[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fractures-comminuted\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fractures-comminuted":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100658717","virtual-surgical-planning-and-preoperative-plate-bending-for-maxillofacial-fractures-100658717",false,"NCT07856589","Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures","Evaluation of the Effectiveness of Virtual Surgical Planning and Preoperative Plate Bending in the Treatment of Maxillofacial Fractures Requiring Reconstruction Plate Fixation","Inclusion Criteria:\n\n* Patients with maxillofacial trauma diagnosed with complex mandibular. fractures, with or without associated fractures in other maxillofacial regions.\n* Patients indicated for open reduction and internal fixation using reconstruction plates.\n* Patients treated at the National Hospital of Odonto-Stomatology in Ho Chi. Minh City or the University Medical Center Ho Chi Minh City.\n* Patients recruited during the study period from January 2026 to December. 2027.\n* Patients who agree to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study or do not provide informed consent.\n* Patients with mandibular fractures not requiring reconstruction plate fixation.\n* Patients with medical conditions contraindicating general anesthesia or surgical treatment.\n* Patients with incomplete preoperative or postoperative clinical or radiographic data.\n* Patients who are unable to complete postoperative follow-up assessment.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","Purpose: Complex mandibular fractures are commonly associated with high-energy maxillofacial trauma and may result in disruption of mandibular continuity, facial deformity, malocclusion, and impaired mastication and speech. Surgical management is challenging because comminuted or displaced bone fragments can obscure normal anatomical landmarks and make accurate restoration of mandibular anatomy difficult. Although reconstruction plates provide stable fixation, conventional intraoperative plate bending is technically demanding and may contribute to inaccurate plate adaptation, condylar malposition, facial asymmetry, or prolonged operative time. This study aims to evaluate the effectiveness of Virtual Surgical Planning (VSP) combined with three-dimensional (3D) printing and preoperative reconstruction plate bending compared with conventional surgery in patients with complex mandibular fractures requiring reconstruction plate fixation.\n\nMethod: This study is designed as a randomized controlled clinical trial involving patients with maxillofacial trauma diagnosed with complex mandibular fractures, with or without associated maxillofacial fractures, who are indicated for open reduction and internal fixation using reconstruction plates. The study will be conducted at the National Hospital of Odonto-Stomatology in Ho Chi Minh City and the University Medical Center Ho Chi Minh City from August 2026 to August 2028.\n\nEligible participants will be randomly allocated to two groups. The Virtual Surgery Group will undergo preoperative computed tomography (CT)-based virtual fracture reduction, followed by fabrication of a patient-specific 3D-printed mandibular model and preoperative bending of the reconstruction plate according to the virtually restored mandibular anatomy. The Conventional Surgery Group will undergo standard open reduction and internal fixation with reconstruction plate adaptation and bending performed intraoperatively.\n\nData collection will include preoperative clinical and radiographic characteristics, operative parameters, and postoperative clinical and radiographic outcomes. Postoperative imaging will be used to assess the accuracy of mandibular reduction and restoration of anatomical relationships. Operative time and early postoperative outcomes, including pain and swelling, will also be compared between the two treatment approaches.\n\nExpected Results: The investigators anticipate that VSP combined with 3D printing and preoperative reconstruction plate bending will provide greater accuracy in restoring mandibular anatomy compared with conventional surgery. Improved preoperative planning and plate adaptation are expected to reduce the need for intraoperative plate adjustment, shorten operative time, and decrease postoperative swelling and pain. The approach may also improve restoration of mandibular symmetry, occlusion, and condylar position.\n\nConclusions: If this study demonstrates that VSP, 3D printing, and preoperative reconstruction plate bending provide greater surgical accuracy and improved perioperative outcomes compared with conventional techniques, these findings could support their broader application in the management of complex mandibular fractures. This approach may provide oral and maxillofacial surgeons with a more precise and efficient method for restoring mandibular anatomy, while reducing operative burden and early postoperative morbidity in patients with complex maxillofacial trauma.",[26,27,28],"Mandibular Fractures","Maxillofacial Injuries","Fractures, Comminuted",[30,26,31,32,33],"Virtual Surgical Planning","Preoperative Plate Bending","Maxillofacial Trauma","Reconstruction Plate Fixation","NOT_YET_RECRUITING","2026-09-30",{"date":37,"type":38},"2026-10-02","ACTUAL",{"date":40,"type":20},"2026-09-20",{"date":42,"type":20},"2028-12-31",{"name":44,"class":45},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER"]