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

NCT06142409 | Completed

• 1 other identifier: NZ-2022-05
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 phases, one each for the investigation of in-vivo and in-situ grown dental biofilm

Conditions

Dental Biofilm Accumulation

Outcome Measures

Primary Outcomes (1)

• Change in in-vivo dental biofilm accumulation

  To investigate the effect of an enzyme-containing lozenge on dental biofilm accumulation in caries-active subjects in vivo assessed by the planimetric plaque index (PPI)

  1 day

Secondary Outcomes (3)

• Change in in-vivo dental biofilm accumulation

  1 days

• Change in in-situ grown dental biofilm accumulation

  2 days

• Change in oral microbial community composition of in-situ grown dental biofilm

  2 days

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Enzyme-containing lozenge

Dietary Supplement: Enzyme containing lozenge

Placebo arm

PLACEBO COMPARATOR

Placebo lozenge

Dietary Supplement: Enzyme containing lozenge

Interventions

Enzyme containing lozenge DIETARY_SUPPLEMENT

Lozenge containing multiple enzyme combination

Active arm; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novozymes A/S: lead
• University of Aarhus: collaborator

Study Sites (1)

Department of Dentistry and Oral Health, Aarhus University

Aarhus, DK-8000 Aarhus C, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 21, 2023
• Study Start: August 17, 2023
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)