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

Conditions

• Dental Prosthesis

Eligibility Criteria

Sex

ALL

Age

65 Years - 105 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Aug 28, 2024

Status verified

Nov 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Assessment of changes in the oral microbiome composition over time [ Time Frame: Multiple time points (baseline, two weeks, and four weeks) ]

Locations (1)

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