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.
Method: 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.
Eligible 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.
Data 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.
Expected 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.
Conclusions: 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.
Patients with maxillofacial trauma diagnosed with complex mandibular. fractures, with or without associated fractures in other maxillofacial regions.
Patients indicated for open reduction and internal fixation using reconstruction plates.
Patients treated at the National Hospital of Odonto-Stomatology in Ho Chi. Minh City or the University Medical Center Ho Chi Minh City.
Patients recruited during the study period from January 2026 to December. 2027.
Patients who do not agree to participate in the study or do not provide informed consent.
Patients with mandibular fractures not requiring reconstruction plate fixation.
Patients with medical conditions contraindicating general anesthesia or surgical treatment.
Patients with incomplete preoperative or postoperative clinical or radiographic data.
Parallel
Conventional Open Reduction and Internal Fixation With Intraoperative Plate Bending
Procedure/SurgeryParticipants will undergo conventional open reduction and internal fixation with intraoperative reconstruction plate bending.
Virtual Surgical Planning-Assisted Open Reduction and Internal Fixation With Preoperative Plate Bending
Procedure/SurgeryParticipants will undergo virtual surgical planning-assisted open reduction and internal fixation using a preoperatively bent reconstruction plate.
Postoperative radiographic reduction outcome
The primary endpoint is the difference in postoperative radiographic reduction outcome between the conventional surgery group and the virtual surgical planning-assisted surgery group. Radiographic assessment will evaluate mandibular fracture reduction and reconstruction plate position after surgery.
Postoperative Occlusal Status
The secondary endpoint is the difference in postoperative clinical outcomes between the two groups. Postoperative occlusion will be assessed in maximal intercuspation by visual inspection without articulating paper. Patients will be asked about their pre-injury occlusion when necessary. Occlusal status will be classified into three categories: Normal occlusion, all tooth pairs achieve maximal intercuspation; Mild malocclusion, 1-3 tooth pairs fail to achieve maximal intercuspation; Severe malocclusion, more than 3 tooth pairs fail to achieve maximal intercuspation. The number of participants in each category will be recorded.
Operative time
The secondary endpoint is the difference in operative time between the two groups. Operative time will be measured in minutes from the first skin or mucosal incision to completion of the surgical procedure.
Surgical Site Infection
Surgical site infection will be recorded as absent or present. When present, infection will be classified as mild, moderate, or severe. Mild infection: edema with purulent discharge \<1 mL, requiring antibiotics alone. Moderate infection: edema with purulent discharge of 1-5 mL, requiring incision and drainage plus antibiotics. Severe infection: edema with purulent discharge \>5 mL, with or without fever, requiring surgical drainage and irrigation plus intravenous antibiotics. The number of participants in each category will be recorded.
Wound Dehiscence
The presence or absence of postoperative wound dehiscence will be assessed by clinical examination and recorded as a binary outcome (yes/no). The number of participants with wound dehiscence will be recorded.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
