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Completed

NCT Number: NCT07433842

Surgery-First Orthognathic Surgery in Skeletal Class III Treatment

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University Hospital

Hanoi, 10000, Vietnam

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Surgery-First Orthognathic Surgery

Procedure

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

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Pre-surgical Dental Arch Characteristics and Treatment Need Indices

    Time frame: Baseline (T0)

    Assessment of pre-surgical occlusal characteristics and arch morphology using 3D digital dental models. The evaluated parameters include, but are not limited to, overbite, overjet, Arch Length Discrepancy (ALD), Intercanine Width (ICW) and Intermolar Width (IMW) discrepancies, Arch Form Asymmetry Index (AI), Asymmetric Tooth Number (ATN), and the depth of the Curve of Spee. Additionally, the complexity and functional need for treatment are evaluated using standardized indices such as the Index of Complexity, Outcome and Need (ICON) and the Index of Orthognathic Functional Treatment Need (IOFTN).

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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