Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-11 @ 8:55 PM
Study NCT ID:
NCT02658305
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011378', 'term': 'Prognathism'}, {'id': 'D063173', 'term': 'Retrognathia'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-14', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications (rate of screw removal and/or infection)', 'timeFrame': 'within 4 weeks postoperative'}], 'secondaryOutcomes': [{'measure': 'The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications', 'timeFrame': 'within 4 weeks postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transoral approach', 'transbuccal approach', 'postoperative complications'], 'conditions': ['Prognathism', 'Retrognathia', 'Jaw Abnormalities']}, 'descriptionModule': {'briefSummary': 'Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic surgery, which is less often used.\n\nThe aim of this study was to compare postoperative outcome of transoral versus transbuccal bicortical screw placement during orthognathic surgery.\n\nThis study comprises an academic, retrospective, monocentric study in which the charts of orthognathic patients operated between January 2010 and December 2012 were retrospectively reviewed. Postoperative complications were registered. Demographic, dental and surgical parameters are examined as potential risk factors for the occurence of postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All orthognathic patients operated in the lower jaw between January 2010 and December 2012 at the Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Belgium', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of all ages\n* patients of all genders\n* patients who had undergone a bimaxillary osteotomy, a bilateral sagittal split ramus osteotomy (BSSO), a BSSO with a chin osteotomy or a trimaxillary osteotomy\n\nExclusion Criteria:\n\n* patients where cement had been used at the osteotomy sites\n* patients who had undergone a multisegmented mandibular osteotomy\n* patients who had undergone an osteosynthesis with plates\n* patients where the postoperative orthopantomogram was unavailable\n* patients where data regarding the type of screw placement was unavailable'}, 'identificationModule': {'nctId': 'NCT02658305', 'briefTitle': 'Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'orgStudyIdInfo': {'id': 'B049201525558'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'transoral group', 'description': 'orthognathic patients that were treated with a transoral surgical approach'}, {'label': 'transbuccal group', 'description': 'orthognathic patients that were treated with a transbuccal surgical approach'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bruges', 'country': 'Belgium', 'facility': 'General Hospital Saint-John Bruges', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Johan Abeloos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maxillofacial surgeon, Head of Department', 'investigatorFullName': 'Johan Abeloos', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}