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

July 1, 2019 updated by: Procter and Gamble

Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

172

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.

Description

Inclusion Criteria:

  • healthy subjects

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 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Surface profilometry
Time Frame: 10 days
Enamel samples will be measured via profilometry after 10 days of study use.
10 days

Collaborators and Investigators

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

Sponsor

Procter and Gamble

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

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019SnF2ErosionAnalysis

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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