Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-02 @ 4:17 AM
Study NCT ID:
NCT06013059
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-02', 'size': 444499, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-08-14T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-07', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mouth opening measurement', 'timeFrame': '1, 3 and 6 months postoperatively', 'description': 'measuring the maximal interincisal opening (MIO)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Disc Disorder']}, 'descriptionModule': {'briefSummary': 'The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with TMJ internal derangement Wilkes III\n\nExclusion Criteria:\n\n1. Medically unfit patients.\n2. Patients with TMDs secondary to malocclusion.\n3. Psychological instability.\n4. Patients operated before for other TMJ problems.'}, 'identificationModule': {'nctId': 'NCT06013059', 'briefTitle': 'A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '001056 - IORG 0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'level (I) arthroscopy (Lysis and lavage)', 'interventionNames': ['Procedure: three levels of TMJ arthroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'level (II) arthroscopy (operative arthroscopy)', 'interventionNames': ['Procedure: three levels of TMJ arthroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)', 'interventionNames': ['Procedure: three levels of TMJ arthroscopy']}], 'interventions': [{'name': 'three levels of TMJ arthroscopy', 'type': 'PROCEDURE', 'description': 'Group I: 10 patients will be treated with Lysis and lavage', 'armGroupLabels': ['level (I) arthroscopy (Lysis and lavage)']}, {'name': 'three levels of TMJ arthroscopy', 'type': 'PROCEDURE', 'description': 'Group II: 10 patients will be treated with operative arthroscopy', 'armGroupLabels': ['level (II) arthroscopy (operative arthroscopy)']}, {'name': 'three levels of TMJ arthroscopy', 'type': 'PROCEDURE', 'description': 'Group III: 10 patients will be treated with operative arthroscopy + discopexy', 'armGroupLabels': ['level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mohamed Fayad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Hamza Fayad', 'investigatorAffiliation': 'Alexandria University'}}}}