Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus
      a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no
      signs of periodontal disease or excessive recession to remove dental plaque after a single
      tooth brushing event. Prior to each treatment visit, participants will abstain from oral
      hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation.
      Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and
      1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque
      assessment will be carried out.
    

Detailed description: 
      This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial
      crossover study in healthy participants with no signs of periodontal disease or excessive
      recession, to assess a prototype PTB in removing dental plaque after a single brushing event.

      At the screening visit, following provision of written informed consent, participants will be
      provided PTB training to familiarize themselves with how the different modes and different
      PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and
      toothbrush for use at home during the study.

      Participants will then be scheduled to attend appointment after a minimum of 3 days. For each
      treatment visit, participants must abstain from oral hygiene for a period of 12hours,
      immediately preceding the pre-brushing dental plaque evaluation.

      All the participants will undergo an oral soft tissue (OST) examination followed by plaque
      disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque
      Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study
      treatment sequence with the prototype PTB and MTB used in a crossover manner and participants
      will then brush under supervision followed by disclosing and post-brushing plaque
      assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in
      'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode.

      Participants will then brush once (1.3 grams [g] ± 0.1 g of assigned toothpaste), under
      supervision of study staff after which 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 standard washout toothpaste
    

Intervention name(s): Reference MTB; Reference PTB; Prototype PTB (Gum line mode); Prototype PTB (Combined mode)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.; Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.; Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff.; Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oral Health, Dental care, Lifestyle