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Effect of Enzymes on Dental Biofilm Accumulation

NCT05579938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-04-12

No results posted yet for this study

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

Conditions

  • Dental Plaque

Interventions

DIETARY_SUPPLEMENT

Enzyme-containing lozenge

A lozenge containing 3 active enzymes

DIETARY_SUPPLEMENT

Placebo lozenge

Identical placebo lozenge

Sponsors & Collaborators

  • Novozymes A/S

    lead INDUSTRY

Principal Investigators

  • Jeffery L Milleman, DDS, MPA · Salus Research Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2022-10-19
Completion
2022-11-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579938 on ClinicalTrials.gov