Working… Menu

Meta-analysis of Stannous Fluoride and the Effects on Enamel Erosion

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. Identifier: NCT04006470
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.

Condition or disease Intervention/treatment
Enamel Erosion Drug: Stannous fluoride dentifrice Drug: Positive control dentifrice Drug: Negative control dentifrice

Layout table for study information
Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
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 use
Drug: Stannous fluoride dentifrice
Stannous fluoride (0.454%) dentifrice

Positive control dentifrice
Twice daily use
Drug: Positive control dentifrice
Positive control dentifrice containing potassium nitrate or arginine.

Negative control dentifrice
Twice daily use
Drug: Negative control dentifrice
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Primary Outcome Measures :
  1. Change from Baseline Surface profilometry [ Time Frame: 10 days ]
    Enamel samples will be measured via profilometry after 10 days of study use.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

Inclusion Criteria:

  • healthy subjects

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 identifier (NCT number): NCT04006470

Layout table for location information
United States, Ohio
Multiple P&G Investigation Clinical Sites
Cincinnati, Ohio, United States, 45040
Sponsors and Collaborators
Procter and Gamble
Layout table for additonal information
Responsible Party: Procter and Gamble Identifier: NCT04006470    
Other Study ID Numbers: 2019SnF2ErosionAnalysis
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs