Effect of Enzymes on Dental Biofilm Accumulation

Dental Plaque Clinical Trial

Official title: A Randomised, Double-blind Clinical Trial to Determine the Effect of a Lozenge Containing Enzymes on Dental Biofilm Accumulation in Healthy Adults Using a 4-day Plaque Regrowth Model.

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Dental Plaque

• NCT number: NCT05579938
• Study type: Interventional
• Source: Novozymes A/S
• Status: Completed
• Phase: N/A
• Start date: September 19, 2022
• Completion date: November 20, 2022