Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The rate of molar Distalization
研究概览
简要总结
A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.
详细描述
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.
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)
盲法说明
The study will be a single blinded because both the patients and the investigator will be aware of the allocation during treatment, but the cephalograms and digital models will be scored and coded by an independent person, i.e. pre-and post-treatment cephalograms and digital models will be analyzed after replacing the patients' names with codes, and the examiner conducting the measurement analysis will be unaware of the group to which the patient has been allocated.
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class II molar relationships bilaterally, with fully erupted 2nd molar.
- •No or minor crowding on the mandible to [reserve Class I posterior occlusion after treatment.
- •Good oral health free from caries and periodontal problems at the start of treatment.
排除标准
- •Previous history of orthopedic and/or orthodontic treatment.
- •Patients with cleft lip and palate and/or craniofacial syndrome
- •Patients with bad oral habit.
- •Active periodontal disease.
- •Sever rotation of maxillary molars. -
结局指标
主要结局
The rate of molar Distalization
时间窗: 6 months
• The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements.
次要结局
- Patient discomfort(10 days)
- Molar distalization(6 months)
研究者
Mushriq F. Abid
Professor
University of Baghdad