Dentoskeletal Changes Resulting From Treatment of Skeletal Class II With an Esthetic Twin Block Appliance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dentoskeletal mandible changes as measured by tomographic
研究概览
简要总结
This experimental study will evaluate the effect of an esthetic Twin-block appliance on the correction of class II malocclusion compared with the traditional Twin-block appliance.
The study sample will consist of 50 patients with class II malocclusion. The sample will be allocated randomly into two groups: the control group and the experimental group.
The traditional Twin-block appliance will be applied for the control group patients, while the esthetic Twin-block appliance will be applied for the experimental group patients. The dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared.
详细描述
Class II malocclusion is one of the most frequent orthodontic problems, and most class II malocclusion cases are the result of mandibular deficiency. Twin block (TB) is one of the most popular functional appliances to treat this condition. Despite excellent treatment results with TB, its acceptance and compliance may be hampered by its wiry structure and appearance. Furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. Various modifications were proposed to reduce lower incisors proclination but had no significant effect. Patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional Twin-Block (CTB), a novel esthetic Twin-Block (ETB) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. There is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (ETB) and (CTB) in the treatment of Class II malocclusions. However, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. The aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (ETB) and to compare them to the changes in the matched group will be treated with (CTB), by studying the cephalometric radiographs, profile photographs, and a questionnaire.
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)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angle class II malocclusion because of mandibular retrognathia
- •O.J > 5 , SNB < 78
- •Patient during growth spurt
- •Normal or horizontal growth pattern Björk > 402
排除标准
- •TMJ disorders
- •Poor oral hygiene
- •Previous orthodontic treatment.
- •Patients with syndromes, clefts, or craniofacial abnormalities.
- •Reason of contraindication of functional treatment
研究组 & 干预措施
Conventional Twin-block appliance
The patients in this control group will be treated using the conventional Twin-block appliance (CTB).
干预措施: CTB (Device)
Esthetic Twin-block appliance
the patients in this experimental group will be treated using the esthetic Twin-block appliance (ETB).
干预措施: ETB (Device)
结局指标
主要结局
Dentoskeletal mandible changes as measured by tomographic
时间窗: Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1).
changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs
Lower incisor angle changes
时间窗: Changes will be evaluated before treatment and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
ANB angle changes
时间窗: Changes will be evaluated before treatment and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
次要结局
- SNB angle changes(Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1).)
- Number of broken appliances(During the treatment time which will take approximately 8 months.)
- SNA angle changes(Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1))
- The duration of functional treatment(After obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months)
- Levels of acceptance(A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.)
- Soft tissue changes(Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1))
- Levels of pain(A questionnaire will be given to the patients five times during treatment; after 1 week, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.)
- Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base(Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1))
- Levels of discomfort(A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.)