A Comparison of the Effectiveness of Two Types of Myofunctional Appliances: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Dentoskeletal changes
研究概览
简要总结
A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
详细描述
It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after 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
- Single (Outcomes Assessor)
盲法说明
Blinding to treatment allocation is possible only for the outcomes assessor because the clinicians could know the intervention. All the trial documents will be labeled with the study ID number, which be used for participant identification and data collection without unmasking the allocation group.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Growing children who need myofunctional appliance.
- •Cl II div. 1 malocclusion.
- •No previous orthodontic or orthopaedic treatments.
排除标准
- •Patients with systemic involvement.
- •Congenital malformations such as cleft lip and palate.
- •Facial deformities.
- •Finger sucking habit will be excluded
结局指标
主要结局
Dentoskeletal changes
时间窗: T1 at the start of treatment and T2 at the end of treatment around 9 months
Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles.
次要结局
- Soft tissue changes(T1 at the start of treatment and T2 at the end of treatment around 9 months)
- Patient satisfaction(At the end of treatment (around 9 months))
研究者
Mushriq F. Abid
Professor
University of Baghdad