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A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride

2019-10-16 10:39:19 | BioPortfolio

Summary

The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.

Description

This will be a single-center, examiner-blinded, randomized, stratified, two-treatment parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. Eligible participants will be stratified based on gender and baseline mean whole mouth modified gingival index (MGI) score (Low: less than or equal to [<=] 2.00/High greater than [>]2.00) to ensure a balance in gingivitis across both treatment groups, and then randomized into one of two treatment groups. Treatment effect will be evaluated by comparing MGI , bleeding index and plaque index scores after 12 and 24 weeks use of a dentifrice containing 0.454% w/w stannous fluoride to a negative control dentifrice. During the 24 week treatment period, participants will apply a full ribbon of dentifrice to the head of a study toothbrush and brush their teeth in their usual manner at home for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.

Study Design

Conditions

Gingivitis

Intervention

Stannous fluoride, Sodium monofluorophosphate

Location

GSK Investigational Site
Fort Wayne
Indiana
United States
46825

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:19-0400

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Medical and Biotech [MESH] Definitions

Inorganic fluorides of tin. They include both stannic fluoride (tin tetrafluoride) and stannous fluoride (tin difluoride). The latter is used in the prevention of dental caries.

A source of inorganic fluoride which is used topically to prevent dental caries.

A sodium fluoride solution, paste or powder, which has been acidulated to pH 3 to 4 and buffered with a phosphate. It is used in the prevention of dental caries.

Calcium fluoride. Occurring in nature as the mineral fluorite or fluorspar. It is the primary source of fluorine and its compounds. Pure calcium fluoride is used as a catalyst in dehydration and dehydrogenation and is used to fluoridate drinking water. (From Merck Index, 11th ed)

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