NCT02834832

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2.7 years

First QC Date

June 30, 2016

Last Update Submit

July 21, 2020

Conditions

Denture StomatitisWear of Denture Teeth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • wear of denture teeth

    6 months

Study Arms (2)

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

Interventions

PECVD coatingDEVICE

SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.

PECVD Coatings

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Medical contraindication for dental treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Stomatitis, Denture

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Study Officials

  • Josephine F. Esquivel-Upshaw, DMD, MS

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 15, 2016

Study Start

November 1, 2016

Primary Completion

July 18, 2019

Study Completion

July 18, 2019

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)