Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-08 @ 3:52 PM
Study NCT ID:
NCT02466269
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Diacapitular Condylar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}, {'id': 'D020220', 'term': 'Facial Nerve Injuries'}], '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'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020209', 'term': 'Cranial Nerve Injuries'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from facial nerve function at 24 hours postoperatively', 'timeFrame': '24 hours', 'description': 'The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.'}, {'measure': 'Change from facial nerve function at 1 week postoperatively', 'timeFrame': '1 week', 'description': 'The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.'}, {'measure': 'Change from facial nerve function at 3 months postoperatively', 'timeFrame': '3 months', 'description': 'The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.'}, {'measure': 'Change from facial nerve function at 6 months postoperatively', 'timeFrame': '6 months', 'description': 'The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.'}, {'measure': 'Change from facial nerve function at 12 months postoperatively', 'timeFrame': '12 months', 'description': 'The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Facial Nerve Injuries'], 'conditions': ['Mandibular Fractures']}, 'referencesModule': {'references': [{'pmid': '3478083', 'type': 'BACKGROUND', 'citation': 'Amaratunga NA. A study of condylar fractures in Sri Lankan patients with special reference to the recent views on treatment, healing and sequelae. Br J Oral Maxillofac Surg. 1987 Oct;25(5):391-7. doi: 10.1016/0266-4356(87)90088-x.'}, {'pmid': '1527654', 'type': 'BACKGROUND', 'citation': 'Silvennoinen U, Iizuka T, Lindqvist C, Oikarinen K. Different patterns of condylar fractures: an analysis of 382 patients in a 3-year period. J Oral Maxillofac Surg. 1992 Oct;50(10):1032-7. doi: 10.1016/0278-2391(92)90484-h.'}, {'pmid': '21458284', 'type': 'BACKGROUND', 'citation': 'Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN. 1,454 mandibular fractures: a 3-year study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofac Surg. 2012 Feb;40(2):116-23. doi: 10.1016/j.jcms.2011.03.012. Epub 2011 Mar 31.'}, {'pmid': '3856795', 'type': 'BACKGROUND', 'citation': 'Ellis E 3rd, Moos KF, el-Attar A. Ten years of mandibular fractures: an analysis of 2,137 cases. Oral Surg Oral Med Oral Pathol. 1985 Feb;59(2):120-9. doi: 10.1016/0030-4220(85)90002-7. No abstract available.'}, {'pmid': '11010766', 'type': 'BACKGROUND', 'citation': 'Marker P, Nielsen A, Bastian HL. Fractures of the mandibular condyle. Part 1: patterns of distribution of types and causes of fractures in 348 patients. Br J Oral Maxillofac Surg. 2000 Oct;38(5):417-21. doi: 10.1054/bjom.2000.0317.'}, {'pmid': '15620780', 'type': 'BACKGROUND', 'citation': 'Loukota RA, Eckelt U, De Bont L, Rasse M. Subclassification of fractures of the condylar process of the mandible. Br J Oral Maxillofac Surg. 2005 Feb;43(1):72-3. doi: 10.1016/j.bjoms.2004.08.018.'}, {'pmid': '402318', 'type': 'BACKGROUND', 'citation': 'Lindahl L. Condylar fractures of the mandible. I. Classification and relation to age, occlusion, and concomitant injuries of teeth and teeth-supporting structures, and fractures of the mandibular body. Int J Oral Surg. 1977 Feb;6(1):12-21. doi: 10.1016/s0300-9785(77)80067-7.'}, {'pmid': '13152606', 'type': 'BACKGROUND', 'citation': 'THOMA KH. Treatment of condylar fractures. J Oral Surg (Chic). 1954 Apr;12(2):112-20. No abstract available.'}, {'pmid': '17055280', 'type': 'BACKGROUND', 'citation': 'Zachariades N, Mezitis M, Mourouzis C, Papadakis D, Spanou A. Fractures of the mandibular condyle: a review of 466 cases. Literature review, reflections on treatment and proposals. J Craniomaxillofac Surg. 2006 Oct;34(7):421-32. doi: 10.1016/j.jcms.2006.07.854. Epub 2006 Oct 19.'}, {'type': 'BACKGROUND', 'citation': 'Spiessl B, Schroll K. Gelenkfortsatz und gelenkkopfchenfracturen (Fractures of the condylar neck and head). Spezielle frakture und luxationslehre (Textbook of specialised fractures and dislocations) BD. I/I. Stuttgart: Thieme. 1972.'}, {'pmid': '19896755', 'type': 'BACKGROUND', 'citation': 'Loukota RA, Neff A, Rasse M. Nomenclature/classification of fractures of the mandibular condylar head. Br J Oral Maxillofac Surg. 2010 Sep;48(6):477-8. doi: 10.1016/j.bjoms.2009.08.036. Epub 2009 Nov 6. No abstract available.'}, {'pmid': '22842852', 'type': 'BACKGROUND', 'citation': 'Chrcanovic BR. Open versus closed reduction: diacapitular fractures of the mandibular condyle. Oral Maxillofac Surg. 2012 Sep;16(3):257-65. doi: 10.1007/s10006-012-0337-6. Epub 2012 Jul 28.'}, {'pmid': '20430506', 'type': 'BACKGROUND', 'citation': 'He D, Yang C, Chen M, Bin J, Zhang X, Qiu Y. Modified preauricular approach and rigid internal fixation for intracapsular condyle fracture of the mandible. J Oral Maxillofac Surg. 2010 Jul;68(7):1578-84. doi: 10.1016/j.joms.2009.07.076.'}, {'pmid': '12089693', 'type': 'BACKGROUND', 'citation': 'Hlawitschka M, Eckelt U. Assessment of patients treated for intracapsular fractures of the mandibular condyle by closed techniques. J Oral Maxillofac Surg. 2002 Jul;60(7):784-91; discussion 792. doi: 10.1053/joms.2002.33246.'}, {'type': 'BACKGROUND', 'citation': 'Molina CV, Moreno RO, Coloma OB, Meza VD, Silva MA. Preauricular approach: our alternative for surgical treatment of condylar fractures. International Journal of Oral and Maxillofacial Surgery. 2013;42:1236'}, {'pmid': '24293937', 'type': 'BACKGROUND', 'citation': 'Mohan AP, Jeevan Kumar KA, Venkatesh V, Pavan Kumar B, Patil K. Comparison of preauricular approach versus retromandibular approach in management of condylar fractures. J Maxillofac Oral Surg. 2012 Dec;11(4):435-41. doi: 10.1007/s12663-012-0350-1. Epub 2012 Apr 4.'}, {'pmid': '6877014', 'type': 'BACKGROUND', 'citation': 'House JW. Facial nerve grading systems. Laryngoscope. 1983 Aug;93(8):1056-69. doi: 10.1288/00005537-198308000-00016.'}, {'pmid': '3921901', 'type': 'BACKGROUND', 'citation': 'House JW, Brackmann DE. Facial nerve grading system. Otolaryngol Head Neck Surg. 1985 Apr;93(2):146-7. doi: 10.1177/019459988509300202. No abstract available.'}, {'type': 'RESULT', 'citation': 'Rowe NL, Killey HC. Fractures of the facial skeleton: E. & S. Livingstone; 1955.'}, {'pmid': '12621288', 'type': 'RESULT', 'citation': 'Cascone P, Leonardi R, Marino S, Carnemolla ME. Intracapsular fractures of mandibular condyle: diagnosis, treatment, and anatomical and pathological evaluations. J Craniofac Surg. 2003 Mar;14(2):184-91. doi: 10.1097/00001665-200303000-00009.'}, {'type': 'RESULT', 'citation': 'Rowe NL, Killey HC. Fractures of the facial skeleton: Churchill Livingstone; 1968.'}, {'pmid': '5024527', 'type': 'RESULT', 'citation': 'Rowe NL. Surgery of the temporomandibular joint. Proc R Soc Med. 1972 Apr;65(4):383-8. doi: 10.1177/003591577206500438. No abstract available.'}, {'pmid': '298842', 'type': 'RESULT', 'citation': 'Al-Kayat A, Bramley P. A modified pre-auricular approach to the temporomandibular joint and malar arch. Br J Oral Surg. 1979 Nov;17(2):91-103. doi: 10.1016/s0007-117x(79)80036-0.'}, {'pmid': '6957557', 'type': 'RESULT', 'citation': 'Dolwick MF, Kretzschmar DP. Morbidity associated with the preauricular and perimeatal approaches to the temporomandibular joint. J Oral Maxillofac Surg. 1982 Nov;40(11):699-700. doi: 10.1016/0278-2391(82)90141-0. No abstract available.'