Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Duration of the orthodontic treatment (overall and every appointment)
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.
详细描述
In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.
In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).
This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.
This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.
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 (Care Provider)
入排标准
- 年龄范围
- 11 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment with fixed orthodontic appliances is indicated
- •complete secondary dentition
- •age: 11-30
- •in good general health
- •patient is informed about study and agrees to participate
排除标准
- •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
结局指标
主要结局
Duration of the orthodontic treatment (overall and every appointment)
时间窗: every 6 weeks until the end of the treatment
次要结局
- Amount of root resorption comparing x-rays before and after the treatment
- Quality measured using a quality index (ABO-Score)
