MedTrace Logo

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

NCT06940024 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-23

No results posted yet for this study

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

Conditions

  • Orthognathic Surgical Procedures
  • 3D Printing
  • Splints

Interventions

DEVICE

VSP Group

Digital surgical splints were generated using Dolphin software and a Form 3D printer

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-04-28
Completion
2025-07-31

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940024 on ClinicalTrials.gov