A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices
Condition: Oral Hygiene
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether spherical silica can achieve similar or
      greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing
      higher concentrations of standard abrasive silica, and how the addition of 5% sodium
      tripolyphosphate (STP) enhances cleaning capability.
    

Detailed description: 
      This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm,
      parallel design study will be conducted in healthy participants with a propensity for
      extrinsic dental stain (based on the judgement of the examiner) on the facial surfaces of the
      anterior teeth. This study will be used to evaluate and compare the extrinsic dental stain
      and plaque removal of an experimental low abrasivity 0.5% spherical silica dentifrice and a
      marketed low abrasivity 6% standard silica abrasive dentifrice, and an experimental moderate
      abrasivity 1% spherical silica / 5% STP dentifrice and a marketed high abrasivity 16%
      standard abrasive silica / 5% STP dentifrice. Stain will be assessed using an established
      clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain
      index (MLSI). Particpants will be stratified by baseline MLSI score (total MLSI (area [A] ×
      intensity [I]) for the facial surfaces of the 4 anterior assessment teeth). Plaque will be
      assessed using an established clinical measure of plaque - the Turesky Modification of the
      Quigley Hein Index. Stain and plaque will be assessed at intervals over an 8 week treatment
      period. Plaque will be assessed at baseline and Week 8 only.
    

Intervention name(s): 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica; 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP; 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica; 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).; Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment