Evaluation of oro-pharyngeal functional unit and TMJ changes in skeletal class-II patients after fixed functional appliance therapy- 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
- 16
- 试验地点
- 1
研究概览
简要总结
This randomized clinical trial will evaluate skeletal Class II patients with mandibular retrusion treated using fixed functional appliances. A total of 16 patients will be recruited and divided into two groups: AdvanSync 2 (n=8) and PowerScope (n=8). Each patient will undergo treatment for 6–8 months. Informed consents will be taken from both parent and participant. Cone Beam Computed Tomography (CBCT) scans will be taken at baseline (T0) and after intervention (T1) to assess changes. Primary outcomes include pharyngeal airway dimensions (area, volume), hyoid bone position, and temporomandibular joint (TMJ) remodeling parameters (condylar head volume, length, width, height, inter-condylar distance, glenoid fossa dimensions, and articular joint spaces). Measurements will be performed using Planmeca Romexis software. Data will be statistically analyzed to compare treatment effects between appliances. All imaging will follow ALARA principles to ensure minimal radiation exposure. The study aims to identify which appliance provides better functional and structural outcomes, thereby improving orthodontic treatment safety and effectiveness.
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
- 13.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Skeletal class II malocclusion (ANB greater than or equal to 4-6degrees), overjet greater than or equal to 4-7 mm 2)Class II malocclusion due to mandibular retrusion 3)Positive visual treatment objective.
排除标准
- •History of tonsillectomy or adenoidectomy, craniofacial syndromes or congenital anomalies 2) Previously orthodontic treated patients.
研究者
Dr Biradavolu Sri Sivani
Vishnu Dental College
