Enhanced Efficacy of Early Orthopedic Intervention With Rapid Maxillary Expansion and Facemask Protraction on Skeletal and Quality of Life Outcomes in Class III Malocclusion: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Change in Vertical Linear Cephalometric Measurements
研究概览
简要总结
This multicenter randomized controlled trial compares the efficacy of Rapid Maxillary Expansion (RME) combined with facemask (FM) protraction versus FM protraction alone in treating growing children with skeletal Class III malocclusion. The study aims to evaluate the differences in vertical skeletal changes and Oral Health-Related Quality of Life (OHRQoL) between the two treatments.
详细描述
Skeletal Class III malocclusion is a challenging craniofacial anomaly, particularly prevalent in Asian populations. Early orthopedic intervention aims to correct the discrepancy and guide favorable growth. While facemask (FM) protraction is a standard treatment, its efficacy can be enhanced by Rapid Maxillary Expansion (RME), which is thought to disarticulate the circummaxillary sutures and facilitate a better orthopedic response. This prospective, multicenter, randomized controlled trial was designed to rigorously compare the combined RME+FM therapy against FM therapy alone. The study's primary objective was to assess the impact of these interventions on vertical skeletal dimensions, a key concern in Class III treatment. The secondary objective was to evaluate the patient-centered outcome of Oral Health-Related Quality of Life (OHRQoL). Eligible patients aged 7-12 were randomly assigned to one of two treatment groups. Cephalometric and OHRQoL data were collected at baseline and after 12 months of active treatment to determine if the combined approach offers superior clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletal Class III malocclusion (ANB angle ≤ 0°) with a Wits appraisal ≤ -2 mm.
- •Maxillary deficiency (SNA angle ≤ 80°).
- •Prepubertal stage of skeletal development (Cervical Vertebral Maturation Stage CS1-CS3).
- •Age between 7 and 12 years.
- •Anterior crossbite or edge-to-edge incisor relationship.
- •Angle Class III or end-on molar relationship.
- •No previous orthodontic treatment.
排除标准
- •Functional Class III malocclusion with no centric relation-centric occlusion discrepancy.
- •Congenital craniofacial anomalies (e.g., cleft lip/palate).
- •Severe systemic diseases.
- •History of maxillofacial trauma.
结局指标
主要结局
Change in Vertical Linear Cephalometric Measurements
时间窗: Baseline, 12 Months
Measured from standardized lateral cephalograms and Cone-Beam Computed Tomography (CBCT) scans. Key measurements include overbite (mm), maxillary molar vertical position (PP-Ms distance, mm), and maxillary anterior position (X-A distance, mm).
Change in Angular Cephalometric Measurements
时间窗: Baseline, 12 Months
Measured from standardized lateral cephalograms and CBCT scans. Key measurements include sagittal jaw relationship (ANB angle, degrees), mandibular plane angle (SN-MP, degrees), and palatal plane angle (SN-PP, degrees).
次要结局
- Change in Dental Positional Measurements(Baseline (T0) and 6-month follow-up (T1).)
- Change in Dental Positional Measurements(Baseline (T0) and 6-month follow-up (T1).)
- Change in Dental Cephalometric Measurements(Baseline, 12 Months)
研究者
Lulu Wang
Principal investigator
Wuhan Integrated Traditional Chinese and Western Medicine Hospital