Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures

NCT07856589 | Not Yet Recruiting DMC

• 1 other identifier: 3418/DHYD-HDDD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Fractures; Maxillofacial Injuries; Fractures, Comminuted

Keywords

Virtual Surgical Planning; Mandibular Fractures; Preoperative Plate Bending; Maxillofacial Trauma; Reconstruction Plate Fixation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Postoperative Occlusal Status

  At 7 days and 1, 3, 4, and 6 months postoperatively

• Operative time

  During surgery

• Surgical Site Infection

  At 7 days and 1, 3, 4, and 6 months postoperatively

• Wound Dehiscence

  At 7 days and 1, 3, 4, and 6 months postoperatively

• Reconstruction Plate Exposure

  At 7 days and 1, 3, 4, and 6 months postoperatively

Study Arms (2)

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

Procedure: Conventional Open Reduction and Internal Fixation With Intraoperative Plate Bending

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.

Procedure: Virtual Surgical Planning-Assisted Open Reduction and Internal Fixation With Preoperative Plate Bending

Interventions

Conventional Open Reduction and Internal Fixation With Intraoperative Plate Bending PROCEDURE

Participants will undergo conventional open reduction and internal fixation with intraoperative reconstruction plate bending.

Conventional Surgery With Intraoperative Plate Bending

Virtual Surgical Planning-Assisted Open Reduction and Internal Fixation With Preoperative Plate Bending PROCEDURE

Participants will undergo virtual surgical planning-assisted open reduction and internal fixation using a preoperatively bent reconstruction plate.

Virtual Surgical Planning-Assisted Surgery With Preoperative Plate Bending

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 agree to participate in the study and provide informed consent.

You may not qualify if:

• 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.
• Patients who are unable to complete postoperative follow-up assessment.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

National Hospital of Odonto-Stomatology at Ho Chi Minh city

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Mandibular Fractures; Maxillofacial Injuries; Fractures, Comminuted

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Jaw Fractures; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Principal Investigator

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: October 2, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 2030
• Access Criteria: Students and researchers. Through my email address, anhtruong@ump.edu.vn

Locations

VN (1)