4-day test of an MIIP-E2 chewing gum to reduce dental plaque
Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Lactea Therapeutics, LLC Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06984744 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.