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4-day Plaque Accumulation Model Evaluating Compound Containing Gum

Lactea Therapeutics, LLC · with Indiana University · NCT06984744

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
32
US sites recruiting
1
Study start
June 23, 2025
Record last updated
August 27, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: MIIP-E2 containing gum; placebo gum without MIIP-E2

Conditions: Dental Plaque Accumulation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Oral Health Research Institute

    Indianapolis, IN 46202

    Site contact: Lorena Galvez · 317-274-8838 · logalvez@iu.edu

Study contacts (from the official record)

  • Matthew Bender, PHD · 12406565322 · matt@agrilogicsgroup.com
  • Lorena Galvez · 3172748838 · logalvez@iu.edu
All healthy volunteers studies in Indiana →
4-day Plaque Accumulation Model Evaluating Compound Containing Gum (NCT06984744) | Bored Studies