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

Dental Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06406751
• Other study ID #: 202401429
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Prosthesis

Intervention

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 7 days. Afterward, subjects will return to the clinic for another sterile swab to be collected.

Locations

Country	Name	City	State
United States	University of Iowa College of Dentistry	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)