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Trial record 21 of 32 for:    FLUORIDE ION AND NITRATE ION

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.
 
ClinicalTrials.gov Identifier: NCT04006470
Recruitment Status : Completed
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
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

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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.



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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04006470


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: NCT04006470     History of Changes
Other Study ID Numbers: 2019SnF2ErosionAnalysis
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 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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Fluorides
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs