 
 20g 
2 
Yes 
 20g 
2 
Yes
None 
Yes 
0 
0 
 20g 
3 
Yes 
 20g 
3 
Yes
None 
Yes 
0 
0 
 20g 
2 
Yes 
 20g 
3 
No
None 
Yes 
0 
0 
 
3 
Yes 
 
2 
No
Eligibility against each selection criterion is determined sequentially. 
*Adjacent to the test area only 
VAS is completed at Screening and Baseline, but is a qualifying measure for 
Test Tooth Selection at Baseline ONLY. 
4.3 
Justification for Dose 
Study products are toothpastes, intended for topical oral use, and will be applied by 
toothbrushing using a manual toothbrush. 
The usage regimen of twice daily brushing (morning and evening) will be the same for all 
subjects, based on widely recommended oral hygiene practice and typical consumer habit. 
Study subjects will brush for 1-timed minute with their assigned study toothpaste on each 
brushing occasion in line with typical brushing times specified for similar DH efficacy studies 
(Parkinson, 2011; Makin, 2013; Hall et al., 2017; Docimo et al., 2009). Subjects allocated to 
the test toothpaste will be instructed to brush their two test teeth first, to ensure their sensitive 
teeth are treated, then their whole mouth for 1-timed minute. The usage regimen specified for 
the negative and positive control products is aligned with the usage instructions provided on the 
commercial packaging of both toothpastes. 
After 12 weeks (85 ± 4 days) twice daily usage, each subject should complete between 162-178
brushings with their randomized product. Subjects will complete a supervised brushing with 
their assigned study toothpaste at the end of each study visit (while still at the study site) to 
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enable staff to confirm correct usage and to encourage compliance with the required usage 
regimen for the duration of the study. 
Tongue cleaning forms an integral part of typical oral hygiene practice for many Chinese 
consumers; it will be permitted during the current study (using the toothbrush provided), after 
completing each 1-minute toothbrushing with study toothpaste but before the 10ml water rinse. 
Tongue brushing is not permitted while toothbrushing. 
To help ensure the study toothpaste is retained in the oral cavity for the 1-minute brushing time, 
subjects must not rinse with water or expectorate during toothbrushing.  
A recent consumer study (sponsor data on file) observed rinsing with variable, often copious
amounts of water following toothbrushing to be common practice in Chinese consumers. To 
standardise rinsing practice across the study population, all subjects will be instructed to rinse
once with water (10 ml dispensed from a dosing cup) after each brushing occasion. 
4.4 
End of Study Definition 
A subject will be considered to have completed the study if they have completed all phases of 
the study including the last visit or the last scheduled procedure shown in the Schedule of 
Activities. 
The end of this study is defined as the date of the last scheduled procedure, as described in the 
Schedule of Activities (Table 1-1), for the last subject. 
5 
STUDY POPULATION 
5.1 
Type and Planned Number of Subjects 
The study will be conducted in a Chinese population (in China). Subjects will be male or female, 
with a minimum of 20 natural teeth, a self-reported history of tooth sensitivity and at least two 
teeth with clinical examiner-
 and Schiff sensitivity score 
; 
Baseline). In addition, the selected test 
teeth must demonstrate a consistent response to the evaporative (air) stimulus at the Screening 
and Baseline visits ( Schiff sensitivity score = 2 at Screening and Baseline, or Schiff sensitivity 
score = 3 at Screening and Baseline). 
Sufficient subjects will be screened to randomize approximately 240 subjects to study treatment 
to ensure approximately 235 subjects complete the study (approximately 94 each for test 
toothpaste and negative control, and 47 for positive control), allowing for approximately 2% 
dropouts after randomization, as observed in previous clinical studies conducted in China.
Whilst the study products are not contra-indicated for pregnancy and breastfeeding, pregnant 
and/or lactating females will be excluded from this study due to the increased prevalence and 
severity of gingivitis and periodontal disease observed during pregnancy (Samant et al., 1976) 
and breastfeeding (Aghazadeh et al, 2019) which, together with the increased amounts of 
calculus and plaque observed during pregnancy,  could impact DH assessments (Samant et al., 
1976).   
An enrolled subject is one who has agreed to participate in the clinical study following 
completion of the informed consent process (directly or via their legally authorized 
representative) and successfully met the eligibility criteria to proceed beyond the screening visit 
as described in the protocol design. 
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This study can fulfill its objectives only if appropriate subjects are enrolled. The following 
eligibility criteria are designed to select subjects for whom participation in the study is 
considered appropriate. All relevant medical and non-medical conditions should be taken into 
consideration when deciding whether a subject is suitable for this protocol.   
Subject eligibility to participate in the clinical study should be reviewed and documented by an 
appropriate member of the investigator study team before a subject is included in the study. 
5.2 
Inclusion Criteria 
An individual must meet all of the following inclusion criteria to be eligible for enrollment into 
the study: 
1. Provision of a signed and dated informed consent document indicating that the subject has 
been informed of all pertinent aspects of the study before any study procedures are 
performed. 
2. Male or female who, at the time of screening, is between the ages of 18 to 70 years inclusive.
3. Subject who is willing and able to understand and comply with scheduled visits, product 
usage requirements and other study procedures. 
4. Subject in good general, oral and mental health with, in the opinion of the investigator or 
medically qualified designee, no clinically significant or relevant abnormalities in medical 
history, 
 or wellbeing, or 
the outcomes of the study, if they were to participate in the study, or affect the 
s
ability to understand and follow study procedures and requirements. 
5. Subject who owns a smartphone with WeChat application installed. 
6. At Screening (Visit 1) 
Subject must have: 
a) Self-reported history of tooth sensitivity lasting more than 6 months but not more than 
(Screening Questionnaire, Appendix 15.2). 
b) Good general oral health, with a minimum of 20 natural teeth. 
c) Minimum of two accessible, non-adjacent teeth (incisors, canines, pre-molars), 
preferably in different quadrants, with clinically confirmed DH. 
Each eligible tooth must meet all the following criteria: 
i. Exposed dentine due to facial/cervical erosion, abrasion or gingival recession 
(EAR). 
ii. MGI = 0 directly adjacent to the exposed dentine (i.e., the test area) only.
iii. Clinical mobility = 0. 
iv. DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity 
(tactile threshold  20g and Schiff sensitivity score 2). 
 
 
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7. At Baseline (Visit 2): 
All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be re-
assessed for tactile sensitivity first; eligible teeth with Baseline 
then be re-assessed for evaporative (air) sensitivity. 
Subjects must have: 
A minimum of two non-adjacent, accessible teeth (incisors, canines, pre-molars), preferably 
in different quadrants, with clinically confirmed DH as evidenced by qualifying levels of 
tactile and evaporative (air) sensitivity:  
a) T
 at Screening and Baseline  
b) Schiff sensitivity score  2 at Screening and Baseline.  
c) VAS 
40 mm at Baseline. 
The clinical examiner will select two 
ose eligible teeth which meet 
the tactile threshold and Schiff sensitivity score criteria at both Screening and
Baseline, and the VAS criterion at Baseline.  
Each test tooth must demonstrate a consistent DH response to the evaporative (air) 
stimulus at both Screening and Baseline:  
Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2
OR
Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3
The procedure for selecting test teeth is summarised in Table 4-1. 
5.3 
Exclusion Criteria 
An individual who meets any of the following exclusion criteria will be excluded from the 
study: 
1. Subject who is an employee of the study site, either directly involved in the conduct of the 
study or a member of their immediate family; or an employee of the study site otherwise 
supervised by the investigator; or a sponsor employee directly involved in the conduct of 
the study or a member of their immediate family. 
2. Subject who is participating in, or has participated in, other studies (including non-medicinal 
studies) involving investigational product(s) within 30 days of Screening (Visit 1).
3. Subject who is participating in, has participated in, a study evaluating a tooth desensitising 
treatment within 8 weeks of Screening (Visit 1). 
4. Subject who is using, or has used, an oral care product indicated for DH relief within 8 
weeks of Screening (Visit 1). Subjects will be required to bring their current oral care 
products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and 
DH claims. 
5. Subject who has had a professional de-sensitising treatment within 8 weeks of Screening 
(Visit 1). 
6. Subject who habitually rinses with water during toothbrushing (self-reported at Screening
(Visit 1)). 
7. Subject seen to rinse with water while brushing with the acclimatization toothpaste during 
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review of their brushing compliance videos at Baseline (Visit 2). 
8. Subject with known or suspected intolerance or hypersensitivity to the study products or 
any of their stated ingredients (or closely related compounds).  
9. Subject who is unwilling or unable to comply with product usage instructions (Section 4.3) 
or Lifestyle Considerations (Section 5.5) as described in the protocol.  
10. Female subject who is pregnant or intending to become pregnant during the study (self-
reported). 
11. Female subject who is breastfeeding. 
12. Subject with a recent history (within the last year) of alcohol and/or substance abuse.
13. Subject with, in the opinion of the investigator or medically qualified designee, an acute or 
chronic medical or psychiatric condition or laboratory abnormality that may increase the 
risk associated with study participation or study product administration or may interfere 
with the interpretation of study results and, in the judgment of the investigator or medically 
qualified designee, would make the subject inappropriate for entry into this study.
14. Subject taking daily doses of medications or traditional herbal treatments which, in the 
opinion of the investigator or medically qualified designee, could interfere with their
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.  
- 
Examples of herbal treatments include clove oil, olive oil or other treatments directly 
applied to the oral cavity for the treatment of oral health conditions. 
15. Subject taking daily doses of a medication which, in the opinion of the investigator or 
medically qualified designee, is causing xerostomia. 
16. Subject who requires antibiotic prophylaxis for dental procedures. 
17. At Screening (Visit 1) 
Subject who has taken antibiotics within 2 weeks of their Screening visit. 
18. At Baseline (Visit 2) 
Subject who has taken antibiotics within 2 weeks of their Baseline visit (during the 
acclimatisation period). 
19. Subject who has had a professional or self-applied tooth bleaching procedure within 8 weeks 
of Screening (Visit 1). 
20. Subject who has had dental prophylaxis within 4 weeks of Screening (Visit 1). 
21. Subject who has had treatment for periodontal disease (including surgery) within 12 months 
of Screening (Visit 1).  
22. Subject who has had scaling or root planning within 3 months of Screening (Visit 1).
23. Subject with a tongue or lip piercing. 
24. Subject with, in the opinion of the investigator or medically qualified designee, gross
periodontal disease. 
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25. Subject with evidence of gross intra-oral neglect or the need for extensive dental therapy. 
26. Subject with a fixed or removable partial prosthesis which, in the opinion of the investigator 
or medically qualified designee, would impact study outcomes.  
27. Subject with multiple dental implants which, in the opinion of the investigator or medically 
qualified designee, would impact study outcomes.  
28. Subject with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
29. 
 
a) Tooth with evidence of current or recent caries or reported treatment of decay within 12 
months of Screening (Visit 1).  
b) Tooth with exposed dentin but with deep, defective or facial restorations.  
c) Tooth with full crown or veneer. 
d) Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator 
or medically qualified designee, would impact study outcomes. 
e) Sensitive tooth with contributing aetiologies other than erosion, abrasion or recession to 
exposed dentine. 
f) Sensitive tooth, in the opinion of the investigator or medically qualified designee, not 
expected to respond to treatment with an anti-sensitivity toothpaste. 
30. Subject who has previously been enrolled in this study.  
31. Any subject who, in the opinion of the investigator or medically qualified designee, should 
not participate in the study. 
5.4 
Randomization Criteria 
Subjects who satisfy all selection criteria will be randomized into the study. Randomisation 
numbers will be assigned in ascending numerical order as each subject is determined to be fully 
eligible.  
Subjects will be stratified by the maximum Baseline Schiff sensitivity score of their two selected 
test teeth. The stratification factor will give rise to two strata. 
 Stratum 1: Maximum Schiff sensitivity score = 2  
 Stratum 2: Maximum Schiff sensitivity score = 3  
Within each stratum, subjects will be randomized to test toothpaste, negative control or positive 
control with 2:2:1 allocation ratio using permuted randomised blocks (see Section 12.1).
5.5 
Lifestyle Considerations 
If, in the opinion of the investigator or medically qualified designee, a subject has not complied 
with a study restriction (oral hygiene, dietary or alcohol-related) prior to a study visit or cannot 
attend a study visit, every effort will be made to reappoint them within the permitted visit 
tolerances (see Schedule of Activities, Table 1-1). The reason for re-appointment will be 
documented in the electronic case report form (eCRF).  
 
 
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If re-appointment is not possible, the following visit specific actions should be taken:
 Baseline (Visit 2): if the subject cannot be reappointed (within the 2-4 week visit 
tolerance), they will be withdrawn from the study. No clinical efficacy assessments will 
be performed. The subject may be replaced.  
 Week 6 (Visit 3): if the subject cannot be reappointed (within the visit tolerance) the 
subject will continue in the study. No clinical efficacy assessments will be performed. 
 Week 12 (Visit 4): if the subject cannot be reappointed (within the visit tolerance), they 
will be withdrawn from the study. No clinical efficacy assessments will be performed. 
The subject will not be replaced. 
5.5.1 
Oral Care Restrictions 
For the Duration of the Study: From Screening (Visit 1) to the 
  
 Subjects should stop using their own oral care products 
 Subjects should not use any other oral care products (e.g., toothpastes, toothbrushes, 
oral rinses, tongue cleaners, whitening/bleaching products, interdental cleaning 
products) than those provided during the study. 
Note: Dental floss can be used but only to remove impacted food.  
 Subjects should not chew gum.  
Before a Clinical Assessment Visit: Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4)  
 Subjects will refrain from all oral hygiene procedures for at least 8 hours prior to their 
appointment (subjects will be sent a WeChat reminder the day before their appointment 
to remind them of this). 
5.5.2 
Dietary and Alcohol Restrictions 
Before a Clinical Assessment Visit: Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4)
 Subjects must not eat or drink for at least 2 hours before a clinical assessment visit.
Note: Small sips of room-temperature water are permitted to take medications or to 
relieve a dry mouth up to 1 hour before their appointment time 
 Subjects should refrain from excessive alcohol consumption for 24 hours before a 
clinical assessment visit. 
5.5.3 
Covid-19 
Local Chinese guidelines and/or clinical site requirements will be followed.  
5.5.4 
Contraception 
Given the study products are commercially available toothpastes, regulated as General Goods
in China, and no drugs will be utilised in this clinical study, pregnancy testing and contraceptive 
requirements are not deemed necessary.  
 
 
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5.6 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but are 
not subsequently randomised. To ensure transparent reporting of screen failure subjects, a 
minimal set of screen failure information will include demography, screen failure details (e.g.,
withdrawal of consent), eligibility criteria, any protocol deviations and any AEs, as applicable. 
Individuals who do not meet the criteria for participation in this study (screen failure) may not 
be re-screened. 
5.7 
 
Contact information for the sponsor's appropriately qualified and experienced medical/dental 
personnel or Clinical Research Scientist (CRS) for the study is documented in the Study Contact 
List located in the investigator site master file held at the study site. 
The contact number is only to be used by study staff seeking advice on medical/dental questions 
or problems in the event that the established communication pathways between the study site 
and the 
study team are not available.   
The contact number is not intended for direct use by study subjects. To facilitate access to 
appropriately qualified sponsor personnel on study-related medical/dental questions or 
problems, subjects will be provided with a contact card.  The contact card will provide, as a 
for the study site, and contact details in the event that the study site cannot be reached to provide 
advice on a medical question or problem identified by a healthcare professional other than the 
investigator.   
5.8 
Clinical Assessor Qualifications  
The examiners responsible for the clinical efficacy measures will be qualified dentists, trained 
in the clinical assessment of DH (tactile and evaporative (air) sensitivity).  
Additional qualified dentists, not trained in the clinical assessment of DH, will be permitted to 
conduct the oral (OST/OHT) examinations required at each study visit.   
 
 
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6 
STUDY PRODUCTS 
For the purposes of this study, per International Conference on Harmonization (ICH) 
guidelines, and sponsor policy, study intervention is defined as any investigational 
intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered 
to a study participant according to the study protocol. 
6.1 
Study Product Supplies 
The following study products will be supplied by the 
Clinical Supplies Department:
Table 6-1 
Study Product Supplies 
Product 
Description 
Test Toothpaste 
Reference 
Toothpaste 
(Positive Control) 
Reference Toothpaste
(Negative Control)
Product  
Name** 
0.454% w/w SnF2 toothpaste 
(Sensodyne Sensitivity & Gum*) 
5.0% w/w CSPS 
toothpaste 
(Sensodyne Repair & 
Protect*) 
Regular Fluoride 
toothpaste
(Crest Cavity Protection 
Fresh Lime*)
Fluoride 
Content 
1100 ppm fluoride as SnF2 
1150 ppm fluoride as 
NaF 
1150 ppm ppm 
fluoride as NaF 
MFC 
 
 
N/A 
Pack Design 
One carton containing 6 over-wrapped tubes of toothpaste
Dispensing 
Details 
Baseline (Visit 2): One carton 
Product 
Application 
Dose the toothbrush with a strip of toothpaste (a ribbon of toothpaste across the 
full brush head) on each brushing occasion 
Route of 
Administration
Topical Oral Use 
Usage 
Instructions  
Brush the two test teeth first, 
then the whole mouth (all 
teeth) for 1-timed minute, 
twice daily (morning and 
evening).  
After brushing, rinse once with 
10 ml water using the 
measuring cup provided. 
Brush the whole mouth (all teeth) for 1-timed 
minute. After brushing, rinse once with 10 ml 
water using the measuring cup provided.
Return 
Requirements 
All used/unused samples to be returned 
*Chinese commercial product   
After completing each toothbrushing, subjects will be permitted to clean their tongue using the 
toothbrush provided (but this is not a study requirement). Tongue brushing must be completed after 
toothbrushing but before rinsing with 10 ml water. 
 
 
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Table 6-2 
Acclimatization Product  
Product Description 
Acclimatization Toothpaste 
Product Name 
Regular fluoride toothpaste 
(Crest Cavity Protection Fresh Lime*) 
Fluoride Content 
1150ppm ppm fluoride as NaF 
MFC 
N/A 
Pack Design 
One carton containing 2 over-wrapped tubes of toothpaste
Dispensing Details 
Screening (Visit 1): One carton 
Product Application 
Dose the toothbrush with a strip of toothpaste (a ribbon of 
toothpaste across the full brush head) on each brushing occasion 
Route of Administration 
Topical Oral Use 
Usage Instructions  
Brush the whole mouth (all teeth) for 1-timed minute.  
After brushing, rinse once with 10 ml water using the measuring 
cup provided. 
Return Requirements 
All used/unused samples to be returned 
*Chinese commercial product   
On completing each toothbrushing, subjects will be permitted to clean their tongue 
using the toothbrush provided (but this is not a study requirement). Tongue brushing must be 
completed after toothbrushing but before rinsing with 10 ml water. 
Table 6-3 
Sundry Items 
Sundry Items to be supplied: 
Item 
Supplied 
By 
Pack Design 
Dispensing Details 
Return/Disposal Details
Used 
Samples 
Unused 
Samples
Lion Thin 
Bristle 
toothbrush 
(Chinese 
commercial 
product)  
Sponsor or 
designated 
vendor 
 
Commercial pack  
Screening (Visit 1): 
One toothbrush 
Baseline (Visit 2):  
One toothbrush 
Week 6 (Visit 3):  
One toothbrush 
Destroy at site 
using site 
disposal 
procedures 
 
Return to 
sponsor 
Countdown 
timer 
Commercial pack 
containing 1 timer  Screening (Visit 1) 
Subject to keep 
or destroy at site 
using site 
disposal 
procedures 
Measuring 
cups 
N/A 
Screening (Visit 1):
4 cups 
Baseline (Visit 2):  
12 cups 
Opaque 
plastic bags 
N/A 
Screening (Visit 1):
One bag 
Baseline (Visit 2):  
One bag 
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For further information, please refer to the Global Clinical Supplies Packaging and Labelling 
Proposal. The sponsor will ensure copies of the diary (including toothpaste usage instructions), 
clinical assessment score sheets and Subject Contact Cards are provided to the study site.
Detailed instructions for the return of study supplies for accountability checks and subsequent 
destruction which will be provided by the sponsor during the study in time for study close out.
6.1.1 
Dosage Form and Packaging 
All study products (test, negative control, positive control and acclimatization products) are 
toothpastes, intended for topical oral use, and will be applied using a manual toothbrush. All 
will be sourced in China. 
All toothpastes will be provided to the clinical study site in their commercial packs, 
overwrapped in white vinyl (to mask their identity and obscure any branding) with a study label 
affixed. The content of the product labels will be in accordance with all applicable regulatory 
requirements and will be the responsibility of the 
Global Clinical Supplies 
Department. Each study label will contain, but not be limited to, protocol number, directions 
for use and storage requirements.  
Each subject will receive sufficient tubes of the acclimatization toothpaste and their assigned 
study toothpaste to cover usage during the acclimatization and treatment periods, respectively.
Sundry items will be supplied in their commercial packaging for dispensing by study staff as 
required.  
Care should be taken with the supplied products and their labels to ensure they are maintained 
in good condition. It is important that all labels remain intact and legible for the duration of the 
study. Subjects should be instructed to not remove or deface any part of the over-wrapping or 
study label.  
All products supplied are for use only in this clinical study and should not be used for any other 
purpose. 
6.1.2 
Product Dispensing  
Subjects will be assigned to study product in accordance with the randomization schedule 
generated by a sponsor-approved vendor, prior to the start of the study, using validated software.
The product dispensing area will be separate from the clinical examination area. Study 
toothpastes will be dispensed per protocol in blinded fashion to the subject, by trained study 
personnel. These staff members will not be involved in any safety or clinical efficacy 
assessments or any other aspect of the study that could be influenced by knowing which product 
a subject has been assigned to. An additional member of the study staff will verify the 
dispensing procedure has been completed accurately for each subject.   
A record of product dispensing to each subject will be maintained in the dispensing log; 
completion of the dispensing procedure will be recorded in the eCRF. 
6.2 
Administration  
Subjects will self-administer the acclimatization toothpaste (from Visit 1 to Visit 2) and their 
assigned study toothpaste (from Visit 2 to Visit 4) according to the usage instructions provided 
by study personnel at the study site and record each brushing in their diary.  
 
 
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To help ensure subjects fully understand the amount of toothpaste to use, the brushing 
instructions and how to complete the diary:  
 Screening (Visit 1): Staff will demonstrate dispensing a full ribbon of toothpaste along 
the length of the toothbrush head to each qualifying subject and supervise their first 
brushing with the acclimatization toothpaste/diary completion at the end of the visit, 
after all clinical assessments have been completed.  
 Baseline (Visit 2): Staff will check the dispensing of a full ribbon of toothpaste by each 
randomized subject and supervise the first brushing with their assigned study 
toothpaste/diary completion. Staff will clearly show subjects randomized to test 
toothpaste the location of their 2 test teeth prior to starting their supervised brushing.
 Week 6 (Visit 3): Staff will supervise each subject brushing with their assigned study 
toothpaste/completing their diary at the end of the visit, after all clinical assessments 
have been completed.  
On-site administration of study products will be recorded in the dispensing log and the eCRF.
6.2.1 
Product Dosing Errors 
In this study, dosing errors may result from the administration or consumption of the wrong 
product, by the wrong subject, in the wrong way. Such dosing errors should be captured in the 
eCRF.  Dosing errors are reportable irrespective of the presence of an associated AE, including:
 Dosing errors involving subject exposure to any of the study products. 
 Potential dosing errors or uses outside of what was foreseen in the protocol that do or 
do not involve the participating subject. 
If a dosing error is accompanied by an AE, as determined by the investigator or medically 
qualified designee, the dosing error and any associated AEs are to be captured in the eCRF AE 
form.  
6.2.2 
Overdose 
An overdose is a deliberate or inadvertent administration of a product at an amount higher than 
specified in the protocol. Overdose is not likely to occur in this study. 
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. 
6.3 
Study Product Storage  
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study products received and any discrepancies are reported and 
resolved before use according to the supplied shipping documentation. 
The investigator, or designee, will ensure that all study products are stored in a secured area 
with controlled access under required storage conditions and in accordance with applicable 
regulatory requirements and the product labels.   
Site systems must be capable of measuring and documenting (e.g., via a log), at a minimum, 
the daily minimum and maximum temperatures for all site storage locations, as applicable 
(including frozen, refrigerated, and/or room-temperature products). This should be captured 
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from the time of first product receipt throughout the study. Even for continuous monitoring 
systems, a log or site procedure that ensures active daily evaluation for excursions should be 
available. The operation of the temperature-monitoring device/storage unit (e.g., refrigerator), 
as applicable, should be regularly inspected to ensure it is maintained in working order. 
Any excursions from the product-label storage conditions should be reported to appropriate site 
staff upon discovery and communicated to sponsor as soon as possible.  The site should actively 
pursue options for returning the product to the storage conditions as described in the labeling, 
as soon as possible. Excursions from the storage requirements, including any actions taken, 
must be documented as a protocol deviation and reported to the Sponsor.   
Once an excursion is identified, the affected product (or products) must be quarantined and not 
used until the sponsor provides documentation of permission to use. Use of any of the affected 
product(s) prior to sponsor approval will be considered a protocol deviation.  
Site staff will instruct subjects on the proper storage requirements for all take-home products. 
6.4 
Study Product Accountability 
All products supplied are for use only in this clinical study and should not be used for any other 
purpose. 
All study products must be received by a designated person at the study sites, handled and stored 
safely and properly, and kept in a secured location to which only the staff have access. Upon 
receipt, all study products should be stored according to the instructions specified on the product 
labels. Study products are to be dispensed by authorized site staff only to subjects enrolled in 
the study in accordance with the protocol. 
The site must maintain adequate records documenting the receipt, use, loss, or other disposition 
of all the product supplies. All study products will be accounted for using the 
investigational/study product accountability form/record. The investigator is responsible for 
study product accountability, reconciliation, and record maintenance.  
Subjects will return used and unused tubes of the acclimatisation toothpaste to the study site at 
their Baseline visit (Visit 2). Subjects will bring the used and unused tubes of their assigned 
study toothpaste to each of their scheduled visits to the study site, per the Schedule of Activities
(Table 1-1); all study products will be returned at study conclusion. Study product return will 
be documented using the study product accountability form/record.  
The accountability records must be available for inspection by the study monitor during the 
study. Monitoring of product accountability will be performed by the monitor during site visits 
and at the completion of the study. 
6.4.1 
Destruction of Study Product Supplies  
At the end of the study, the investigator, or an appropriate designee, and a representative of the 
sponsor (study monitor) will inventory all used and unused study products and sundry items. 
The study product accountability record for returned study products will then be completed. All 
study product (used and unused) for this clinical study, will be returned for destruction to the 
 Clinical Supplies Department, or designated vendor, using the return instructions 
provided.  
Detailed instructions for the return of study product/study supplies (including empty tubes) for 
the accountability checks and subsequent destruction will be provided by the sponsor in time 
for study close out visit. 
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6.5 
Blinding and Allocation/Randomization 
All subjects will be centrally randomized to one of the three study toothpastes using an 
Interactive Response Technology (IRT). Before the study is initiated, training, login 
information and directions for the IRT will be provided to the study site. Study products will be 
dispensed according to the instruction received through the IRT at the appropriate study visits.
Returned study products should not be re-dispensed to any subject. 
This study is described as examiner-blind (clinical examiners will be blinded to product 
received). Subjects, site staff, study statistician(s), data management staff, other employees of 
the Sponsor (including the CRS) and vendors acting on behalf of the sponsor, who may 
influence study outcomes will also be blinded to product allocation. The monitors and the 
s
Clinical Study Manager cannot be fully blinded as they will observe subjects brushing 
with their allocated study product while at the study site. As a matter of study conduct, including 
emergency unblinding events, only the investigator may learn the contents of one or more of 
the product codes used to allocate study product, not the clinical examiners. Given the 
application of IRT within this study, any such knowledge will not affect the decision to enroll 
a subject or influence the order in which subjects are enrolled. 
To ensure the clinical examiners remain blinded throughout the study: 
 Site staff involved in the dispensing of study products and supervision of on-site 
brushing will work in a separate area and will not be involved in any safety or product 
efficacy assessments. 
 Clinical examiners will not be permitted in any area where study product or diaries are
stored, dispensed, or in use.  
 Subjects will be instructed not to remove their study product or diary from its opaque 
carrier bag outside of the dispensing room, while at the study site. 
 Subjects will be instructed not to discuss which study product they have been assigned
or usage instructions with the clinical examiners. 
6.6 
Breaking the Blind 
At the initiation of the study, the study site will be instructed on the method for breaking the 
blind in case of emergency. The method will be an electronic process. 
The electronic system will be programmed with blind-breaking instructions. In case of an 
emergency, the investigator has the sole responsibility for determining if unblinding of a 
in making such a determination. If the investigator decides that unblinding is warranted, the 
product assignment unless this could delay emergency treatment of the subject. 
 within 24 hours 
after breaking the blind. The date and reason that the blind was broken must be recorded in the 
source documentation and the eCRF, as applicable. 
Any AE associated with breaking the blind must be recorded and reported as specified in this 
protocol. The study site may also be required be required to inform the Institutional Review 
Board (IRB) if the blind is broken.  
 
