Trial Outcomes & Findings for A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity (NCT NCT03244618)

NCT ID: NCT03244618

Last Updated: 2020-10-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 272 participants
• Primary outcome timeframe: 4-weeks of product use (Day 28)
• Results posted on: 2020-10-05

Participant Flow

Participants were recruited at a single center in Bristol, United Kingdom.

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)

Participant milestones

Measure	CSSP Toothpaste 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.	Fluoride Toothpaste 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.
Overall Study STARTED	132	131
Overall Study Week 2	128	125
Overall Study COMPLETED	125	122
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	CSSP Toothpaste 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.	Fluoride Toothpaste 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.
Overall Study Lost to Follow-up	3	4
Overall Study Protocol Violation	4	3
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CSSP Toothpaste n=132 Participants 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.	Fluoride Toothpaste n=131 Participants 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 n=263 Participants Total of all reporting groups
Age, Continuous	34.4 years STANDARD_DEVIATION 12.7 • n=5 Participants	37.4 years STANDARD_DEVIATION 13.5 • n=7 Participants	35.9 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	106 Participants n=5 Participants	104 Participants n=7 Participants	210 Participants n=5 Participants
Race/Ethnicity, Customized Asian	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United Kingdom	132 participants n=5 Participants	131 participants n=7 Participants	263 participants n=5 Participants
Thermo-evaporative (Schiff air blast) stimuli	2.193 units on a scale STANDARD_DEVIATION 0.336 • n=5 Participants	2.256 units on a scale STANDARD_DEVIATION 0.336 • n=7 Participants	2.224 units on a scale STANDARD_DEVIATION 0.337 • n=5 Participants

PRIMARY outcome

Timeframe: 4-weeks of product use (Day 28)

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

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.

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Thermo-evaporative (Schiff Air Blast) Stimuli Baseline	2.188 score on a scale Standard Deviation 0.334	2.246 score on a scale Standard Deviation 0.329
Thermo-evaporative (Schiff Air Blast) Stimuli Week 4	1.268 score on a scale Standard Deviation 0.723	1.811 score on a scale Standard Deviation 0.624

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Tactile (Yeaple Probe) Stimuli Baseline	17.5 score on a scale Standard Deviation 3.46	16.6 score on a scale Standard Deviation 3.75
Tactile (Yeaple Probe) Stimuli Week 4	38.2 score on a scale Standard Deviation 14.4	27.5 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Visual Analogue Scale Baseline	48.1 score on a scale Standard Deviation 20.5	49.9 score on a scale Standard Deviation 19.8
Visual Analogue Scale Week 4	31.1 score on a scale Standard Deviation 22.8	42.0 score on a scale Standard Deviation 22.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Thermo-evaporative (Schiff Air Blast) Stimuli Baseline	2.188 score on a scale Standard Deviation 0.334	2.246 score on a scale Standard Deviation 0.329
Thermo-evaporative (Schiff Air Blast) Stimuli Day 29, 12hr after last product use	1.044 score on a scale Standard Deviation 0.773	1.713 score on a scale Standard Deviation 0.671

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Tactile (Yeaple Probe) Stimuli Baseline	17.5 score on a scale Standard Deviation 3.46	16.6 score on a scale Standard Deviation 3.75
Tactile (Yeaple Probe) Stimuli Day 29, 12hr after last product use	41.5 score on a scale Standard Deviation 14.2	29.7 score on a scale Standard Deviation 11.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	CSSP Toothpaste n=125 Participants 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.	Fluoride Toothpaste n=122 Participants 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.
Visual Analogue Scale Baseline	48.1 score on a scale Standard Deviation 20.5	49.9 score on a scale Standard Deviation 19.8
Visual Analogue Scale Day 29, 12hr after last product use	27.2 score on a scale Standard Deviation 23.2	38.1 score on a scale Standard Deviation 22.7

Adverse Events

CSSP Toothpaste

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fluoride Toothpaste

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CSSP Toothpaste n=132 participants at risk 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.	Fluoride Toothpaste n=131 participants at risk 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.
Nervous system disorders Headache	0.76% 1/132 • Number of events 1 • From start of screening until final assessment visit (up to 61 days) Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.	3.1% 4/131 • Number of events 4 • From start of screening until final assessment visit (up to 61 days) Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.
Infections and infestations Cold	0.76% 1/132 • Number of events 1 • From start of screening until final assessment visit (up to 61 days) Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.	0.00% 0/131 • From start of screening until final assessment visit (up to 61 days) Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.

Additional Information

Dr Jane Matheson

Unilever

Phone: +44 (0)1516413633

Email: jane.matheson@unilever.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60