Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-28 @ 3:52 AM
Study NCT ID:
NCT02891967
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical performance and durability of restoration', 'timeFrame': 'one year', 'description': 'Outcome measure is Clinical performance and durability of composite resin restoration, Device for measurement is FDI criteria , Unit of measurement 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': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Dental Restoration']}, 'descriptionModule': {'briefSummary': 'restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of performance and durability of both restorations during one year follow up', 'detailedDescription': 'The treated cavities will be divided into 2 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 (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²) and other group of cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.\n\nArticulation will be checked carefully with an articulating paper and occlusal adjustments will be performed using flame shaped carbide and diamond finishing burs (DENTSPLY) using water spray, restorations will be finished occlusally with finishing burs and finally polished with aluminium oxide polishing paste and a rubber cup (DENTSPLY).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good oral hygiene.Patients must show no signs of orofacial pain. The presence of molar teeth requiring composite restorations for the treatment of primary carious lesions\n\nExclusion Criteria:\n\n* Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations. Teeth with old restorations or severely destructed dental crowns.Tempro-mandibular joint problems involving symptomatic pain.Pregnancy or breast feeding, acute and chronic systemic diseases, immune-compromised patients'}, 'identificationModule': {'nctId': 'NCT02891967', 'briefTitle': 'One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'One-year Clinical Evaluation of Bulk-fill Resin Composite Using FDI Criteria in Comparison to Conventional Incremental Posterior Restoration', 'orgStudyIdInfo': {'id': 'CEBD-CU-08-184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bulk full composite (3M)', 'description': 'bulk fill composite in posterior class one cavities', 'interventionNames': ['Other: bulk fill composite', 'Other: Nano resin composite (K Z350 xt)']}, {'type': 'OTHER', 'label': 'Incremental packing composite resin', 'description': 'Nano resin composite (K Z350 xt) restoration in class one cavities', 'interventionNames': ['Other: bulk fill composite', 'Other: Nano resin composite (K Z350 xt)']}], 'interventions': [{'name': 'bulk fill composite', 'type': 'OTHER', 'description': 'cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)', 'armGroupLabels': ['Bulk full composite (3M)', 'Incremental packing composite resin']}, {'name': 'Nano resin composite (K Z350 xt)', 'type': 'OTHER', 'description': 'cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.', 'armGroupLabels': ['Bulk full composite (3M)', 'Incremental packing composite resin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mary', 'role': 'CONTACT'}], 'facility': 'Mary', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mary ST Tadros, Phd', 'role': 'CONTACT', 'email': 'mora.dentist@hotmail.com', 'phone': '01223729423', 'phoneExt': 'Maadi'}, {'name': 'Mina GA Awad, Phd', 'role': 'CONTACT', 'email': 'mora.doc04@gmail.com', 'phone': '01211958836', 'phoneExt': 'Helwan'}], 'overallOfficials': [{'name': 'Mary ST Tadros, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Mary Sabry Tawfik Tadros', 'investigatorAffiliation': 'Cairo University'}}}}