Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-05 @ 8:49 PM
Study NCT ID:
NCT05401994
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2022-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2022-05-29', 'studyFirstSubmitQcDate': '2022-05-29', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of surgical procedure in minutes', 'timeFrame': 'intraoperative', 'description': 'Duration between the starting of fixation and complete fixation of fracture'}, {'measure': 'maxillomandibular fixation stability in nominal scale(stable-unstable)', 'timeFrame': 'immediately postoperative', 'description': 'stability after fixation'}, {'measure': 'maxillomandibular fixation stability in nominal scale(stable-unstable)', 'timeFrame': '4-6 weeks', 'description': 'stability after fixation'}, {'measure': 'oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)', 'timeFrame': 'immediately postoperative', 'description': 'the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.'}, {'measure': 'oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)', 'timeFrame': '4-6 weeks', 'description': 'the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.'}], 'secondaryOutcomes': [{'measure': 'number of iatrogenic injuries', 'timeFrame': 'intraoperative', 'description': 'iatrogenic injuries to teeth and gingiva'}, {'measure': 'number of needle and wire stick injuries', 'timeFrame': 'intraoperative', 'description': 'injuries to the surgeon and the assistants.'}, {'measure': 'pain assessment using numeric rating scale (NRS)', 'timeFrame': 'immediately postoperative', 'description': 'participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Fractures']}, 'descriptionModule': {'briefSummary': "A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation", 'detailedDescription': "2\\) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients age ranges from 18 to 50 years.\n2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.\n3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.\n\nExclusion Criteria:\n\n* 1\\) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.'}, 'identificationModule': {'nctId': 'NCT05401994', 'briefTitle': "Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation", 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': "Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation", 'orgStudyIdInfo': {'id': 'A03080921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "conventional Erich's arch bar", 'description': "• Patients will receive conventional Erich's arch bar", 'interventionNames': ["Procedure: conventional Erich's Arch Bar"]}, {'type': 'EXPERIMENTAL', 'label': 'Screw Retained Arch Bar', 'description': 'patients will receive modified screw retained arch bar.', 'interventionNames': ['Procedure: screw retained arch bar']}], 'interventions': [{'name': 'screw retained arch bar', 'type': 'PROCEDURE', 'description': 'maxillomandibular fixation with bone screwed arch bar', 'armGroupLabels': ['Screw Retained Arch Bar']}, {'name': "conventional Erich's Arch Bar", 'type': 'PROCEDURE', 'description': 'maxillomandibular fixation with conventional arch bar fixed to the teeth', 'armGroupLabels': ["conventional Erich's arch bar"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}