Denture StomatitisNCT02834832
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
An observational study of Denture Stomatitis and Wear of Denture Teeth, run by University of Florida at 1 site in United States.
Trial summary
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis, Wear of Denture Teeth
- What is being tested?
- PECVD coating
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 18 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seeking care in a Dental Clinic who have removable dentures.
Who may be able to join
- Patients who are missing some teeth and will need removable dentures
Who cannot join
- Medical contraindication for dental treatment
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.
Read the 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.
- Conditions
- Denture Stomatitis, Wear of Denture Teeth
- Being tested
- PECVD coating
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECVD coatingDevice
SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PECVD coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2,4 and 12 weeks
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josephine F. Esquivel-Upshaw, DMD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834832
- Sponsor's protocol ID
- IRB201600805
- Other IDs
- UFirst 5154
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
- ClinicalTrials.gov ID
- NCT02834832
- Acronym / sponsor ID
- IRB201600805
- Conditions
- Denture Stomatitis, Wear of Denture Teeth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: PECVD coatingThe patients will be given removable partial dentures with PECVD coatings on both the tissue surface of the dentures and the acrylic denture teeth. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking care in a Dental Clinic who have removable dentures.
Key inclusion criteria (1 listed)
- Patients who are missing some teeth and will need removable dentures
Key exclusion criteria (1 listed)
- Medical contraindication for dental treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PECVD coatingSiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth. | Device | PECVD Coatings |
Primary outcome
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
1 secondary outcome
wear of denture teeth
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine F. Esquivel-Upshaw, DMD, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Denture Stomatitis and Wear of Denture Teeth, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bacterial Count (time frame: 2,4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.