Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-06 @ 3:16 PM
Study NCT ID:
NCT02764450
Status:
COMPLETED
Last Update Posted:
2016-05-06
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10 Years Evaluation of Composite Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-06-13', 'releaseDate': '2016-05-09'}, {'resetDate': '2016-08-26', 'releaseDate': '2016-07-18'}], 'estimatedResultsFirstSubmitDate': '2016-05-09'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cavity filled with problem in marginal adaptation and in marginal discoloration', 'timeFrame': '5 years', 'description': 'Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial.\n\nThe evaluation was done using both SQUACE and USPHS criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['composite', 'restoration', 'polymerization'], 'conditions': ['Dental Restoration, Permanent']}, 'referencesModule': {'references': [{'pmid': '23454329', 'type': 'BACKGROUND', 'citation': 'Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects at least 18 years old,\n* require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,\n* having no restoration in the antagonist,\n\nExclusion Criteria\n\n* allergic to resin-based materials,\n* pregnant or nursing,\n* periodontal disease'}, 'identificationModule': {'nctId': 'NCT02764450', 'briefTitle': '10 Years Evaluation of Composite Restoration', 'organization': {'class': 'OTHER', 'fullName': 'BNM Clinic and Research'}, 'officialTitle': 'Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols', 'orgStudyIdInfo': {'id': 'TEX-10y-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Astralis 10 HPM', 'description': 'Polymerization High-power mode: 1300 mW/cm2 for 10 s', 'interventionNames': ['Device: Astralis 10 RM']}, {'type': 'EXPERIMENTAL', 'label': 'Astralis 10 RM', 'description': 'Polymerisation regular mode: 650 mW/cm2 for 20', 'interventionNames': ['Device: Astralis 10 HPM']}], 'interventions': [{'name': 'Astralis 10 HPM', 'type': 'DEVICE', 'description': 'The cavity to be filled is in quadrant I or III', 'armGroupLabels': ['Astralis 10 RM']}, {'name': 'Astralis 10 RM', 'type': 'DEVICE', 'description': 'The cavity to be filled is in quadrant II or IV', 'armGroupLabels': ['Astralis 10 HPM']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BNM Clinic and Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicola Barabanti', 'investigatorAffiliation': 'BNM Clinic and Research'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-05-09', 'type': 'RELEASE'}, {'date': '2016-06-13', 'type': 'RESET'}, {'date': '2016-07-18', 'type': 'RELEASE'}, {'date': '2016-08-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nicola Barabanti, Principal Investigator, BNM Clinic and Research'}}}}