 
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6.7 
Compliance 
To facilitate compliance with product usage, subjects will be provided with a diary at Screening 
(Visit 1), at Baseline (Visit 2) and Week 6 (Visit 3) to record each brushing with the 
acclimatization toothpaste and their assigned study product, respectively.  
 The diaries will provide detailed usage instructions for the subject to refer to throughout 
their participation in the study. 
 Subjects will be instructed to note any missed/additional brushings, the reasons for any 
missed/additional brushings, any issues with the toothpaste used, oral problems, 
illnesses and any new medications/treatments in their diaries.  
 Completed diaries will be reviewed by study staff at the start of each study visit. Any 
missed or additional brushings will be captured in the eCRF as protocol deviations. 
Subjects will be re-instructed in correct product usage requirements/diary completion,
as needed.  
Information recorded in the diary relating to changes in health and medications/ treatments will
be reviewed by the investigator, or medically qualified designee, with the subject and 
transcribed into the eCRF, as appropriate (e.g., as an AE). Information related to product use 
should also transcribed into the eCRF, as appropriate, taking care to maintain the blind.
Subjects will be instructed to bring all tubes of toothpaste provided (used and unused) to each 
study visit. Study staff will perform a visual check of product usage. Any suspected over or 
under use will be documented in the eCRF and the subject will be re-instructed in the correct 
usage requirements.  
To confirm subjects understood the usage instructions provided at Screening (Visit 1), they will 
be asked to record 2-4 brushings (one per week) during the 2-4 week acclimatisation period 
using their smartphone video. At Baseline (Visit 2), a designated member of the study team will 
check these videos to confirm compliance with the usage requirements against a checklist 
(Appendix 15.3). Any subjects who rinse with water during brushing with the acclimatisation 
toothpaste will be excluded; subjects deemed non-compliant with any other aspect of study 
usage requirements will be re-instructed in correct product usage.  
Supervised brushings will be carried out at the study site at the end of each study visit to 
facilitate compliance with usage instructions. If any deviations from per protocol product usage 
are observed, the subject will be re-instructed of correct product usage.  
Subjects will be sent reminders on WeChat to adhere to study lifestyle restrictions every 2 
weeks for the duration of the study. 
6.8 
Concomitant Medications/Treatments 
Any medications, treatments or vaccine (including over-the-counter or prescription medicines, 
vitamins, and/or herbal supplements) taken or received during the study, from signing the 
informed consent, must be recorded in the eCRF with indication, reason for use, unit dose, daily 
dose, and start and stop dates of administration. All subjects will be questioned about 
medications/treatments at each site visit. 
Medication/treatments taken or received within 30 days of signing the informed consent form 
will be documented as a prior medication/treatment. Medications/treatments taken or received 
after signing the informed consent form will be documented as concomitant 
medication/treatments.  
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 Subjects should delay any non-emergency, elective dental treatments until after study 
completion (including dental prophylaxis).  
 Should a randomized subject start a course of treatment which includes daily, regular or 
intermittent use of any medication, details of that medication/treatment will be recorded 
in the eCRF. The investigator, or their medically qualified designee, will decide if the 
subject can continue on the study or should be withdrawn.  
 Should a subject take a medication which, in the opinion of the investigator or their 
medically qualified designee, could impact the 
 perception of DH (e.g., an 
analgesic) within 8 hours of a scheduled study visit, the medication should be recorded 
in the eCRF and every effort will be made to reappoint them within permitted visit 
tolerances (see Schedule of Activities, Table 1-1). The reason for re-appointment will 
be documented in the eCRF.  
If re-appointment is not possible, the following visit specific actions should be taken:
 Screening (Visit 1): the subject will be withdrawn from the study. No tooth sensitivity 
assessments will be performed. The subject may be replaced. 
 Baseline (Visit 2): the subject will be withdrawn from the study. No tooth sensitivity 
assessments will be performed. The subject will not be replaced.  
 Weeks 6 & 12 (Visits 3 & 4): the subject will continue in the study. Tooth sensitivity 
assessments will be performed. 
7 
DISCONTINUATION OF STUDY INTERVENTION AND 
SUBJECT DISCONTINUATION/WITHDRAWAL  
7.1 
Subject Discontinuation/Withdrawal  
A subject may withdraw from the study at any time at their own request or may be withdrawn 
at any time, at the discretion of the investigator or sponsor, for safety or behavioral reasons, or 
the inability of the subject to comply with the protocol-required schedule of study visits,
procedures or lifestyle considerations.   
The following circumstances require discontinuation of study product and/or premature subject 
withdrawal: 
 
 
 Inability of the subject to comply with the protocol-required schedule of study visits,
procedures or lifestyle considerations 
 Withdrawal of informed consent 
 Subject lost to follow-up  
 Unblinding of the subject  
 Pregnancy 
If a subject is discontinued or prematurely withdraws from the study, the reason(s) for 
discontinuation or withdrawal and the associated date must be documented in the relevant 
section(s) of the eCRF.  
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7.2 
Lost to Follow up 
If a subject fails to return to the site for a required study visit, the site must attempt to contact 
the subject and reschedule the missed visit as soon as possible, counsel the subject on the 
importance of maintaining the assigned visit schedule and ascertain whether the subject wishes 
to and/or should continue in the study. 
A subject will be considered lost to follow up if they repeatedly fail to return for scheduled 
visits and cannot be contacted by the study site. Before a subject is deemed lost to follow up, 
the investigator or designee must make every effort to regain contact with the subject (where 
address or local equivalent methods). All contact attempts should be documented in the eCRF. 
If contact is made, the investigator or designee should inquire about the reason for withdrawal, 
request that the subject return all study products provided and, if appropriate, request the subject 
return for a final visit and follow-up with the subject regarding any unresolved AEs. 
Final safety assessments may be carried out when the subject returns to the study site, at the 
may include an oral examination. 
Should the subject be unreachable, they will be considered to have withdrawn from the study 
and lost to follow up.  
Lack of completion of all or any of the early termination procedures will not be viewed as 
protocol deviations provided 
 
If the subject withdraws from the study and withdraws consent for disclosure of future 
information, no further evaluations should be performed and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
8 
STUDY PROCEDURES 
This section lists the procedures to be completed at each planned study visit. The timing of each 
procedure is listed in the Schedule of Activities section (Table 1-1). 
Adherence to the study design requirements, including all procedures are essential and required 
for study conduct.  
8.1 
Visit 1/Screening 
The following procedures and assessments will be completed by the investigator, or a suitably 
qualified/experienced designee, and the clinical examiners, 14-28 days prior to randomisation 
to study product. Where practically feasible, they should be completed in the order listed below. 
Data collected will be recorded in the eCRF. 
8.1.1 
Informed Consent 
The investigator, or designee, must obtain informed consent from each subject participating in 
the study after adequate explanation of the aims, methods, objectives, and potential hazards of 
the study. Study information will be communicated to the subjects by the investigator, or 
designee, and by interactive video which will also be sent to the subjects via WeChat for their 
own reference. After signing the ICF, subjects will be asked to complete a knowledge check (a
quiz) to ensure key information and study expectations are understood. If the subject answers 
one or more questions incorrectly, the study information will be re-explained and the subject 
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will be asked to complete knowledge check again. If subjects are not able to understand the 
study information, they will be excluded. 
A list of ingredients in the toothpastes to be used during the study will be provided to each 
subject during the consent process to enable them to confirm they are not aware of any allergy 
or hypersensitivity to any of the ingredients listed.  
The investigator, or designee, must 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 consent will be provided by either the investigator or the 
sponsor. Two copies of the ICF will be signed and dated by the subject; the subject will retain 
one copy, the other will be kept at site. The time the ICF was signed by the subject will be 
recorded on the ICF; AEs will be captured from that time. The investigator, or designee, will
sign and date each copy of the ICF after the subject has signed to confirm that the consent 
process was completed correctly. The date and time subject received the ICF and signed the 
ICF will be recorded in the eCRF. 
If new information becomes available during the course of the study that could affect 
willingness to participate, each participating subject will receive a copy of the new information 
and be re-consented into the study (2 copies as before). Each subject will be provided with a 
copy of the signed and dated amended consent form. The date and time of re-consent will be 
recorded in the eCRF. 
After signing the ICF, subjects will undergo the screening assessments to confirm they meet the 
subject selection criteria for the study. If the subject is confirmed eligible by the investigator or 
designee to participate, the subject will be considered enrolled in the study. 
8.1.2 
Demographics 
The following demographic information will be recorded in the CRF: year of birth, sex (male 
or female) and race. 
8.1.3 
Check of the WeChat Application 
Subjects will be also asked to show study staff their mobile phone to confirm the WeChat 
application is installed. Subjects who do not have WeChat and are not willing to install it while 
at the study site will be excluded. 
8.1.4 
DH Screening Questionnaire 
Subjects will complete a screening questionnaire (Appendix 15-2) to confirm self-reported DH 
symptoms. Subjects who report experiencing DH symptoms only several times a month
e study.  
8.1.5 
Review of Oral Care Products  
Subjects will be required to bring their current oral care products to the Screening visit for study 
staff to confirm the absence of known anti-sensitivity ingredients and DH relief claims on the 
packaging. Presence/absence of fluoride will also be documented in the eCRF.  
Subjects who are currently using anti-sensitivity oral care product(s) will be excluded. 
Subjects will also be asked about the oral care products they have been using in the last 8 weeks; 
those who report using anti-sensitivity product(s) in the previous 8 weeks will also be excluded.
 
 
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8.1.6 
Review of Brushing Habits 
Subjects will be asked to describe their typical oral care routine. Subjects who habitually rinse 
with water during toothbrushing will be excluded. 
8.1.7 
Medical History and Prior Medication/Treatment 
The following will be documented in the eCRF: 
 Details of relevant medical history and recent surgery (within the last year), including 
allergies and drug sensitivities. 
 Pregnancy status (self-reported by female subjects only). 
 Prior medications/treatments, including prescription and non-prescription drugs, dietary 
supplements and herbal remedies, taken in the last 30 days. 
8.1.8 
Clinical Examinations and Assessments 
Prior to commencing the clinical examinations and assessments, subjects will be shown how to 
complete a VAS (Section 9.1.3). 
The following clinical examinations will be completed as described in Study Assessments and 
the findings recorded in the eCRF. To facilitate subject flow, source documents can be used to 
record the eligible teeth and DH assessments for later transcription into the eCRF (transcription
from source documents must be completed within 5 days of recording the data for each subject).
 OST examination 
 OHT examination  
 Clinical assessment of incisors, canines and pre-molars for dentition exclusions, EAR, 
MGI (adjacent to the test area only) and clinical mobility to identify eligible teeth for 
DH assessment (as described in Section 9.1). 
 Clinical assessment of tactile sensitivity (tactile threshold (g)) for each eligible tooth (no 
dentition exclusions, presence of EAR, MGI = 0 adjacent to the test area only, clinical 
mobility = 0). 
 Clinical assessment of evaporative (air) sensitivity (Schiff sensitivity score [examiner 
assessed], followed by VAS [subject completed]) for each eligible tooth with a tactile 
. 
There should be at least a 5-minute break between completing the tactile assessments 
and starting the evaporative (air) assessments. 
To prepare for the Baseline visit, the clinical examiners will confirm those teeth which are 
eligible for ongoing DH assessment at Baseline (Visit 2). 
 
 (Table 4-1): incisors, canines and pre-molars 
with none of the study-specific dentition exclusions, which meet EAR, MGI adjacent to 
the test area only and mobility inclusion criteria, and record a qualifying tactile threshold 
of 
a qualifying Schiff sensitivity score of 
).
8.1.9 
Inclusion/Exclusion Criteria 
Information relating to all inclusion and exclusion criteria will be completed in the eCRF.
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8.1.10 
Subject Eligibility 
The investigator, or medically qualified designee, will review the inclusion/exclusion criteria 
to confirm subject eligibility to participate in the study; this will be documented in the eCRF.
Note: In addition to meeting all other study requirements, only those subjects with a 
can continue on the study. 
To prepare for study participation, enrolled subjects will be instructed in the Lifestyle 
Guidelines and Concomitant Medications/Treatments requirements of the study (as already 
detailed in the ICF and described during the consent process). Adherence to the requirements 
of the study protocol is essential for successful study conduct. 
8.1.11 
Supervised Brushing with Acclimatization Toothpaste 
Enrolled subjects will be provided with the acclimatization toothpaste, a toothbrush, a timer, 
rinsing cups and a diary to use during the acclimatization period.  
Staff will describe the toothpaste usage instructions to the subject and demonstrate covering the 
full brush head with a ribbon of toothpaste. Staff will then supervise the subject carrying out 
first their first brushing with the acclimatization toothpaste and recording the first use in their 
diary.  
Any deviation from the product usage instructions will be captured as a protocol deviation in 
the eCRF and the subject will be reminded of the correct directions for use. Dispensing of the 
acclimatization toothpaste and completion of the supervised first brushing will also be 
documented in the eCRF.  
Spontaneously reported AEs, and any AEs elicited by asking subjects to respond to a non-
leading question, 
the acclimatization toothpaste will be recorded in the eCRF. 
Staff will remind subjects to bring their acclimatisation products to their next study visit and to 
note any changes in health, medications or treatments in their diary (or report such changes to 
study staff between visits using the contact numbers provided or inform the staff at their next 
visit, if preferred). 
8.2 
Study Period 
8.2.1 
Visit 2 (Baseline/Day 1)  
The following procedures and assessments will be completed by the investigator, or a suitably 
qualified/experienced designee and the clinical examiners. Where practically feasible, they 
should be completed in the order listed below. All data collected should be recorded in the 
eCRF. 
8.2.1.1 
Compliance Checks 
Complete visual checks of returned acclimatization toothpaste, review completed diary and 
watch the brushing videos (using the Video Compliance Checklist (Appendix 15.3) to help 
determine compliance). Subjects seen to rinse with water while brushing with the 
acclimatization toothpaste during review of their brushing compliance videos will be excluded.
 
 
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Record any suspected over or under use and the number of any missed or additional brushings 
in the eCRF. Any deviation from the product usage instructions or missed brushing videos will 
be captured as protocol deviations in the eCRF and subjects will be re-instructed in the correct 
directions for use.  
Do not return the acclimatization toothpaste, toothbrush or completed diary to the subject. 
8.2.1.2 
Changes in Medical History and Concomitant Medications/Treatments 
Staff will ask subjects if there have been any changes in their health, concomitant medications
and non-drug treatments/procedures. All changes will be documented in the eCRF.  
Spontaneous reporting of AEs and those elicited by asking subjects to respond to a non-leading 
question, such as 
, will be assessed and any AEs recorded in the eCRF. 
Any AEs and/or changes in medications/treatments identified during review of the completed 
diary will also be recorded in the eCRF.  
8.2.1.3 
Subject Adherence and Continuance 
Confirm subject adherence to the requirements of the protocol and document their continuance 
in the eCRF. Record any deviations from study requirements in the eCRF. 
8.2.1.4 
Clinical Examinations and Assessments 
Prior to commencing the clinical examinations and assessments, subjects will be reminded how 
to complete a VAS (Section 9.1.3). 
The following clinical examinations will be completed as described in Study Assessments and 
the findings recorded in the eCRF. To facilitate subject flow, source documents can be used to 
record the DH assessments for later transcription into the eCRF (transcription from source 
documents must be completed within 5 days of recording the data for each subject).
 OST examination 
 Clinical assessment of tactile sensitivity (tactile threshold (g)) for each eligible tooth 
identified at Screening (eligibility criteria described in Section 8.1.8 and Table 4-1).
 Clinical assessment of evaporative (air) sensitivity (Schiff sensitivity score [examiner 
assessed], followed by VAS [subject completed]) for each eligible tooth identified at 
Screening with a Baseline 
. 
There should be at least a 5-minute break between completing the tactile assessments 
and starting the evaporative (air) assessments.  
Subjects must have at least two eligible teeth with the qualifying tactile 
and qualifying 
at both Screening and Baseline
mm at Baseline to continue. 
8.2.1.5 
Selection of Test Teeth 
The procedure for selecting test teeth is summarised in Table 4-1 
The clinical examiner responsible 
both at Screening and Baseline to identify 
 for DH assessment at subsequent 
study visits. The identity of the two test teeth will be recorded in the eCRF. Subjects with fewer 
than two suitable test teeth will be discontinued. 
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s of DH: 
- 
Tactile threshold 
 at Screening (Visit 1) and Baseline (Visit 2).
- 
 (Visit 1) and Baseline (Visit 2).
- 
VAS 
 (Visit 2).  
 Each test tooth must have the same Schiff sensitivity score at Screening and Baseline.  
Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2
OR
Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3
8.2.1.6 
Subject Eligibility 
The investigator, or medically qualified designee, will review the inclusion/exclusion criteria 
and verify the presence of two test teeth which meet all study criteria before confirming each
subject  suitability to continue in the study; eligibility will be documented in the eCRF.
8.2.1.7 
Stratification and Randomization 
Eligible subjects will be stratified to one of two strata as described in Section 5.4. Subject 
stratum will be entered directly into the eCRF. Each subject will be assigned a randomisation 
number from their designated stratum in ascending numerical order, and as each subject is 
determined to be fully eligible. The randomized toothpaste code will be entered directly into 
the eCRF. 
8.2.1.8 
Supervised Brushing with Study Toothpaste 
Randomised subjects will be provided with their allocated study toothpaste, a new toothbrush, 
more rinsing cups and a new diary. 
Toothpaste usage instructions will be re-described, and those subjects randomized to the test 
toothpaste will be shown the 
diagram/model and a mirror, as appropriate). Staff will then supervise the subject carrying out 
first the first brushing with their study toothpaste and recording the first use in their diary. A 
brushing video will be also shared with the subjects via WeChat according to their allocated 
study toothpaste.  
Any deviation from the product usage instructions will be captured as a protocol deviation in 
the eCRF and the subject will be reminded of the correct directions for use. Dispensing of study 
toothpaste and completion of the supervised first brushing will also be documented in the eCRF. 
Spontaneously reported AEs, and any AEs elicited by asking subjects to respond to a non-
leading question, 
the study toothpaste will be recorded in the eCRF. 
Randomized subjects will be re-instructed of the Lifestyle Guidelines and Concomitant 
Medications/Treatments requirements of the study. Staff will remind them to bring their study 
products to their next study visit and to note any changes in health, medications or treatments 
in their diary (or report such changes to study staff between visits using the contact numbers 
provided or inform the staff at their next visit, if preferred).  
 
 
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8.2.2 
Visit 3 (Week 6/Day 43 ± 4) and Visit 4 (Week 12/Day 85 ± 4)   
The following procedures and assessments will be completed by the investigator, or a suitably 
qualified/experienced designee and the clinical examiners. Where practically feasible, they 
should be completed in the order listed below. All data collected should be recorded in the 
eCRF. 
8.2.2.1 
Compliance Checks 
Complete visual checks of returned study toothpaste and review completed diary. Record any 
suspected over or under use and the number of any missed or additional brushings in the eCRF. 
Any deviation from the product usage instructions will be captured as protocol deviations in the 
eCRF and subjects will be re-instructed in the correct directions for use.  
Week 6 (Visit 3): Return the study toothpaste to the subject; retain the used toothbrush and 
completed Week 
diary at site. Dispense new diary card and new toothbrush. 
Week 12 (Visit 4): Retain the study toothpaste, toothbrush and completed 
12  diary.  
8.2.2.2 
Changes in Medical History and Concomitant Medications/Treatments 
Staff will ask subjects if there have been any changes in their health, concomitant medications
and non-drug treatments/procedures. All changes will be documented in the eCRF.  
Spontaneous reporting of AEs and those elicited by asking subjects to respond to a non-leading 
question, 
, will be assessed and any AEs recorded in the eCRF. 
Any AEs and/or changes in medications/treatments identified during review of the completed 
diary will also be recorded in the eCRF. 
8.2.2.3 
Subject Adherence and Continuance 
Confirm subject adherence to the requirements of the protocol and document their continuance 
in the eCRF. Record any deviations from study requirements in the eCRF. 
8.2.2.4 
Clinical Examinations and Assessments 
Prior to commencing the clinical examinations and assessments, subjects will be reminded how 
to complete a VAS (Section 9.1.3). 
The following clinical examinations will be completed as described in Study Assessments and 
the findings recorded in the eCRF. To facilitate subject flow, source documents can be used to 
record the DH assessments for later transcription into the eCRF (transcription from source 
documents must be completed within 5 days of recording the data for each subject).
 OST examination 
 Week 12 (Visit 4) only: OHT examination 
 Clinical assessment of tactile sensitivity (tactile threshold (g)) for the two test teeth 
only.  
 Clinical assessment of evaporative (air) sensitivity (Schiff sensitivity score, followed by 
VAS) for the two test teeth only. 
There should be at least a 5-minute break between completing the tactile assessments and 
starting the evaporative (air) assessments. 
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8.2.2.5 
Supervised Brushing with Study Toothpaste 
Week 6 (Visit 3) only: 
Subjects will be provided with a new toothbrush and a new diary; staff will supervise each 
subject completing another on-site brushing with their study toothpaste and recording this use 
in their diary.  
Any deviation from the product usage instructions will be captured as a protocol deviation in 
the eCRF and the subject will be reminded of the correct directions for use. Completion of the 
 
Spontaneously reported AEs, and any AEs elicited by asking subjects to respond to a non-
leading question, 
the study toothpaste will be recorded in the eCRF. 
Subjects will be re-instructed of the Lifestyle Guidelines and Concomitant Medications/
Treatments requirements of the study. Staff will remind them to bring their study products to 
their next study visit and to note any changes in health, medications or treatments in their diary
(or report such changes to study staff between visits using the contact numbers provided or
inform the staff at their next visit, if preferred). 
Week 12 (Visit 4) only:  
No supervised brushing. 
8.3 
Study Conclusion 
The Study Conclusion page of the eCRF will be completed for all subjects whether or not they 
complete all study procedures (e.g., if they are discontinued from the study early). If the subject 
is discontinued early, at any point during the study, the primary reason for withdrawal should 
be recorded on the Study Conclusion page.  
For subjects who attend all study visits, the Study Conclusion page of the eCRF will be 
completed at Visit 4. Staff will remind each subject to inform the site if they experience any 
change in health, medications or treatments in the next 5 days (i.e., in the 5 days following their 
last use of study product). 
If a subject has any clinically significant, study-related abnormalities or AEs at the end of the 
study, the 
 medical monitor (or designated representative) should be notified and, the 
subject may be asked to return for a follow-up visit to ensure any issue is resolved or deemed 
not clinically significant.  
8.4 
Follow-up Visit / Phone Call 
The study site may contact a subject to follow up an AE post-study completion/withdrawal and, 
in some circumstances, request they return to the site for additional follow-up visits (final safety 
assessments). At the discretion of the investigator, or medically qualified designee, additional 
oral examinations may be carried out at such visits. 
9 
STUDY ASSESSMENTS 
Every effort should be made to ensure the protocol-required examinations and assessments are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances, outside of the investigator
 that may make it unfeasible to complete an 
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examination or assessment.  In these cases, the investigator must take all steps necessary to 
ensure the safety and well-being of the subject. When a protocol-required examination or
assessment cannot be performed, the investigator (or designee) will document the reason for 
the missed procedure as a protocol deviation and any corrective and preventative actions they 
have taken to ensure that required processes are adhered to as soon as possible. The Sponsor 
must be informed of any missed examinations or assessments in a timely manner. 
9.1 
Screening Assessments 
Screening assessments will be performed by appropriately trained staff/clinical examiners
(dentists) at the times, and in the order, defined in the Study Procedures section of this protocol.
The eligibility of each tooth will be assessed against the inclusion/exclusion criteria and 
recorded in the eCRF. 
9.1.1.1 
Erosion, Abrasion and Recession (EAR)  
The facial surfaces of all incisor, canine and pre-molar teeth (Figure 9-1) that do not present 
any of the general dentition exclusion criteria, or specific dentition exclusion criteria for eligible 
teeth, will be examined for signs of cervical EAR (Addy, 2000). 
 
Figure 9-1 
Dental Nomenclature. (Dempsey and Townsend, 2001)
9.1.1.2 
Modified Gingival Index (MGI)  
The MGI is a non-invasive visual assessment of gingival health (Lobene, 1986). MGI will be 
assessed for incisor, canine and pre-molar teeth exhibiting none of the dentition exclusions and 
facial/cervical EAR. MGI should be scored for the facial gingiva, directly adjacent to the area 
of exposed dentine (i.e., the test area) only.  
Eligible teeth will have a MGI of zero (0) directly adjacent to the test area. 
Score
Description
0
Absence of inflammation
1 
Mild inflammation; slight change in colour, little change in colour; 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. 
3 
Moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal 
or papillary gingival unit. 
4 
Severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or 
papillary gingival unit, spontaneous bleeding, congestion, or ulceration. 
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9.1.1.3 
Clinical Mobility  
Clinical mobility will be assessed for incisor, canine and pre-molar teeth exhibiting none of the 
dentition exclusions, with facial/cervical EAR and a MGI = 0 adjacent to the test area only, 
using a modification of the Miller Index (Laster, 1975).  
Eligible teeth will have clinical mobility = 0. 
Degree
Description 
0 
No movement or mobility of the crown of the tooth < 0.2mm in a horizontal direction
1 
Mobility of the crown of the tooth 0.2 - 1mm in a horizontal direction 
2 
Mobility of the crown of the tooth exceeding 1mm in a horizontal direction 
3 
Mobility of the crown of the tooth in a vertical direction as well. 
9.1.2 
Qualifying Tactile Sensitivity  
The tactile sensitivity of incisor, canine and pre-molar teeth (Figure 9-1) exhibiting none of the 
dentition exclusions, and meeting the EAR, MGI (adjacent to the test area only) and clinical 
mobility criteria, will be assessed using a constant pressure probe (Yeaple probe (Polson et al., 
1980). The probe tip will be placed perpendicular to the facial surface of the tooth and drawn 
slowly across the exposed dentine to ensure application of the stimulus across the potentially 
.  
After each application of the tactile stimulus, the subject will be asked to indicate whether they 
experienced any pain or discomfort. The examiner will tell the subject to only 
yes if 
they feel PAIN or DISCOMFORT when the probe is applied to their tooth. 
es  and
o are 
the only acceptable answers. The subject may respond yes  if they feel pressure. The examiner 
will remind them, as needed, that they will feel pressure each time the probe is in contact with 
the tooth but they should only respond yes  if they feel pain or discomfort. The gram setting 
the source document. At Screening, the upper force setting will be 20g.  
 
 If no sensitivity is found at the upper force setting, the tactile threshold will be 
recorded as > 20g and the tooth will be disqualified from further testing.
If a subject fails to give a definite answer, the examiner will re-prompt them to provide a yes
or no  response. If their uncertainty continues, this should be recorded on the source document. 
and the next stimulus should be at the next step in the upward direction. If the subject continues 
to be unsure, or the examiner is unsure of the reliability of their response, the examiner may opt 
to re-probe at the same force setting (indicated to the scribe by a non-verbal signal, e.g., a hand 
gesture) or move to the next force setting (10g increase). If the examiner considers the subject
 response may be between gram settings, a conservative approach should always be 
  
The examiner will generally make the force setting adjustments (this can also be done by an 
assistant/scribe); the scribe will record the micro-
in 
the source document. 
Calibration of the Yeaple Probe:  
The Yeaple probe will be calibrated by an appropriately trained member of the study staff 
(typically the clinical examiner or their assistant/scribe) before use on each day subjects are 
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assessed. The microamp settings may vary from day to day (partly due to battery power 
consumption), but the difference should not be significant. Thus, previous probe settings can 
serve as a guide. Calibration should start at the lowest microamp setting and then increase. 
Either calibration method described below is acceptable. 
 
 The Yeaple probe is fixed to a clamp attached to a ring stand 
so that the probe tip is vertical. A small paper cup attached with cotton thread is balanced 
over the end of the Yeaple probe, without the probe tripping. The probe dial is set to the 
microamp setting and water is fed into the paper cup using a dropper until the probe 
trips. The gram setting is recorded and the Yeaple probe reset to the next microamp 
value. The procedure is repeated until data has been collected to more than 80 g. 
 Method 2: The Yeaple probe is fixed to a clamp attached to a ring stand so that the top 
is perpendicular to the pan of an ohaus dial-o-gram® balance or equivalent. The probe 
tip is positioned to just touch the pan when the balance is set at zero grams. The probe 
dial is set to the microamp setting and the gram setting is increased on the balance until 
the probe trips. The gram setting is recorded and the Yeaple probe reset to the next 
microamp value. 
The data are plotted, and the points connected with line segments in order to interpolate the 
micro-amp values equivalent to 10, 20, 30, 40, 50, 60, 70 and 80 g. This calibration should be 
be recorded on the Yeaple probe calibration record (along 
 
9.1.3 
Qualifying Evaporative (Air) Sensitivity 
Evaporative (air) sensitivity will be assessed on the facial surfaces of incisor, canine and pre-
molar teeth (Figure 9-1) which exhibit none of the dentition exclusions, and meet the EAR, 
MGI (adjacent to the test area only), clinical mobility and tactile threshold (  20g) criteria. 
Assessment will start a minimum of 5 minutes after the tactile assessments have completed. 
The assessment will be made by directing a 1-second application of air from a standard dental 
syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival
margin, and from a distance of approximately 1 cm. The dental examiner will take appropriate 
measures to isolate the tooth surface to prevent stimulation of adjacent teeth or surrounding soft 
tissue. 
Subject response to the stimulus will be evaluated using the Schiff sensitivity scale (Schiff, 
1994). This is an examiner-based index, scored immediately following administration of the 
evaporative (air) stimulus. The scale focuses on a combination of specific, observable, physical, 
behavioural and verbal responses from the subject, which may facilitate discrimination.  
 
Score 
Description 
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 
 
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If the clinical examiner assesses the subject response to be between scores, a conservative 
approach should always be 
. 
After the clinical examiner has communicated each Schiff sensitivity score to the scribe (non-
verbally), the subject will rate the intensity of their response to the evaporative (air) stimulus 
using a 100 mm VAS (example below). The clinical examiner and the subject should be blinded
to their respective scores. 
 
 
0 
100mm (not to scale) 
No discomfort  
 
 
 
 
 
        Extreme discomfort 
 
 
 
 
 
 
 
 
       (worst imaginable)
A trained member of staff will measure the distance (mm) from zero (0) to the left of the line 
marked by the subject and record this value in the eCRF. 
 
 
 If Schiff sensitivity score = 0 or 1, the tooth will be disqualified from further testing
(
VAS response will still be recorded). 
9.2 
Dentine Hypersensitivity Efficacy Assessments 
The following product efficacy assessments will be performed by appropriately trained clinical 
examiners (who are blind to product received), at the times and in the order defined in the Study 
Procedures section of this protocol.  
The same examiner will be responsible for a given DH assessment (tactile or evaporative (air) 
sensitivity) throughout the study (Visit 1 to Visit 4). 
9.2.1 
Tactile Sensitivity Assessment (Yeaple Probe)  
Baseline (Visit 2):  
The tactile sensitivity of all eligible teeth identified at Screening (Visit 1) will be assessed for 
all enrolled subjects. The tactile stimulus will be administered, and subject response recorded 
as described in Section 9.1.2. At Baseline, the upper force setting will be 20g.  
 
 
 If no sensitivity is found at the upper force setting, the tactile threshold will be 
recorded as > 20g and the tooth will be disqualified from further testing.
Note: Eligible teeth identified at Screening
 defined as incisors, canines and pre-molars 
with none of the study-specific dentition exclusions, which meet the EAR, MGI (adjacent to 
the test area only) and mobility inclusion criteria, and record a qualifying tactile threshold of 
20g and a qualifying Schiff sensitivity score of 
  
Week 6 (Visit 3) & Week 12 (Visit 4): 
The tactile sensitivity of the two test teeth identified by the clinical examiners at Baseline (Visit 
2) will be assessed for all randomized subjects. The tactile stimulus will be administered, and 
subject response recorded as described in Section 9.1.2.  
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At Week 6 and Week 12, the upper force setting will be 80g. The gram setting, which elicits 
two consecutive yes  responses, will be recorded as the tactile threshold (g). If no sensitivity 
is found, the tactile threshold should be recorded as >80g.  
9.2.2 
Evaporative (Air) Sensitivity Assessments  
Baseline (Visit 2):  
The evaporative (air) sensitivity of all eligible teeth identified at Screening (Visit 1), with a 
Baseline tactile threshold 
, will be assessed for all enrolled subjects. The evaporative (air)
stimulus will be administered, and subject response (Schiff sensitivity score, followed by VAS) 
recorded as described in Section 9.1.3. Assessment will start a minimum of 5 minutes after the 
tactile assessments have completed. 
 
, a Schiff 
 
.  
 If Schiff sensitivity score is < 2, the tooth will be disqualified from further testing.
Week 6 (Visit 3) & Week 12 (Visit 4): 
The evaporative (air) sensitivity of the two test teeth identified by the clinical examiners at 
Baseline (Visit 2) will be assessed for all randomized subjects. The evaporative (air) stimulus 
will be administered, and subject response (Schiff sensitivity score, followed by VAS) recorded 
as described in Section 9.1.3 . 
9.3 
Safety and Other Assessments 
The following safety assessments will be performed by appropriately trained clinical examiners, 
at the times and in the order defined in the Study Procedures section of this protocol.  
9.3.1 
Oral Soft Tissue (OST) Examination 
The OST examination will be accomplished by direct observation and palpation, using 
retraction aids as appropriate, and will include examination of the labial mucosa (including 
lips), buccal mucosa, mucogingival folds, gingival mucosa, hard palate, soft palate, tonsillar 
area, pharyngeal area, tongue, sublingual area, submandibular area and salivary glands. The 
results of the examination will be recorded in the eCRF as either normal  or abnormal
of any abnormalities will be documented in the eCRF.  
Any observation that changes from normal  to abnormal
om the OST 
examination completed at Screening will be recorded as an AE. 
9.3.2 
Oral Hard Tissue (OHT) Examination 
The OHT examination will be accomplished by direct observation, using retraction aids as 
appropriate, and will identify enamel irregularities, tooth fractures, grossly carious lesions/gross 
decay, defective/faulty restorations (all direct & indirect restorations including fixed/removal 
prostheses), non-carious tooth surface loss (abrasion, attrition, abfraction and erosion), any 
other hard tissue irregularities (e.g., hypo/hypermineralisation, decalcification) and significant 
tooth staining. Observations will be listed as bsent  or 
resent
conditions noted as present
will be described in the eCRF. Any observation that changes from 
bsent  to 
resent
worsens, from the OHT examination completed at Screening will be recorded as an AE. 
 
 
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The presence of any implants, fixed or removable dentures, fixed or removable orthodontic 
braces/bands, fixed orthodontic retainers, full crowns or veneers will be recorded, along with 
evidence of gross intra-oral neglect or the need for extensive dental therapy. 
The OHT examination is also used to assess the dentition against the general and specific 
dentition exclusions described in Section 5.3 (Exclusion Criteria 25, 26, 27, 28 and 29 a) to f)).
9.3.3 
Pregnancy  
This clinical study will evaluate toothpastes classified as general goods in China. Sponsor
studies in which no drug is utilized do not require pregnancy testing.  
Female subjects will provide verbal confirmation of pregnancy status at Screening (Visit 1) and 
will be asked to inform study staff immediately should this change at any point during the study.
Female subjects who are pregnant or intending to become pregnant during the study (self-
reported) will be excluded. 
10 
ADVERSE EVENT AND SERIOUS ADVERSE EVENTS
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following 
up AEs that are serious, considered related to the study product or the study, or that caused the 
subject to discontinue the study product or study. 
10.1 
Definition of an Adverse Event (AE) 
An AE is any untoward medical occurrence in a clinical study subject, temporally associated 
with the use of a study product including any washout or lead-in product (or medical device), 
whether or not considered related to the study product, including any washout or lead-in product 
(or medical device). 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the 
use of a study product including any washout or lead-in product (or medical device).
Events Meeting the AE Definition:   
 Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (e.g., electrocardiogram (ECG), radiological scans, vital sign 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator (i.e., not related to 
progression of underlying disease). 
 Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
 New conditions detected or diagnosed after study product administration even though 
it may have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
product or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
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Lack of efficacy  or failure of expected pharmacological action  per se will not be 
reported as an AE. Such instances will be captured in the efficacy assessments. 
However, the signs, symptoms, and/or clinical sequelae resulting from lack of efficacy 
will be reported as AE if they fulfill the definition of an AE.  
Events NOT meeting the AE definition:  
 Any clinically significant abnormal laboratory findings (if applicable) or other abnormal 
safety assessments which are associated with the underlying disease, unless judged by 
 
 The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder be
condition.  
 Medical or surgical procedure (e.g., endoscopy, appendectomy) is not the AE. The 
condition that leads to the procedure is an AE (e.g., appendicitis). 
 Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen.  
10.2 
Definition of a Serious Adverse Event (SAE) 
A serious adverse event (SAE) is a particular category of an AE where the adverse outcome is 
serious. If an event is not an AE per definition above, then it cannot be an SAE, even if serious 
conditions are met (e.g. hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease). 
A serious adverse event is any untoward medical occurrence at any dose that: 
 Results in death 
 Is life-threatening  
- 
The term 'life-threatening' in the definition of 'serious' refers to an event in which 
the subject was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe. 
 Requires inpatient hospitalization or prolongation of existing hospitalization  
- 
In general, hospitalization signifies that the subject has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether 
hospitalization  occurred, or was necessary, the AE should be considered serious. 
- 
Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
 Results in persistent or significant disability/incapacity 
- 
The term dis
normal life functions. 
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- 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (e.g., sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption
 Results in congenital anomaly/birth defect 
 Other situations: 
- 
Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the subject or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious. 
- 
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse. 
Note: 
in determining reporting requirements. 
10.3 
Time Period and Frequency for Collecting AE and SAE 
Information 
All AEs, and therefore all SAEs, will be collected immediately after a subject provides consent
to participate in the study by the completion (signature) of the ICF and until 5 days following 
last administration of the study product (or last study procedure).  
Medical occurrences that began before obtaining informed consent will be recorded in the 
Medical History/Current Medical Conditions section of the eCRF, not the AE section.
Details recorded by the subject on a diary or similar document that meet the definition of an AE 
must also be discussed with the subjects and transcribed in the AE section of the eCRF. 
All SAEs will be recorded and reported to the sponsor or designee immediately and under no 
circumstance should this exceed 24 hours. The investigator will submit any updated SAE data 
to the sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek AEs or SAEs after the conclusion of the study 
participation. However, if the investigator learns of any SAE, including a death, at any time 
after a subject has been discharged from the study, and they consider the event to be reasonably 
related to the study product or study participation, the investigator must promptly notify the 
sponsor. 
10.4 
Reporting Procedures 
The investigator and any designees are responsible for detecting, documenting and reporting 
events that meet the definition of an AE and remain responsible for following up on AEs that 
are serious, considered related to the study product(s), participation in the study, or a study 
procedure, or that caused the subject to discontinue the study product or study.  
 
 
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Spontaneous reporting of AEs and those elicited by asking subjects to respond to non-leading
question, such as How do you feel?  will be assessed and any AEs recorded in the eCRF and 
reported appropriately. 
The investigator (or medically qualified designee) is to report all directly observed AEs and all 
AEs spontaneously reported by the study subject. In addition, each study subject will be 
questioned about AEs.  
Each AE is to be assessed to determine if it meets the criteria for a SAE. If an SAE occurs, 
expedited reporting will follow local and international regulations, as appropriate. 
When an AE occurs, it is the responsibility of the investigator (or medically qualified designee) 
to review all documentation (e.g., hospital progress notes, laboratory, and diagnostics reports) 
related to the event. 
The investigator or site staff will then record all relevant information regarding an AE in the 
eCRF and all details relating to an SAE in the paper SAE Form provided. 
It is not acceptable for the investigator (or medically qualified designee) to send photocopies 
the sponsor in lieu of completion of the AE eCRF 
screen/SAE form. 
There may be instances when copies of medical records for certain cases are requested by the 
sponsor.  In this instance, all subject identifiers, except for the subject number, will be redacted 
on the copies of the medical records prior to submission to the sponsor. 
The investigator (or medically qualified designee) will attempt to establish a diagnosis of the 
event based on signs, symptoms, and/or other clinical information.  The diagnosis will be the 
documented as the AE/SAE, were known, and not the individual signs/symptoms. (e.g., upper 
respiratory tract infection, seasonal allergy, etc. not cough, runny nose). 
AEs elicited by the investigator (or medically qualified designee) in a standard manner at the 
study visits should also be recorded in the AE section of the eCRF and/or using the SAE form 
(subject to the classification of the AE). Care will be taken not to introduce bias when 
questioning a subject about any changes in their health. Open-ended and non-leading verbal 
questioning should be used.  
10.4.1 
Reporting of an Adverse Event 
All AEs will be reported on the AE page of the eCRF by the investigator or site staff.  It should 
be noted that the form for collection of SAE information is not the same as the AE eCRF screen.  
Where the same data are collected, the AE eCRF screen and the SAE form must be completed 
in a consistent manner (e.g., the same AE term should be used on both).  AEs should be reported 
using concise medical terminology in the eCRF as well as on the paper SAE form. 
10.4.2 
Reporting of a Serious Adverse Event 
In addition to recording the details of each AE on the AE eCRF screen, an SAE form should be 
completed, as fully as possible. Hard copies of the paper SAE form will be provided in the 
investigator site master file. Original SAE forms will be retained in the investigator site master 
file. 
 
 
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It is essential to enter the following information:  
 Protocol and subject identifiers 
 Subject demography 
 Description of events, with diagnosis (if available) 
 Investigator opinion of relationship to study product (or study procedure, if appropriate)
 Criterion for seriousness. 
The following are desirable and are of particular relevance for investigator and sponsor
assessment of the SAE report: 
 Date of onset of AE  
 Date AE stopped (if relevant) 
 Study product start date 
 Study product end date (if relevant) 
 Action taken in relation to the study product 
 Outcome if known 
The SAE form, completed as fully as possible, must be scanned and e-mailed to the Case 
Management Group mailbox 
,with copy to the appropriate 
sponsor Study Manager, with the study number and subject number in the subject line of the 
email immediately and under no circumstance should this exceed 24 hours after study site 
personnel learn of the event. The investigator will submit any updated SAE data to the sponsor, 
immediately and under no circumstance should this exceed 24 hours of it being available.  
The initial report will be followed up with more information as relevant, or as requested by the
sponsor study manager. The 
 Study Manager will be responsible for forwarding the 
SAE form to other sponsor personnel as appropriate. 
10.5 
Evaluating Adverse Events  
10.5.1 
Assessment of Intensity 
The investigator or medically qualified designee will make an assessment of intensity for each 
AE reported during the study and will assign it to one of the following categories: 
 Mild: An event that is easily tolerated by the subject, causing minimal discomfort and 
not interfering with everyday activities. 
 Moderate: An event that is sufficiently discomforting to interfere with normal everyday 
activities 
 Severe: An event that prevents normal everyday activities.  
NOTE: An AE that is assessed as severe  should not be confused with an SAE. Severe  is a 
category utilized for rating the intensity of an event; and both non-serious AEs and SAEs can 
be assessed as severe . For example, a headache may be severe  (interferes significantly with 
the subject's usual function) but would not be classified as serious  unless it met one of the 
criteria for SAEs, listed above. An event 
predefined outcomes as described in the definition of an SAE, not when it is rated as severe .
10.5.2 
Assessment of Causality 
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The causality assessment is one of the criteria used when determining regulatory reporting 
requirements.  
For each AE (serious and non-serious), the investigator (or medically qualified designee) must
provide an assessment of causality on the AE eCRF screen and the paper SAE form (subject to 
the classification of the AE). The investigator will also document in the medical notes that they 
have reviewed the AE and assessed causality, where applicable.  
A reasonable possibility  of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
Generally, the facts (evidence) or arguments to suggest a causal relationship should be provided.
The investigator will use clinical judgment to determine the relationship and will also consult 
the Product Information, for marketed products, in the determination of their assessment.  
Alternative causes, such as underlying disease(s), concomitant therapy, other risk factors, and 
the temporal relationship of the event to the study product will be considered and investigated. 
For each AE/SAE, the investigator must document in the medical notes that they have reviewed 
the AE/SAE and has provided an assessment of causality. 
-
serious); the investigator must record the causal relationship in the eCRF, as appropriate, and 
report such an assessment in accordance with the SAE reporting requirements, if applicable.
There may be situations when an SAE has occurred, and the investigator has minimal 
information to include in the initial report to the sponsor.  However, it is very important that 
the investigator always make an assessment of causality for every event prior to the initial 
transmission of the SAE data to the sponsor. The investigator may change their opinion of 
causality in light of follow-up information and send an SAE follow-up report with the updated 
causality assessment.   
10.6 
Follow-up of AEs and SAEs  
After the initial AE/SAE report, the investigator is required to proactively follow up with each 
subject and provide further information on 
 
All AEs (serious and non-serious) will be followed until resolution, until the condition 
stabilises, until the event is otherwise explained, or until the subject is lost to follow-up.  
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as may be indicated or as requested by the sponsor to elucidate 
as fully as possible the nature and/or causality of the AE. This may include additional laboratory 
tests or investigations, histopathological examinations, or consultation with other health care 
professionals. 
New or updated information will be recorded on the AE eCRF screen and on the paper SAE 
form (subject to the classification of the AE). 
The investigator will submit any updated SAE data to the sponsor within 24 hours of receipt of 
the information. 
Investigators are not obliged to actively seek AEs in former subjects.  However, if the 
investigator learns of a SAE, including death, at any time after a subject has been discharged 
from the study, and considers the event reasonably related to the study product or study 
participation, the investigator will promptly notify the sponsor by emailing the information to 
the Case Management Group mailbox
 with copy to the 
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appropriate sponsor Study Manager. 
The investigator will submit any updated SAE data to the sponsor within the designated 
reporting time frames. 
10.7 
Withdrawal Due to an Adverse Event  
Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according 
to the definition of an AE noted earlier, and recorded on the appropriate AE eCRF screen.  
When a subject withdraws because of an SAE, the SAE must be reported in accordance with 
the reporting requirements defined. 
10.8 
Regulatory Reporting Requirements for SAEs 
The sponsor 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 the sponsor is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects are met. 
The sponsor will comply with country specific regulatory requirements relating to safety 
reporting to the regulatory authority, Good Clinical Practice (GCP) Office/Institutional Review 
Board (IRB) and the investigator.  
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
(SUSAR) according to local regulatory requirements and sponsor policy. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (e.g., summary or listing of SAEs from the sponsor) will review and then 
file it in the investigator site master file, and will notify the GCP office/IRB, if appropriate 
according to local requirements. 
10.9 
Pregnancy 
10.9.1 
Time Period for Collecting Pregnancy Information 
Pregnancy information will be collected on all pregnancies reported while a female subject is 
participating in the study from the signing of informed consent until 5 days after last 
administration of study product. 
10.9.2 
Action to be Taken if Pregnancy Occurs 
The investigator will record pregnancy information on the appropriate form scan and e-mail it 
to the Case Management Group mailbox
  with copy to the 
appropriate sponsor Study Manager. Original pregnancy information forms will be retained in 
the investigator site master file.  
The subject will be followed to determine the outcome of the pregnancy. Information on the 
status of the mother and infant / neonate (including concomitant medications taken by the 
mother during the pregnancy) will be forwarded by the investigator to the Case Management 
Group mailbox
, with copy to the appropriate sponsor Study 
Manager. Generally, follow-up will be no longer than 6 to 8 weeks following the estimated 
delivery date. Any termination of the pregnancy will be reported. 
While pregnancy itself is not considered to be an AE, abnormal pregnancy outcomes (e.g.,
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spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are, and 
should be recorded as an SAE. 
Any female subject who becomes pregnant while participating in the study will be withdrawn. 
11 
DATA MANAGEMENT 
As used in this protocol, the term CRF is understood to refer to either a paper form or an 
electronic data record or both, depending on the data collection method.  
For this study, subject data will be entered into an electronic CRF (eCRF), using a validated 
system. Data relating to clinical screening/efficacy assessments, SAEs and pregnancy will also 
be collected on paper forms. 
The investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF. 
The source documents (e.g. hospital records, clinical and office charts, laboratory notes, 
memoranda, subject diaries, questionnaires, evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files and records kept at the pharmacy, at the 
laboratory and at the medico-technical departments involved in the clinical study) which 
contain the source of data recorded in the eCRF should be specified.  The eCRF, paper forms
and diary can be used as a source document at the discretion of data management. 
Each subject will be assigned and identified by a unique Screening Subject Number. Any 
reference made to an individual subject within the study must be done using their unique 
Screening Subject Number. 
11.1 
Case Report Form 
A CRF is a printed, optical, or electronic document designed to record the protocol required 
information to be reported to the sponsor on each trial subject. For each subject who has given 
informed consent/assent, the eCRF must be completed and signed by the investigator (or 
authorized designee) to certify the data are complete and correct. The investigator must maintain 
accurate documentation (source data) that supports the information entered in the eCRF.
Management of clinical data will be performed in accordance with Third Party Biostatistics and 
Data Management (BDM) Vendor applicable standards and data cleaning procedures with 
oversight by the sponsor to ensure integrity of the data, for example, to remove errors and 
inconsistencies in the data.  
To protect the privacy of subjects, no Personal Information (PI) (including the subject's name 
or initials or full birth date) is to be recorded in the eCRF or as part of the query text.
All eCRF pages should be completed during a subject assessment when the eCRF has been 
designated as the source.  Data that is sourced elsewhere should be entered into the eCRF in an 
agreed upon timeframe between the investigator and sponsor.   
The sponsor will obtain and retain all eCRFs and associated study data as applicable at the 
completion of the study.  
 
