FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/068067 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Other 
Public Title of Study   Comparision of two different types of dental environments to reduce dental anxiety in children with special healthcare needs 
Scientific Title of Study   Comparative Evaluation of the Effect of Visual Stimulation and Auditory Stimulation on Dental Anxiety in Children with Special Health Care Needs 
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 Ananya Sharma 
Designation  PG student 
Affiliation  I T S Dental College Hospital & Research Centre 
Address  Room No. 9, Fourth Floor, Department of Paediatric and Preventive Dentistry
47, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9760933521  
Fax    
Email  ananyaurfanu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Aditya Saxena 
Designation  Professor 
Affiliation  I T S Dental College Hospital & Research Centre 
Address  Room No. 9, Fourth Floor, Department of Paediatric and Preventive Dentistry
47, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9760933521  
Fax    
Email  adisaxen85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ananya Sharma 
Designation  PG student 
Affiliation  I T S Dental College Hospital & Research Centre 
Address  Room No. 9, Fourth Floor, Department of Paediatric and Preventive Dentistry
47, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9760933521  
Fax    
Email  ananyaurfanu@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric and Preventive Dentistry I T S Dental College Hospital & Research Centre Greater Noida 
 
Primary Sponsor  
Name  ITS Dental College Hospital and Research Centre 
Address  Room No. 9, Fourth Floor, Department of Paediatric and Preventive Dentistry, ITS Dental College Hospital and Research Centre, 47, Knowledge Park 3, Greater Noida, Uttar Pradesh, Pin Code- 201310 
Type of Sponsor  Research institution and hospital 
 
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 Ananya Sharma  I T S Dental College Hospital & Research Centre  Room No. 9, Fourth Floor, Department of Paediatric and Preventive Dentistry, ITS Dental College Hospital and Research Centre, 47, Knowledge Park 3, Greater Noida, Pin Code- 201310
Gautam Buddha Nagar
UTTAR PRADESH 
9760933521

ananyaurfanu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I T S Dental College Hospital & Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Auditory Stimulation  In second appointment we will use auditory stimulation through instrumental music for 30 minutes while patient is undergoing preventive treatment. 
Comparator Agent  Visual Stimulation  In the first appointment we will use visual stimulation by integrating bubble tube and multicolored lights for 30 minutes while patient is undergoing preventive treatment. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age Group- 6 to 12 years
Children with Mild Intellectual Developmental disorders (IDDs)
Parents giving consent for the study
 
 
ExclusionCriteria 
Details  Children with Auditory Impairment
Children with Visual Impairment
Parents not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Measurement Of Behavioural Distress, Sensory Discomfort, Physiological Distress  At Baseline
After Treatment 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/06/2024 
Date of Study Completion (India) 24/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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)  

In the clinical setting of the Department of Pediatric and Preventive Dentistry at I.T.S. Dental College, Greater Noida, in children with Mild Intellectual Developmental Disorders (Mild IDD) in the age group of 6 to 12 years. To ensure a conducive and child-friendly environment, we will modify a designated room, incorporating a carefully selected colour theme and child-appropriate depictions. The room will be illuminated with dim lighting, while Lavender Essential Oil will be diffused using an electric vaporizer to provide olfactory stimulation. Additionally, we will employ wraps to offer a comforting hugging effect. The initial appointment will focus on visual stimulation, integrating a bubble tube, as reported by the parents. In the subsequent session, we will introduce auditory stimulation through instrumental music.

The preventive dental treatment will be administered in two sequential appointments. The first session will involve the application of Pit and Fissure sealant on the right side, followed by a similar procedure on the left side during the second appointment. The time interval between these two appointments will be at least 15 days.

The objective of this study is to assess outcomes such as behavioural distress, sensory discomfort, and physiological distress in these young patients, thereby enhancing our understanding of providing optimal dental care for children with Mild IDD.

 
Close