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临床试验/CTRI/2026/04/107415
CTRI/2026/04/107415尚未招募不适用

Evaluation of oro-pharyngeal functional unit and TMJ changes in skeletal class-II patients after fixed functional appliance therapy- a randomized clinical trial

Dr Biradavolu Sri Sivani1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年4月13日最近更新:

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

发起方
Dr Biradavolu Sri Sivani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Biradavolu Sri Sivani

Vishnu Dental College

研究点 (1)

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