The Efficacy of a Toothpaste to Reduce Sensitivity

Study Overview
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Brief Summary
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Hypersensitivity

Official Title
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The Efficacy of a Toothpaste to Reduce Sensitivity

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Drug: Triclosan, Silicon dioxide, fluoride
* Drug: Triclosan, fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects, ages: 12 years or older. Availability for the eight-week duration of the study. Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force. Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study. Good general health with no known allergies to products being tested. Use of a non-desensitizing dentifrice for one month prior to entry into the study. Signed Informed Consent Form. Exclusion Criteria: Gross oral pathology, chronic disease, or history of allergy to test products. Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. Sensitive teeth with a mobility greater than one. Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics. Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month. Current participation in any other clinical study. Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients. Medical condition which prohibits not eating/drinking for 4 hours.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 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: A<br>sensitive toothpaste | Drug: Triclosan, Silicon dioxide, fluoride<br>* Brush twice daily<br>|
| Active Comparator: B<br>Triclosan control toothpaste | Drug: Triclosan, fluoride<br>* Brush twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity Tactile(Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | 4 weeks | 
| Hypersensitivity Tactile (Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air Blast Hypersensitivity (4 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. | 4 weeks | 
| Air Blast Hypersensitivity (8 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. | 8 weeks |