[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658717":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":49,"studyPopulation":37,"armGroups":50,"interventions":63,"overallOfficials":37,"centralContacts":37,"locations":73,"responsibleParty":95,"collaborators":37,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":37,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":37,"enrollmentInfo":107,"targetDuration":37,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":123,"whyStopped":37,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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.","At 7 days and 1, 3, 4, and 6 months postoperatively",[14,17,21,24,27,30,34],{"measure":15,"description":16,"timeFrame":12},"Postoperative Occlusal Status","The secondary endpoint is the difference in postoperative clinical outcomes between the two groups.\n\nPostoperative 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.",{"measure":18,"description":19,"timeFrame":20},"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.","During surgery",{"measure":22,"description":23,"timeFrame":12},"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 \\\u003C1 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.",{"measure":25,"description":26,"timeFrame":12},"Wound Dehiscence","The presence or absence of postoperative wound dehiscence will be assessed by clinical examination and recorded as a binary outcome (yes\u002Fno). The number of participants with wound dehiscence will be recorded.",{"measure":28,"description":29,"timeFrame":12},"Reconstruction Plate Exposure","The presence or absence of postoperative reconstruction plate exposure will be assessed by clinical examination and recorded as a binary outcome (yes\u002Fno).",{"measure":31,"description":32,"timeFrame":33},"Lower Lip and Chin Numbness","The presence or absence of numbness involving the lower lip and\u002For chin will be recorded as a binary outcome (yes\u002Fno).","At 7 days and 1, 3, 4, and 6 months postoperatively.",{"measure":35,"description":36,"timeFrame":33},"Postoperative Facial Nerve (Cranial Nerve VII) Dysfunction","Postoperative facial nerve function will be assessed clinically based on facial soft-tissue symmetry during smiling, adapted from the assessment described by Ellis (2000). Symmetry of the upper and lower lips will be observed during animation. Facial nerve dysfunction will be recorded as a binary outcome: absent when the upper and lower lips are symmetric during smiling, and present when asymmetry of the upper and\u002For lower lip is observed. The number of participants with facial nerve dysfunction will be recorded.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":45},"TRIPLE","Participants will be randomly allocated to either conventional surgery with intraoperative reconstruction plate bending or virtual surgical planning-assisted surgery using a preoperatively bent reconstruction plate. Allocation will be performed by an operating nurse using sealed envelopes. Participants, the investigator, and the outcomes assessor will remain unaware of group assignment during data collection and postoperative clinical and radiographic assessment. Surgeons and operating room staff will not be masked because the surgical procedure requires knowledge of whether an intraoperatively bent or preoperatively bent reconstruction plate is used.",[46,47,48],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Introduction:\n\nMaxillofacial trauma is one of the most common traumatic conditions, particularly in countries with a high incidence of traffic accidents. High-energy trauma, including high-speed traffic collisions, falls, occupational accidents, and other severe injuries, may result in complex maxillofacial fractures. Among these injuries, complex mandibular fractures are particularly challenging because they may disrupt mandibular continuity, cause facial deformity, alter occlusion, and impair important functions such as mastication and speech. Comminuted mandibular fractures frequently consist of multiple displaced bone fragments. The displacement and fragmentation of the mandible may obscure normal anatomical landmarks, making accurate reduction and restoration of the original mandibular anatomy difficult. Complex mandibular fractures may also occur together with fractures of other regions of the maxillofacial skeleton, further increasing the difficulty of surgical reconstruction.\n\nIn patients with complex mandibular fractures, reconstruction plates may be required to provide stable load-bearing fixation, restore mandibular continuity, and facilitate postoperative functional recovery. Reconstruction plates may also be indicated in selected cases of atrophic mandibular fractures, postoperative nonunion, and fracture-dislocation of the mandibular condyle.