CompletedNot Applicable

Effect of Enzyme-containing Lozenge on Dental Biofilm Formation, Composition and Functionality

Denmark34 participantsStarted 2023-08-17

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females ≥ 18 years old. * Have three or more active carious lesions. * Anatomically possible to manufacture an intraoral lower-jaw splint. * Able to understand and follow instructions, as well as to read and sign the informed consent form. * A plaque index score ≥ 2 according to the Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI), following 8 to 12 hours plaque accumulation period. Exclusion Criteria: * History of allergies towards any of the ingredients in the test products * Self-reported pregnant or nursing * Antibiotic or anti-inflammatory medication within 90 days of the screening visit. * Orthodontic appliances, including retainers, or removable partial dentures. * Self-reported serious medical conditions

What they're measuring

Change in in-vivo dental biofilm accumulation

Timeframe: 1 day

Trial details

NCT IDNCT06142409

SponsorNovozymes A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-25

View on ClinicalTrials.gov More Dental Biofilm Accumulation trials