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

NCT06406751 | Enrolling By Invitation FDA Device

• 1 other identifier: 202401429
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

MI Paste Application for 14 days

EXPERIMENTAL

Subjects will apply 1 cubic centimeter of MI Paste for 14 days.

Device: MI Paste

Interventions

MI Paste DEVICE

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.

MI Paste Application for 14 days

Eligibility Criteria

• Age: 65 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• milk allergy

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Study Officials

• Robert Bowers, DDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)