Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity (NCT NCT02293044)

Last Updated: 2019-06-25

Results Overview

The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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

15 participants

Primary outcome timeframe

1 Day

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Crest® Sensi-Stop™ Strips Self Applied Crest® Sensi-Stop™ Strips
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Self Applied Crest® Sensi-Stop™ Strips
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.9 years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	12 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: Fifteen (15) subjects received study products. Fifteen (15) subjects completed the study.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Self Applied Crest® Sensi-Stop™ Strips
Change From Baseline Cold Water Challenge	-1.00 Units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: 1 Day

Population: Fifteen (15) subjects received study products. Fifteen (15) subjects 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. The mean change from Baseline was calculated for this measure.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Self Applied Crest® Sensi-Stop™ Strips
Change From Baseline Visual Analog Scale	-18.00 Units on a scale Standard Deviation 13.61

Adverse Events

Crest® Sensi-Stop™ Strips

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