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CompletedNCT04006470Updated Jul 5, 2019

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

An observational study in Enamel Erosion, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Procter and Gamble · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
172
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Enamel Erosion
03

In context

Lead sponsor

Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This meta-analysis includes healthy adult male and females.

Eligibility criteria

Inclusion Criteria:

  • healthy subjects
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
172 participants (actual)
Patient registry
No

Groups and cohorts

  • Stannous Fluoride Dentifrice

    Twice daily use

    Drug: Stannous fluoride dentifrice

  • Positive control dentifrice

    Twice daily use

    Drug: Positive control dentifrice

  • Negative control dentifrice

    Twice daily use

    Drug: Negative control dentifrice

Interventions

  • DrugStannous fluoride dentifrice

    Stannous fluoride (0.454%) dentifrice

  • DrugPositive control dentifrice

    Positive control dentifrice containing potassium nitrate or arginine.

  • DrugNegative control dentifrice

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

06

What researchers measure

Primary outcomes

  1. Change from Baseline Surface profilometry

    Enamel samples will be measured via profilometry after 10 days of study use.

    Time frame: 10 days

07

Study locations

1 site
  • Multiple P&G Investigation Clinical Sites
    Cincinnati, Ohio 45040, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04006470
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
Jan 8, 2018
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Jul 5, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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