 
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11.2 
Data Handling 
Documentation of all data management activities should allow step-by-step retrospective 
assessment of data quality and study performance.  
Any changes or corrections to data will be performed in the Electronic Data Capture (EDC) 
System, which 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.
AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) and any 
concomitant medication terms (if applicable) using a validated medication dictionary, 
WHODrug.   
11.2.1 
Data Queries 
Programmed edit checks will be generated automatically, as the data are being entered into the 
system. Reports and listings on the eCRF data will also be run, in addition to the queries already 
programmed and generated by the system, to raise manual queries as needed for site 
clarification or correction. The third-party vendor will raise queries as needed on safety data to 
code the terms (AEs and Drugs or concomitant medication) appropriately.  
The study monitor will perform ongoing review the of the eCRFs in accordance with the 
monitoring plan, to confirm that data entered into the eCRF by authorised site personnel are 
accurate, complete, and verifiable from source documents; that the safety and rights of 
participants are being protected; and that the study is being conducted in accordance with the 
currently approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
Any queries will be generated in the EDC System to the investigator or designee, enabling the 
errors to be addressed in parallel with Data Management review. The monitor can also run 
reports and listings on the eCRFs to raise manual queries, as needed, for site clarification or 
correction. 
12 
STATISTICAL CONSIDERATIONS AND DATA ANALYSES
12.1 
Sample Size Determination 
Sufficient subjects will be screened to randomize approximately 240 subjects to study treatment 
to ensure approximately 235 complete the study (approximately 94 subjects each for test 
toothpaste and negative control, and 47 subjects for positive control), allowing for 2% dropouts
after randomization, as observed in previous clinical studies conducted in China. 
The study will be powered sufficiently to demonstrate statistical superiority of the test 
toothpaste compared to the negative control for the change from Baseline in the Schiff 
sensitivity score after 12 weeks of treatment.  
The true effect size is expected to be 0.5 (effect size (ES) = mean difference [test toothpaste 
negative control] / pooled standard deviation [SD]; mean difference = 0.3, SD=0.6). Such 
assumptions would also infer at least a 15% superior relative mean change from Baseline for 
the test toothpaste compared to the negative control (assuming mean change from a Baseline 
Schiff sensitivity score for negative control less than 2), a requirement of the Chinese MoH 
guidelines for the testing of functional (desensitising) toothpastes for at least one clinical DH 
measure (Ministry of Health (China), 2010).   
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With 94 subjects per group (for test toothpaste and negative control arms), there is 92.65% 
power to detect an effect size of 0.5 at the two-sided 5% significance level based on a two-
sample t-test (using PASS software version 19.0.1).  
Estimates of the above dropout rate and SD are based on results from three similar clinical 
studies (sponsor clinical studies: 205794, 208153, 216954).  
The positive control has clinically proven longer-term DH efficacy in two clinical studies 
conducted in China on Chinese populations (sponsor clinical studies:
which satisfied the China MoH requirements (Ministry of Health (China), 2010). As such, it 
has been included in this study as a benchmark of performance in the Chinese population for 
; 47 subjects in the positive control group are deemed sufficient to 
demonstrate statistical superiority for positive vs. negative controls. 
12.2 
Populations for Analysis 
12.2.1 
Definitions of Analysis Populations 
The Safety population will include all randomized subjects who complete at least one use of 
study product. This population will be based on the study product the subject received. All 
assessments of safety will be based on this analysis population. 
The modified Intent-To-Treat (mITT) population will include all randomized subjects who 
complete at least one use of study product and have at least one post Baseline efficacy 
assessment. This population will be based on the study product to which the subject was 
randomized. All assessments of efficacy will be primarily based on this analysis population. 
The per protocol (PP) population is defined as all subjects in the mITT population who have at 
least one assessment of efficacy considered unaffected by protocol deviations. 
12.2.2 
Exclusion of Data from Analysis  
Exclusion of any data from the analyses will be determined during Blinded Data Review (BDR) 
prior to database lock. Any reasons for exclusion from an analysis population will be listed, if 
applicable. 
A PP analysis will be performed for each change from Baseline in Schiff sensitivity score and 
tactile threshold endpoints if there is more than 10% difference in the number of subjects 
between the PP and mITT populations. A decision to perform a PP analysis should be made 
prior to study unblinding (release of the randomization codes). 
12.3 
Statistical Analyses 
This is a summary of the planned statistical analyses; the detail of the proposed statistical 
analyses will be documented in the statistical analysis plan (SAP), written following finalization 
of the protocol and prior to study unblinding. 
Significance testing will be conducted at the two-sided 5% significance level. 
Schiff sensitivity score, tactile threshold (g) and VAS (mm) will be derived as the average score 
or value, respectively, of the 2 test teeth (identified at Baseline). Change from Baseline will be 
derived for the individual teeth first before calculating the average change of the 2 test teeth.
 
 
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12.3.1 
Primary Analysis  
The primary endpoint of this study is the change from Baseline in the Schiff sensitivity score at 
Week 12; the primary hypothesis test will be the comparison between the test toothpaste and
the negative control in the mITT population. 
Change from Baseline in Schiff sensitivity score will be analysed using a Mixed Model with 
Repeated Measures (MMRM), with study product, visit and study product by visit interaction
as fixed effects, and Baseline Schiff sensitivity score as a covariate. Subject will be included as 
a repeated measure with unstructured covariance matrix. Kenward Rogers degrees of freedom 
approach will be applied (Kenward and Roger, 1997). The difference between least square 
means for the test toothpaste compared to the negative control at Week 12 will be presented 
along with two-sided p-value and 95% CIs.  
As a sensitivity analysis, the change from Baseline in Schiff sensitivity score at Week 12 will 
be compared between study products (test toothpaste vs. negative control) using an Analysis of 
Covariance (ANCOVA) model with study product as a fixed effect and Baseline Schiff 
sensitivity score as a covariate. 
The assumption of normality and homogeneity of variance in each MMRM will be investigated. 
In case of violation of these assumptions, a suitable non-parametric test (adjusted for the 
randomisation stratification) will be performed to assess change from Baseline comparisons 
(test toothpaste vs. negative control at Week 12) and the results will be provided to support the 
MMRM results; the non-parametric results will be considered confirmatory under the 
observation of strong violations of the assumptions. 
12.3.2 
Secondary Analyses 
Change from Baseline in Tactile Threshold (g) at Week 12: 
Change from Baseline in tactile threshold (g) will be analysed using the same MMRM as the 
primary endpoint but with Baseline tactile threshold (g) as a covariate, rather than Baseline 
Schiff sensitivity score. In addition, the maximum Baseline Schiff sensitivity score of the two
test teeth (2 or 3) will be fitted as a fixed effect. The difference between least square means for 
the test toothpaste vs. negative control at Week 12 will be presented, along with the two-sided 
p-value and 95% CIs.  
As a sensitivity analysis, the change from Baseline in tactile threshold (g) at Week 12 will be 
compared between study products (test toothpaste vs. negative control) using an Analysis of 
Covariance (ANCOVA) model with study product and the maximum Baseline Schiff sensitivity 
score of the two test teeth (2 or 3) as fixed effects and the Baseline tactile threshold (g) as a 
covariate. 
Change from Baseline in VAS (mm) at Week 12: 
Change from Baseline in VAS (mm) will be analysed using the same MMRM and ANCOVA 
(as a sensitivity analysis) as for the change from Baseline in tactile threshold (g) but with 
Baseline VAS (mm) as a covariate, rather than the Baseline tactile threshold (g). The difference 
between least square means for the test toothpaste vs. negative control at Week 12 will be 
presented, along with the two-sided p-value and 95% CIs.  
 
 
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Other Secondary Endpoints: 
 Test toothpaste vs. negative control  
- 
Change from Baseline in Schiff sensitivity score, tactile threshold (g) and VAS 
(mm) at Week 6 
 Positive control vs. negative control 
- 
Change from Baseline in Schiff sensitivity score, tactile threshold (g) and VAS 
(mm) at Week 6 and Week 12.  
These other secondary endpoint analyses will utilise the results at Week 6 (test toothpaste vs. 
negative control and positive vs. negative control) and Week 12 (positive vs. negative control) 
from the same respective MMRM model applied for the change from Baseline in Schiff 
sensitivity score, tactile threshold (g) and VAS (mm) described above.   
The results from each MMRM will be tabulated together, presenting the following information,
in addition to the results already specified for the primary and secondary analyses above.  
 Least square mean change from Baseline for each study product at Week 6 and Week 
12 (based on the observed stratification margins for tactile threshold model) and used to 
test for any change from Baseline with two-sided p-values and 95% CIs. 
 Differences between least square mean change from Baseline (test toothpaste vs. 
negative control at Week 6, positive control vs. negative control at Week 6 and Week 
12) with two-sided p-values and 95% CIs. 
The assumption of normality and homogeneity of variance in each MMRM will be investigated. 
In case of violation of these assumptions, a suitable non-parametric test (adjusted for the 
randomisation stratification) will be performed for each required secondary endpoint 
comparison between study products at each time point and results will be provided to support 
the MMRM results; the non-parametric results will be considered to supersede the MMRM 
results under the observation of strong violations of the assumptions. 
The ANCOVA sensitivity analysis results at Week 12 for positive vs. negative control for each 
endpoint will be obtained from the same ANCOVA models using Week 12 data as described 
above for the test toothpaste vs. negative control comparisons. As additional sensitivity 
analyses, the change from Baseline in Schiff sensitivity score, tactile threshold (g) and VAS 
(mm) at Week 6 will be analysed using the same ANCOVA model as for the Week 12 sensitivity 
analyses detailed above.  
12.3.3 
Safety Analyses 
Safety analyses will be performed on the Safety population, according to study product 
 if they occur on or after the first study 
product use at Baseline (Visit 1). In case of misallocation, compared to the randomisation 
schedule, TEAEs will be associated with the most recent study product received.   
Each AE will be categorized as oral or non-oral by the investigator, or medically qualified 
designee. All will be reviewed by the CRS prior to database lock and unblinding, and coded 
using the MedDRA.  
A listing of all AEs will be presented for all subjects in the Safety population with the following 
AEs summaries (number of distinct AEs and frequency/proportion of subjects affected) will be 
presented by product group and overall:  
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 Treatment emergent AEs 
 Treatment emergent AEs by System Organ Class (SOC) and Preferred Term (PT)  
 Treatment emergent AEs by Oral/Non-Oral and PT  
 Treatment emergent treatment related AEs by Oral/Non-Oral and PT 
 Treatment emergent treatment related serious AEs by SOC and PT 
Separate listings will be presented for: 
 Deaths, SAEs and any AEs leading to product or study discontinuation. 
 OST findings (with a summary of abnormalities by visit) 
 OHT findings (with a summary of changes by visit) 
 Exposure to study product Section 12.3.5.1.  
12.3.4 
Demographic and Baseline Characteristics 
Demographic and Baseline characteristics will be summarized by treatment group for the Safety 
and mITT populations, and the PP population if a PP analysis is performed. 
Categorical variables (such as sex, race and Baseline Schiff stratification score) will be 
summarized by the number and percentage of subjects with each relevant characteristic in each 
product group. Continuous variables such as (age) will be summarized by mean, SD, median, 
minimum and maximum values in each product group. 
12.3.5 
Study Product Compliance and Use of Other Therapies 
12.3.5.1 Study Product Compliance 
Compliance with product use (number of brushings) will be listed and summarized for the mITT 
population at each visit, and cumulatively for the overall treatment period (for most subjects 
this will be 12 weeks) by product group.  
Number of expected brushings =  
2 × Number of days between Visit X and Visit (X+1)
Number of actual brushings      =  
(Number of expected brushings)  (Number of missed
brushings) + (Number of additional brushings)
=  
 (Number of actual brushings prior to Visit X)     x 100
(Number of expected brushings prior to Visit X) 
12.3.5.2 Prior and Concomitant Medications and Treatments 
Prior medications, concomitant medications and significant non-drug therapies taken during the 
study will be listed for the Safety population. 
12.3.6 
Handling of Dropouts and Missing Data  
MMRM analyses account for missing data using a missing at random  assumption, i.e., there 
is a systematic relationship between the propensity for missing values and the observed data, 
but not the missing data. Under such assumptions, MMRM is shown to provide unbiased 
estimates of the treatment effect, whilst the analysis of only complete cases using ANCOVA
are biased (Baron et al, 2008; Ashbeck et al, 2016). Such complete case analysis requires a 
 to remain unbiased and this is unlikely to hold, i.e.,
the fact that the data are missing is independent of the observed and unobserved data.
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Using an MMRM, it will therefore be assumed that a subject with missing data at one post-
Baseline visit would have obtained a similar efficacy result at that visit compared to a subject 
using the same study product with similar non-missing results at other timepoints (Baseline and 
the other post-Baseline visit).  
Sensitivity analyses will present results from the separate ANCOVA models using only non-
missing values at each single time point. Additional sensitivity analyses may be added to the 
SAP prior to unblinding in case of high drop-out rates and/or exclusion from PP population. 
12.3.7 
Interim Analysis  
No interim analysis is planned for this study 
13 
STUDY GOVERNANCE CONSIDERATIONS 
13.1 
Quality Control  
In accordance with applicable regulations, including GCP and 
 procedures, the 
sponsor or designee (i.e., third-party vendor monitors) will contact the site to review the 
protocol, study requirements, and staff responsibilities with study personnel prior to the start of 
the study to satisfy regulatory, ethical, and sponsor requirements. When reviewing data 
collection procedures, the discussion will include identification, agreement and documentation 
of data items for which the eCRF will serve as the source document. 
The sponsor or designee will monitor the study and site activity to verify: 
 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 the 
sponsor. The investigator (or designee) agrees to allow the monitor(s) direct access to all 
relevant documents and agrees to co-operate with the monitor(s) to ensure that any problems 
detected during these monitoring visits are resolved. 
13.2 
Quality Assurance 
To ensure compliance with GCP and all applicable regulatory requirements, the sponsor may 
conduct a quality assurance assessment and/or audit of the site records, and regulatory agencies 
may conduct regulatory inspections at any time during or after completion of the study. 
In the event of an assessment, audit or inspection, the investigator (and institution) must agree 
to grant the advisor(s), auditor(s) and inspector(s) direct access to all relevant documents and 
to allocate their time and the time of their staff to discuss the conduct of the study, any 
findings/relevant issues and to implement any corrective and/or preventative actions to address 
any findings/issues identified. 
The investigator will notify the sponsor or its agents immediately of any regulatory inspection 
notification in relation to the study. Furthermore, the investigator will cooperate with the 
sponsor or its agents to prepare the study site for the inspection and will allow GSK CH or its 
agent, whenever feasible, to be present during the inspection. The investigator will promptly 
supply copies of the inspection finding to the sponsor or its agent. Before response submission 
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to the regulatory authority, the investigator will provide the sponsor or its agents with an 
opportunity to review and comment on responses to any findings.  
The sponsor will be available to help the investigator prepare for an inspection. 
13.3 
Regulatory and Ethical Considerations 
13.3.1 
Institutional Review Board 
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, informed consent documents, investigator brochure/safety statement 
(including any updates) and other relevant documents (e.g., recruitment advertisements, if 
applicable) from the GCP Office/IRB.  All correspondence with the GCP Office/IRB should be 
retained in the investigator site file.  Copies of GCP Office/IRB approvals should be forwarded 
to the sponsor prior to the initiation of the study, and also when amendments to the protocol are 
made. 
The only circumstance in which an amendment may be initiated prior to GCP Office/IRB 
approval is where the change is necessary to eliminate apparent immediate hazards to the 
subjects.  In that event, the investigator must notify the GCP Office/IRB and sponsor in writing 
immediately after the implementation. 
13.3.2 
Ethical Conduct of the Study 
The study will be conducted in accordance with the protocol and legal and regulatory 
requirements, as well as the general principles set forth in the International Ethical Guidelines 
for Biomedical Research Involving Human Subjects (Council for International Organizations 
of Medical Sciences 2002), International Ethical Guidelines for Health-Related Research 
Involving Humans (Council for International Organizations of Medical Sciences, 2016), 
guidelines for GCP (ICH 1996 and revision 2), and the Declaration of Helsinki (World Medical 
Association 2013).  
In addition, the study will be conducted in accordance with the protocol, the ICH guideline on 
GCP, and applicable local regulatory requirements and laws. 
13.3.3 
Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject names or 
other identifiable data in any reports, publications, or other disclosures, except where required 
by laws.  
When study data are compiled for transfer to the sponsor and other authorised parties, subject 
names, addresses, and other identifiable data will be replaced by numerical codes based on a 
numbering system provided by the sponsor in order to de-identify study subjects.   
Note that the use of initials should be avoided.   
The study site will maintain a confidential list of subjects who participated in the study, linking 
the sponsor
consistent with applicable privacy laws. 
The informed consent document must be in compliance with ICH GCP, local regulatory 
requirements, and legal requirements, including applicable privacy laws. 
 
