4-day Plaque Accumulation Model Evaluating Compound Containing Gum
United States32 participantsStarted 2025-06-23
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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)
* PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
* Willing to comply with the study procedures.
Exclusion Criteria:
* 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
* Requiring the need for antibiotic premedication prior to dental procedures
* Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
* Orthodontic appliances or any removable, except lingual bar retainers
* Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
* Self-reported alle…