Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 8:28 AM
Study NCT ID:
NCT02834832
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bacterial Count', 'timeFrame': '2,4 and 12 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'wear of denture teeth', 'timeFrame': '6 months', 'description': 'Denture teeth will be analyzed for wear at 6 months to determine the effect of PECVD coatings on the wear of denture teeth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denture Stomatitis', 'Wear of Denture Teeth']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.', 'detailedDescription': '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.\n\nAnother 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seeking care in a Dental Clinic who have removable dentures.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are missing some teeth and will need removable dentures\n\nExclusion Criteria:\n\n* Medical contraindication for dental treatment'}, 'identificationModule': {'nctId': 'NCT02834832', 'briefTitle': 'Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic', 'orgStudyIdInfo': {'id': 'IRB201600805'}, 'secondaryIdInfos': [{'id': 'UFirst 5154', 'type': 'OTHER', 'domain': 'UFirst'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'The patients will be given removable dentures with no coatings. These dentures are part of the standard of care to treat their edentulism.'}, {'label': 'PECVD Coatings', 'description': 'The patients will be given removable partial dentures with PECVD coatings on both the tissue surface of the dentures and the acrylic denture teeth.', 'interventionNames': ['Device: PECVD coating']}], 'interventions': [{'name': 'PECVD coating', 'type': 'DEVICE', 'description': 'SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.', 'armGroupLabels': ['PECVD Coatings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Josephine F. Esquivel-Upshaw, DMD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}