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NCT04006483 Clinical Trial

Meta-analysis of Stannous Fluoride and the Effects on Dental Plaque

Dental Plaque Clinical Trial

Official title:
A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Dental Plaque

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04006483
Other study ID # 2019SnF2PlaqueAnalysis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2018
Est. completion date November 30, 2018

Study information
Verified date November 2023
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on dental plaque relative to a positive or negative control dentifrice.

Recruitment information / eligibility
Status Completed
Enrollment 2359
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Subjects were excluded from this study for the following reasons; - pregnancy, - rampant caries, - severe periodontitis, - at discretionary of the Principal Investigator.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stannous fluoride dentifrice
Stannous fluoride (0.454%) dentifrice
• Positive control dentifrice
Positive control dentifrice containing (0.3%) triclosan.
• Negative control dentifrice
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Locations
Country Name City State
United States Multiple P&G Investigation Clinical Sites Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dental Plaque Scores Change from baseline as measured by mean plaque score reduction from baseline (via Quigley-Hein, Turesky Modification Index or Rustogi Modification of the Navy Plaque index). Up to 12 weeks
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