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

NCT02476032 | Completed Results

• 1 other identifier: 1503M65361
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter \& Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips (Procter \& Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter \& Gamble™) effectiveness when the product is placed by a dental professional compared to self-placement by the person with sensitive teeth. This product is not experimental.

Conditions

Tooth Sensitivity

Outcome Measures

Primary Outcomes (1)

• Schiff Air Test: Mean Reduction in Sensitivity Between Groups

  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

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

Secondary Outcomes (1)

• Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups

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

Study Arms (3)

Prof applied oxalate

EXPERIMENTAL

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.

Device: Prof applied oxalate

Self-applied oxalate

ACTIVE COMPARATOR

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.

Device: Self applied oxalate

Prof applied placebo

SHAM COMPARATOR

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.

Device: Prof applied placebo

Interventions

Prof applied oxalate DEVICE

Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.

Prof applied oxalate

Self applied oxalate DEVICE

Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.

Self-applied oxalate

Prof applied placebo DEVICE

Crest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.

Prof applied placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presents in good general health with no allergies to commercial dental products and are currently not using any desensitizing agents.
• If participants are using desensitizing agent the participant must agree to not use any desensitizing agents in the 4 weeks leading up to the baseline data collection appointment and during the following 8 week length of the study.
• Patients with a history of having used Sensi-Stop Strips (Procter \& Gamble™) in the past will not be eligible to participate because it will not be possible to maintain blindness to the treatment that they receive.
• Patients will also have at least the following baseline measurements:
• i. Schiff Air Scale = equal to or greater than 1
• ii. Verbal Rating Scale = equal to or greater than 1
• iii. Recession= 1mm or greater

You may not qualify if:

• Any dental pathology resulting in pain that could confound the study findings would render the patient ineligible: e.g. advanced dental decay, pulpitis, fractured teeth, fractured restorations, chipped teeth, cracked teeth, severe gingival inflammation, post-restorative sensitivity, marginal leakage, severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
• Also, if potential study subjects are not willing to agree to avoid the use of desensitizing and/or whitening products they will not be enrolled.
• Adults lacking in the ability to give consent will also be excluded.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Oral Health Research Clinic at the School of Dentistry at the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Patricia Lenton Director of Oral Health Research Clinic
• Organization: University of Minnesota

lento001@umn.edu

Study Officials

• Patricia A. Lenton, MA, CCRP

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 19, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 23, 2017
• Results First Posted: October 23, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)