Effect of Enzymes on Dental Biofilm Accumulation (NCT05579938) | Clinical Trial Compass
CompletedNot Applicable
Effect of Enzymes on Dental Biofilm Accumulation
United States28 participantsStarted 2022-09-19
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Generally healthy males and females 18-75 years of age.
. Able to read, sign and receive a copy of the signed informed consent form.
. Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
. Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
. Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
4-day biofilm accumulation in the absence of oral mechanical hygiene
Timeframe: 4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4
. Willing and able to comply with scheduled visits, treatment plan and other study procedures.
. Willing to refrain from all oral hygiene (with the exception of lozenge consumption 5 times per day) for a 96-hour (4-day) period between Visits 2-4/Visits 5-7
Exclusion criteria
. A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
. Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
. Uncontrolled diabetes or hypertension.
. Health condition requirement for antibiotic premedication prior to dental procedures.
. Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
. Subject is a smoker or user of smokeless tobacco, nicotine containing products (including chewing gum, patches, pouches or mints).
. Subject has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
. Presence of moderate or severe periodontal disease (Stage II, III or IV), or actively under treatment for periodontal disease.