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 range18 Years – 75 Years
SexALL
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
✓. At the Screening Visit, subject presents with:
✓. 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.
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
✕. 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.