4-day test of an MIIP-E2 chewing gum to reduce dental plaque
Official title: Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model
Run by Lactea Therapeutics, LLC · NCT06984744 · Data updated 2026-11-12
This 4-day crossover test will try an MIIP-E2 chewing gum to see if it reduces plaque in healthy adults with at least 20 natural teeth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Lactea Therapeutics, LLC Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | January 30, 2026 |
| Study ends | February 27, 2026 |
| Registry record updated | August 27, 2025 |
| Trial ID | NCT06984744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18–65 with at least 20 natural teeth and a baseline plaque index score of 2 or greater who can comply with temporary restrictions on oral hygiene.
✕Probably not a fit
People with active oral disease, extensive restorations or orthodontic bands, significant systemic conditions or medications affecting oral health, or those unable to attend in-person visits are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-blind, single-center, randomized 3-way crossover trial enrolls 32 adults and compares three 4-day treatment periods: MIIP-E2 gum, an inactive (placebo) gum, and no gum. Each participant receives all three regimens in randomized sequence with approximately 10-day washout periods between treatment periods. Participants refrain from oral hygiene during each 4-day accumulation period and plaque is measured using a validated index. The trial is conducted at the Oral Health Research Institute in Indianapolis under oversight from Lactea Therapeutics with collaboration from Indiana University.
Why it matters
Potential benefit: If successful, the MIIP-E2 gum could reduce short-term plaque buildup and lower short-term risk factors for gingivitis.
How similar studies have gone: Previous plaque-accumulation models and chewing-gum interventions have shown modest plaque reductions, but MIIP-E2 itself is a novel compound with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Oral Health Research Institute
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Ana G Gossweiler, DDMSD — Oral Health Research Institute Indiana University
- Study coordinator: Matthew Bender, PHD
- Email: matt@agrilogicsgroup.com
- Phone: 12406565322
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.