Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
Condition: Extrinsic Dental Stain; Oral Hygiene
Study type: Interventional

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.
    

Intervention name(s): Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica; Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%); Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80; Stannous fluoride (SnF2, 0.454%), RDA~120
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single centre, randomised, examiner blind, parallel design study to evaluate the buildup of extrinsic dental stain over a 4 week treatment period
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental stain, stannous fluoride, dentifrice