\n\nConventionally, reconstruction plates are adapted and bent intraoperatively after exposure and reduction of the fractured mandibular segments. However, intraoperative plate bending is technically demanding and depends substantially on the surgeon's ability to reproduce the original mandibular contour. In complex fractures, particularly comminuted fractures with loss of reliable anatomical landmarks, accurate plate adaptation may be difficult. Inaccurate restoration of mandibular anatomy may contribute to condylar malposition, facial asymmetry, malocclusion, and compromised mandibular function.\n\nVirtual Surgical Planning (VSP), combined with three-dimensional (3D) printing, provides an alternative approach for the management of complex mandibular fractures. Computed tomography (CT) data can be converted into three-dimensional anatomical models, allowing individual fracture fragments to be identified and virtually repositioned before surgery. Following virtual fracture reduction, a corrected mandibular model can be fabricated using 3D printing. A reconstruction plate can then be bent preoperatively according to the reconstructed patient-specific mandibular anatomy.\n\nThis approach allows several technically demanding procedures to be completed before surgery. Virtual restoration of mandibular anatomy and preoperative reconstruction plate adaptation on a corrected 3D-printed model may improve the accuracy of fracture reduction and plate positioning while reducing the amount of plate manipulation required during surgery.\n\nVSP and 3D printing have been increasingly applied in oral and maxillofacial surgery, particularly in mandibular reconstruction after segmental resection and orthognathic surgery. However, their application in traumatic maxillofacial fracture management remains relatively limited. Preliminary studies suggest that three-dimensional planning and preoperative plate bending may improve anatomical reduction, increase surgical accuracy, and reduce operative time compared with conventional intraoperative plate bending.\n\nIn Vietnam, conventional reduction and intraoperative reconstruction plate bending remain commonly used for the management of complex mandibular fractures. The application of VSP, virtual fracture reduction, 3D-printed mandibular models, and preoperatively bent reconstruction plates in maxillofacial trauma is still developing. Clinical evidence comparing this approach with conventional surgery remains limited.\n\nTherefore, the investigators initiated this study to evaluate the effectiveness of Virtual Surgical Planning combined with three-dimensional printing and preoperative reconstruction plate bending in the treatment of complex mandibular fractures requiring reconstruction plate fixation.\n\nResearch Question: Is virtual surgical planning combined with three-dimensional printing and preoperative reconstruction plate bending more effective than the conventional approach?\n\nMethod:\n\nThis study is designed as a randomized controlled clinical trial involving patients with maxillofacial trauma diagnosed with complex mandibular fractures, with or without associated fractures of other maxillofacial regions, who are indicated for open reduction and internal fixation using reconstruction plates.\n\nParticipants will be recruited 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. Only eligible patients who agree to participate and provide informed consent will be included in the study.\n\nThe study is going to be conducted through a series of sequential steps, including preoperative assessment, digital treatment planning, randomization, surgical treatment, and postoperative evaluation.\n\nStep 1: Patient Enrollment and Preoperative Assessment\n\n* Potential participants will be screened according to the study eligibility criteria. Eligible patients will receive information regarding the study, including the characteristics of the surgical approaches, and will be provided with a study information sheet and informed consent form.\n* After informed consent is obtained, baseline information will be collected using a predesigned case report form. Recorded variables will include age, sex, occupation, address, telephone number, cause of trauma, relevant systemic diseases, and smoking status.\n* Causes of trauma will include traffic accidents, occupational accidents, assault, and other causes such as sports injuries or domestic accidents. Relevant systemic diseases, including hypertension, cardiovascular disease, diabetes mellitus, and other medical conditions, will also be documented.\n* Clinical examination will document maxillofacial signs and symptoms, including facial deformity, facial asymmetry, subconjunctival hemorrhage, enophthalmos or exophthalmos, diplopia, decreased visual acuity, optic nerve injury, globe rupture, and malocclusion.\n* Malocclusion will be defined as at least one pair of teeth that does not achieve appropriate intercuspation at maximum intercuspation.\n\nNeurological assessment will include signs of trigeminal nerve injury, facial nerve injury, and other cranial nerve abnormalities, including ptosis, pupillary dilation, or ophthalmoplegia. Signs of cerebrospinal fluid leakage through the nose or ear will also be documented.