Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity

Study Overview
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Brief Summary
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The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.

Official Title
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Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion

Conditions
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Dentine Hypersensitivity

Intervention / Treatment
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* Drug: Stannous fluoride dentifrice
* Drug: Positive control dentifrice
* Drug: Negative control dentifrice


Participation Criteria
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Eligibility Criteria
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Subjects were excluded from this study for the following reasons; severe periodontitis at discretionary of the Principal Investigator

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stannous fluoride dentifrice<br>Twice daily brushing | Drug: Stannous fluoride dentifrice<br>* Stannous fluoride (0.454%) dentifrice<br>|
| Positive control dentifrice<br>Twice daily brushing | Drug: Positive control dentifrice<br>* Positive control dentifrice containing potassium nitrate or arginine.<br>|
| Negative control dentifrice<br>Twice daily brushing | Drug: Negative control dentifrice<br>* Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)<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 is assessed for each test tooth via an evaporative air challenge. The examiner records 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. | Up to 8 weeks | 
| Change from Baseline in Tactile Threshold | Tactile Threshold is measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and is recorded as the threshold on the Tactile Sensitivity Score form. | Up to 8 weeks |