RECRUITING

4-day Plaque Accumulation Model Evaluating Compound Containing Gum

Description

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).

Conditions

Dental Plaque Accumulation
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Related Conditions:

Dental Plaque Accumulation

Study Overview

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Study Details

Study overview

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).

Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model

4-day Plaque Accumulation Model Evaluating Compound Containing Gum

Condition
Dental Plaque Accumulation
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Oral Health Research Institute, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lactea Therapeutics, LLC,

Ana G Gossweiler, DDMSD, PRINCIPAL_INVESTIGATOR, Oral Health Research Institute Indiana University

Study Record Dates

2026-02-27