\n\n* Associated traumatic injuries, including traumatic brain injury, cervical spine injury, limb fractures, abdominal trauma, and thoracic trauma, will be recorded.\n* Radiographic assessment will include maxillofacial CT with three-dimensional reconstruction. Imaging will be evaluated for fracture location, side, type, displacement, and associated fracture patterns.\n* Mandibular fracture locations will include the condyle, ramus, angle, body, and symphysis or chin region. Fracture involvement will be classified as right-sided, left-sided, or bilateral.\n* Types of mandibular fractures included in the study will comprise comminuted fractures, atrophic mandibular fractures, postoperative nonunion, fracture-dislocation of the mandibular condyle.\n* Associated maxillofacial fractures will include zygomatic complex fractures; maxillary fractures including Le Fort I, Le Fort II, Le Fort III, midline sagittal and lateral sagittal fractures; naso-orbito-ethmoidal complex fractures; and frontal bone fractures.\n\nStep 2: Virtual Surgical Planning and 3D Model Preparation\n\n* Maxillofacial CT data will be used for digital surgical planning. Digital Imaging and Communications in Medicine (DICOM) data will be imported into imaging software to reconstruct a three-dimensional model of the maxillofacial skeleton, which will then be exported in a suitable three-dimensional file format for further processing.\n* The reconstructed three-dimensional model will subsequently be processed using appropriate digital planning software. Individual fractured bone fragments will be digitally segmented and repositioned to their intended anatomical locations to simulate fracture reduction and restore mandibular anatomy.\n* Virtual fracture reduction will include restoration of mandibular continuity and repositioning of both mandibular condyles into the glenoid fossae. After completion of virtual reduction, the corrected mandibular model will be exported as a stereolithography (STL) file.\n* The corrected model will be used to establish landmarks for reconstruction plate positioning and screw placement. The intended reconstruction plate position will be close to the inferior mandibular border and below the inferior alveolar nerve.\n* A screw-positioning guide will be designed to assist fixation at both ends of the fracture, with at least three screw holes planned on each side.\n* The virtually reduced mandibular model will then be fabricated using three-dimensional printing. A 2.4-mm titanium reconstruction plate will be bent according to the contour of the printed mandibular model so that it closely adapts to the reconstructed bone surface.\n* The preoperatively bent reconstruction plate and related surgical aids will be prepared and sterilized according to the hospital infection control protocol before surgery.\n\nStep 3: Randomization and Group Allocation Before surgery, eligible participants will be randomly allocated by drawing lots into one of two treatment groups.\n\nGroup A - Conventional Surgery Group - Participants allocated to Group A will undergo conventional open reduction and internal fixation, with reconstruction plate bending and adaptation performed intraoperatively.\n\nGroup B - Virtual Surgical Planning-Assisted Surgery Group\n\n* Participants allocated to Group B will undergo surgery using CT-based Virtual Surgical Planning, virtual fracture reduction, a three-dimensional printed corrected mandibular model, a screw-positioning guide, and a reconstruction plate preoperatively bent according to the virtually reconstructed mandibular anatomy.\n* After randomization, the allocation form will be placed in a sealed envelope according to the study allocation procedure. The allocation information will be concealed from the investigator responsible for postoperative outcome assessment until completion of data collection, according to the study protocol.\n\nStep 4: Surgical Treatment Participants in both groups will undergo general anesthesia with nasotracheal or submental endotracheal intubation. Local anesthesia using 2% lidocaine with epinephrine 1:200,000 will be administered at the fracture site and planned incision site.\n\nFor participants with associated maxillary or zygomatic fractures, fracture reduction will be performed from superior to inferior and from lateral to medial according to the fracture pattern.\n\nSurgical approaches may include coronal, orbital rim, upper eyelid, lower eyelid, preauricular, or maxillary vestibular incisions as appropriate for each fracture pattern.\n\nSurgical treatment of comminuted mandibular fractures will generally be performed after reduction and fixation of associated maxillary or zygomatic fractures.\n\nA vestibular approach may be used when the comminuted mandibular fracture segment is relatively short and accessible intraorally. In most comminuted fractures, an extraoral approach will be required. The incision will be placed approximately 1.5 to 2 cm below the inferior mandibular border and extended according to the location and extent of the fracture.\n\nFollowing surgical exposure, fractured bone segments will be identified. Loose bone fragments, fibrous tissue, and hematoma will be removed when appropriate. Reduction and definitive fixation will then be performed according to treatment allocation.\n\nGroup A - Conventional Surgery:\n\n* In Group A, the fractured mandibular segments will be reduced using the conventional surgical technique.\n* The reconstruction plate will be manually bent and adapted intraoperatively according to the reconstructed mandibular contour. After satisfactory plate adaptation has been achieved, drilling and screw fixation will be performed.\n* The surgical field will subsequently be irrigated, followed by layered wound closure and drain placement.\n\nGroup B - Virtual Surgical Planning-Assisted Surgery\n\n* In Group B, the fractured mandibular segments will be anatomically reduced according to the preoperative virtual plan.\n* The screw-positioning guide designed during virtual planning will be positioned at both ends of the fracture, and pilot drilling will be performed to reproduce the predetermined screw positions.\n* The preoperatively bent reconstruction plate will then be positioned over the fracture region. Plate position and bone reduction will be verified clinically, followed by drilling and screw fixation.\n* The surgical field will subsequently be irrigated, followed by layered wound closure and drain placement.\n\nStep 5: Measurement of Operative Time\n\n* Operative time will be recorded for each participant during surgery.\n* Operative time will be defined as the interval, measured in minutes, from the first skin or mucosal incision to completion of the surgical procedure.\n\nOperative time will subsequently be compared between the Conventional Surgery Group and the Virtual Surgical Planning-Assisted Surgery Group.\n\n\\- Time Frame: During surgery.\n\nStep 6: Postoperative Management\n\n* All participants will receive the same postoperative medication regimen according to the study protocol, including Augmentin 1 g twice daily for 3 days, Dexamethasone 4 mg intramuscularly twice daily for 3 days, and intravenous Perfalgan 1 g\u002F100 mL twice daily for 3 days.\n* Participants will be discharged after 3 days and will return for follow-up 4 days after discharge, corresponding to postoperative day 7.\n\nStep 7: Postoperative Clinical and Radiographic Evaluation\n\n* Postoperative clinical and radiographic evaluation will be performed on postoperative day 7.\n* The investigator will assess the postoperative condition using standardized clinical and radiographic criteria. The findings will be compared between the Conventional Surgery Group and the Virtual Surgical Planning-Assisted Surgery Group.\n* Radiographic assessment will evaluate mandibular fracture reduction and reconstruction plate position after surgery.\n* Clinical assessment will include occlusion, facial symmetry, wound healing, and neurosensory or functional findings.\n\nTogether with operative time recorded during surgery, these findings will be used to evaluate the comparative effectiveness of the two surgical approaches.\n\nStudy Variables:\n\n* The predictor variable for this study is the surgical treatment approach used for reconstruction plate preparation and fixation, either conventional intraoperative plate bending or Virtual Surgical Planning-assisted preoperative plate bending on a three-dimensional printed mandibular model.\n* Other variables collected during the study will include: Age, Sex, Cause of trauma, Smoking status. Relevant systemic diseases, Clinical signs and symptoms, Malocclusion, Neurological findings, Associated traumatic injuries, Location of the mandibular fracture, Side of the fracture, Type of mandibular fracture, Associated maxillofacial fractures.\n\nThe primary outcome is the difference in postoperative radiographic reduction between the two groups, assessed by mandibular fracture reduction and reconstruction plate position on postoperative day 7. The secondary clinical outcome is the difference in postoperative occlusion, facial symmetry, wound healing, and neurosensory or functional findings between the two groups on postoperative day 7.\n\nThe secondary outcome variable is the operative time, measured in minutes from the first skin or mucosal incision to completion of surgery. This outcome will also be compared between the two groups.\n\nStatistical Analysis\n\n* Descriptive statistics will be used to summarize baseline demographic, clinical, and radiographic characteristics of the two groups. Continuous variables will be presented as mean ± standard deviation or median and interquartile range, depending on data distribution, while categorical variables will be presented as frequencies and percentages.\n* Baseline characteristics between the Conventional Surgery Group and the Virtual Surgical Planning-Assisted Surgery Group will be compared using the independent-samples t-test or Mann-Whitney U test for continuous variables, and the chi-square test or Fisher's exact test for categorical variables, as appropriate.\n* For the primary outcome, postoperative radiographic reduction outcomes on postoperative day 7 will be compared between the two groups using an appropriate test according to the type and distribution of the outcome data. Continuous radiographic measurements will be compared using the independent-samples t-test or Mann-Whitney U test, while categorical radiographic outcomes will be compared using the chi-square test or Fisher's exact test.\n* For the secondary outcomes, postoperative clinical treatment outcomes, including occlusion, facial symmetry, wound healing, and neurosensory or functional findings, will be compared between the two groups using the chi-square test or Fisher's exact test, as appropriate. Operative time will be compared between the two groups using the independent-samples t-test if normally distributed or the Mann-Whitney U test if the normality assumption is not met.\n* All statistical tests will be two-sided, and a p-value \\\u003C 0.05 will be considered statistically significant. Statistical analyses will be performed using appropriate statistical software.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Conventional Surgery With Intraoperative Plate Bending","ACTIVE_COMPARATOR","Participants in this arm will undergo conventional open reduction and internal fixation for complex mandibular fractures requiring reconstruction plate fixation. The fractured bone segments will be reduced intraoperatively, and the 2.4-mm titanium reconstruction plate will be manually bent during surgery to adapt to the mandibular anatomy before screw fixation. Standard irrigation, layered wound closure, drain placement, and postoperative care will be performed",[56],"Procedure: Conventional Open Reduction and Internal Fixation With Intraoperative Plate Bending",{"label":58,"type":59,"description":60,"interventionNames":61},"Virtual Surgical Planning-Assisted Surgery With Preoperative Plate Bending","EXPERIMENTAL","Participants in this arm will undergo open reduction and internal fixation using a reconstruction plate pre-bent before surgery according to a three-dimensional printed mandibular model. Preoperative CT data will be converted into a three-dimensional model, followed by virtual fracture reduction and printing of the corrected mandibular model. A 2.4-mm titanium reconstruction plate will be bent on the printed model and sterilized before surgery. During surgery, the fractured bone segments will be anatomically reduced, the pre-bent plate will be placed over the fracture site, and screw fixation will be performed. Standard irrigation, layered wound closure, drain placement, and postoperative care will be performed.",[62],"Procedure: Virtual Surgical Planning-Assisted Open Reduction and Internal Fixation With Preoperative Plate Bending",[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":37},"PROCEDURE","Conventional Open Reduction and Internal Fixation With Intraoperative Plate Bending","Participants will undergo conventional open reduction and internal fixation with intraoperative reconstruction plate bending.",[52],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":37},"Virtual Surgical Planning-Assisted Open Reduction and Internal Fixation With Preoperative Plate Bending","Participants will undergo virtual surgical planning-assisted open reduction and internal fixation using a preoperatively bent reconstruction plate.",[58],[74],{"facility":75,"status":37,"city":76,"state":37,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"National Hospital of Odonto-Stomatology at Ho Chi Minh city","Ho Chi Minh City","700000","Vietnam","VN",{"type":81,"coordinates":82},"Point",[83,84],106.62965,10.82302,{"lat":84,"lon":83},[87,92],{"name":88,"role":89,"phone":90,"phoneExt":37,"email":91},"Anh T Hoang, MSc.","CONTACT","+84339964769","anhtruongbmt@gmail.com",{"name":93,"role":94,"phone":37,"phoneExt":37,"email":37},"Anh T.T. Hoang, MSc.","PRINCIPAL_INVESTIGATOR",{"type":94,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Anh Thai Hoang Truong","Lecturer and Principal Investigator","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":108,"type":109},30,"ESTIMATED","INTERVENTIONAL",[112],"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.",[115,116,117],"Mandibular Fractures","Maxillofacial Injuries","Fractures, Comminuted",[119,115,120,121,122],"Virtual Surgical Planning","Preoperative Plate Bending","Maxillofacial Trauma","Reconstruction Plate Fixation","NOT_YET_RECRUITING","2026-09-30",{"date":126,"type":127},"2026-10-02","ACTUAL",{"date":129,"type":109},"2026-09-20",{"date":131,"type":109},"2028-12-31",{"name":5,"class":6},1]