MI Paste for Denture Wearers

Overseen By Robert Bowers, DDS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Antibiotics, Antifungals

Disqualifiers: Ill-fitting dentures, Pathology, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken antibiotics or antifungals in the past two months.

Is MI Paste safe for denture wearers?

The research does not provide specific safety data on MI Paste for denture wearers, but it highlights that some dental materials can cause allergic reactions, especially in people with previous allergies or burning mouth syndrome. It's important to consult with a healthcare provider to discuss any potential risks. ^{1 2 3 4 5}

How does MI Paste differ from other treatments for denture wearers?

MI Paste is unique because it is specifically designed to remove denture plaque and has antimicrobial properties, effectively targeting microorganisms like streptococci and yeast. This makes it different from other denture-cleaning pastes, which may not have the same level of antimicrobial action or patient acceptance. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Robert Bowers, DDS

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for elderly individuals who wear removable dentures. Participants should be interested in testing whether a dental product, MI Paste, can improve the health of their mouth by affecting bacteria and fungus, as well as enhance denture comfort and fit.

Inclusion Criteria

I can make my own medical decisions.

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))

I am 65 years old or older.

Exclusion Criteria

I have taken antibiotics or antifungals in the last two months.

Milk allergy

I need immediate treatment for severe mouth sores or similar conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants apply MI Paste under their removable upper denture for 14 days

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in oral microbiome composition and denture comfort

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• MI Paste

Trial Overview The study tests if applying MI Paste above the upper denture has benefits beyond its usual use for sensitive teeth or enamel repair. It's examining its effects on oral microbiome and how it might improve denture comfort and retention.

Participant Groups

Group I: MI Paste Application for 7 days Experimental Treatment 1 Intervention

Subjects will apply 1 cubic centimeter of MI Paste for 7 days.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Allergy to dental materials with special reference to the use of amalgam and polymethylmethacrylate. [2005]

2. England pubmed.ncbi.nlm.nih.gov

Five hundred patients reporting on adverse effects from dental materials: Frequencies, complaints, symptoms, allergies. [2019]

3. England pubmed.ncbi.nlm.nih.gov

An overview of the current status of national reporting systems for adverse reactions to dental materials. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Side-effects of dental materials reported in Scandinavian countries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cytotoxicity of denture base and hard chairside reline materials: a systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

An in vitro investigation of the abrasive qualities of a selection of denture-cleaning pastes on poly(methyl methacrylate) denture base material. [2006]

7. Brazil pubmed.ncbi.nlm.nih.gov

Capacity of denture plaque/biofilm removal and antimicrobial action of a new denture paste. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Effect of addition of titanium dioxide nanoparticles on the antimicrobial properties, surface roughness and surface hardness of polymethyl methacrylate: A Systematic Review. [2023]

9. Iran pubmed.ncbi.nlm.nih.gov

Denture base adaptation, retention, and mechanical properties of BioHPP versus nano-alumina-modified polyamide resins. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Flexural Strength Analysis of Different Complete Denture Resin-Based Materials Obtained by Conventional and Digital Manufacturing. [2023]