Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The change of the ANB angle
研究概览
简要总结
This experimental study aims to evaluate the efficiency of the orthodontic removable traction appliance in the treatment of skeletal class III malocclusion. The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and control group. The dentoskeletal changes will be assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm positive overjet.
详细描述
Treatment of class III malocclusion is a major challenge in orthodontic contemporary practice, Several appliance have suggested for the treatment of class III malocclusion, such as the facial mask and chin cup.
Despite of the efficiency of this extraoral appliance, its external appearance and its big size reduce patients' cooperation which decrease its clinical effects.
Another Class III treatment modality is the Orthodontic Removable Traction Appliance (ORTA). It is a removable appliance that can be used in conjunction with rapid palatal expansion or fixed appliances, It was developed in the 1980's by Dr. David Musich who developed this appliance in order to overcome issues of compliance that Dr. Musich experienced with use of the protraction facemask.
There is only one study that evaluated this appliance which is a retrospective study compared the treatment effects of the ORTA and protraction facemask in treatment of Class III malocclusions. However, this study has a lot of limitations which made it difficult to accurately evaluate the efficiency of this device.
The aim of this study is studying the dentoskeletal changes that result from treatment by this device, by comparing them to the changes in matched untreated group,by studying the cephalometric x-rays.
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
盲法说明
No masking could be applied
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in early mixed dentation (8-10 years old).
- •Skeletal class III caused by maxillary deficiency with or without mandibular prognathism judged clinically and confirmed radiographically(ANB≤1).
- •Anterior crossbite on two teeth or more or an edge-to-edge bite.
- •Normal inclination of the lower incisors with the mandibular plane.
排除标准
- •Poor oral hygiene.
- •Previous orthodontic treatment.
- •Patients with syndromes, clefts, or craniofacial abnormalities.
- •Severe skeletal class III primarily resulting from mandibular prognathism (ANB less than - 4)
- •Patients with facial asymmetry.
- •Patients with vertical growth pattern.
结局指标
主要结局
The change of the ANB angle
时间窗: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
The change of the ANB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
次要结局
- The change of the SNA angle(Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).)
- Levels of acceptance(A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.)
- The change of the SNB angle(Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).)
- Levels of pain(A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.)
- Levels of discomfort(A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.)