| 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
|
|
|
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
|
|
|
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. |