60 Participants Needed

MI Paste for Denture Wearers

RB
Overseen ByRobert Bowers, DDS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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

RB

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.
See 2 more

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
1Treatment groups
Experimental Treatment
Group I: MI Paste Application for 7 daysExperimental Treatment1 Intervention
Subjects will apply 1 cubic centimeter of MI Paste for 7 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

References

Allergy to dental materials with special reference to the use of amalgam and polymethylmethacrylate. [2005]
Five hundred patients reporting on adverse effects from dental materials: Frequencies, complaints, symptoms, allergies. [2019]
An overview of the current status of national reporting systems for adverse reactions to dental materials. [2022]
Side-effects of dental materials reported in Scandinavian countries. [2019]
Cytotoxicity of denture base and hard chairside reline materials: a systematic review. [2018]
An in vitro investigation of the abrasive qualities of a selection of denture-cleaning pastes on poly(methyl methacrylate) denture base material. [2006]
Capacity of denture plaque/biofilm removal and antimicrobial action of a new denture paste. [2015]
Effect of addition of titanium dioxide nanoparticles on the antimicrobial properties, surface roughness and surface hardness of polymethyl methacrylate: A Systematic Review. [2023]
Denture base adaptation, retention, and mechanical properties of BioHPP versus nano-alumina-modified polyamide resins. [2022]
Flexural Strength Analysis of Different Complete Denture Resin-Based Materials Obtained by Conventional and Digital Manufacturing. [2023]
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