NCT02084277Unknown不适用
A Randomized Clinical Trial to Compare Oral Health Related Quality of Life Outcome for Patients With Malocclusion Receiving Orthodontic Treatment: Before Treatment vs. During Initial Treatment; Self-ligating Brackets vs. Conventional Brackets
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient Reported Outcome - Oral Health Related Quality of Life
研究概览
简要总结
The objective of this prospective study is to compare these two treatments (conventional brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will provide the better oral health related quality of life (OHRQoL) outcomes for patients during the initial orthodontic treatment compared with pretreatment.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malocclusion patients
- •age between 12 to 40 years
- •suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.
排除标准
- •Any surgery performed in the previous days,
- •Previous temporomandibular joint arthrotomies,
- •Fewer than 20 teeth total or fewer than 10 teeth in each arch,
- •Unstable residence or travel restrictions,
- •Periodontal disease judged to be severe by the surgeon,
- •Pregnancy,
- •Previous mandibular surgery, and
- •Inability to follow instructions or the study protocol.
结局指标
主要结局
Patient Reported Outcome - Oral Health Related Quality of Life
时间窗: one month
次要结局
- Pain(one month)
研究者
Dr. Tai-ting Lai
Director of Orthodontic Department
Mackay Memorial Hospital
研究点 (2)
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