Ability of Four Toothpastes to Remove Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The aim of this study is to evaluate and compare the plaque removal efficacy of four
      experimental toothpastes following a single timed brushing. Prior to each treatment visit,
      participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs),
      immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush
      once under supervision for one timed minute with each dentifrice after which re-disclosing
      and a post-brushing plaque assessment will be carried out.
    

Detailed description: 
      This study will be a single centre, randomized, controlled, examiner blind, four treatment,
      four period crossover design. At the screening visit, following provision of written informed
      consent, eligible participants will be provided with a washout toothpaste and toothbrush for
      use at home during the study and for at least 14 days prior to the first treatment visit.

      Participants will then be scheduled to attend the first of four treatment visits a minimum of
      14 days later. For each treatment visit, participants must abstain from oral hygiene for a
      period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque
      evaluation. All the participants will undergo an oral soft tissue (OST) examination followed
      by disclosing and a dental plaque assessment.

      At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient
      amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment.
      Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under
      supervision of study staff for one timed minute, with one of the four test toothpastes after
      which re-disclosing and a post-brushing plaque assessment will be carried out. Participants
      will be allowed to brush with the washout paste following the post assessment plaque
      assessments.

      A minimum of three days washout period will follow each treatment period during which period
      Participants will brush with a commercial washout toothpaste. Participants will complete four
      treatment visits and will brush once with each of the four test toothpastes throughout the
      course of the study.
    

Intervention name(s): 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride; 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride; 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium; 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride; Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride; Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium; Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment