A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Study Overview
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Brief Summary
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This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Official Title
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A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Potassium oxalate
* Drug: Sodium fluoride paste
* Drug: Stannous fluoride paste


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 confidentiality disclosure agreement Be in good general health as determined by the Investigator/designee Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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 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 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: oxalate liquid & gel plus SnF2 paste<br>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied | Device: Potassium oxalate<br>* Professionally applied (liquid) and self applied (gel)<br>Drug: Stannous fluoride paste<br>* Toothpaste used by subject<br>* Other names: SnF2 paste;|
| Other: oxalate liquid & gel plus NaF paste<br>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied | Device: Potassium oxalate<br>* Professionally applied (liquid) and self applied (gel)<br>Drug: Sodium fluoride paste<br>* Toothpaste used by subject<br>* Other names: NaF paste;|

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/subjects responds to stimulus and requests discontinuation or moves from 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. | 60 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. | 60 days | 

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