Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 7:26 PM
Study NCT ID:
NCT04629859
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2020-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthognathic Surgeries and Pharyngeal Airway Space
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008313', 'term': 'Malocclusion, Angle Class III'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total pharyngeal airway space surface area', 'timeFrame': '6 months', 'description': 'Cephalometric analyses will be performed, the pharyngeal airway is demarcated inferiorly by a line passing through the tip of epiglottis and the superior tip of the hyoid bone, namely Line A, while the retro-glossal and the retro-palatal airway is separated by a line extending from the basion parallel to line A.\n\nAll the reference points and lines were conveyed to the images . The Pharyngeal airway space was measured and compared.'}], 'secondaryOutcomes': [{'measure': 'Epworth sleepiness scale', 'timeFrame': '6 months', 'description': '(0-24) score to assess sleep apnea indirect'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthognathic surgery', 'Pharyngeal airway space', 'skeletal class III patients.'], 'conditions': ['Mandibular Prognathism']}, 'descriptionModule': {'briefSummary': 'twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and maxillary advancement surgeries. the total pharyngeal airway will be measured on lateral cephalometric radiographs, integrating retro-palatal and retro-glossal area, and statistically will be compared preoperative, immediate postoperative, and at 6 months post-surgically'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy\n* no previous orthognathic surgery\n\nExclusion Criteria:\n\n* Patients with craniofacial syndromes.\n* Medically compromised patients and patients with bone anomalies'}, 'identificationModule': {'nctId': 'NCT04629859', 'briefTitle': 'Orthognathic Surgeries and Pharyngeal Airway Space', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Malocclusion Patients', 'orgStudyIdInfo': {'id': '12/10/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study arm', 'description': 'dento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement', 'interventionNames': ['Procedure: mandibular setback and maxillary advancement']}, {'type': 'EXPERIMENTAL', 'label': 'controlled arm', 'description': 'dento skeletal class III patients will undergo a mandibular setback surgery', 'interventionNames': ['Procedure: mandibular setback']}], 'interventions': [{'name': 'mandibular setback and maxillary advancement', 'type': 'PROCEDURE', 'description': '12 patients will undergo mandibular setback and maxillary advancement', 'armGroupLabels': ['study arm']}, {'name': 'mandibular setback', 'type': 'PROCEDURE', 'description': '12 patients will undergo mandibular setback', 'armGroupLabels': ['controlled arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Fayoum University', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'hussien hatem, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Shaimaa Mohsen', 'investigatorAffiliation': 'Fayoum University'}}}}