Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05337358
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
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': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical performance', 'timeFrame': '2 years', 'description': 'Using the modified United States Public Health Service criteria (Modified USPHS)- categorical'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lithium dislocate', 'fiber reinforced composite'], 'conditions': ['Clinical Performance']}, 'descriptionModule': {'briefSummary': 'In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with good oral hygiene\n* Patients having one or more endodontically treated molars that need prosthetic restoration.\n* Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival\n* Fully erupted molars\n* Molars free of developmental defect\n* Healthy periodontium\n* Absence of periapical pathosis\n* Acceptable endodontic treatment and proper bone support\n\nExclusion Criteria:\n\n* Patients with bad oral hygiene\n* Patients with active periodontal disease\n* Patients with missing teeth opposing to the area intended for restoration\n* Patients with parafunctional habits or psychiatric problems or unrealistic expectation.'}, 'identificationModule': {'nctId': 'NCT05337358', 'briefTitle': 'Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).', 'orgStudyIdInfo': {'id': 'CEBD-2021-3-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lithium disilicate', 'description': 'The intervention will be: Prosthetic endocrown', 'interventionNames': ['Procedure: endocrown']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fiber reinforced composite', 'description': 'The intervention will be: Prosthetic endocrown', 'interventionNames': ['Procedure: endocrown']}], 'interventions': [{'name': 'endocrown', 'type': 'PROCEDURE', 'description': 'endocrown', 'armGroupLabels': ['Fiber reinforced composite', 'Lithium disilicate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sameh Sh Abou-steit', 'role': 'CONTACT', 'email': 'samehabousteit@gmail.com', 'phone': '01001891010'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sameh Sh Abou-steit, PhD', 'role': 'CONTACT', 'email': 'samehabousteit@hotmail.com', 'phone': '01001891010', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Sameh Sh Abou-steit, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Fixed Prosthodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of fixed prosthodontics', 'investigatorFullName': 'Sameh Abou-steit', 'investigatorAffiliation': 'Cairo University'}}}}