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

NCT06940024 | Active Not Recruiting DMC

• 1 other identifier: 647/HĐĐĐ-ĐHYD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthognathic Surgery; 3D planning; Splints; Accuracy of maxillary postion

Outcome Measures

Primary Outcomes (1)

• 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

  The accuracy of surgical outcomes was evaluated through: Positional Change of A Point, ANS, maxillary central incisors midpoint (U1), left maxillary central incisor (U1L), right maxillary central incisor (U1R), Maxillary Canines (U3L, U3R), Maxillary First Molars (U6L, U6R) (mm) Comparison of surgical accuracy between Planning and Acutual (mm differences) in each group • Description: The distance differences (in millimeters) between the planned 3D position (P3D) and the actual postoperative position (Actual) of each anatomical landmark was measured using voxel-based registration on superimposed preoperative and postoperative CT scans (2 weeks after surgery) using Invivo 7.0 software. Comparison of Surgical Accuracy Between VSP and CSP (mm deviation) • Description: The absolute positional deviations (in mm) of each anatomical landmark were compared between the VSP and CSP groups to assess which surgical planning method yielded higher accuracy

  From August 2023 to February 2025

Study Arms (2)

CSP Group (Conventional Resin Occlusal Splint)

NO INTERVENTION

Splints were manually fabricated based on 3D planning movement values

VSP Group

EXPERIMENTAL

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

Device: VSP Group

Interventions

VSP Group DEVICE

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

VSP Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with malocclusion requiring orthognathic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

201A, Nguyen Chi Thanh Street

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

Related Publications (5)

• Chen H, Bi R, Hu Z, Chen J, Jiang N, Wu G, Li Y, Luo E, Zhu S. Comparison of three different types of splints and templates for maxilla repositioning in bimaxillary orthognathic surgery: a randomized controlled trial. Int J Oral Maxillofac Surg. 2021 May;50(5):635-642. doi: 10.1016/j.ijom.2020.09.023. Epub 2020 Oct 31.

  PMID: 33131986 BACKGROUND

• Schneider D, Kammerer PW, Hennig M, Schon G, Thiem DGE, Bschorer R. Customized virtual surgical planning in bimaxillary orthognathic surgery: a prospective randomized trial. Clin Oral Investig. 2019 Jul;23(7):3115-3122. doi: 10.1007/s00784-018-2732-3. Epub 2018 Nov 15.

  PMID: 30443778 BACKGROUND

• Ritto FG, Schmitt ARM, Pimentel T, Canellas JV, Medeiros PJ. Comparison of the accuracy of maxillary position between conventional model surgery and virtual surgical planning. Int J Oral Maxillofac Surg. 2018 Feb;47(2):160-166. doi: 10.1016/j.ijom.2017.08.012. Epub 2017 Sep 23.

  PMID: 28950997 BACKGROUND

• Song KG, Baek SH. Comparison of the accuracy of the three-dimensional virtual method and the conventional manual method for model surgery and intermediate wafer fabrication. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jan;107(1):13-21. doi: 10.1016/j.tripleo.2008.06.002. Epub 2008 Aug 28.

  PMID: 18755612 BACKGROUND

• Xu R, Ye N, Zhu S, Shi B, Li J, Lai W. Comparison of the postoperative and follow-up accuracy of articulator model surgery and virtual surgical planning in skeletal class III patients. Br J Oral Maxillofac Surg. 2020 Oct;58(8):933-939. doi: 10.1016/j.bjoms.2020.04.032. Epub 2020 May 20.

  PMID: 32446591 BACKGROUND

Study Design

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

Model Details: After determining the desired the maxillary and mandibular position by 3D planning, involved fabricating surgical splints using two different methods: * CSP Group (Conventional Resin Occlusal Splint - Control group): Splints were manually fabricated based on P3D movement values. Maxillary landmark points were marked, and the upper jaw cast model was segmented and repositioned to match P3D maxillary to the nearest approximation base on anterior-posterior and superior-inferior changes of these points. The actual movement distances of U1L, U1R, U3L, U3R, U6L, and U6R were recorded as PCM (Planning Cast Model). * VSP Group (Virtual Digital Occlusal 3D Print Splint - Interventional group): Digital surgical splints were generated using Dolphin software and a Form 3D printer.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 23, 2025
• Study Start: August 1, 2023
• Primary Completion: April 28, 2025
• Study Completion: July 31, 2025
• Last Updated: April 23, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)