Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-03-23 @ 3:15 PM
Study NCT ID:
NCT03090061
Status:
UNKNOWN
Last Update Posted:
2017-08-02
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2017-03-18', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeatability for both diagnostic methods', 'timeFrame': '20 minutes', 'description': 'Three examiners will record the dental findings of 29 resin composte restorations using both the intervention and control assessment methods. Each method will be repeated twice to calculate the repeatability. The intra-operator agreement will be evaluated using the kappa statistics.'}, {'measure': 'Reproducibility for both diagnostic methods', 'timeFrame': '1 week', 'description': 'Three examiners will record the dental findings of 29 resin composite restorations using both the intervention and control assessment methods. Each method will be repeated after one week interval to calculate the reproducibility. The inter-operator agreement will be evaluated using the kappa statistics.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microleakage Around Resin Composite Restorations']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the margins of resin composite restorations', 'detailedDescription': 'Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.\n\nEach examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be over 18 years of age.\n* Patients should have an acceptable oral hygiene level.\n* Patients must have at least one posterior resin composite restoration.\n\nExclusion Criteria:\n\n* Patients with a compromised medical history.\n* Severe or active periodontal disease.\n* Heavy bruxism or a traumatic occlusion.'}, 'identificationModule': {'nctId': 'NCT03090061', 'briefTitle': 'Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-03-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light induced fluorescence intraoral camera', 'interventionNames': ['Diagnostic Test: Light induced fluorescence intraoral camera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Visual-tactile assessment method according to FDI criteria', 'interventionNames': ['Diagnostic Test: Visual-tactile assessment method according to FDI criteria']}], 'interventions': [{'name': 'Light induced fluorescence intraoral camera', 'type': 'DIAGNOSTIC_TEST', 'description': 'assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera', 'armGroupLabels': ['Light induced fluorescence intraoral camera']}, {'name': 'Visual-tactile assessment method according to FDI criteria', 'type': 'DIAGNOSTIC_TEST', 'description': 'assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,', 'armGroupLabels': ['Visual-tactile assessment method according to FDI criteria']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Oral and Dental Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'internal resident', 'investigatorFullName': 'Aya Mohamed Adly', 'investigatorAffiliation': 'Cairo University'}}}}