Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 7:28 PM
Study NCT ID:
NCT05013866
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance', 'timeFrame': 'Baseline', 'description': 'Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).'}, {'measure': 'Clinical Performance', 'timeFrame': '12 months', 'description': 'Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).'}, {'measure': 'Clinical Performance', 'timeFrame': '18 months', 'description': 'Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).'}, {'measure': 'Clinical Performance', 'timeFrame': '24 months', 'description': 'Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Composite Dental Resin'], 'conditions': ['Dental Diseases']}, 'descriptionModule': {'briefSummary': 'Bulk Fill" (RBF) composite resins (RC) has been on the market, with the main advantage of being applied in a single layer, faster and easier than a conventional RC. Repair of RC restorations is a validated treatment option in dentistry, which has been shown to increase the longevity of restorations by minimizing tooth damage such as complete replacement. Currently there are no clinical studies that support the actual performance of RBF repair', 'detailedDescription': 'Main objective: Compare the clinical performance with FDI of repairs proximal RC restorations between a conventional resin and a RBF in a period of 24 months. Hypothesis: There is not different clinical performance of proximal RC repairs done with RBF when compared to conventional RC repairs. Material and method: 80 volunteer patients will be randomly recruited to attend the clinic of the Faculty of Dentistry of the University of Chile who have two proximal RC restorations with indication of repair according to the FDI system (n per group = 80). Each patient must accept and sign an informed consent. The repairs will be randomly divided into two groups on the same patient. Control Group: Conventional RC repair (Z350 XT). Experimental Group: RBF (Tetric Evoceram Bulk Fill) Repair. For the restorative technique, a three-step adhesive with acid-etched enamel-dentin will be used. It will be evaluated at 2 weeks (Baseline), at 6, 12, 18, 24 months by two blind and calibrated evaluators (Cohen Kappa\\> 0.8). The data will be analyzed with the SSPS 21.0 software and the Friedman, Wilcoxon and Mann Whitney tests will be applied with a significance level of 95%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\> 18 years,\n* healthy\n* high cariogenic risk,\n* Vital molars and premolars,\n* Natural antagonist and proximal\n* Indication of repair in the proximal with depth\\> 2mm.\n\nExclusion Criteria:\n\n* Patients has xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients -inability to perform hygiene\n* pregnant women\n* severe bruxism\n* Prosthesis\n* Not absolute isolation\n* Tooth fracture and / or restoration."}, 'identificationModule': {'nctId': 'NCT05013866', 'briefTitle': 'Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional Andres Bello'}, 'officialTitle': 'Repair of Proximal Restoration With Resin Composite Bulk-Fill. Double Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DIFO 2017/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Repair of resin Z350', 'description': 'Repair with Z350 on resin composite proximal', 'interventionNames': ['Procedure: Repair resin composite proximal']}, {'type': 'EXPERIMENTAL', 'label': 'Repair of Tetric Evo Ceram Bulkfill', 'description': 'Repair with Tetric Evo Ceram on resin composite proximal', 'interventionNames': ['Procedure: Repair resin composite proximal']}], 'interventions': [{'name': 'Repair resin composite proximal', 'type': 'PROCEDURE', 'description': 'Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin', 'armGroupLabels': ['Repair of Tetric Evo Ceram Bulkfill', 'Repair of resin Z350']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7510583', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Patricio Vildosola Grez', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Patricio Vildosola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional Andres Bello', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chile', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Patricio Vildosola Grez', 'investigatorAffiliation': 'University of Chile'}}}}