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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
a. A plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 12 hours plaque accumulation period.
Willing and able to comply with scheduled visits, treatment plan and other study procedures.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new participants in this research?

"According to the clinicaltrials.gov website, this clinical trial is currently seeking suitable candidates, with the initial posting on September 19th 2022 and an update as recent as October 13th 2022."

Answered by AI

How many individuals are contributing to the data collection of this research endeavor?

"Affirmative. According to the information made available on clinicaltrials.gov, this medical project is still seeking enrolment; it was initially published on September 19th 2022 and most recently modified in October 13th 2022. This research requires 28 volunteers from a single centre."

Answered by AI

What are the criteria for prospective candidates of this clinical trial?

"This clinical trial is currently recruiting 28 participants between the ages of 18 and 75, with dental plaque visible in their mouths. In order to be eligible, individuals must satisfy a range of criteria; they need to possess at least 20 natural teeth that can be examined by medical personnel, have literacy capabilities sufficient for signing informed consent forms, abstain from oral hygiene 8-12 hours prior to screening visits and all chewing gum over 4 day periods during the intervention, display a plaque index score higher than 1.95 following an 8-12 hour period without brushing or flossing their teeth as well as refrain from using any chemotherapeutic antipl"

Answered by AI

Is enrollment open to individuals below the age of forty for this experiment?

"This trial is open to individuals aged 18-75. In addition, there are 4 studies for minors and 9 trials specifically catering to seniors."

Answered by AI
~11 spots leftby Mar 2025