Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers
Enrolling by invitation · Not applicable
Conditions studied: Dental Prosthesis
In brief
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 facts
- Study ID
- NCT06406751
- Run by
- University of Iowa
- People needed
- 50
- Starts
- 2024-08-28
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-11-10
Who can join
Age: 65 and older, up to 105. Sex: any. Healthy volunteers: not accepted.
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.
- 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
Where it is running
- University of Iowa College of Dentistry — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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