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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
220
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.
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.
GSK Investigational Site
Mississauga, Ontario, Canada
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Baseline and Week 4
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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.
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.