NCT06984744

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

August 27, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 14, 2025

Last Update Submit

August 26, 2025

Conditions

Dental Plaque Accumulation

Keywords

dental plaquegum chewing

Outcome Measures

Primary Outcomes (1)

  • dental plaque

    Dental plaque was identified using a disclosing solution and scored using the Turesky modification of the Quigley-Hein Plaque Index (PLI). The index score was scored between 0 and 5, with 0 = no plaque detected and 5= = Plaque covering 2/3 or more of the tooth's crown. The remaining values are based on the amount of plaque covering the tooth. The higher the score, the more plaque accumulated and the worse the outcome for the surface. Each tooth, except the third molars, will be scored at six sites: Mesio-Buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual. The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined. A score would range from 0.1 to 3.0 (0.1-1.0= = mild inflammation; 1.1-2.0= = moderate inflammation; and 2.1-3.0= = severe inflammation).

    At the end of 4 days of intervention.

Secondary Outcomes (2)

  • 16S sequencing

    At the end of 4 days of intervention.

  • Dental Plaque Visual Assessment with photographs

    At the end of 4 days of intervention.

Study Arms (3)

Control regimen

NO INTERVENTION

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.

Intervention Experimental MIIP-E2 regimen

EXPERIMENTAL

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.

Device: MIIP-E2 containing gum

Negative control regimen

PLACEBO COMPARATOR

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.

Device: placebo gum without MIIP-E2

Interventions

MIIP-E2 containing gumDEVICE

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.

Intervention Experimental MIIP-E2 regimen
placebo gum without MIIP-E2DEVICE

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.

Negative control regimen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (24)

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    PMID: 10828502RESULT

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    PMID: 36712548RESULT

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    PMID: 22101278RESULT

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    PMID: 8636452RESULT

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MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Ana G Gossweiler, DDMSD

    Oral Health Research Institute Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Bender, PHD

CONTACT

12406565322matt@agrilogicsgroup.com

Lorena Galvez

CONTACT

3172748838logalvez@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The clinical examiners will remain blind to the individual subjects' treatment group during the study. If the treatment assignment must be unblinded for a subject, such as in the case of an emergency, the Principal Investigator will provide written documentation of the unblinding request. Otherwise, blinding will not be broken, unless required in the circumstances detailed above, until all subjects have completed the final study visit and the database has been monitored, locked, and approved by the Principal Investigator.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Subjects who previously participated in other Oral Health Research Institute studies (OHRI) or who have contacted OHRI expressing interest in potential studies will be contacted by a team member who will conduct a screening phone interview. If the potential subjects appear to qualify, they will be scheduled for the screening visit. A sufficient number of subjects will be screened to participate, and 32 will be randomized to finish with at least 30 subjects. We intend to randomize a nearly equal number of female and male subjects. A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned according to appearance at the study site. Subjects who meet all inclusion and exclusion criteria will be randomized into the study. Block randomization will be used to assign subjects to one of the three treatment regimen sequences: 1\. Control regimen (Tx 3) followed by experimental regimen (Tx 1), followed by a negative control (Tx 2), or
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

June 23, 2025

Primary Completion

January 30, 2026

Study Completion

February 27, 2026

Last Updated

August 27, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)