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Completed

NCT Number: NCT03970759

Meta-analysis of Stannous Fluoride and the 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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple P&G Investigation Clinical Sites

Cincinnati, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Subjects were excluded from this study for the following reasons;

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

Treatment and study plan

Stannous Fluoride Dentifrice

Drug

Experimental stannous fluoride (0.454%) dentifrice

Positive control dentifrice

Drug

Positive control dentifrice containing (0.3%) triclosan.

Negative Control Dentifrice

Drug

Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 3, 2019
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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