A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

Study Overview
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Brief Summary
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This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Crest® Sensi-Stop™ Strips
* Device: Colgate® Sensitivity Relief Pen


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 agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study agree to not participate in any other oral care study for the duration of this study agree to return for scheduled visits and follow all study procedures have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 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 a history of kidney stones self-reported pregnancy or nursing 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crest® Sensi-Stop™ Strips<br>Professionally Applied | Device: Crest® Sensi-Stop™ Strips<br> <br> |
| Active Comparator: Colgate® Sensitivity Relief Pen<br>Professionally Applied | Device: Colgate® Sensitivity Relief Pen<br> <br> |

What is the study measuring?
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Primary 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. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Air Challenge | The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air 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 | 

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