Evaluation of Volumetric Changes in the Mandible After Treatment with Twin Block and Mandibular AdvanSyncâ„¢ 2 Appliance in Skeletal Class II Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Volumetric changes in mandible
研究概览
简要总结
The primary purpose of the protocol titled "Evaluation of Volumetric Changes in the Mandible After Treatment with Twin Block and Mandibular AdvanSyncâ„¢ 2 Appliance in Skeletal Class II Patients: A Randomized Clinical Trial" is to evaluate and compare the volumetric changes in the mandible six months after treatment using the Twin Block and Mandibular AdvanSyncâ„¢ 2 appliances in growing Skeletal Class II patients. The hypothesis being tested is that there is no significant difference in the change of mandibular volume between the two treatment groups (Twin Block and Mandibular AdvanSyncâ„¢ 2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 11.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Growing Class II patients due to retrognathic mandible (Twin block and Mandibular AdvanSyncâ„¢ 2 Appliance).
- •â€¢ Overjet ≥ 5 mm • Presence of a Class II Skeletal pattern with an ANB angle ≥ 5 degrees.
- •â€¢ Good oral hygiene maintenance and no active periodontal disease.
- •â€¢ Patients in stage 3 or 4 cervical vertebrae maturation indicators (CVMI).
- •â€¢ Patients with FMA less than 28 degrees.
- •â€¢ Age group – 11 to 15 years.
排除标准
- •â€¢ Patients exhibiting craniofacial syndromes or cleft lip and palate.
- •â€¢ Patients with systemic disorders such as thyroid, parathyroid, or renal and liver diseases that affects bone and growth.
- •â€¢ Patients with TMJ diseases.
- •â€¢ Patients with previous history of orthodontic treatment.
结局指标
主要结局
Volumetric changes in mandible
时间窗: before the start of treatment and 6 months after the start of treatment
次要结局
- Ramus length, mandibular body length, effective mandibular length(before the start of treatment and 6 months after the start of treatment)
研究者
Jaspreet Singh
Post Graduate Institute of Medical Science