Effect of Enzymes on Dental Biofilm Accumulation
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation
      after 4-days in 28 subjects randomised to receive:

      Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week
      washout period followed by 5 identical placebo lozenges per day for 4-days or

      Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period
      followed by 5 identical active enzyme lozenges per day for 4-days
    

Detailed description: 
      28 healthy subjects (aged 18-75y) will be randomised to receive Sequence 1 or Sequence 2 in a
      double-blind, placebo-controlled cross-over study. Subjects will refrain from all mechanical
      oral hygiene over the course of each 4-day intervention period (e.g. no brushing, flossing,
      chewing gum) and will brush twice daily with a standard ADA accepted toothbrush and fluoride
      toothpaste during the 2-week washout period.

      Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week
      washout period followed by 5 id entical placebo lozenges per day for 4-days or

      Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period
      followed by 5 identical active enzyme lozenges per day for 4-days.

      The primary outcome measure is 4-day biofilm accumulation as assessed by the Lobene-Soparkar
      Modification of the Turesky Modification of the Quigley-Hein Plaque Index score from Baseline
      (following dental prophy and score of 0) to Day 4 in the absence of oral mechanical hygiene
      (e.g. brushing, flossing).

      The secondary outcome measure is 24-hour biofilm accumulation as assessed by the
      Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index
      score from Baseline (following dental prophy and score of 0) to Day 1 (approximately
      24-hours) in the absence of oral mechanical hygiene (e.g. brushing, flossing).

      Exploratory measures include:

        1. Shift in S. mutans relative abundance and richness (number of species) from baseline to
           Day 4 based on Next Generation Sequencing (alpha/beta diversity and individual Amplicon
           Sequence Variants [ASV] measured by 16S sequencing)

        2. Shift in detected oral bacterial species of interest from baseline to Day 4, based on
           Next Generation Sequencing (alpha/beta diversity and individual Amplicon Sequence
           Variants [ASV] measured by 16S sequencing)

        3. Change in IL-1-beta, IL-6, IL-8 and TNF-alpha from baseline to Day 4, based on
           electrochemiluminescence assay

        4. Post-product use questionnaire (developed by sponsor) after 4 days of product use
    

Intervention name(s): Enzyme-containing lozenge; Placebo lozenge
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A lozenge containing 3 active enzymes; Identical placebo lozenge
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Enzymes; Dental biofilm; Dental plaque