Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual surgical planning and 3D model printing, Prebent titanium miniplates, Conventional open reduction and internal fixation (ORIF), Titanium miniplates and screws (Anton Hipp).
- Who it may be relevant to
- Registry conditions: Facial Bone Fracture, Maxillofacial Injury, Zygomaticomaxillary Complex Fracture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study
Overview
This randomized clinical trial aims to evaluate the accuracy and outcomes of virtual surgical planning (VSP) compared to the traditional surgical technique in the reduction of zygomaticomaxillary complex (ZMC) fractures. Twenty patients with ZMC fractures will be randomly assigned into two equal groups: one treated using virtual planning and prebent titanium miniplates, and the other treated conventionally without virtual planning. Clinical evaluation will include facial symmetry, eye movement, and postoperative complications, while radiographic assessment will be performed using CT scans three months after surgery to measure bone formation and alignment accuracy. The study seeks to determine whether virtual surgical planning improves anatomical restoration, esthetics, and functional outcomes compared to traditional methods.
Detailed description
Background:
The zygomaticomaxillary complex (ZMC) is one of the most frequently fractured regions of the facial skeleton due to its prominent anatomical position. Improper reduction can lead to functional impairment, facial asymmetry, and poor esthetic results. Virtual surgical planning (VSP) and 3D printing have recently been introduced to enhance surgical precision through preoperative simulation and prebending of fixation plates. However, the clinical superiority of this technique over traditional surgical methods remains under investigation.
Objective:
To compare the accuracy and clinical outcomes of virtual surgical planning and prebent titanium miniplates versus conventional open reduction and internal fixation techniques in the management of zygomaticomaxillary complex fractures.
Methods:
This randomized clinical trial will include 20 patients diagnosed with unilateral ZMC fractures, divided equally into two groups.
Group I: Patients treated using virtual surgical planning with 3D model reconstruction, virtual reduction, and prebending of titanium miniplates.
Group II: Patients treated using traditional open reduction and fixation without virtual planning.
All surgeries will be performed under general anesthesia using standard approaches. Clinical evaluation will include assessment of facial symmetry, eye movement, enophthalmos, diplopia, wound healing, and postoperative complications. Radiographic evaluation will be conducted by comparing postoperative 3D CT scans (after 3 months) with preoperative virtual models to assess reduction accuracy and bone formation.
Statistical Analysis:
Data will be analyzed using SPSS software. Descriptive statistics will be presented as mean ± standard deviation. Independent t-tests and ANOVA will be used to compare outcomes between groups, with significance set at p ≤ 0.05.
Expected Outcomes:
It is anticipated that virtual surgical planning will yield superior anatomical accuracy, improved facial symmetry, and reduced intraoperative time and complications compared to conventional techniques.
Ethical Approval:
Approved by the Research Ethics Committee, Faculty of Dentistry, Suez Canal University, on 30 September 2025 (Board Status: Approved).
Study Start Date: October 2025 Estimated Completion Date: October 2026
Interventions
- Procedure Virtual surgical planning and 3D model printing
Preoperative CT segmentation, virtual reduction of fracture fragments using 3D planning software, and printing of the reduced 3D anatomical model for plate prebending. - Device Prebent titanium miniplates
Titanium miniplates prebent on the printed model and used for rigid internal fixation at standard zygomatic fixation points (frontozygomatic suture, infraorbital rim, zygomaticomaxillary buttress) as indicated. - Procedure Conventional open reduction and internal fixation (ORIF)
Standard surgical exposure and manual reduction of fracture fragments with intraoperative confirmation of alignment, followed by contouring and application of titanium miniplates and screws for fixation. - Device Titanium miniplates and screws (Anton Hipp)
Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.
Primary outcome measures
- Accuracy of Fracture Reduction [Time frame: 3 months postoperatively]
Secondary outcome measures (5)
- Facial symmetry [Time frame: 1 week, 1 month, and 3 months postoperatively]
- Eye Movement (Diplopia in Gaze Positions) [Time frame: 1 week and 3 months postoperatively]
- Postoperative Complications [Time frame: Up to 3 months postoperatively]
- Surgical Time [Time frame: Intraoperative (single measurement)]
- Bone Healing [Time frame: 3 months postoperatively]
Eligibility criteria
Inclusion criteria
- Adults (≥18 years) with clinically and radiographically confirmed ZMC fracture.
- Fit for general anesthesia and able to undergo CT imaging.
- Willing to sign informed consent.
Exclusion criteria
- Systemic diseases impairing bone healing (osteoporosis, cancer, long-term steroid use).
- Noncompliance or inability to attend follow-up visits.
- ASA class IV-VI.
- Previous facial deformities or fractures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Suez Canal University — Cairo
Publications
- Longeac M, Depeyre A, Pereira B, Barthelemy I, Pham Dang N. Virtual surgical planning and three-dimensional printing for the treatment of comminuted zygomaticomaxillary complex fracture. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):386-390. doi: 10.1016/j.jormas.2020.05.009. Epub 2020 May 18. PMID 32439600
- Abdul Lateef Hassan T, Abbood Mohammed D. Virtual Surgical Planning and 3-Dimensional Printing for the Treatment of Zygomaticomaxillary Complex and/or Orbital Fracture. J Craniofac Surg. 2023 May 1;34(3):e218-e222. doi: 10.1097/SCS.0000000000009056. Epub 2022 Oct 11. PMID 36217233
- Committeri U, Magliulo R, Carraturo E, Arena A, Abbate V, Salzano G, Troise S, Barone S, Germano C, Vaira LA, Giovacchini F, Cataldo R, Grassia MG, Califano L, Piombino P. Virtual surgical planning in tripod zygomatico-maxillary complex fractures: A prospective comparison between two different strategies. J Craniomaxillofac Surg. 2024 Dec;52(12):1497-1504. doi: 10.1016/j.jcms.2024.08.020. Epub 202 PMID 39349348
- Dubron K, Van Camp P, Jacobs R, Politis C, Shaheen E. Accuracy of virtual planning and intraoperative navigation in zygomaticomaxillary complex fractures: A systematic review. J Stomatol Oral Maxillofac Surg. 2022 Nov;123(6):e841-e848. doi: 10.1016/j.jormas.2022.07.003. Epub 2022 Jul 7. PMID 35809796
Identifiers
NCT: NCT07280533 · 1002/2025