Actively Recruiting
4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Led by Lactea Therapeutics, LLC · Updated on 2025-08-27
32
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
L
Lactea Therapeutics, LLC
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects between 18 and 65 years old
- Willing to read and sign the IRB-approved informed consent
- Healthy as determined by medical history and dentist's assessment
- At least 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth
- Plaque Index (PLI) score of 2 or greater based on the Turesky modification of the Quigley and Hein Plaque Index
- Willing to comply with all study procedures
You will not qualify if you...
- Any acute or chronic condition, organ system disease, or medication that may affect study participation
- Gross oral pathologies including caries, calculus, or chronic soft tissue conditions
- Acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
- Use of antibiotics within 30 days before or during the study
- Need for antibiotic premedication before dental procedures
- Sensitivity to bovine products (lactoferrin) or any inactive ingredients
- Orthodontic appliances or removable devices except lingual bar retainers
- Pregnant, planning pregnancy, or breastfeeding females
- Allergy to disclosing solution ingredients (red dye #28)
- Acute Temporomandibular Disorders (TMD)
- Participation in other studies involving products within 30 days before screening
- Previous participation in this study
- Employment at the study site with direct involvement in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oral Health Research Institute
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Matthew Bender, PHD
CONTACT
L
Lorena Galvez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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