Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

Study Overview
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Brief Summary
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This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

Official Title
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A Clinical Study Comparing the Safety and Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Existing Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Potassium oxalate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent to participate in the study Be at least 18 years of age Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study Agree to refrain from participating in any other oral/dental product studies for the duration of the study Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study Agree to comply with study/product usage instructions; and Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening Exclusion Criteria: Gross oral neglect or urgent dental treatment needs Severe periodontal disease and/or generalized mobility Active treatment for periodontitis Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study Self-reported pregnancy or nursing

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: potassium oxalate gel<br>Professional application | Device: Potassium oxalate<br>* Professional application<br>|
| Active Comparator: Potassium oxalate liquid<br>Professional application | Device: Potassium oxalate<br>* Professional application<br>|

What is the study measuring?
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Primary 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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. | 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Dentin Sensitivity | 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. | 36 days | 

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