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:
- 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)
- 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)
- Change in IL-1-beta, IL-6, IL-8 and TNF-alpha from baseline to Day 4, based on electrochemiluminescence assay
- Post-product use questionnaire (developed by sponsor) after 4 days of product use
Source: View full study details on ClinicalTrials.gov
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