Clinical and cephalometric comparison of Pre-orthodontic Trainer and Twin Block appliance in growing patients with a retropositioned mandible in skeletal Class II malocclusion: A randomised clinical trail
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Both the pre-orthodontic trainer and the twin block appliance will cause forward positioning of the mandible correcting the skeletal Class II malocclusion.
研究概览
简要总结
The aim of this study is to compare clinically and cephalometricallythe changes brought by use of preorthodontic trainer and twin block applianceon both hard and soft tissues in patients with skeletal Class II relation withmandibular retroposition.
AIMS:
The aim of this study is to evaluate and compare clinicallyand cephalometrically the hard and soft tissue effects of preorthodontictrainer and twin block appliance in patients with a retropositioned mandible inskeletal Class II relationship.
OBJECTIVES:
1) To evaluate the pre andpost treatment effects of myofunctional trainer in patients with a retropositioned mandible inskeletal Class II relationship.
2) To evaluate the pre andpost treatment effects of a conventional removable Twin Block in patients with a retropositioned mandible inskeletal Class II relationship.
3) To compare clinically theeffect of myofunctional trainer and conventional removable twin block in patients with a retropositioned mandible inskeletal Class II relationship.
4) To comparecephalometrically the effect of myofunctional trainer and conventionalremovable twin block inpatients with a retropositioned mandible in skeletal Class II relationship.
- To evaluate andcompare the soft tissue changes of a conventional removable twin block and apreorthodontic trainer in patients with a retropositioned mandible inskeletal Class II relationship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Skeletal Class II patients with mandibular retroposition 2)Overjet more than 4mm 3)Angle ANB more than 4 degree 4)Growing patients (CVMI 1-4) 5)Patients whose parents/guardians willing to give written and informed consent to this study 6)Patients with no previous orthodontic treatment.
排除标准
- •Skeletal Class I malocclusion 2)Skeletal Class III malocclusion 3)Patients whose skeletal growth has completed 4)Patients with missing teeth 5)Patients with bone metabolic disorders 6)Patients with congenital deformity of orofacial structures or any craniofacial syndromes 7)Patients with chronic ulcers in oral cavity 8)Patients not showing compliance with the treatment.
结局指标
主要结局
Both the pre-orthodontic trainer and the twin block appliance will cause forward positioning of the mandible correcting the skeletal Class II malocclusion.
时间窗: The patients will be assessed after 12 months to compare the efficiency of the pre-orthodontic trainer and the twin block appliance.
次要结局
- Both the pre-orthodontic trainer and the twin block appliance will improve the soft tissue profile of the patient(12 months)