A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

Study Overview
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Brief Summary
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This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.

Official Title
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A Pilot Clinical Study to Evaluate the Safety and Efficacy of a Self-Applied Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Crest® Sensi-Stop™ Strips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years of age sign an informed consent form and be given a copy be in good general health as determined by the Investigator/designee have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the cold water challenge. Exclusion Criteria: severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession active treatment for periodontitis any diseases or conditions that might interfere with the subject safely completing the study inability to undergo study procedures fixed facial orthodontic appliances self-reported pregnancy or nursing a history of kidney stones known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crest® Sensi-Stop™ Strips<br>Self Applied | Device: Crest® Sensi-Stop™ Strips<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Cold Water Challenge | The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Visual Analog Scale | Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensitivity