Active — Not RecruitingNot Applicable

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

Vietnam20 participantsStarted 2023-08-01

Plain-language 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

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with malocclusion requiring orthognathic surgery Exclusion Criteria: * cleft lip and palate congenital abnormalities * the facial deformities were caused by trauma, tumor, or iatrogenic factors * temporomandibular joint disorders * history of previous orthognathic surgery * patients scheduled for multipiece Le Fort I osteotomy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in the anteroposterior, mediolateral, and superoinferior changes of the maxillary landmarks were calculated to assess accuracy and validate the effectiveness of virtual surgical planning

Timeframe: From August 2023 to February 2025

Trial details

NCT IDNCT06940024

SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-28

View on ClinicalTrials.gov More Orthognathic Surgical Procedures trials