Trial Outcomes & Findings for A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity (NCT NCT02406573)

Last Updated: 2019-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Day 1

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Crest® Sensi-Stop™ Strips Professionally Applied Crest® Sensi-Stop™ Strips
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crest® Sensi-Stop™ Strips n=30 Participants Professionally Applied Crest® Sensi-Stop™ Strips
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 7.86 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian Oriental	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	24 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Thirty (30) subjects received study product and completed the study.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=30 Participants Professionally Applied Crest® Sensi-Stop™ Strips
Change From Baseline for Visual Analog Scale - Cold Water	-22.93 Units on a scale Standard Deviation 31.10

PRIMARY outcome

Timeframe: Day 1

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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=30 Participants Professionally Applied Crest® Sensi-Stop™ Strips
Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index	-0.17 Units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: Day 2

Population: Thirty (30) subjects received study product and completed the study.

Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=30 Participants Professionally Applied Crest® Sensi-Stop™ Strips
Change From Baseline for 5 Face Emoticon Scale	-1.07 Units on a scale Standard Deviation 1.53

Adverse Events

Crest® Sensi-Stop™ Strips

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Crest® Sensi-Stop™ Strips n=30 participants at risk Professionally Applied Crest® Sensi-Stop™ Strips
Gastrointestinal disorders Gingivitis	13.3% 4/30 • Number of events 4
Gastrointestinal disorders Mucous Mem Dis	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Cheilitis	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Stomatitis	3.3% 1/30 • Number of events 1

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