Dentine Hypersensitivity Clinical Trial
Official title:
Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
Verified date | July 2019 |
Source | Procter and Gamble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1036 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Subjects were excluded from this study for the following reasons; - severe periodontitis - at discretionary of the Principal Investigator |
Country | Name | City | State |
---|---|---|---|
United States | Multiple P&G Investigation Clinical Sites | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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