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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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