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

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834832
• Other study ID #: IRB201600805
• Secondary ID: UFirst 5154
• Status: Completed
• Start date: November 2016
• Est. completion date: July 18, 2019

Study information

• Verified date: July 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Medical contraindication for dental treatment

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture
• Tooth Wear
• Wear of Denture Teeth

Intervention

Device:
• PECVD coating
SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bacterial Count	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	wear of denture teeth	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