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

Not Applicable

Completed

• Conditions: Tooth Sensitivity
• Interventions: Device: Prof applied placebo; Device: Prof applied oxalate; Device: Self applied oxalate

• Registration Number: NCT02476032
• Lead Sponsor: University of Minnesota

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.

Detailed Description

There are two groups in this research study: 1) The Self Applied group, and 2) the Professionally Applied group.

Once it is determined that interested individuals qualify to participate in the study and have determined that they want to participate, the group that participants are in will be determined. The study has been designed to ensure that 66% of the study participants receives strips that contain the active ingredient and 33% of the subjects receive strips without the active ingredient. This means that there is a 1 out of 3 chance that participants will be assigned to receive the strip(s) without the active desensitizing ingredient. At the end of your 8-week participation, if it turns out that participants received the strips without the active ingredient, they will be offered a sample pack with two strips that contain the active desensitizing ingredient for them to use at home.

Study Timeline

• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Study Start: 2015-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-06-15
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-21
• Last Update Submitted: 2017-09-21
• Results First Posted: 2017-10-23
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prof applied placebo	Prof applied placebo	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 oxalate	Prof applied oxalate	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.
Self-applied oxalate	Self applied oxalate	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.

Primary Outcome Measures

Name	Time	Method
Schiff Air Test: Mean Reduction in Sensitivity Between Groups	30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline	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

Secondary Outcome Measures

Name	Time	Method
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups	30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline	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.; Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain; 0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain

Trial Locations

Locations (1)

Oral Health Research Clinic at the School of Dentistry at the University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States