A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Transverse dimensional changes and bucco-lingual inclination changes
研究概览
简要总结
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
详细描述
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
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 (Investigator)
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
- 是
入选标准
- •Young adults aged 16 years and over;
- •Fit and well and on no medication;
- •In the permanent dentition;
- •Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care
- •Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment;
- •Crowding less than 6mm
- •Exclusion Criteria
- •Cleft lip and palate and other craniofacial anomalies.
排除标准
- 未提供
结局指标
主要结局
Transverse dimensional changes and bucco-lingual inclination changes
时间窗: 3 years 10 months
Width in mm
次要结局
- Subjective pain experience(3 years 10 months)