A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

Study Overview
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Brief Summary
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This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Potassium Oxalate
* Drug: Stannous fluoride paste
* Device: Manual toothbrush
* Device: Power toothbrush


Participation Criteria
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Eligibility Criteria
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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 photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs; be in good general health as determined by the Investigator/designee; and have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air 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; 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
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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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: oxalate liquid, SnF2 paste, manual toothbrush<br>Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush | Device: Potassium Oxalate<br>* Professionally applied liquid<br>Drug: Stannous fluoride paste<br>* SnF2 Paste<br>Device: Manual toothbrush<br>* Marketed manual toothbrush<br>|
| Other: oxalate liquid, SnF2 paste, power toothbrush<br>Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush | Device: Potassium Oxalate<br>* Professionally applied liquid<br>Drug: Stannous fluoride paste<br>* SnF2 Paste<br>Device: Power toothbrush<br>* Marketed power toothbrush<br>|

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. 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 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. | 30 days | 

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