Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-11 @ 7:38 PM
Study NCT ID:
NCT06349135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2024-03-31', 'studyFirstSubmitQcDate': '2024-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-17', 'timeFrame': '6- weeks', 'description': 'Interleukin-17'}, {'measure': 'OPG', 'timeFrame': '6- weeks', 'description': 'Osteoprotegerin'}], 'secondaryOutcomes': [{'measure': 'Blood Loss', 'timeFrame': 'in operation room'}, {'measure': 'Operative time', 'timeFrame': 'Operative time in minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Fractures']}, 'descriptionModule': {'briefSummary': 'Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with single mandibular fracture.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single mandibular fracture.\n* ORIF is done by two plates fixation with titanium plates and screws.\n* Age (18-50 years).\n* Recent fracture (less than 2 weeks).\n\nExclusion Criteria:\n\n* Pathological fractures.\n* Medical compromised patient.\n* Presence of concomitant injuries.\n* Patients receive radiotherapy.\n* Patients receive blood transfusion.'}, 'identificationModule': {'nctId': 'NCT06349135', 'briefTitle': 'Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'A.Ayman OMFS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Management of Mandibular Fractures via Intraoral approach.', 'description': 'Management of Mandibular Fractures via Intraoral approach.', 'interventionNames': ['Procedure: Open Reduction & Internal Fixation']}, {'label': 'Management of Mandibular Fractures via Extraoral approach.', 'description': 'Management of Mandibular Fractures via Extraoral approach.', 'interventionNames': ['Procedure: Open Reduction & Internal Fixation']}], 'interventions': [{'name': 'Open Reduction & Internal Fixation', 'type': 'PROCEDURE', 'description': 'Open Reduction \\& Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches.', 'armGroupLabels': ['Management of Mandibular Fractures via Extraoral approach.', 'Management of Mandibular Fractures via Intraoral approach.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aya Ayman Ahmed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer assistant', 'investigatorFullName': 'Aya Ayman Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}