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临床试验/CTRI/2026/03/105593
CTRI/2026/03/105593尚未招募2 期

A Comparative Cephalometric Evaluation of Upper Airway Space Changes Following Medical Versus Surgical Management in Pediatric Patients with Adenotonsillar Hypertrophy: A Quasi Experimental Study.

Uttar Pradesh University of Medical Sciences Saifai1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2026年3月20日最近更新:

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

发起方
Uttar Pradesh University of Medical Sciences Saifai
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SWAPNIL

UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI

研究点 (1)

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