Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers

The purpose of this study is to determine if MI Paste affects the bacteria and fungus present within the mouth, as well as to determine if MI Paste increases denture comfort and retention. MI Paste is a water-based topical dental product that is available without a prescription. It is generally used to treat dental/tooth hypersensitivity (sensitive teeth) in patients and/or to help re-mineralize the tooth enamel in patients. Within this study, there is an off-label use for research subjects to apply above the upper denture.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Prosthesis
• Intervention / Treatment: Device: MI Paste

Detailed Description

Potentially-eligible subjects will be invited to the research study that involves consenting and 4 in-person visits (Screening Visit, Visit 1, Visit 2, Visit 3) where the following will be performed at each visit: (i) upper denture/mouth tissues swab sample collected, (ii) survey questions being administered, and (iii) brief oral dental exam (clinical assessment). Furthermore, at Visit 2, subjects will be provided and instructed on how to use MI Paste under their removable upper denture for 14 days and instructed to monitor symptoms of comfort, retention, and dry mouth (if applicable).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Greater than or equal to 65 years of age,
• Capacity to independently provide consent,
• Having an adequately fitting removable complete maxillary (upper jaw) denture (no consideration relative to the presence or type of mandibular prosthesis (lower jaw partial or full denture).

Exclusion Criteria:

• ill-fitting complete denture(s),
• presence of pathology indicated for immediate treatment (epulis fissuratum (excess folds of firm tissue form inside the mouth, as a result of rubbing on the edge of dentures that do not fit well), large denture sores),
• currently or previously taking any form of antibiotics or antifungals (oral, intravenous, mouthwashes) over the previous two months that may impact microbial assessments.
• a history of food-based allergies: casein, lactose, or food/cosmetic ingredient preservatives. These exclusions have been made out of an abundance of caution to avoid any potential adverse reaction to MI Paste which contains casein phosphopeptide--amorphous calcium phosphate (CPP-ACP), and several common preservative ingredients in oral care products that may induce sensitivities/allergic reaction in a small portion of the population.
• milk allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MI Paste Application for 14 days; Subjects will apply 1 cubic centimeter of MI Paste for 14 days.

Device: MI Paste; Sterile swabs will be used to collect plaque from under the subject's upper denture (when the denture is removed) and the subject's mouth tissues. This will be used for genomic DNA, bacteria analysis, and fungus analysis. Subjects will also apply 1 cubic centimeter of MI Paste to the fitting surface on a daily basis for 14 days. Afterward, subjects will return to the clinic for another sterile swab to be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in the oral microbiome composition over time	16S genomic profiling will be done in all recruited subjects via oral swab from under the denture and mouth tissues.	Multiple time points (baseline, two weeks, and four weeks)

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Robert Bowers, DDS, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202401429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No