}, {'pmid': '21778851', 'type': 'RESULT', 'citation': 'Lima SM Jr, Asprino L, Moreira RW, de Moraes M. Surgical complications of mandibular condylar fractures. J Craniofac Surg. 2011 Jul;22(4):1512-5. doi: 10.1097/SCS.0b013e31821d4c6f.'}, {'pmid': '3855313', 'type': 'RESULT', 'citation': 'Hall MB, Brown RW, Lebowitz MS. Facial nerve injury during surgery of the temporomandibular joint: a comparison of two dissection techniques. J Oral Maxillofac Surg. 1985 Jan;43(1):20-3. doi: 10.1016/s0278-2391(85)80008-2.'}, {'pmid': '17448850', 'type': 'RESULT', 'citation': 'do Egito Vasconcelos BC, Bessa-Nogueira RV, da Silva LC. Prospective study of facial nerve function after surgical procedures for the treatment of temporomandibular pathology. J Oral Maxillofac Surg. 2007 May;65(5):972-8. doi: 10.1016/j.joms.2006.06.280.'}, {'pmid': '1527657', 'type': 'RESULT', 'citation': 'Weinberg S, Kryshtalskyj B. Facial nerve function following temporomandibular joint surgery using the preauricular approach. J Oral Maxillofac Surg. 1992 Oct;50(10):1048-51. doi: 10.1016/0278-2391(92)90488-l.'}, {'pmid': '20083736', 'type': 'RESULT', 'citation': 'Babakurban ST, Cakmak O, Kendir S, Elhan A, Quatela VC. Temporal branch of the facial nerve and its relationship to fascial layers. Arch Facial Plast Surg. 2010 Jan-Feb;12(1):16-23. doi: 10.1001/archfacial.2009.96.'}, {'pmid': '17096156', 'type': 'RESULT', 'citation': 'Krayenbuhl N, Isolan GR, Hafez A, Yasargil MG. The relationship of the fronto-temporal branches of the facial nerve to the fascias of the temporal region: a literature review applied to practical anatomical dissection. Neurosurg Rev. 2007 Jan;30(1):8-15; discussion 15. doi: 10.1007/s10143-006-0053-5. Epub 2006 Nov 10.'}, {'pmid': '16192853', 'type': 'RESULT', 'citation': 'Kim S, Matic DB. The anatomy of temporal hollowing: the superficial temporal fat pad. J Craniofac Surg. 2005 Sep;16(5):760-3. doi: 10.1097/01.scs.0000180010.83480.10.'}, {'pmid': '15346360', 'type': 'RESULT', 'citation': 'Politi M, Toro C, Cian R, Costa F, Robiony M. The deep subfascial approach to the temporomandibular joint. J Oral Maxillofac Surg. 2004 Sep;62(9):1097-102. doi: 10.1016/j.joms.2003.10.013.'}]}, 'descriptionModule': {'briefSummary': 'A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.', 'detailedDescription': 'Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diacapitular condylar fractures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical and radiographical diagnosis of DFs;\n\nExclusion Criteria:\n\n1. condylar fractures with undisplaced fractures;\n2. Fractures without the reduction of the condylar height;\n3. A obvious scar at the temporal region, affecting the placement of the original incision.'}, 'identificationModule': {'nctId': 'NCT02466269', 'briefTitle': 'Treatment of Diacapitular Condylar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'West China College of Stomatology'}, 'officialTitle': 'A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach', 'orgStudyIdInfo': {'id': 'hui_owen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the preauricular approach', 'description': 'A classic preauricular incision was used to treat diacapitular condylar fractures', 'interventionNames': ['Procedure: The supratemporalis approach']}], 'interventions': [{'name': 'The supratemporalis approach', 'type': 'PROCEDURE', 'description': 'The supratemporalis approach was applied in treatment of diacapitular condylar fractures', 'armGroupLabels': ['the preauricular approach']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lei Li, DMD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hui Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'West China College of Stomatology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hui Li', 'investigatorAffiliation': 'West China College of Stomatology'}}}}