Recruiting

MIIP-E2

Sponsor:

Lactea Therapeutics, LLC

Code:

NCT06984744

Conditions

Dental Plaque Accumulation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

MIIP-E2 containing gum

placebo gum without MIIP-E2

Study Details

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 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

Dental Plaque Accumulation

Study ID

NCT06984744

Start date

Jun 23, 2025

Status verified date

May, 2025

Completion date

Feb 27, 2026

Anticipated

Primary completion date

Jan 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control regimen

Subjects will chew no gum during this regimen. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Subjects in the no intervention regimen will use no gum. Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

experimental: Intervention Experimental MIIP-E2 regimen

Gum will contain gum base with 30mg of compound being evaluated. Gum will contain gum base only without compound being evaluated. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

placebo comparator: Negative control regimen

Gum will contain gum base only without compound being evaluated. Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

Interventions

MIIP-E2 containing gum

Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit. MIIP-E2 is an ultrapure (>99%) fully native and completely active form of bovine lactoferrin purified directly from raw milk.

placebo gum without MIIP-E2

Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.

Primary outcome measure

  • dental plaque [ Time Frame: At the end of 4 days of intervention. ]

Central Contacts and Locations

Central contacts

Matthew Bender, PHD

12406565322matt@agrilogicsgroup.com

Lorena Galvez

3172748838logalvez@iu.edu

Locations

Oral Health Research Institute

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lorena Galvez

317-274-8838logalvez@iu.edu

More Information

Sponsor

Lactea Therapeutics, LLC

Last update posted

Aug 27, 2025

Last verified

May, 2025

Keywords

  • dental plaque
  • gum chewing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lactea Therapeutics, LLC on 2025-08-27.