What this study is
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.
What's being tested
- MI Paste
Intervention · 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
- Sponsor
- University of Iowa
- Conditions
- Dental Prosthesis
- Enrolling
- 50 people
- Starts
- 2024-08-28
- Est. completion
- 2027-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years – 105 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Iowa College of Dentistry
Iowa City, Iowa, United States
Study team
Sponsor
University of Iowa
Study ID 202401429
Principal investigator
Robert Bowers, DDS
University of Iowa
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.