Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.

Conditions
-----------------
Dentin Sensitivity

Intervention / Treatment
-----------------
* Device: Potassium Oxalate
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be at least 18 years of age; provide written informed consent prior to participation and be given a signed copy of the informed consent form; complete a confidentiality disclosure agreement; be in good general health as determined by the Investigator/designee; agree not to participate in any other oral/dental product studies during the course of this study; agree to delay any dentistry (including dental prophylaxis) until the study has been completed; agree to refrain from the use of any non-study oral hygiene products; agree to return for all scheduled visits and follow study procedures; and. have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge Exclusion Criteria: self-reported pregnancy or nursing; severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; active treatment of periodontitis; fixed facial orthodontic appliances; 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 any diseases or conditions that might interfere with the safe completion of the study; or an inability to undergo any study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potassium Oxalate Gel<br>Self Applied | Device: Potassium Oxalate<br> <br> |
| Other: Water<br>Self Applied | Other: Water<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline 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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tactile Threshold | Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure. | 30 days | 

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