Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic

July 21, 2020 updated by: University of Florida
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture acrylic material is very conducive for the growth and adhesion of bacteria because of its porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings on the surface of acrylic dentures can produce a less porous surface which may minimize the adhesion of bacteria and therefore colonization. The goal is the application of these coatings will help minimize the occurrence of denture stomatitis.

Another issue of removable dentures is the low wear resistance of denture teeth. The application of these coatings on denture teeth should minimize wear of these teeth and prolong the life of removable dentures.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seeking care in a Dental Clinic who have removable dentures.

Description

Inclusion Criteria:

  • Patients who are missing some teeth and will need removable dentures

Exclusion Criteria:

  • Medical contraindication for dental treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
The patients will be given removable dentures with no coatings. These dentures are part of the standard of care to treat their edentulism.
PECVD Coatings
The patients will be given removable partial dentures with PECVD coatings on both the tissue surface of the dentures and the acrylic denture teeth.
Device: PECVD coating
SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bacterial Count
Time Frame: 2,4 and 12 weeks
Biofilms on the tissue surface of the dentures will be obtained for the aforementioned time intervals. Biofilm counts will be analyzed to determine the effect of the coatings on the number of disease causing bacteria on the surface of the denture
2,4 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wear of denture teeth
Time Frame: 6 months
Denture teeth will be analyzed for wear at 6 months to determine the effect of PECVD coatings on the wear of denture teeth.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Josephine F. Esquivel-Upshaw, DMD, MS, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

July 18, 2019

Study Completion (ACTUAL)

July 18, 2019

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201600805
  • UFirst 5154 (OTHER: UFirst)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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