Status:
RECRUITING
4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Lead Sponsor:
Lactea Therapeutics, LLC
Collaborating Sponsors:
Indiana University
Oral Health Research Institute, Indiana University School of Dentistry
Conditions:
Dental Plaque Accumulation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 d...
Detailed Description
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06984744
Start Date
June 23 2025
End Date
February 27 2026
Last Update
August 27 2025
Active Locations (1)
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1
Oral Health Research Institute
Indianapolis, Indiana, United States, 46202