Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Measurements on the lateral cephalograms and digital 3D model casts.
研究概览
简要总结
The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.
详细描述
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:
- Group I: patients treated with amda®
- Group II: patients treated with buccal mini-implants
More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:
- point T0: baseline data - before initiation of the treatment
- point T1: immediately after distalization (8-12 months)
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
- None
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients to have permanent dentition
- •with or without the 2nd molar erupted
- •bilateral Class II molar relationships (a quarter to 1 molar cusp).
排除标准
- •Past orthodontic treatment
- •crossbites,
- •severe carious lesions,
- •poor oral hygiene,
- •mobility of the maxillary first molars,
- •anterior open bites,
- •vertical growth pattern,
- •tongue habits.
结局指标
主要结局
Measurements on the lateral cephalograms and digital 3D model casts.
时间窗: 8-12 months
Angular measurements of the lateral cephalograms and digital models
Anteroposterior position changes of upper first molars.
时间窗: 8-12 months
Anteroposterior position movement in mm of the upper first molars
次要结局
未报告次要终点
研究者
Nikolaos Karvelas
Principal Investigator
Grigore T. Popa University of Medicine and Pharmacy