Trial Outcomes & Findings for An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity (NCT NCT02476032)

Last Updated: 2017-10-23

Results Overview

An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model. Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity 0 Tooth/Patient did not respond to the air stimulus 1. Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus 2. Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus 3. Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline

Results posted on

2017-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Prof Applied Oxalate Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter \& Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Professionally applied Crest Sensi-Stop strips (Procter \& Gamble™): Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.	Self-applied Oxalate Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter \& Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied Crest Sensi-Stop strips (Procter \& Gamble™): Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.	Prof Applied Placebo Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter \& Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	19	19
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prof Applied Oxalate n=20 Participants Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter \& Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied oxalate: Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.	Self-applied Oxalate n=20 Participants Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter \& Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied oxalate: Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.	Prof Applied Placebo n=20 Participants Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter \& Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied placebo: Crest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.	Total n=60 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 16.1 • n=5 Participants	47.3 years STANDARD_DEVIATION 12.0 • n=7 Participants	40.3 years STANDARD_DEVIATION 15.4 • n=5 Participants	43.8 years STANDARD_DEVIATION 14.5 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized White	17 participants n=5 Participants	17 participants n=7 Participants	14 participants n=5 Participants	48 participants n=4 Participants
Race/Ethnicity, Customized African American	2 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	9 participants n=4 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	60 participants n=4 Participants
Schiff Air Scale	1.4 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.3 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	2.0 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.9 units on a scale STANDARD_DEVIATION 0.83 • n=4 Participants
Verbal Rating Scale	4.3 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	6.5 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	5.8 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	5.5 units on a scale STANDARD_DEVIATION 1.9 • n=4 Participants

PRIMARY outcome

Timeframe: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline

Outcome measures

Outcome measures
Measure	Prof Applied Oxalate n=20 Participants Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter \& Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Professionally applied Crest Sensi-Stop strips (Procter \& Gamble™): Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.	Self-applied Oxalate n=20 Participants Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter \& Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied Crest Sensi-Stop strips (Procter \& Gamble™): Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.	Prof Applied Placebo n=20 Participants Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter \& Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
Schiff Air Test: Mean Reduction in Sensitivity Between Groups 30 Minutes Post	-0.66 units on a scale Standard Error 0.23	-1.12 units on a scale Standard Error 0.23	-0.52 units on a scale Standard Error 0.22
Schiff Air Test: Mean Reduction in Sensitivity Between Groups 4 Weeks Post	-1.11 units on a scale Standard Error 0.26	-0.86 units on a scale Standard Error 0.26	-0.22 units on a scale Standard Error 0.24
Schiff Air Test: Mean Reduction in Sensitivity Between Groups 8 Weeks Post	-1.24 units on a scale Standard Error 0.26	-1.12 units on a scale Standard Error 0.26	-0.78 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline

Outcome measures

Outcome measures
Measure	Prof Applied Oxalate n=20 Participants Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter \& Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Professionally applied Crest Sensi-Stop strips (Procter \& Gamble™): Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.	Self-applied Oxalate n=20 Participants Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter \& Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied Crest Sensi-Stop strips (Procter \& Gamble™): Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.	Prof Applied Placebo n=20 Participants Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter \& Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment.
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups 30 Minutes Post	-1.27 units on a scale Standard Error 0.42	-1.85 units on a scale Standard Error 0.41	-0.83 units on a scale Standard Error 0.39
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups 4 Weeks Post	-2.22 units on a scale Standard Error 0.51	-1.34 units on a scale Standard Error 0.52	-0.20 units on a scale Standard Error 0.48
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups 8 Weeks Post	-2.26 units on a scale Standard Error 0.52	-1.66 units on a scale Standard Error 0.52	-1.33 units on a scale Standard Error 0.50

Adverse Events

Prof Applied Oxalate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-applied Oxalate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prof Applied Placebo

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

Patricia Lenton Director of Oral Health Research Clinic

University of Minnesota

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place