Trial Outcomes & Findings for A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen (NCT NCT02384044)

Last Updated: 2019-06-25

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. A negative change from Baseline score represents a decrease in sensitivity from baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

1 Day

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Crest® Sensi-Stop™ Strips Professionally Applied Crest® Sensi-Stop™ Strips	Colgate® Sensitivity Relief Pen Professionally Applied Colgate® Sensitivity Relief Pen
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Professionally Applied Crest® Sensi-Stop™ Strips	Colgate® Sensitivity Relief Pen n=15 Participants Professionally Applied Colgate® Sensitivity Relief Pen	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 7.97 • n=5 Participants	43.5 years STANDARD_DEVIATION 7.77 • n=7 Participants	43.4 years STANDARD_DEVIATION 7.73 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian Oriental	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

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

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Professionally Applied Crest® Sensi-Stop™ Strips	Colgate® Sensitivity Relief Pen n=15 Participants Professionally Applied Colgate® Sensitivity Relief Pen
Change From Baseline Visual Analog Scale	-22.933 Units on a scale Standard Deviation 19.252	-3.200 Units on a scale Standard Deviation 11.857

SECONDARY outcome

Timeframe: 1 Day

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

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.

Outcome measures

Outcome measures
Measure	Crest® Sensi-Stop™ Strips n=15 Participants Professionally Applied Crest® Sensi-Stop™ Strips	Colgate® Sensitivity Relief Pen n=15 Participants Professionally Applied Colgate® Sensitivity Relief Pen
Change From Baseline for Air Challenge	-0.800 Units on a scale Standard Deviation 0.561	0.000 Units on a scale Standard Deviation 0.378

Adverse Events

Crest® Sensi-Stop™ Strips

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Colgate® Sensitivity Relief Pen

Serious events: 0 serious events

Other events: 1 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=15 participants at risk Professionally Applied Crest® Sensi-Stop™ Strips	Colgate® Sensitivity Relief Pen n=15 participants at risk Professionally Applied Colgate® Sensitivity Relief Pen
Gastrointestinal disorders Cheilitis	0.00% 0/15	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Stomatitis	13.3% 2/15 • Number of events 2	0.00% 0/15

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