Dental ProsthesisNCT06406751
Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers
A study testing MI Paste in people with Dental Prosthesis, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Dental Prosthesis
- What is being tested?
- MI Paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
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.
Read the detailed 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).
- Conditions
- Dental Prosthesis
- Being tested
- MI Paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI PasteDevice
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 group | Role | What they receive |
|---|---|---|
| MI Paste Application for 14 days | Experimental | Subjects will apply 1 cubic centimeter of MI Paste for 14 days. Receives: Device: MI Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Multiple time points (baseline, two weeks, and four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start28 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bowers, University of Iowa
- Investigators
- Robert Bowers, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406751
- Sponsor's protocol ID
- 202401429
- Status last verified
- Nov 2025
- First submitted
- 6 May 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Effects of Extended Use of MI Paste in Elderly Removable Denture Wearers
- ClinicalTrials.gov ID
- NCT06406751
- Acronym / sponsor ID
- 202401429
- Conditions
- Dental Prosthesis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI Paste Application for 14 days | Experimental | Device: MI PasteSubjects will apply 1 cubic centimeter of MI Paste for 14 days. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI PasteSterile 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. | Device | MI Paste Application for 14 days |
Primary outcome
Assessment of changes in the oral microbiome composition over time
Time frame: Multiple time points (baseline, two weeks, and four weeks)
16S genomic profiling will be done in all recruited subjects via oral swab from under the denture and mouth tissues.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bowers, DDS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI Paste in people with Dental Prosthesis, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in the oral microbiome composition over time (time frame: Multiple time points (baseline, two weeks, and four weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.