NCT02937636

To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population

A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12 weeks use in a Chinese population.

Detailed description

This clinical study will be carried out in healthy adult volunteers with moderate gingivitis. Treatment effect will be determined by evaluating the efficacy, in a Chinese population, of a dentifrice containing 0.454% w/w stannous fluoride to control gingivitis and supra-gingival plaque following 6 and 12 weeks twice daily brushing, compared to a fluoride control dentifrice. During the 12 week treatment period, participant will brush with their allocated study product twice daily.

Conditions

• Gingivitis

Interventions

Type	Name	Description
OTHER	Stannous fluoride	Experimental dentifrice containing 0.454% w/w stannous fluoride \& 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride
OTHER	Sodium monofluorophosphate	Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride

Timeline

• Start date: 2017-09-19
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2016-10-18
• Last updated: 2019-06-14
• Results posted: 2019-06-14

Locations

1 site across 1 country: China