Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 11:02 PM
Study NCT ID:
NCT07099833
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aetiology and Pattern of 122 Patients With Mandibular Condylar Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}, {'id': 'D005151', 'term': 'Facial Injuries'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-25', 'size': 868615, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-29T02:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'targetDuration': '100 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of mandibular condylar fracture types (MacLennan classification)', 'timeFrame': 'At initial evaluation (2018-2020)', 'description': 'Frequency and percentage of fracture types (Class I-IV) based on MacLennan classification at initial clinical evaluation.'}, {'measure': 'Anatomical location of mandibular condylar fractures', 'timeFrame': 'At initial evaluation (2018-2020)', 'description': 'Distribution of fracture sites: subcondylar, condylar neck, or condylar head based on CT scan classification (Loukota system).'}, {'measure': 'Etiology of mandibular condylar fractures', 'timeFrame': 'At initial evaluation (2018-2020)', 'description': 'Proportion of fractures attributed to road traffic accident, falling, or assault based on patient report.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mandibular Condylar Fracture', 'Subcondylar Fracture', 'Craniofacial Trauma'], 'conditions': ['Mandibular Fractures', 'Facial Injuries']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study aimed to investigate the aetiology and fracture patterns among patients with mandibular condylar fractures (MCF) who were treated at a trauma center in Shiraz, Iran, between 2018 and 2020. A total of 122 patients were included. The study involved collecting data on fracture characteristics, including anatomical location, classification (MacLennan and Loukota systems), angle of fracture lines, and the presence of concomitant maxillofacial injuries. The objective was to examine correlations between these characteristics and demographic or clinical factors such as age, sex, and mechanism of injury.', 'detailedDescription': 'This is a retrospective cohort study conducted at a major trauma center affiliated with Shiraz University of Medical Sciences, Iran. The study enrolled patients diagnosed with unilateral or bilateral mandibular condylar fractures between January 2018 and December 2020. Data were extracted from clinical records and radiographic evaluations. Fractures were classified according to the MacLennan and Loukota systems, and relevant demographic and injury-related information was recorded. No interventions were administered as part of this registry. All procedures were conducted under approval from the institutional ethics committee. The primary aim was to investigate patterns in fracture characteristics and their associations with trauma mechanisms and patient demographics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 12 to 65 years with trauma-induced unilateral or bilateral mandibular condylar fractures who were admitted to a trauma center affiliated with Shiraz University of Medical Sciences between January 2018 and December 2020. All included patients had complete clinical and radiographic records and no prior history of condylar fracture.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with unilateral or bilateral mandibular condylar fracture\n* Trauma-related fracture confirmed by clinical and radiographic evaluation\n* Complete medical record and imaging data available\n* Age between 12 and 65 years at the time of trauma\n\nExclusion Criteria:\n\n* History of prior mandibular condylar fracture\n* Incomplete medical or imaging records\n* Patients younger than 12 or older than 65 at time of injury'}, 'identificationModule': {'nctId': 'NCT07099833', 'briefTitle': 'Aetiology and Pattern of 122 Patients With Mandibular Condylar Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Aetiology and Pattern of Mandibular Condylar Fractures: A Retrospective Cohort Study of 122 Patients', 'orgStudyIdInfo': {'id': 'IR.SUMS.DENTAL.REC.1399.120'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Azita Sadeghzade', 'type': 'OTHER', 'description': 'Azita Sadeghzade'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1111', 'city': 'Shiraz', 'country': 'Iran', 'facility': 'University of Medical Sciences, Shiraz, Iran.', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azita Sadeghzade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Oral and Maxillofacial Medicine', 'investigatorFullName': 'Azita Sadeghzade', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}