| CTRI Number |
CTRI/2025/08/092808 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
What your childs face can tell you about their Sleep and Breathing |
|
Scientific Title of Study
|
Association of Craniofacial
Morphology and Ethnicity with Paediatric Sleep Related Breathing Disorder: A
Multicentre Cross-Sectional 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 |
Dr Keisham Anupama Devi |
| Designation |
Junior Resident |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Institute of Dental Sciences Department of Orthodontic Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8787895755 |
| Fax |
|
| Email |
anupamakeisham123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Institute of Dental Sciences Department of Orthodontics Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9410879124 |
| Fax |
|
| Email |
drankurgupta81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keisham Anupama Devi |
| Designation |
Junior Resident |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Institute of Dental Sciences Department of Orthodontics Pilibhit Bypass Road
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8787895755 |
| Fax |
|
| Email |
anupamakeisham123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences Bareilly |
| Address |
Department of orthodontics & dentodacial orthopedics Institute of Dental Sciences Bareilly Pilibhit Bypass Road 243006 |
| Type of Sponsor |
Other [private dental college] |
|
|
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 |
| DrKeisham Anupama Devi |
Institute of Dental Sciences |
Departmnet of Orthodontics & Dentofacial Orthopedics, Room no.242
Bareilly
UTTAR PRADESH |
8787895755
anupamakeisham123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Institute of Dental Sciences, Bareilly (U.P.) Pin-243006 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age of 10-18 years who are seeking for orthodontic treatment. |
|
| ExclusionCriteria |
| Details |
History of respiratory conditions such as asthma, respiratory allergies.
• History of adenotonsillectomy/nasal septal deviation.
• History of craniofacial disorder (eg, cleft lip and/or palate, Down, Crouzon, hemifacial
microsomia, Treacher-Collins, or Pierre-Robin syndrome).
• Patient with history of orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
association of craniofacial morphology & ethnicity with paediatric
sleep related breathing disorder |
4 week
8week
12 week
16 week
20 week
24 week
28 week
32 week
36 week
40 week
44 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
27/08/2025 |
| 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="1"
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
|
To our knowledge, no study has simultaneously evaluated sleep related breathing disorder risk and craniofacial morphology in diverse pediatric populations across multiple ethnicities in India. Hence this study aims to investigate the relationship between craniofacial morphology with sleep related breathing disorder in children across different ethnicities of India. |