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

Tooth Sensitivity Clinical Trial

— SSDH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476032
• Other study ID #: 1503M65361
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: September 21, 2017
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Sensitivity

Intervention

Device:
• 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
Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
• Prof applied placebo
Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.

Locations

Country	Name	City	State
United States	Oral Health Research Clinic at the School of Dentistry at the University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus; Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus; 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	Verbal Rating Scale: 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.; 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	30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline