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4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model
Who can join
Ages 18 to 65 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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 allergy to disclosing solution ingredients (red dye #28) * Acute Temporomandibular Disorders (TMD) * Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening. * Subject who has previously been randomized in this study * An employee of the study site directly involved with the study
About the study
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).
What is being tested
- MIIP-E2 containing gum (device)
- placebo gum without MIIP-E2 (device)
Sponsor: Lactea Therapeutics, LLC · Participants: 32 · Started: Jun 23, 2025
Contact the study team
- Matthew Bender, PHD · Phone: 12406565322
- Lorena Galvez · Phone: 3172748838
Official record on ClinicalTrials.gov — NCT06984744
Locations in the U.S.
| Indiana | Oral Health Research Institute, Indianapolis |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.