Comparison of skeletal and dentoalveolar changes in skeletal class II correction with Advansync 2 between two different bracket prescriptions- A randomized controlled trial.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- lower incisor proclamation
研究概览
简要总结
Comparison of skeletal and dentoalveolar changes in skeletal class II correction with Advansync 2 between two different bracket prescriptions- A randomized controlled trial.
Aim: To compare the skeletal and dentoalveolar changes in skeletal class II correction achieved with Advansync 2 between two different bracket prescriptions.
Objective and rationale
To evaluate whether lower incisor proclination can be controlled when Advansync is used in conjunction with Damon. True and adequate mandibular advancement is achieved by maintaining average lower incisor inclination in the mandibular basal bone. Self ligating bracket system mainly achieves tooth alignment and relieves crowding by arch expansion. Arch expansion in Damon self ligating system is greater than that achieved in conventional pre-adjusted edgewise appliance. Excessive proclination of the lower incisors restrict forward rotation of the mandible and also hinders mandibular advancement. Thus this study was undertaken to evaluate the amount of mandibular advancement and other associated skeletal, dentoalveolar and soft tissue changes achieved by both the systems when used in conjunction with Advansync 2 appliance.
Sample size: 22 patients
Group 1: 11(Damon with Advansync) Group 2: 11 (MBT with Advansync)
Methodology:
22 growing subjects with Skeletal class II malocclusion selected based on their CVMI staging. Group A (11 subjects) to be treated with MBT with Advansync 2, and Group B (11 subjects) to be treated with Damon Q with Advansync 2. Sample size was determined using G power version 3.0.1 with power of 0.8. Simple random sampling to be done. Case records to be taken for each patient at pre- AdvanSync2 (T1) and post-AdvanSync2 (T2), which includes cephalometric radiographs, extraoral, and intraoral photographs. Informed consent to be obtained from each participant for the use of their case records for scientific research and publication
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Skeletal class II due to retrognathic mandible ANB>4 degrees Growing children.
排除标准
- •Growing children with Skeletal class II due to prognathic maxillary Adults with class II malocclusion.
结局指标
主要结局
lower incisor proclamation
时间窗: initial, 6 months
mandibular length
时间窗: initial, 6 months
SNB
时间窗: initial, 6 months
ANB
时间窗: initial, 6 months
次要结局
- Soft tissue changes(initial, 6 months)