Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 1:09 AM
Study NCT ID:
NCT06629935
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057909', 'term': 'Orthognathic Surgery'}], 'ancestors': [{'id': 'D013515', 'term': 'Surgery, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lateral nasal wall fracture type', 'timeFrame': '6 months', 'description': 'Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line'}], 'secondaryOutcomes': [{'measure': 'pterygomaxillary junction fracture type', 'timeFrame': '6 months', 'description': 'Class 1: Separation at the tuberosity of the maxilla Class 2: Separation at the pterygomaxillary junction Class 3: Separation of the pterygoids plates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthognthic surgery', 'le fort I', 'lateral nasal wall', 'pterygomaxillary junction'], 'conditions': ['Le Fort; I', 'Blood Loss']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.\n\nThe primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.', 'detailedDescription': 'While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring Le Fort I or bimaxillary surgery\n* Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)\n* Patients without cleft lip or palate\n* Patients with no history of midface fractures or craniofacial trauma\n\nExclusion Criteria:\n\n* Patients with cleft lip and/or palate requiring orthognathic surgery\n* Patients with a history of trauma needing orthognathic surgery for malocclusion correction\n* Patients who have previously undergone orthognathic surgery and require revision surgery'}, 'identificationModule': {'nctId': 'NCT06629935', 'briefTitle': 'Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction', 'orgStudyIdInfo': {'id': '2024-KAEK-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nievert osteotomy group', 'description': 'lateral nasal wall osteotomy has been performed with single guided Nievert osteotome.', 'interventionNames': ['Procedure: orthognathic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blade osteotomy group', 'description': 'lateral nasal wall osteotomy has been performed with blade osteotome.', 'interventionNames': ['Procedure: orthognathic surgery']}], 'interventions': [{'name': 'orthognathic surgery', 'type': 'PROCEDURE', 'description': 'Le Fort I surgery', 'armGroupLabels': ['Blade osteotomy group', 'Nievert osteotomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf Universty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}