NCT07433842

Surgery-First Orthognathic Surgery in Skeletal Class III Treatment

Surgery First Orthognathic Surgery in Skeletal Class III Treatment: A Study on Digital Dental Models and Computed Tomography Changes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm interventional study designed to evaluate the efficacy and stability of the Surgery-First approach in patients with skeletal Class III malocclusion. The study utilizes a combined retrospective and prospective data collection method. The study protocol was approved by the Institutional Ethics Committee in October 2022. The study population includes patients diagnosed with skeletal Class III malocclusion who underwent the Surgery-First orthognathic surgery between June 2019 and March 2025. Study Procedures: Baseline Assessment (T0): Pre-operative evaluation includes clinical examination, digital dental model analysis (to assess occlusal characteristics, arch morphology, and treatment need/complexity indices such as ICON and IOFTN), and Computed Tomography (CT) scanning to measure hard and soft tissue characteristics. Surgical Intervention: All patients underwent the surgery-first orthognathic approach without pre-surgical orthodontic preparation. A CT scan was performed 1 week post-surgery (T1) to evaluate the immediate surgical results. Follow-up (T2): Post-operative assessment and CT scanning are conducted 12 months post-surgery (T2) to evaluate skeletal stability and soft tissue adaptation. Data Analysis: The analysis focuses on the pre-surgical dentoskeletal characteristics and treatment need indices at baseline, as well as the displacement of the maxilla/mandible and soft tissue changes between time points (T0, T1, and T2).

Conditions

• Skeletal Class III Malocclusion

Interventions

Type	Name	Description
PROCEDURE	Surgery-First Orthognathic Surgery	Orthognathic surgery (Le Fort I, BSSO, or double jaw surgery) performed before orthodontic treatment to correct skeletal discrepancy.

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Vietnam