Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT03353116
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2017-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-23', 'size': 1006313, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-22T22:14', 'hasProtocol': True}, {'date': '2017-11-16', 'size': 422747, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-11-16T12:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in maxilla stability', 'timeFrame': '6 months', 'description': 'to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative.\n\nthe measuring unit is millimeter'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '6 month', 'description': '"the quality of life questionnaire" describes the patient\'s satisfaction during the entire treatment period which is done through a questionnaire answered by the patient through a score between 0-10 the measuring unit is numerical'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class III Malocclusion']}, 'referencesModule': {'references': [{'pmid': '24531245', 'type': 'BACKGROUND', 'citation': 'Esteves LS, Castro V, Prado R, de Moraes e Silva CA, do Prado CJ, Trindade Neto AI. Assessment of skeletal stability after counterclockwise rotation of the maxillomandibular complex in patients with long-face pattern subjected to orthognathic surgery. J Craniofac Surg. 2014 Mar;25(2):432-6. doi: 10.1097/SCS.0000000000000395.'}, {'pmid': '27668193', 'type': 'BACKGROUND', 'citation': 'Ann HR, Jung YS, Lee KJ, Baik HS. Evaluation of stability after pre-orthodontic orthognathic surgery using cone-beam computed tomography: A comparison with conventional treatment. Korean J Orthod. 2016 Sep;46(5):301-9. doi: 10.4041/kjod.2016.46.5.301. Epub 2016 Sep 19.'}, {'pmid': '19939425', 'type': 'BACKGROUND', 'citation': 'Beziat JL, Babic B, Ferreira S, Gleizal A. [Justification for the mandibular-maxillary order in bimaxillary osteotomy]. Rev Stomatol Chir Maxillofac. 2009 Dec;110(6):323-6. doi: 10.1016/j.stomax.2009.09.009. Epub 2009 Nov 25. French.'}, {'pmid': '28839184', 'type': 'BACKGROUND', 'citation': 'Liebregts J, Baan F, de Koning M, Ongkosuwito E, Berge S, Maal T, Xi T. Achievability of 3D planned bimaxillary osteotomies: maxilla-first versus mandible-first surgery. Sci Rep. 2017 Aug 24;7(1):9314. doi: 10.1038/s41598-017-09488-4.'}]}, 'descriptionModule': {'briefSummary': 'The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery', 'detailedDescription': 'The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery\n2. Patients free from any systemic disease\n3. Patients who approved to be included in the trial and signed the informed consent\n4. Patients with no signs or symptoms of temporomandibular disorders.\n\nExclusion Criteria:\n\n1. Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"\n2. Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "\n3. Patients who refused to be included in the trial'}, 'identificationModule': {'nctId': 'NCT03353116', 'briefTitle': 'Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2017-11-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'maxilla first group', 'description': 'the maxillary osteotomy is going to be done and fixed first', 'interventionNames': ['Procedure: the maxilla first']}, {'type': 'EXPERIMENTAL', 'label': 'mandible first group', 'description': 'the mandibular osteotomy is going to be done and fixed first', 'interventionNames': ['Procedure: the mandible first']}], 'interventions': [{'name': 'the mandible first', 'type': 'PROCEDURE', 'otherNames': ['the inverted sequence'], 'description': 'the mandible osteotomy is going to be done and fixed first', 'armGroupLabels': ['mandible first group']}, {'name': 'the maxilla first', 'type': 'PROCEDURE', 'otherNames': ['the regular sequence'], 'description': 'the maxilla osteotomy is going to be done and fixed first', 'armGroupLabels': ['maxilla first group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'state': 'Middle East', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mohamed mh hamdy, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after the completion of my research i will publish the data in an international journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Hamdy', 'investigatorAffiliation': 'Cairo University'}}}}