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Enzyme-containing lozenge

Verum Lozenges for Dental Plaque

N/A
Waitlist Available
Led By Jeffery L Milleman, DDS, MPA
Research Sponsored by Novozymes A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hour biofilm accumulation from baseline following dental prophylaxis (score of 0) to 24-hours
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hour biofilm accumulation from baseline following dental prophylaxis (score of 0) to 24-hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hour biofilm accumulation from baseline following dental prophylaxis (score of 0) to 24-hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
4-day biofilm accumulation in the absence of oral mechanical hygiene
Secondary outcome measures
24-hour biofilm accumulation in the absence of oral mechanical hygiene
Other outcome measures
Abundance of salivary and plaque S. mutans
Change in inflammatory markers from Baseline to Day 4
Post-product use questionnaire
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Verum LozengesActive Control1 Intervention
Active enzyme-containing lozenges to be consumed 5 times per day for 4 days
Group II: Identical Placebo LozengesPlacebo Group1 Intervention
Placebo lozenges to be consumed 5 times per day for 4 days

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Who is running the clinical trial?

Novozymes A/SLead Sponsor
12 Previous Clinical Trials
916 Total Patients Enrolled
2 Trials studying Dental Plaque
104 Patients Enrolled for Dental Plaque
Jeffery L Milleman, DDS, MPAPrincipal InvestigatorSalus Research Inc
5 Previous Clinical Trials
385 Total Patients Enrolled
1 Trials studying Dental Plaque
82 Patients Enrolled for Dental Plaque
~10 spots leftby Jun 2025
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