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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02834832
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Actual Duration (Months): 32.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Denture Stomatitis; Wear of Denture Teeth	Device: PECVD coating

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 Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Jul 18, 2019
• Actual Study Completion Date: Jul 18, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Change in Bacterial Count [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

Secondary Outcome Measures

1. wear of denture teeth [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Medical contraindication for dental treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02834832
• Other Study ID Numbers: IRB201600805; UFirst 5154
• First Posted: Jul 15, 2016
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomatitis; Tooth Wear; Stomatitis, Denture

Study Results

No Results Posted as of Jul 23, 2020