4-day Plaque Accumulation Model Evaluating Compound Containing Gum

NARecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

January 30, 2026

Study Completion Date

February 27, 2026

Conditions
Dental Plaque Accumulation
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

46202

RECRUITING

Oral Health Research Institute, Indianapolis

Sponsors
All Listed Sponsors
collaborator

Indiana University

OTHER

collaborator

Oral Health Research Institute, Indiana University School of Dentistry

UNKNOWN

lead

Lactea Therapeutics, LLC

INDUSTRY

NCT06984744 - 4-day Plaque Accumulation Model Evaluating Compound Containing Gum | Biotech Hunter | Biotech Hunter