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Trial record 37 of 43 for:    FLUORIDE ION AND TRICLOSAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970759
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gingivitis Drug: Stannous Fluoride Dentifrice Drug: Positive control dentifrice Drug: Negative control dentifrice

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Study Type : Observational
Actual Enrollment : 2890 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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%)




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This meta-analysis includes healthy adult male and females with mild-moderate gingivitis.
Criteria

Subjects were excluded from this study for the following reasons;

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970759


Locations
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United States, Ohio
Multiple P&G Investigation Clinical Sites
Cincinnati, Ohio, United States, 45040
Sponsors and Collaborators
Procter and Gamble

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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT03970759     History of Changes
Other Study ID Numbers: 2019SnF2GIAnalysis
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs