NCT03160703

Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices

A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.

Detailed description

This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be used to evaluate and compare the stain buildup of two 0.454% SnF2/ 5% STP dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice. Stain will be assessed following a full professional dental prophylaxis, at intervals over a 4 week treatment period, using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Participants will be stratified by pre-prophylaxis MLSI score (total MLSI Area x Intensity (A×I) for the facial surfaces of the 12 anterior teeth) and smoking status. The study will be conducted in healthy participants with a propensity for extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the anterior teeth.

Conditions

• Extrinsic Dental Stain
• Oral Hygiene

Interventions

Type	Name	Description
OTHER	Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica	Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica (RDA\~58) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
OTHER	Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%)	Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica (RDA\~77) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
OTHER	Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80	Participants will apply a full brush head of their dentifrice containing 1000 ppm fluoride as SMFP with moderate abrasivity (RDA\~80) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
OTHER	Stannous fluoride (SnF2, 0.454%), RDA~120	Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 with higher abrasivity (RDA\~120) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.

Timeline

• Start date: 2017-07-10
• Primary completion: 2017-08-25
• Completion: 2017-08-25
• First posted: 2017-05-19
• Last updated: 2019-06-04
• Results posted: 2019-01-17

Locations

1 site across 1 country: Canada