NCT05822271招募中不适用
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of life accessed by validated questionnaires.
研究概览
简要总结
The purpose of this prospective study is to compare treatment outcomes and the quality of life of skeletal Class III patients treated with conventional fixed appliances and aligners undergoing Surgery-first approach. Data will be collected through validated questionnaires: OQLQ (Orthognathic Quality of Life Questionnaire), OHIP-14 (Oral Health Impact Profile), SF-36 (Medical Outcomes Study 36 - Item Short-Form Health Survey) and IOTN (Index of Orthodontic Treatment Need).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skeletal malocclusion;
- •ANB Angle zero or negative;
- •Witts negative;
- •Etiology: mandibular excess, a maxillary deficiency, or a combination of both;
- •Indication for bimaxillary surgery;
排除标准
- •Previous orthodontic treatment;
- •Craniofacial anomaly or previous fracture of the facial bones;
- •Total edentulism;
- •Deep curve of Spee;
- •Vertical asymmetry;
- •Any medication use that contraindicates surgical treatment.
结局指标
主要结局
Quality of life accessed by validated questionnaires.
时间窗: at the end of orthodontic treatment (up to 2 years).
Comparison between quality of life changes in the two groups at the end of treatment.
次要结局
- Periodontal status.(at the end of orthodontic treatment (up to 2 years).)
- Treatment duration.(at the end of orthodontic treatment (up to 2 years).)
- Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.(12 months post-operative.)
- Facial changes as measured by tomographic superimposition of the face.(at the end of orthodontic treatment (up to 2 years).)
- Incisors inclination(at the end of orthodontic treatment (up to 2 years).)
- Alveolar bone changes around incisors.(at the end of orthodontic treatment (up to 2 years).)
- Swelling as measured by tomographic images.(12 months post-operative.)
- Surgery stability as measured by tomographic superimposition.(12 months post-operative.)
研究者
Arthur Cunha
Clinical Professor
Rio de Janeiro State University
研究点 (2)
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