NCT00871091Unknown不适用
Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Sum of differences between resulted and shortest path of tooth movements in each patient
研究概览
简要总结
In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.
May treatment be improved with customized archwires?
Study hypotheses:
- By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
- The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic 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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment of front teeth with fixed orthodontic appliances is indicated
- •complete secondary dentition
- •age: 18-35
- •in healthy general condition
- •patient is informed about study and agrees to participate
排除标准
- •treatment of premolars and molars is necessary
- •syndromes affecting bones and teeth
- •cleft lip and palate
- •inflammation or reduction (more than 50%) of periodontium
- •intake of drugs affecting tooth movement and bone formation
- •disturbance of bone formation
- •disturbance of thyroidal function
- •pregnancy
- •participation in additional study affecting oral hygiene
- •former therapy with ionized radiation or cytostatic drugs
- •caries (active phase)
- •alcohol dependency
研究组 & 干预措施
1
Experimental
CAD/CAM group, customized archwires
干预措施: orthodontic treatment with customized archwires (Procedure)
2
Active Comparator
prefabricated archwires (superelastic)
干预措施: orthodontic treatment with prefabricated archwires (Procedure)
3
Active Comparator
prefabricated archwires with manual adjustments
干预措施: orthodontic tx w/ conventional archwires+manual adjustments (Procedure)
结局指标
主要结局
Sum of differences between resulted and shortest path of tooth movements in each patient
时间窗: measurements every 14 days until end of treatment
次要结局
- Difference between resulted and shortest path of movements for each tooth(measurements every 14 days until end of treatment)
研究者
研究点 (1)
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