RECRUITING

4-day Plaque Accumulation Model Evaluating Compound Containing Gum

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-06-23
Study Completion:2026-02-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06984744

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult subjects between 18 and 65 years old
  2. * Willing to read and sign the IRB-approved informed consent.
  3. * Healthy, as determined by pertinent medical history at the study dentist's discretion.
  4. * 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)
  5. * 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.
  6. * Willing to comply with the study procedures.
  1. * 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.
  2. * Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect.
  3. * Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
  4. * Use of antibiotics 30 days prior to or during the study
  5. * Requiring the need for antibiotic premedication prior to dental procedures
  6. * Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
  7. * Orthodontic appliances or any removable, except lingual bar retainers
  8. * Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
  9. * Self-reported allergy to disclosing solution ingredients (red dye #28)
  10. * Acute Temporomandibular Disorders (TMD)
  11. * Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening.
  12. * Subject who has previously been randomized in this study
  13. * An employee of the study site directly involved with the study

Contacts and Locations

Study Contact

Matthew Bender, PHD
CONTACT
12406565322
matt@agrilogicsgroup.com
Lorena Galvez
CONTACT
3172748838
logalvez@iu.edu

Principal Investigator

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

Study Locations (Sites)

Oral Health Research Institute
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Lactea Therapeutics, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2026-02-27

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2026-02-27

Terms related to this study

Keywords Provided by Researchers

  • dental plaque
  • gum chewing

Additional Relevant MeSH Terms

  • Dental Plaque Accumulation