Surgery First Orthognathic Surgery in Skeletal Class III Treatment: A Study on Digital Dental Models and Computed Tomography Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Three-Dimensional Skeletal and Soft Tissue Changes on Computed Tomography (CT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Surgery-First Cohort
Patients diagnosed with skeletal Class III malocclusion who undergo the Surgery-First approach.
干预措施: Surgery-First Orthognathic Surgery (Procedure)
结局指标
主要结局
Three-Dimensional Skeletal and Soft Tissue Changes on Computed Tomography (CT)
时间窗: 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.
次要结局
- Pre-surgical Dental Arch Characteristics and Treatment Need Indices(Baseline (T0))
研究者
Nguyen Truong Minh
PhD Candidate, Lecturer
Hanoi Medical University