A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Study Overview
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Brief Summary
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The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.

Official Title
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A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Conditions
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Dentinal Hypersensitivity

Intervention / Treatment
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* Device: Super Seal® Desensitizer
* Device: Acclean® Fluoride Varnish


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; be in good general health as determined by the Investigator/designee; and have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge. Exclusion Criteria: allergy to rosin or to pine nuts; self-reported pregnancy or nursing; severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; active treatment for periodontitis; fixed facial orthodontic appliances; 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 |
| --- | --- |
| Experimental: Super Seal® Desensitizer<br>Professionally Applied | Device: Super Seal® Desensitizer<br>* Single dose professional application.<br>|
| Sham Comparator: Acclean® Fluoride Varnish<br>Professionally Applied | Device: Acclean® Fluoride Varnish<br>* Single dose professional application.<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. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure. | Within 5 minutes after treatment was applied | 
| 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. A negative change from Baseline score represents a decrease in sensitivity from baseline. | Within 5 minutes after treatment was applied |