| CTRI Number |
CTRI/2026/01/101223 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence and Severity of Gag Reflex |
|
Scientific Title of Study
|
Prevalence and Gag Reflex in 4-12 year old children: A 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 |
Jasmin J Winnier |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9773284371 |
| Fax |
|
| Email |
drjaswinnie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kruti Kruti K |
| Designation |
Post Graduate Student |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry, DY Patil University, School of Dentistry, Nerul, Navi mumbai,
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
09662373732 |
| Fax |
|
| Email |
ruhi182804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kruti Kruti K |
| Designation |
Post Graduate Student |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
09662373732 |
| Fax |
|
| Email |
ruhi182804@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Deemed to be University School of Dentistry |
| Address |
Dr. D. Y. Patil Deemed to be University School of Dentistry Sector 7, Highway Road, Neural, Navi Mumbai, Maharashtra, 400706 |
| Type of Sponsor |
Private medical 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 |
| Dr Jasmin J Winnier |
Dr. D. Y. Patil Deemed to be University School of Dentistry |
Dept of Pediatrics , Dr D Y
Patil Deemed to be
University, School Of Medicine
, Sector 7, Highway Road, ,
Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
09662373732
jasmin.winnier@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
GAG REFLEX |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. 4–12 years
2. parents or guardians provided informed consent
3. who were themselves willing to participate. Only children classified as ASA I or II |
|
| ExclusionCriteria |
| Details |
1. Mental or physical disabilities, systemic disease
2. Fell into ASA classes III, IV, or V. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence and severity of the gag reflex in children aged 4–12 years |
AT baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of gag reflex with age & fear |
AT baseline |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
07/12/2026 |
| 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="0"
Months="6"
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
|
The study will aim to assess the prevalence and severity of the gag reflex in children aged 4–12 years and to examine its correlation with age and dental fear. A total of 350 children in this age group will be evaluated using the Classification of Gagging Problem (CGP) index and the modified Gagging Problem Assessment–dentist part for children (GPA-de-c/SF). Dental fear will be assessed using the Children’s Fear Survey Schedule–Dental Subscale (CFSS-DS). Statistical analysis will be carried out using SPSS software, with chi-square and z-tests applied to compare the variables. |