A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity

• Sponsor: Unilever R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03244618
• Collaborator: University of Bristol (Other)
• Enrollment: 272
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.8
• Patients Per Site Per Month: 23.1

Study Details

Study Description

Brief Summary

Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Device: CSSP Toothpaste; Device: Fluoride Toothpaste	N/A

Detailed Description

This is a double blind parallel design, with respect to the clinical assessor and subject, study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the test site on six (6) occasions.

Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).

On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).

Subjects will be randomly assigned to the test groups.

Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.

At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.

Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.

At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.

At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
• Actual Study Start Date: Jun 19, 2017
• Actual Primary Completion Date: Jun 13, 2018
• Actual Study Completion Date: Jun 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CSSP Toothpaste Toothpaste containing Calcium Silicate and Sodium Phosphate	Device: CSSP Toothpaste; Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
Placebo Comparator: Fluoride Toothpaste Toothpaste containing Sodium monofluorphosphate	Device: Fluoride Toothpaste; Toothpaste containing sodium monofluorphosphate

Outcome Measures

Primary Outcome Measures

1. Thermo-evaporative (Schiff Air Blast) Stimuli [4-weeks of product use (Day 28)]

   Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.

Secondary Outcome Measures

1. Tactile (Yeaple Probe) Stimuli [4-weeks of product use (Day 28)]

   The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.

2. Visual Analogue Scale [4-weeks of product use (Day 28)]

   Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).

Other Outcome Measures

1. Thermo-evaporative (Schiff Air Blast) Stimuli [Day 29, 12 hours after product use has ceased]

   Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.

2. Tactile (Yeaple Probe) Stimuli [Day 29, 12 hours after product use has ceased]

   The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.

3. Visual Analogue Scale [Day 29, 12 hours after product use has ceased]

   Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male and female subjects aged 18 years and older.

• Willing and physically able to carry out all study procedures.

• Willing and able to give written informed consent and complete a medical history form.

• Have at least one hypersensitive tooth in two quadrants, which are anterior to the molars and demonstrate cervical dentine, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and Baseline and a tactile hypersensitivity score of 10-20 grams of force at baseline.

• Willing to comply with the oral hygiene and food and drink restrictions.

Exclusion Criteria:

• Subjects who have used anti sensitivity products in the 4 weeks prior to screening

• Subjects with an active oral ulcer (Aphthous ulcer), or have similar experience within past 1 month.

• Subjects who use a powered toothbrush at least 4 times a week to brush their teeth

• Subjects whose indicator teeth have abnormal oral pathology, for example:

• Extensive restorations.

• Observable caries.

• Observable cracked enamel.

• Leaking fillings or other restorations.

• Cracked Tooth Syndrome

• Suspected pulp pathology/abscess/pulpitis.

• Atypical facial pain

• Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition(s) that provide confusing symptoms to those of cervical dentine hypersensitivity.

• Currently undergoing dental treatment, including orthodontic treatment.

• Subjects who have had vital bleaching within 4 weeks of the screening visit

• Known allergies to any toothpaste ingredients, including the flavour components.

• Obvious physical disability reducing tooth brushing ability.

• Receiving concomitant medication/therapy that might affect dentine hypersensitivity, e.g. regular use of analgesics, anti-histamines, non-steroidal anti-inflammatory drug and selective serotonin reuptake inhibitor medication

• Severe gingivitis, periodontitis and/or marked tooth mobility.

• Gingival surgery in the previous six months.

• In the opinion of the investigator unable to comply fully with the trial requirements.

• Participation in other dental clinical trials in the previous 28 days

• Subjects who have participated in an dentinal hypersensitivity study within the previous 1 month.

• Diabetic (both Type 1 and Type 2)

• Medical condition(s) and/or regular use of any medication, which either could affect the scientific validity of the study or if the subject was to participate in the study could, affect their wellbeing.

• Smokers or e-cigarette use or those who have smoked/vaped in the previous 12 months

• Brushing < 10 times a week during the Run-In period (self-reported)

• Using <17g or > 53g of toothpaste in a two week period during the test phase

• The subject is an employee of Unilever or the site conducting the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Oral and Dental Science	Bristol		United Kingdom	BS1 2LY

Sponsors and Collaborators

• Unilever R&D
• University of Bristol

Investigators

• Principal Investigator: Nicola X West, Professor, University of Bristol

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 4, 2017

More Information

Publications

None provided.

