Effect of Maxillary Morphology on Eustachian Tube Function in Children with Adenoid Hypertrophy: An Observation Study
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
- 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:
- 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
Ashank Khaitan
AIIMS New Delhi
