A Comparative Cephalometric Evaluation of Upper Airway Space Changes Following Medical Versus Surgical Management in Pediatric Patients with Adenotonsillar Hypertrophy: A Quasi Experimental Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
研究概览
简要总结
Upper airway obstruction in pediatric patients, predominantly caused by adenotonsillar hypertrophy, is associated with obstructive sleep apnea , craniofacial growth disturbances, and behavioral and academic impairments. Chronic mouth breathing can exacerbate these issues, potentially leading to persistent anatomical abnormalities into adulthood. Treatment is typically either medical using corticosteroids and leukotriene receptor antagonists or surgical via adenotonsillectomy. While surgery has shown to improve airway patency, comparative radiographic data between medical and surgical interventions is lacking.
Novelty This quasi-experimental study, conducted in a rural population of Northern India, is novel in its use of standardized cephalometric analysis to evaluate anatomical changes post treatment. Previous studies have focused on clinical outcomes or used retrospective designs. By employing baseline and 6-month follow-up lateral cephalograms, this study aims to offer objective, reproducible evidence of treatment efficacy
Objective The primary objective is to evaluate and compare nasopharyngeal and oropharyngeal structural changes in children aged 4 to15 years treated either medically or surgically for adenotonsillar hypertrophy. Secondary objectives include assessing cephalometric markers and correlating these with symptom resolution. Methodology- Methodologically, the study will include 136 participants, 4-15 years of age divided into two groups based on AAOHNS criteria, undergo radiographic and clinical evaluation, and be tracked over 6 months. Expected outcomes include quantifiable data on airway dimensional improvement, guiding future clinical decision-making and fostering interdisciplinary care among otorhinolaryngology, radiology, and orthodontics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 15.00 Year(s)(—)
- 性别
- All
入选标准
- •History of URTI, AOM, OSA.
- •Able to undergo lateral cephalometric radiography.
排除标准
- •Refusal to give consent or lost to follow up Craniofacial anomalies such as cleft palate, down syndrome, Pierre Robin sequence.
- •Airway surgery such as prior adenoidectomy, tonsillectomy, or retrognathic surgery.
- •Chronic cardio respiratory illness, such as uncontrolled asthma, and congenital heart disease.
研究者
DR SWAPNIL
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI
