Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 6:48 AM
Study NCT ID:
NCT05465850
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance (USPHS criteria)', 'timeFrame': 'baseline: 1 week', 'description': 'USPHS criteria'}, {'measure': 'Clinical performance (USPHS criteria)', 'timeFrame': '6 months', 'description': 'USPHS criteria'}, {'measure': 'Clinical performance (USPHS criteria)', 'timeFrame': '12 months', 'description': 'USPHS criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class V Dental Caries']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class V carious lesions in anterior teeth\n* Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.\n* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth\n\nExclusion Criteria:\n\n* Deep carious defects ( Close to pulp, less than 1 mm distance)\n* Periapical pathology or signs of pulpal pathology\n* Endodontically treated teeth\n* Tooth hypersensitivity\n* Possible prosthodontic restoration of teeth\n* Heavy occlusion and occlusal contacts or history of bruxism\n* Severe periodontal affection\n* Lesions in premolars and molars\n* Posterior teeth'}, 'identificationModule': {'nctId': 'NCT05465850', 'briefTitle': 'Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up', 'orgStudyIdInfo': {'id': '14422019428237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek Z350XT', 'interventionNames': ['Diagnostic Test: Modified USPHS criteria']}, {'type': 'EXPERIMENTAL', 'label': 'Essentia universal shade, GC composite', 'interventionNames': ['Diagnostic Test: Modified USPHS criteria']}, {'type': 'EXPERIMENTAL', 'label': 'Omnichroma composite', 'interventionNames': ['Diagnostic Test: Modified USPHS criteria']}], 'interventions': [{'name': 'Modified USPHS criteria', 'type': 'DIAGNOSTIC_TEST', 'description': 'It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.', 'armGroupLabels': ['Essentia universal shade, GC composite', 'Filtek Z350XT', 'Omnichroma composite']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dina Khaled Mokhtar Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}