Clinical Research Directory

Comparison of Accuracy of Maxilla Between Virtual and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Summary

Study Title Comparison of Maxillary Accuracy Between Virtual and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery: A Randomized Controlled Trial Study Design * Type: Prospective, single-center, randomized, blinded, case-controlled trial * Location: National Hospital of Odonto-Stomatology, Ho Chi Minh City * Period: August 2023 - February 2025 * Sample size: 20 patients * Ethical approval: Granted by the University of Medicine and Pharmacy at HCMC (Approval No. 647/HĐĐĐ-ĐHYD) Inclusion Criteria * Patients aged 18-30 years * Diagnosed with malocclusion requiring bimaxillary orthognathic surgery * Completed presurgical orthodontic treatment Exclusion Criteria * Cleft lip/palate, craniofacial syndromes * Deformities due to trauma, tumors, or iatrogenic causes * TMJ disorders * History of previous orthognathic surgery * Planned multipiece Le Fort I osteotomy Randomization and Blinding * All patients underwent both 2D and 3D surgical planning. * Two splints (CSP and VSP) were fabricated for each patient. * Intraoperative randomization was performed by an OR nurse. * The surgical team and data analysts were blinded to group allocation. * Groups were revealed only after data analysis. Groups * Test group (VSP): 3D virtual planning, simulation, and 3D-printed splints * Control group (CSP): 2D cephalometric planning, model surgery, conventional resin splints Surgical Procedure * All patients underwent Le Fort I and BSSO * Maxilla-first approach with fixation using 4 miniplates * Mandibular repositioning using final splint and fixed with 2 miniplates per side * All surgeries performed by a single experienced surgeon Data Collection \& Measurements * CT scans before and 2 weeks after surgery * Superimposition using Invivo 7.0 software (voxel-based registration) * Measured landmark changes (A point, ANS, U1, U3, U6) in X (medial-lateral), Y (anterior-posterior), and Z (vertical) directions * Compared: * 2D plan (P2D) vs. 3D plan (P3D) * P3D vs. actual postoperative result * VSP vs. CSP accuracy Statistical Analysis * ICC used to test measurement reliability (10 patients, remeasured after 2 weeks) * Normality tested * Paired t-test/Wilcoxon for planned vs. actual * Independent t-test/Mann-Whitney for between-group comparisons * Significance set at p \< 0.05

Official title: Comparison of Accuracy of Maxilla Between Virtual Surgical Planning and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery: a Randomized Controlled Trial

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