 
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The informed consent document used during the informed consent process must be reviewed 
and approved by the sponsor, approved by the GCP Office/IRB before use, and available for 
inspection. 
The investigator must ensure that each study subject, is fully informed about the nature and 
objectives of the study and possible risks associated with participation. 
13.3.4 
Subject Recruitment  
Advertisements approved by GCP Office/IRB and investigator databases may be used to recruit 
study subjects.  Use of a GCP Office/IRB approved, generic, pre-screening questionnaire to 
determine general eligibility for this study is allowed.  This pre-screening questionnaire may be 
used by sites as a phone script and/or to review internal databases to identify subjects. The 
sponsor will have an opportunity to review and approve the content of any study recruitment 
materials directed to potential study subjects before such materials are used.  
13.3.5 
Reporting of Safety Issues and Serious Breaches of the Protocol or 
ICH GCP  
The investigator will inform the sponsor immediately of any urgent safety measures taken by 
the investigator to protect the study subjects against any immediate hazard, and of any serious 
breaches of this protocol or of ICH GCP the investigator becomes aware of. 
The sponsor defines a serious breach as a breach likely to affect to a significant degree the safety 
and rights of a subject or the reliability and robustness of the data generated in sponsored human 
subject research studies.  
In the event of any prohibition or restriction imposed (i.e., clinical hold) or if the investigator is 
aware of any new information that might influence the evaluation of the benefits and risks of 
the investigational product, the sponsor should be informed immediately. 
13.4 
Posting of Information on Publicly Available Clinical Trial 
Registers 
Study-related information from this protocol will be posted on publicly available clinical trial 
registers before enrollment of subjects begins in accordance with applicable 
processes. The sponsor intends to make anonymized subject-level data from this trial available 
to external researchers for scientific analyses or to conduct further research that can help 
advance medical science or improve patient care. This helps ensure the data provided by trial 
participants are used to maximum effect in the creation of knowledge and understanding.
13.5 
Provision of Study Results to Investigators 
Where required by applicable regulatory requirements, an investigator signatory will be 
identified for the approval of the clinical study report.  The investigator will be provided 
reasonable access to statistical tables, figures and relevant reports, and will have the opportunity 
to review the complete study results. The sponsor 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.  
A manuscript will be progressed for publication in the scientific literature if the results provide 
important scientific or medical knowledge. The procedures and timing for public disclosure of 
the results summary and for development of a manuscript for publication will be in accordance 
with 
 policy. 
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13.6 
Records Retention 
Following closure of the study, the investigator must maintain all site study records (except for 
those required by local regulations to be maintained elsewhere), in a safe and secure location.  
The records (study/ site master file) must be maintained to allow easy and timely retrieval, when 
needed (e.g., for a sponsor audit or regulatory inspection) and must be available for review in 
conjunction with assessment of the facility, supporting systems, and relevant site staff.
Where permitted by local laws/regulations or institutional policy, some or all of these records 
can be maintained in a format other than hard copy (e.g., microfiche, scanned, electronic); 
however, caution needs to be exercised before such action is taken.  
The investigator must ensure that all reproductions are legible and are a true and accurate copy 
of the original and meet accessibility and retrieval standards, including re-generating a hard 
copy, if required.  Furthermore, the investigator must ensure there is an acceptable back-up of
these reproductions and that an acceptable quality control process exists for making these 
reproductions. 
documents submitted to the sponsor, subjects should not be identified by their names or initials, 
names and addresses.  Documents not for submission to the sponsor (e.g., 
consent forms) should be maintained by the investigator in strict confidence. 
Records and documents, including signed ICF, pertaining to the conduct of this study must be 
retained by the investigator as per the signed contractual agreement, from the issue of the final 
Clinical Study Report (CSR) or equivalent summary, unless local regulations or institutional 
policies require a longer retention period. The minimum retention time will meet the strictest 
standard applicable to that site for the study, as dictated by any institutional requirements or 
local laws or regulations, sponsor standards/procedures, and/or institutional requirements.  
No study document should be destroyed without a prior written agreement between the sponsor
and the investigator. The investigator must notify the sponsor of any changes in the archival 
arrangements, including, but not limited to, archival at an off-site facility or transfer of 
ownership of the records in the event the investigator is no longer associated with the site.
13.7 
Conditions for Terminating the Study  
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the GCP Office/IRB, or study product safety problems, or at the discretion 
of the sponsor.    
If a study is prematurely terminated, the sponsor will promptly notify the investigator.  After 
notification, the investigator must promptly contact all participating subjects and should assure 
appropriate therapy/ follow-up for the subjects.  As directed by the sponsor, all study materials 
must be collected and all 
completed to the greatest extent possible. Where required by 
the applicable regulatory requirements, the sponsor should inform the regulatory authority(ies) 
and the investigator should promptly inform the GCP Office/IRB and provide the GCP 
Office/IRB with a detailed written explanation of the termination or suspension.  
If the GCP Office/IRB terminates or suspends its approval/favorable opinion of a trial, the 
investigator should promptly notify the sponsor and provide the sponsor with a detailed written 
explanation of the termination or suspension. 
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Upon completion or premature discontinuation of the study, the 
 monitor will conduct 
site closure activities with the investigator or site staff, as appropriate, in accordance with 
applicable regulations including GCP, and the sponsor  Standard Operating Procedures.
14 
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response. A comparison of the effect of strontium acetate, potassium nitrate and fluoride 
toothpastes. J. Clin. Periodontol. 1997, 24, 209 215. 
World Medical Association Declaration of Helsinki, 64th General Assembly, Fortaleza 2013.
 
 
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15 
APPENDICES 
15.1 
ABBREVIATIONS 
The following is a list of abbreviations that may be used in the protocol. 
Table 15-1 
Abbreviations 
Abbreviation 
Term 
AE 
Adverse event 
ANCOVA 
Analysis of Covariance 
BDM 
Biostatistics and Data Management 
BDR 
Blinded data review 
CI 
Confidence interval 
CRF 
Case report form 
CRS 
Clinical Research Scientist 
CSPS 
calcium sodium phosphosilicate 
DH 
Dentine hypersensitivity  
EAR 
Erosion, Abrasion, Recession 
ECs 
Ethics committees 
EDC 
Electronic data capture 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
ES 
Effect size  
g 
Gram 
GCP 
Good Clinical Practice 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
OHT 
Oral hard tissue 
OST 
Oral soft tissue 
OTC 
Over-the-counter 
MFC 
Manufacturing formulation code 
MGI 
Modified gingival index 
mITT 
Modified Intent to Treat 
MMRM 
Mixed model with repeated measures 
MOH 
Ministry of Health 
NaF 
Sodium fluoride 
N/A 
Not applicable 
PI 
Personal information 
PP 
Per protocol 
P&G 
Proctor and Gamble 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SnF2 
Stannous fluoride 
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Abbreviation 
Term 
SUSAR 
Suspected unexpected serious adverse reaction 
TEAEs 
Treatment emergent adverse events 
UK 
United Kingdom 
US 
United States 
vs 
Versus  
 
 
 
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15.2 
Screening questionnaire 
 
1. Which of the following best describe any sensations that you may have felt in your 
teeth? (tick all that apply) 
 
Itchy
Aching
Shooting 
Piercing
Tingling 
Sharp 
Dull
Flashing
Shivery 
Lingering
Twinging
Flickering
Stabbing 
Shattering
Freezing 
Fleeting
Quivering
Pricking 
Pain
Discomfort
Twinges 
Sensitivity None of these
 
 
From now on we are going to call what you feel, the 
. 
 
2. How long have you been experiencing any sensations in your teeth? (tick only one 
response) 
 
Less than six months 
Exclude 
More than six months but less than a year 
Proceed 
More than a year but less than five years  
Proceed 
More than five years but less than 10 years 
Proceed 
More than 10 years 
Exclude 
None 
Exclude 
 
 
3. Which parts of your mouth have been affected by these sensations? (tick all that apply) 
Top front 
Proceed 
Top back 
Proceed 
Bottom front 
Proceed 
Bottom back 
Proceed 
None 
Exclude 
 
 
 
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4. Which of the following cause you to have sensations in your teeth? (tick all that apply)
 
Cold fluids 
Acidy fruits (e.g., oranges) 
Having teeth cleaned at the dentist
Hot foods  
Sweet things  
Tooth Whitening Products  
Hard foods  
Sticky foods  
Metals touching my teeth  
Cold air  
Ice Cream  
flossing certain teeth 
Salty foods  
Cold foods  
Tooth brushing 
Hot fluids 
None of these 
 
 
5. How often do you experience these sensations in your teeth? 
Several times a day 
Proceed
Once a day 
Proceed
Several times a week 
Proceed
Once a week 
Proceed
Several times a month 
Exclude
Once a month 
Exclude
Less than once a month
Exclude
Never 
Exclude
 
6. If you have any sensations, on average how long do these sensations last? (tick only one 
response) 
 
A few seconds 
Proceed 
About a minute 
Proceed 
Several minutes 
Proceed 
About half an hour 
Proceed 
Longer than half an hour  
Exclude  
 
Exclude 
 
 
 
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15.3 
Video Compliance Check-list 
 
Did the subject only use the study products provided? 
Yes  
No* 
Did the subject use the correct amount of toothpaste (full toothbrush 
head)? 
Yes  
No* 
Did the subject brush according to the acclimatisation product usage 
instructions? 
Yes  
No* 
Did the subject rinse with water during tooth brushing? 
Yes**
No 
Did the subject rinse with the correct amount of water after brushing? 
Yes  
No* 
If the subject brushed their tongue, did they do this after toothbrushing? 
N/A (circle if subject did not brush their tongue)  
Yes  
No* 
 
*Non-compliant response; re-instruct in correct product usage procedure 
** Non-compliant response; exclude 
 
 
 
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PPD
PPD
PPD
PPD
PPD
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