• Responsible Party: Unilever R&D
• ClinicalTrials.gov Identifier: NCT03244618
• Other Study ID Numbers: ORL-SEN-2530
• First Posted: Aug 9, 2017
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity; Fluorides

Study Results

Participant Flow

Recruitment Details	Participants were recruited at a single center in Bristol, United Kingdom.
Pre-assignment Detail	Participants brushed for 4-6 weeks with fluoride toothpaste during run-in period between enrollment and randomization. 272 participants were enrolled out of which 263 were randomized. Reasons for participant not being randomized: Did not meet Baseline inclusion criteria (n=1) Withdrawal by subject (n=6) Lost to follow-up (n=2)

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Period Title: Overall Study
STARTED	132	131
Week 2	128	125
COMPLETED	125	122
NOT COMPLETED	7	9

Baseline Characteristics

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste	Total
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Total of all reporting groups
Overall Participants	132	131	263
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.4 (12.7)	37.4 (13.5)	35.9 (13.2)
Sex: Female, Male (Count of Participants)
Female	72 54.5%	71 54.2%	143 54.4%
Male	60 45.5%	60 45.8%	120 45.6%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	106 80.3%	104 79.4%	210 79.8%
Asian	13 9.8%	16 12.2%	29 11%
Black	10 7.6%	11 8.4%	21 8%
Other	3 2.3%	0 0%	3 1.1%
Region of Enrollment (participants) [Number]
United Kingdom	132 100%	131 100%	263 100%
Thermo-evaporative (Schiff air blast) stimuli (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.193 (0.336)	2.256 (0.336)	2.224 (0.337)

Outcome Measures

1. Primary Outcome

Title	Thermo-evaporative (Schiff Air Blast) Stimuli
Description	Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.
Time Frame	4-weeks of product use (Day 28)

Outcome Measure Data

Analysis Population Description

Analysis was based on all available data at week 4 from subjects who were randomised

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	2.188 (0.334)	2.246 (0.329)
Week 4	1.268 (0.723)	1.811 (0.624)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.544
	Confidence Interval	(2-Sided) 95%; -0.712 to -0.377
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.

2. Secondary Outcome

Title	Tactile (Yeaple Probe) Stimuli
Description	The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
Time Frame	4-weeks of product use (Day 28)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	17.5 (3.46)	16.6 (3.75)
Week 4	38.2 (14.4)	27.5 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.8
	Confidence Interval	(2-Sided) 95%; 7.5 to 14.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.

3. Secondary Outcome

Title	Visual Analogue Scale
Description	Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
Time Frame	4-weeks of product use (Day 28)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	48.1 (20.5)	49.9 (19.8)
Week 4	31.1 (22.8)	42.0 (22.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.0
	Confidence Interval	(2-Sided) 95%; -16.4 to -5.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.

4. Other Pre-specified Outcome

Title	Thermo-evaporative (Schiff Air Blast) Stimuli
Description	Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
Time Frame	Day 29, 12 hours after product use has ceased

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	2.188 (0.334)	2.246 (0.329)
Day 29, 12hr after last product use	1.044 (0.773)	1.713 (0.671)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.670
	Confidence Interval	(2-Sided) 95%; -0.850 to -0.489
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.

5. Other Pre-specified Outcome

Title	Tactile (Yeaple Probe) Stimuli
Description	The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
Time Frame	Day 29, 12 hours after product use has ceased

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	17.5 (3.46)	16.6 (3.75)
Day 29, 12hr after last product use	41.5 (14.2)	29.7 (11.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95%; 8.6 to 15.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste

6. Other Pre-specified Outcome

Title	Visual Analogue Scale
Description	Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
Time Frame	Day 29, 12 hours after product use has ceased

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CSSP Toothpaste	Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
Measure Participants	125	122
Baseline	48.1 (20.5)	49.9 (19.8)
Day 29, 12hr after last product use	27.2 (23.2)	38.1 (22.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSSP Toothpaste, Fluoride Toothpaste
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	ANOVA model had treatment and gender as factors.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-10.9
	Confidence Interval	(2-Sided) 95%; -16.6 to -5.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.

Adverse Events

Time Frame	From start of screening until final assessment visit (up to 61 days)
Adverse Event Reporting Description	Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.
Arm/Group Title	CSSP Toothpaste		Fluoride Toothpaste
Arm/Group Description	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.		Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
All Cause Mortality
	CSSP Toothpaste		Fluoride Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/131 (0%)
Serious Adverse Events
	CSSP Toothpaste		Fluoride Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/131 (0%)
Other (Not Including Serious) Adverse Events
	CSSP Toothpaste		Fluoride Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/132 (1.5%)		4/131 (3.1%)
Infections and infestations
Cold	1/132 (0.8%)	1	0/131 (0%)	0
Nervous system disorders
Headache	1/132 (0.8%)	1	4/131 (3.1%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.