Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

Study Overview
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Brief Summary
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This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Oxalate Salt Solution


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, 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 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: 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 orthodontic appliances

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxalate Salt Solution<br>Professionally applied | Device: Oxalate Salt Solution<br>* Applied by dentist<br>|
| No Intervention: No Treatment<br>No Treatment | |

What is the study measuring?
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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. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure. | 10 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Yeaple Probe | 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. | 10 Minutes |