| CTRI Number |
CTRI/2024/09/073552 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Observation Study on the Effect of Upper Jaw Bone Shape on the Middle Ear in Children with Enlargement of Adenoids |
|
Scientific Title of Study
|
Effect of Maxillary Morphology on Eustachian Tube Function in Children with Adenoid Hypertrophy: An Observation Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashank Khaitan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 4057
Dept of Otorhinolaryngology
4th Floor, Teaching Block
AIIMS, New Delhi - 110029
Ansari Nagar, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717841204 |
| Fax |
|
| Email |
ashankkhaitan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hitesh Verma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room 4065
4th floor, Teaching Block,
AIIMS New Delhi
Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9868397480 |
| Fax |
|
| Email |
drhitesh10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitesh Verma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room 4065
4th floor, Teaching Block,
AIIMS New Delhi
Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9868397480 |
| Fax |
|
| Email |
drhitesh10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashank Khaitan |
| Address |
House number 31
Sector 45
Gurugram - 122003
Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashank Khaitan |
AIIMS New Delhi |
AIIMS New Delhi
Ansari Nagar
Delhi - 110029
New Delhi
DELHI |
9717841204
ashankkhaitan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research (Basic Science) AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J352||Hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dental study model of maxilla using alginate impression |
The dental study models of maxilla will be obtained using alginate impression. The arch width, maxillary arch depth and palatal height will be measured from the model. |
| Intervention |
Eustachian Tube Dysfunction - 7 Questionnaire |
Patients are asked questions pertaining to the ear complaints which they had experienced in the past 1 month and score is provided based on their frequency. Score of more than 14.5 is considered as presence of eustachian tube dysfunction. |
| Intervention |
PA and lateral cephalogram |
These are X rays of the head. PA cephalogram is used to assess transverse maxillary width and lateral cephalogram is used to perform standard cephalometric analysis of various facial angles and facial heights. |
| Intervention |
Pediatric Sleep Questionnaire |
It is a subjective scoring system to assess the presence of OSA. It is administered with help of the parent and contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric OSA features. Responses are yes - 1, no - 0, and dont know - missing. The mean response on nonmissing items is the score, which can vary from 0 to 1. Scores more than 0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder.
|
| Intervention |
Tympanometry |
An objective measure of changes in acoustic impedance of the middle ear in response to changes in air pressure. Five types of curves may be obtained, and type B - flat curve suggesting fluid in middle ear, and type C - negative pressure in middle ear, are taken as being representative of Eustachian tube dysfunction. |
|
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Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Age 7-14 years
Both male and female
Patients with adenoid hypertrophy (diagnosed clinically and/or lateral neck X ray) |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. ETDQ-7 questionnaire - score more than 14.5 indicates Eustachian tube dysfunction
2. Tympanometry - type B and type C curves indicate Eustachian tube dysfunction |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Sleep Questionnaire - score more than 0.33 indicates high risk for a pediatric sleep breathing disorder |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
Period of Study: 2 years (July 2024 to June 2026) INCLUSION CRITERIA 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) 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
|