Status:
COMPLETED
Effect of Enzyme-containing Lozenge on Dental Biofilm Formation, Composition and Functionality
Lead Sponsor:
Novozymes A/S
Collaborating Sponsors:
University of Aarhus
Conditions:
Dental Biofilm Accumulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 phase...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06142409
Start Date
August 17 2023
End Date
February 25 2024
Last Update
January 3 2025
Active Locations (1)
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1
Department of Dentistry and Oral Health, Aarhus University
Aarhus, Denmark, DK-8000 Aarhus C