Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-03 @ 10:12 AM
Study NCT ID:
NCT03230604
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities\n\nIntervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance restoration', 'timeFrame': 'six month, one years, two, three, four and five years', 'description': 'Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Dental Restoration', 'Caries, Dental']}, 'descriptionModule': {'briefSummary': 'To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.', 'detailedDescription': 'A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.\n\nThe study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* must have given written informed consent to participate in the trial\n* need at least three posterior restorations\n* must be available for the required post-operative follow-up visits\n* have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips\n* At least one occlusal and proximal contact on a natural tooth\n* Cavities depth \\> 2 mm in cervico-occlusal\n\nExclusion Criteria:\n\n* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations\n* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients\n* chronic periodontitis\n* present with any systemic or local disorders that contra-indicate the dental procedures included in this study\n* an unstable occlusion\n* severe bruxing\n* teeth with periapical pathology or expected pulp exposures\n* are pregnant.\n* Endodontically treated teeth"}, 'identificationModule': {'nctId': 'NCT03230604', 'briefTitle': 'Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional Andres Bello'}, 'officialTitle': 'Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial', 'orgStudyIdInfo': {'id': 'DI-1301-16/CB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bulk-Fill composite Class I, II and V cavities', 'description': 'Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V', 'interventionNames': ['Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite', 'Device: Z 350 Xt Composite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Z 350 xt Composite', 'description': 'Restorative with Z 350 xt composite in class I, II and V', 'interventionNames': ['Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite', 'Device: Z 350 Xt Composite']}], 'interventions': [{'name': 'Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite', 'type': 'DEVICE', 'description': 'Restorative cavities one, two and five with material Filtek Bulk Fill Composite', 'armGroupLabels': ['Bulk-Fill composite Class I, II and V cavities', 'Z 350 xt Composite']}, {'name': 'Z 350 Xt Composite', 'type': 'DEVICE', 'description': 'Restorative cavities one, two and five with material Z 350 XT Composite', 'armGroupLabels': ['Bulk-Fill composite Class I, II and V cavities', 'Z 350 xt Composite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7510583', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Patricio Vildosola Grez', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Odontologia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Andres Bello'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional Andres Bello', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Patricio Vildosola Grez', 'investigatorAffiliation': 'Universidad Nacional Andres Bello'}}}}