| CTRI Number |
CTRI/2025/03/083174 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Oral health examination in autistic children |
|
Scientific Title of Study
|
Assessment of oral health status in autistic children; an observational 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 |
Shailendra Verma |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences ,IMS, BHU,Varanasi , Uttar Pradesh, 221005 |
| Address |
Room No. 9 Unit of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi, Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09984984972 |
| Fax |
|
| Email |
vermashailendra923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vinay Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences ,IMS, BHU,Varanasi , Uttar Pradesh, 221005 |
| Address |
Room no. 9 Unit of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi, Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415087360 |
| Fax |
|
| Email |
Dr.vinaypedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vinay Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences ,IMS, BHU,Varanasi , Uttar Pradesh, 221005 |
| Address |
Room no. 9 Unit of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi, Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415087360 |
| Fax |
|
| Email |
Dr.vinaypedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 9 Unit of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi, 221005,india. |
|
|
Primary Sponsor
|
| Name |
PROF. VINAY KUMAR SRIVASTAVA |
| Address |
Unit of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, BHU, Varanasi, Uttar Pradesh 221005 India |
| 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 |
| Prof Vinay Kumar Srivastava |
Unit OF Paediatric and Preventive Dentistry , Faculty OF Dental Sciences, IMS, BHU |
Room No. 9, Fourth Floor, Unit OF Paediatric and Preventive Dentistry, Faculty OF Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH |
9415087360
Dr.vinaypedo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IMS, BHU, VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children already diagnosed with autism.
Age group 3-17 years.
Autistic children with additional diagnosis or conditions. |
|
| ExclusionCriteria |
| Details |
children without parental consent.
children with highly aggressive behaviour. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of oral health status in autistic children |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
04/04/2025 |
| 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="0"
Months="9"
Days="0" |
|
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
|
Autistic spectrum disorder (ASD) is characterized by impairments in communication and social relationships and a restricted, repetitive and stereotyped repertoire of activities, behaviuors and interests. Therefore, affected children may be incapable to receive proper oral care. This study is designed to explore the oral hygiene practices and oral health status of children with ASD and factors that may affect their oral health and also for evaluate the severity of oral health status in different age groups in autistic children. |