Trial Outcomes & Findings for A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity (NCT NCT03405259)

Last Updated: 2019-06-17

Results Overview

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Within 5 minutes after treatment was applied

Results posted on

2019-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Super Seal® Desensitizer Professionally Applied Super Seal® Desensitizer: Single dose professional application.	Acclean® Fluoride Varnish Professionally Applied Acclean® Fluoride Varnish: Single dose professional application.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Super Seal® Desensitizer n=11 Participants Professionally Applied Super Seal® Desensitizer: Single dose professional application.	Acclean® Fluoride Varnish n=11 Participants Professionally Applied Acclean® Fluoride Varnish: Single dose professional application.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44.6 years STANDARD_DEVIATION 9.84 • n=93 Participants	48.1 years STANDARD_DEVIATION 19.71 • n=4 Participants	46.4 years STANDARD_DEVIATION 15.30 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian Oriental	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Black	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	11 participants n=93 Participants	11 participants n=4 Participants	22 participants n=27 Participants

PRIMARY outcome

Timeframe: Within 5 minutes after treatment was applied

Population: Twenty-two (22) subjects received study product and completed the study.

Outcome measures

Outcome measures
Measure	Super Seal® Desensitizer n=11 Participants Professionally Applied Super Seal® Desensitizer: Single dose professional application.	Acclean® Fluoride Varnish n=11 Participants Professionally Applied Acclean® Fluoride Varnish: Single dose professional application.
Change From Baseline Air Challenge	-0.55 Units on a scale Standard Deviation 0.69	-0.95 Units on a scale Standard Deviation 0.93

PRIMARY outcome

Timeframe: Within 5 minutes after treatment was applied

Population: Twenty-two (22) subjects received product and completed the study.

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.

Outcome measures

Outcome measures
Measure	Super Seal® Desensitizer n=11 Participants Professionally Applied Super Seal® Desensitizer: Single dose professional application.	Acclean® Fluoride Varnish n=11 Participants Professionally Applied Acclean® Fluoride Varnish: Single dose professional application.
Change From Baseline Visual Analog Scale	-17.60 Units on a scale Standard Deviation 21.32	-19.55 Units on a scale Standard Deviation 25.15

Adverse Events

Super Seal® Desensitizer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acclean® Fluoride Varnish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Manager

The Procter & Gamble Company

Phone: 513-622-2489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER