Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:00 AM
Study NCT ID:
NCT07330193
Status:
COMPLETED
Last Update Posted:
2026-01-09
First Post:
2025-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flowable Resin Composite: Two-Year Clinical Performance in Class I Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-27', 'studyFirstSubmitDate': '2025-12-27', 'studyFirstSubmitQcDate': '2025-12-27', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified FDI criteria', 'timeFrame': 'two years', 'description': 'successful restorations percentage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class I Dental Caries']}, 'descriptionModule': {'briefSummary': 'Evaluating Two-year clinical performance of class I restored with four different flowable resin composite restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: •patients with bilateral occlusal small Class I carious lesions\n\n* • Good general health.\n\n * Patient aging 18-25 year.\n * Patient available for follow-up visits\n * Good oral hygiene\n\nExclusion Criteria:\n\nPatients with orthodontic treatment\n\n* Severe or chronic periodontitis\n* Parafunctional habits\n* Sensitivity to resin-based material.\n* Poor oral hygiene.'}, 'identificationModule': {'nctId': 'NCT07330193', 'briefTitle': 'Flowable Resin Composite: Two-Year Clinical Performance in Class I Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Flowable Resin Composite: In Vitro Investigation of Antibacterial Effect and Calcium & Phosphorus Content and Two-Year Clinical Performance in Class I Restorations', 'orgStudyIdInfo': {'id': 'A06080622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional flowable resin composite', 'interventionNames': ['Procedure: Restoration with CFC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'self adhesive flowable resin composite', 'interventionNames': ['Procedure: Restoration with SARC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'highly filled flowable resin composite', 'interventionNames': ['Procedure: Restoration with HFFC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bioactive self adhesive flowable resin composite', 'interventionNames': ['Procedure: Restoration with bioactive SARC']}], 'interventions': [{'name': 'Restoration with CFC', 'type': 'PROCEDURE', 'description': 'using conventional flowable resin composite materials to restore small occlusal carious lesions', 'armGroupLabels': ['conventional flowable resin composite']}, {'name': 'Restoration with HFFC', 'type': 'PROCEDURE', 'description': 'using highly filled flowable resin composite to restore small class I carious lesions', 'armGroupLabels': ['highly filled flowable resin composite']}, {'name': 'Restoration with SARC', 'type': 'PROCEDURE', 'description': 'using self-adhesive flowable resin composite to restore small class I carious lesions', 'armGroupLabels': ['self adhesive flowable resin composite']}, {'name': 'Restoration with bioactive SARC', 'type': 'PROCEDURE', 'description': 'using bioactive self-adhesive flowable resin composite to restore small class I carious lesions', 'armGroupLabels': ['bioactive self adhesive flowable resin composite']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}