Meta-analysis of Stannous Fluoride and the Effects on Gingival Health

Gingivitis Clinical Trial

Official title:

A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970759
• Other study ID #: 2019SnF2GIAnalysis
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• 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 gingivitis relative to a positive or negative control dentifrice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2890
• 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;

• pregnancy,

• rampant caries,

• severe periodontitis,

• at discretionary of the Principal Investigator.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Stannous Fluoride Dentifrice
Experimental 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	Number of Bleeding Sites	Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).	Up to 12 Weeks