| CTRI Number |
CTRI/2025/07/090362 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Alteration in salivary microbial count with oral health education in Autistic children |
|
Scientific Title of Study
|
Effect of Oral Health Education on Salivary Microorganisms in Children with Autism Spectrum Disorder |
| 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 N J Remya |
| Designation |
Post Graduate Resident |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Amrita School of Dentistry, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9656581694 |
| Fax |
|
| Email |
drnjremya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balagopal Varma R |
| Designation |
Principal, HOD |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Amrita School of Dentistry, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balagopal Varma R |
| Designation |
Principal, HOD |
| Affiliation |
Amrita School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Amrita School of Dentistry, Kochi
KERALA
682041
India |
| Phone |
9447032358 |
| Fax |
|
| Email |
balagopalvarma@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Nirmala Training Centre for Exceptional Children, Kusumagiri P O, Kakkanad, Kerala, India
Ernakulam
KERALA |
|
|
Primary Sponsor
|
| Name |
Dr N J Remya |
| Address |
Post Graduate Resident,
Department of Pediatric and Preventive Dentistry, Kochi - 682041, Kerala, India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 N J Remya |
Amrita School of Dentistry |
Department of Pediatric and Preventive Dentistry,
Room No 05,
First Floor,
Amrita School of Dentistry
Ernakulam
KERALA |
9656581694
drnjremya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oral Health Education |
Include use of using dental models, picture cards, videos, etc. At baseline, 3 months, 6 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children with Autism Spectrum Disorder - Mild to moderate.
Children in primary and mixed dentition period |
|
| ExclusionCriteria |
| Details |
Autistic children presenting aggressive behaviour.
Children with serious systemic conditions.
Children with any comorbidities that restrict their participation in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total plate count |
baseline
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2025 |
| Date of Study Completion (India) |
17/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Children were asked to wash mouth and avoid eating or drinking for 1 hour, following which, approximately 1 ml of non-stimulated, naturally outflowed saliva sample was collected from the children using the saliva collection kit. The sample collected was stored in containers along with ice pack to maintain the cold temperature. Oral health education was done using dental models, picture cards, videos, etc. The collected sample were transported to the lab, the same day and each sample was evaluated for total microbial count, using the microbial method called total plate count. Oral health education was given again at 3 months and 6 months and Post intervention saliva samples are to be collected and evaluated at 12 months. |