4-day Plaque Accumulation Model Evaluating Compound Containing Gum
ConditionDental Plaque Accumulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLactea Therapeutics, LLC
About this trial
This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen).
Eligibility criteria
Qualifiers
Adult subjects between 18 and 65 years old
Willing to read and sign the IRB-approved informed consent.
Healthy, as determined by pertinent medical history at the study dentist's discretion.
A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
Disqualifiers
Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study.
Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect.
Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
Use of antibiotics 30 days prior to or during the study
Trial design
Treatments tested in this trial
- MIIP-E2 containing gum
- placebo gum without MIIP-E2
Treatment groups
32 Participants
are divided into 3 treatment groupsSponsors and collaborators
Lactea Therapeutics, LLC
Lead sponsor
Indiana University
Collaborator
Source ClinicalTrials.gov