N/A
N=60
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
Tooth Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02476032 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Schiff Air Test: Mean Reduction in Sensitivity Between Groups — -0.66; -1.12; -0.52; -1.11 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prof applied oxalate (Device); Self applied oxalate (Device); Prof applied placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Schiff Air Test: Mean Reduction in Sensitivity Between Groups |
-0.66; -1.12; -0.52; -1.11; -0.86; -0.22 | 0.05 |
| SECONDARY Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups |
-1.27; -1.85; -0.83; -2.22; -1.34; -0.20 | 0.05 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02476032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.