| CTRI Number |
CTRI/2026/01/101463 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge ,attitude and practice of oral health among preschoolers |
|
Scientific Title of Study
|
Knowledge ,Attitude And Practice of oral helath care among urban mothers of preschoolers - a questionniare 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 |
MAYURI RAMCHANDRA GORULE |
| Designation |
Post Graduate student |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D Y PATIL SCHOOL OF DENTISTRY
DEPARTMENT OF PEDIATRIC AND PEDIATRIC DENTISTRY BASEMENT ROOM NO 1 POST GRADUATE SECTION
Mumbai
MAHARASHTRA
400063
India |
| Phone |
09035494120 |
| Fax |
|
| Email |
mayurigorule97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa S Naik |
| Designation |
Head of department |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D Y PATIL SCHOOL OF DENTISTRY DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY BASEMENT ROOM NO 1 NAVI MUMBAI SECTOR 7
MAHARASHTRA
400063
India |
| Phone |
09035494120 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
MAYURI RAMCHANDRA GORULE |
| Designation |
Post Graduate student |
| Affiliation |
Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai |
| Address |
D Y PATIL SCHOOL OF DENTISTRY
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY BASEMENT ROOM NO 1 POSTGRADUATE SECTION NAVI MUMBAI SECTOR 7
MAHARASHTRA
400063
India |
| Phone |
09035494120 |
| Fax |
|
| Email |
mayurigorule97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
D Y PATIL SCHOOL OF DENTISTRY |
| Address |
D Y PATIL SCHOOL OF DENTISTRY DEPARTEMTN OF PEDIATRIC AND PREVENTIVE DENTISTRY NAVI MUMBAI SECTOR 7 BASEMENT ROOM NO 1 POST GRADUATE SECTION |
| 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 |
| MAYURI RAMCHANDRA GORULE |
D Y PATIL SCHOOL OF DENTISTRY NAVI MUMBAI |
D Y PATIL SCHOOL OF DENTISTRY DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY SECTOR 7 NAVI MUMBAI BASEMENT ROOM NO 1 POST GRADUATE SECTION
Mumbai
MAHARASHTRA |
09035494120
mayurigorule97@gmail.com |
|
|
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 |
Healthy mothers of preschoolers
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Mothers of pre-schoolers (3 to 5 years of age).
2. Healthy children (ASA I).
3.Willing to participate in the study.
4. Mothers who can read and understand English / Hindi / Marathi.
|
|
| ExclusionCriteria |
| Details |
1.Parents not willing to participate.
2. Participants from rural areas.
3. Children with any medical/ systemic conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge , attitude and practice of oral health among urban mothers of preschoolers |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
27/01/2026 |
| 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="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Mothers/ primary care giver of children aged 3–5 years will be included in the study. The participants will informed about the purpose and scope of the research, and informed consent will be obtained prior to participation. A pre-structured and validated questionnaire was administered to the participants through a form in English, Hindi, and Marathi. Subsequently, an awareness program emphasizing the importance of oral health and appropriate measures for maintaining good oral hygiene will be conducted. After the program, a post-test questionnaire will be distributed to the participants. |