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

Completed

• Conditions: Gingivitis
• Interventions: Drug: Positive control dentifrice; Drug: Negative control dentifrice; Drug: Stannous Fluoride Dentifrice

• Registration Number: NCT03970759
• Lead Sponsor: Procter and Gamble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Status Verified: 2019-06
• Study First Posted: 2019-06-03
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2890

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive Control Dentifrice	Positive control dentifrice	Twice daily brushing
Negative Control Dentifrice	Negative control dentifrice	Twice daily brushing
Stannous Fluoride Dentifrice	Stannous Fluoride Dentifrice	Twice daily brushing

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Sites	Up to 12 Weeks	Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).

Trial Locations

Locations (1)

Multiple P&G Investigation Clinical Sites; 🇺🇸 Cincinnati, Ohio, United States