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Meta-analysis of Stannous Fluoride and the Effects on Dental Plaque

NCT04006483 — Completed, 2359 participants, Procter and Gamble

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A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Dental Plaque

RegistryNCT04006483
StatusCompleted
Study typeObservational
Enrollment2359 (Actual)
SponsorProcter and Gamble (Industry)
ConditionsDental Plaque
InterventionsStannous fluoride dentifrice, Positive control dentifrice, Negative control dentifrice (Drug)
Datesstart 2018-01-08, primary completion 2018-11-30, completion 2018-11-30, first posted 2019-07-05, last updated 2023-11-18
Locations1 site in United States

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-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 dental plaque relative to a positive or negative control dentifrice.

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+Arms and interventions

ArmTypeInterventionsDescription
Stannous Fluoride DentifriceDrug: Stannous fluoride dentifriceTwice daily brushing
Positive control dentifriceDrug: Positive control dentifriceTwice daily brushing
Negative control dentifriceDrug: Negative control dentifriceTwice daily brushing
  • Stannous fluoride dentifrice (Drug): Stannous fluoride (0.454%) dentifrice
  • Positive control dentifrice (Drug): Positive control dentifrice containing (0.3%) triclosan.
  • Negative control dentifrice (Drug): Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

+Outcome measures

Primary outcomes

  • Dental Plaque Scores [Up to 12 weeks]: Change from baseline as measured by mean plaque score reduction from baseline (via Quigley-Hein, Turesky Modification Index or Rustogi Modification of the Navy Plaque index).

+Eligibility

Sex: All, ages: 18 Years to any

Subjects were excluded from this study for the following reasons;

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

+Locations (1)

FacilityCityCountryStatus
Multiple P&G Investigation Clinical SitesCincinnati, OhioUnited States

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