NCT01268852已完成不适用
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Total treatment duration
研究概览
简要总结
The hypotheses tested in this study are: There is a statistical significant difference, in treatment duration and result of treatment in cases treated using traditional Damon Q brackets or using Insignia.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Masking was done with generated cmputer randomisation and sealed opaque enveloppes
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects, both male and female
- •No cleft lip or palate or other craniofacial anomalies
- •Treatment with full fixed orthodontic appliances is indicated
- •Complete permanent dentition except for upper second and all third molars
- •Class I, Class II or Class III first molar relationship )1/2 pb or less off)
- •No previous orthodontic treatment
- •Age between 12 and 30 years of age
- •Study models and lateral cephalograms taken not more than 1 month before selection
- •Informed consent signed by patients and parents
排除标准
- •Cleft lip and palate and craniofacial anomalies
- •Syndromes affecting bone (formation) or teeth
- •Agenesis of teeth
- •Missing first molars
- •No bridges or implants
- •Orthognathic cases
- •History of periodontal disease
- •Intake of drugs affecting tooth movement and/or bone formation
- •Pregnancy
结局指标
主要结局
Total treatment duration
时间窗: treatment duration
duration assesed from start treatment to the removal of appliances
次要结局
- Quality of treatment(at start of treatment wand when finished treatment)
- Difference between the planning and the outcome of treatment of the Insignia cases(at start of treatment)
研究者
研究点 (2)
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