Surgery-First Orthognathic Surgery in Skeletal Class III Treatment

NCT07433842 | Completed

• 1 other identifier: 657/GCN-HDDDNCYSH-DHYHN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and stability of the "Surgery-First" approach (SF approach) in treating patients with skeletal Class III malocclusion, utilizing a combined retrospective and prospective data collection method. Unlike the conventional method, the SF approach performs orthognathic surgery first to correct the skeletal discrepancy, followed by orthodontic treatment. The study aims to analyze pre-operative dentoskeletal characteristics, arch morphology, and treatment complexity indices, as well as assess the hard and soft tissue changes at 1 week and 1 year post-surgery using digital dental models and Computed Tomography (CT) scans.

Conditions

Skeletal Class III Malocclusion

Keywords

surgery first orthognathic approach; digital dental model; computed tomography; 3D analysis

Outcome Measures

Primary Outcomes (1)

• Three-Dimensional Skeletal and Soft Tissue Changes on Computed Tomography (CT)

  Evaluation of dentoskeletal and facial soft tissue changes. The measurements include the three-dimensional (3D) spatial displacement of hard and soft tissue landmarks, as well as angular and linear cephalometric parameters (e.g., SNA, SNB, ANB angles) measured on Computed Tomography (CT) images. Comparisons are made across three time points to assess immediate surgical changes and long-term stability.

  Baseline (T0), 1 week post-surgery (T1), and 12 months post-surgery (T2)

Secondary Outcomes (1)

• Pre-surgical Dental Arch Characteristics and Treatment Need Indices

  Baseline (T0)

Study Arms (1)

Surgery-First Cohort

EXPERIMENTAL

Patients diagnosed with skeletal Class III malocclusion who undergo the Surgery-First approach.

Procedure: Surgery-First Orthognathic Surgery

Interventions

Surgery-First Orthognathic Surgery PROCEDURE

Orthognathic surgery (Le Fort I, BSSO, or double jaw surgery) performed before orthodontic treatment to correct skeletal discrepancy.

Surgery-First Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 16 years or older, and male patients aged 18 years or older.
• Diagnosis of skeletal Class III malocclusion.
• Meeting the clinical indications for the Surgery-First orthognathic approach.
• Treatment plan consensus between the orthodontist and maxillofacial surgeon, aligned with the patient's chief complaint and expectations.
• Underwent orthognathic surgery using the Surgery-First approach without pre-surgical orthodontic treatment.
• Good general health, fit for general anesthesia.
• Voluntarily agreed to participate in the study and provided informed consent.

You may not qualify if:

• Dentofacial deformities secondary to maxillofacial trauma (e.g., midface retrusion due to Le Fort fractures, or mandibular retrusion due to bilateral condylar fractures).
• Presence of systemic diseases or conditions that contraindicate general anesthesia or orthognathic surgery.
• Presence of psychiatric disorders that may compromise treatment cooperation or the informed consent process.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University Hospital

Hanoi, Hanoi, 10000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Lecturer

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)