Clinical trial NCT02476032: An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
Official title: An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Sensitivity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Schiff Air Test: Mean Reduction in Sensitivity Between Groups
timeFrame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
Secondary outcomes:
measure: Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups
timeFrame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Patricia A. Lenton, MA, CCRP
role: PRINCIPAL_INVESTIGATOR
References: