| CTRI Number |
CTRI/2025/04/085812 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation Of Impact Of Special Sensory Friendly Dental Environment And Audiovisual Distraction On Dental Procedural Anxiety And Behaviour In Children With Special Care. |
|
Scientific Title of Study
|
Comparative Evaluation Of Impact of Sensory Adapted Dental Environment and Audiovisual Distraction on Dental Procedural Anxiety and Behavior 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 |
DrJanhavi Kanetkar |
| Designation |
Postgraduate |
| Affiliation |
Bharati Vidyapeeth Dental College andHospital Sangli |
| Address |
106, Ground Floor, Department of pediatric and preventive dentistry ,Bharati Vidyapeeth Dental College and Hospital Sangli
Sangli MAHARASHTRA 416416 India |
| Phone |
8983219694 |
| Fax |
|
| Email |
janu.kanetkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrAnil Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Bharati Vidyapeeth Dental College andHospital Sangli |
| Address |
106, Ground floor, Department of Pediatric Dentistry,Bharati Vidyapeeth Dental College and Hospital Sangli
Sangli MAHARASHTRA 416416 India |
| Phone |
8983219694 |
| Fax |
|
| Email |
dranilp0888@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrJanhavi Kanetkar |
| Designation |
Postgraduate |
| Affiliation |
Bharati Vidyapeeth Dental College andHospital Sangli |
| Address |
106,Ground Floor, Department of Pediatric and Preventive Dentistry,Bharati Vidyapeeth Dental College and Hospital Sangli
Sangli MAHARASHTRA 416416 India |
| Phone |
8983219694 |
| Fax |
|
| Email |
janu.kanetkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| 106, Ground floor, Department of pediatric and preventive dentistry,Bharati Vidyapeeth Dental College and Hospital, Sangli, Maharashtra 416416, India |
|
|
Primary Sponsor
|
| Name |
Dr Janhavi Kanetkar |
| Address |
106, Ground floor, Department of pediatric and preventive dentistry,Bharati Vidyapeeth Dental College and Hospital, Sangli, Maharashtra 416416, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Janhavi Kanetkar |
Bharati vidyapeeth dental college and hospital |
106,division 3, Ground floor, Department of pediatric and preventive dentistry,Bharati Vidyapeeth Dental college and Hospital, Sangli, Maharashtra 416416, India Sangli MAHARASHTRA |
8983219694
janu.kanetkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital, Sangli, Maharashtra 416416, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Audiovisual Distraction for 3 months |
Demonstration of animated youtube videos for 3 months |
| Intervention |
Sensory adapted dental environment (SADE) for 3 months |
Modified regular dental environment with lights, wallpapers for 3 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with known diagnosis of autism disorder.
2.Children showing ability to comply with short, simple and clear instructions.
3.Children with fair to poor oral hygiene requiring non-invasive dental treatment procedures.
|
|
| ExclusionCriteria |
| Details |
1.Children with previous history of very violent and highly uncooperative behaviour.
2.Children with history of systemic conditions.
3.Children who are unable to follow short, simple and clear instructions.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory Adapted Dental Environment proves to be a better tool for anxiety reduction and behaviour management in children with autism spectrum disorder. |
Behavioral changes will be observed at baseline and after 10 days of washout period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sensory adapted dental environment & audiovisual distraction may reduce dental anxiety & behaviour in children with autism spectrum disorder. |
behavioral changes will be observed at baseline & after 10 days of washout period. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
10/05/2025 |
| 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="3" 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
|
Fear and anxiety are the primary emotions in children, which need consideration during the dental management of children, especially children with autism spectrum disorder. It is commonly observed that patients with autism spectrum disorder are unable to cooperate in the dental setting as their developmental impairments lead to many difficulties. Changes in the environment, daily schedule or other routines often elicit behavioral resistance and tantrums. In the regular dental setup, disabled children are sensitive and easily invoked to sensory stimuli such as high speed handpiece, overhead light, loud ambient noises. In the dental field, sensory adapted dental environment has been studied as a novel intervention to reduce dental anxiety of children. The sensory adapted dental environment (SADE) comprises a specialized room with controlled multisensory stimuli that is partially lighted, with relaxing music. Distraction is a state of mind that draws the attention away from unpleasant stimuli. Distraction is known to successfully reduce the anxiety and manage children’s dental behavior during procedures. Various methods have been used in literature for the assessment of dental anxiety and distraction techniques but scanty literature is available, in terms of anxiety management and behavior management in children with autism spectrum disorder. Hence this study is planned to evaluate and compare the impact of sensory adapted dental environment and the effect of audiovisual distraction on dental anxiety and behavior in children with autism spectrum disorder. |