| CTRI Number |
CTRI/2025/07/090577 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Hepta Technique in oral hygiene education of children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effectiveness of Hepta Technique and oral hygiene education 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 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 |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. N. J. Remya |
| Address |
Post Graduate Resident,
Department of Pediatric & Preventive Dentistry,
Amrita School of Dentistry, Kochi |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shri Amritasree |
Amrita Institute for Differently Abled |
Amrita Institute for Differently Abled, Valummel, Kochi, Kerala, India
Ernakulam
KERALA |
7034028105
aida@amrita.ind.in |
| Sr Sereena |
Nirmala Training Centre for Exceptional Children |
Nirmala Training Centre for Exceptional Children, Kusumagiri P O, Kakkanad, Kerala, India
Ernakulam
KERALA |
9747284934
nirmalaschool2008@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 |
| Intervention |
Hepta Technique |
A novel tool kit that can help children practice proper oral hygiene maintenance - consists of seven components - a powered toothbrush, self-learning picture cards, short video, dental talking button, a colourful calendar to mark down the day, daily reminder polls on WhatsApp and anytime dental assistance. Provisions will be made for management of dental conditions present, if any. |
| Comparator Agent |
Not Applicable |
Not applicable |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children with Autism Spectrum Disorder - Mild to moderate.
Cooperative caregivers.
Children in primary and mixed dentition. |
|
| ExclusionCriteria |
| Details |
Autistic children presenting aggressive behaviour.
Children with serious systemic conditions.
Children with any comorbidities that restrict their participation in the study.
Children whose caregivers are unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Indices: Plaque index, DMFT index to be recorded |
Baseline
3 months
6 months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KAP Surveys will be conducted |
before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
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)
|
A pre-intervention survey was carried out among the guardians of the children with Autism Spectrum Disorder. Plaque index and DMFT index were recorded before intervention. Oral health education was provided with the help of dental models, picture cards, videos, etc. Hepta technique with seven tools - picture cards, powered toothbrush, brush my teeth - talking button, a short video on tooth brushing, a colourful calendar to mark down the day, daily reminder polls on Whatsapp and anytime dental assistance is being practiced. Provision made for the management of the oral conditions present, if any. Plaque index and DMFT index has been recorded at 3 months, 6 months and will be recorded at 12 months, post intervention, followed by a post intervention survey. |