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

June 13, 2019 updated by: Procter and Gamble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2890

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45040
        • Multiple P&G Investigation Clinical Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This meta-analysis includes healthy adult male and females with mild-moderate gingivitis.

Description

Subjects were excluded from this study for the following reasons;

  • pregnancy,
  • rampant caries,
  • severe periodontitis,
  • at discretionary of the Principal Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stannous Fluoride Dentifrice
Twice daily brushing
Drug: Stannous Fluoride Dentifrice
Experimental stannous fluoride (0.454%) dentifrice
Positive Control Dentifrice
Twice daily brushing
Drug: Positive control dentifrice
Positive control dentifrice containing (0.3%) triclosan.
Negative Control Dentifrice
Twice daily brushing
Drug: Negative control dentifrice
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Bleeding Sites
Time Frame: Up to 12 Weeks
Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).
Up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019SnF2GIAnalysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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