Dental Biofilm Accumulation Clinical Trial
Official title:
The Effect of Non-biocidal Adjuncts on the Formation, Composition, Functionality, and Microscale Architecture of Dental Biofilms: a Randomized Controlled Trial
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation. The study includes two phases, one each for the investigation of in-vivo and in-situ grown dental biofilm
Up to 50 subjects (aged ≥ 18 years old) with 3 or more active caries lesion, will be randomized to receive: Phase 1: The effect of multiple-enzyme treatment on plaque accumulation in vivo Phase 1 includes two experimental periods lasting for one day each, with a washout period of two weeks in between. Each experimental period will include two visits, at day 0 and day 1. At day 0, the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design: Sequence 1: 3 active enzyme-containing lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical placebo lozenges per day for one day (app. 24h). Sequence 2: 3 placebo lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical active enzyme lozenges per day for one day (app. 24h). The participants will be instructed to take one lozenge three times (morning, noon, evening) for one day. No normal oral hygiene procedures will be allowed during the intervention periods of one day. At the end of both experimental phases, plaque is assessed using planimetric recordings obtained with an intraoral camera and TM-QHPI to provide information on the individual level of plaque formation. Phase 2: The effect of multiple-enzyme treatment on in situ-grown biofilms The phase is designed in a double-blind randomized cross-over design, including two experimental periods lasting for 2 days, with a washout period of 5 days in between. Each experimental period will include two visits, on day 0 and day 2. Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 48 hours. The glass slabs will be mounted on the individual lower-jaw splints. At day 0, the participants will be randomized to receive Sequence 1 or Sequence 2: Sequence 1: 3 active enzyme-containing lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical placebo lozenges per day for 2 days. Sequence 2: 3 placebo lozenges per day for 2 days followed by a washout period of 5 days, followed by 3 identical active enzyme lozenges per day for 2 days. Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 2-4 experimental periods of 48 hours. After each experimental period, the in situ-grown biofilms will be collected and stored in a research biobank. ;