跳至主要内容
临床试验/CTRI/2024/09/073552
CTRI/2024/09/073552尚未招募不适用

Effect of Maxillary Morphology on Eustachian Tube Function in Children with Adenoid Hypertrophy: An Observation Study

Ashank Khaitan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月25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
50
试验地点
1
主要终点
1. ETDQ-7 questionnaire - score more than 14.5 indicates Eustachian tube dysfunction

研究概览

简要总结

  1. AIM: To determine association between change in maxillary morphology and Eustachian tube dysfunction (ETD) in children with adenoid hypertrophy (AH), in order to find the basis of ETD in this population

OBJECTIVES:

Primary objectives:

To correlate palatal arch morphology measures with Eustachian tube dysfunction in children with adenoid hypertrophy

To correlate cephalogram parameters with Eustachian dysfunction in children with adenoid hypertrophy

Secondary Objectives:

To correlate Pediatric Sleep Questionnaire with palate morphology and Eustachian tube dysfunction

BRIEF METHODOLOGY:

Number of patients - 50

Place of Study:

  1. Dept of Otorhinolaryngology, AIIMS, New Delhi

CDER, AIIMS, New Delhi 2. Period of Study: 2 years (July 2024 to June 2026)

INCLUSION CRITERIA

  • Age 7-14 years
  • Patients with adenoid hypertrophy

(diagnosed clinically and lateral neck X

ray) 3. EXCLUSION CRITERIA

  • Other causes of palatal arch morphology changes: history of thumb sucking, gross DNS (defined as septum in contact with lateral nasal wall)
  • Patients with cleft palate
  • Patients post surgery
  • Patients with syndromic features
  • Child uncooperative for taking dental

impression

  • Unwilling to participate in the study

Study Design: Case control Study

Investigations: tympanometry, PA and lateral cephalograms, palate arch impression

Questionnaires-

Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

Pediatric Sleep Questionnaire (PSQ)

Brief Methodology

  • After fulfilling the inclusion criteria and taking informed written consent and after approval from ethics committee, the study will proceed.
  • Patient will fill the questionnaires (ETDQ-7 and Pediatric Sleep Questionnaire) and undergo general and local examination.
  • Patient will undergo Eustachian tube function test (tympanometry).
  • Patient’s PA and lateral cephalograms will be taken
  • Patient’s dental study model of maxilla will be obtained using alginate impression
  • The PA and lateral cephalograms will be analysed for standard cephalometric parameters and transverse maxillary width (distance from jugal point to jugal point, and between upper first molars). The maxillary arch width, depth and palatal height will be measured from the palate arch impression.
  • Data analysis

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Age 7-14 years Both male and female Patients with adenoid hypertrophy (diagnosed clinically and/or lateral neck X ray).

排除标准

  • Other causes of palatal arch morphology changes: history of thumb sucking, gross DNS.
  • defined as septum in contact with lateral nasal wall Patients with cleft palate Patients post surgery Patients with syndromic features Child uncooperative for taking dental impression Unwilling to participate in the study.

结局指标

主要结局

1. ETDQ-7 questionnaire - score more than 14.5 indicates Eustachian tube dysfunction

时间窗: At baseline

2. Tympanometry - type B and type C curves indicate Eustachian tube dysfunction

时间窗: At baseline

次要结局

  • Pediatric Sleep Questionnaire - score more than 0.33 indicates high risk for a pediatric sleep breathing disorder(At baseline)

研究者

发起方
Ashank Khaitan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashank Khaitan

AIIMS New Delhi

研究点 (1)

Loading locations...

相似试验