| CTRI Number |
CTRI/2025/07/090853 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effectiveness of newer behaviour modification techniques in children undergoing dental treatment |
|
Scientific Title of Study
|
Comparative Evaluation of effect of distraction techniques using Binaural Beats and Virtual Reality on Pain Perception and Anxiety in Paediatric Pateints during dental restorative procedure: A Randomised Control Trial |
| 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 Kaushikee Yadav |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital , Pune |
| Address |
208, Department of Pediatric And Preventive Dentistry
BVDUDCH
Pune Satara Road
Dhankawadi
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
90212384755 |
| Fax |
|
| Email |
yadav.kaushikee1901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Jajoo |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital , Pune |
| Address |
208, Department of Pediatric And Preventive Dentistry
BVDUDCH
Pune Satara Road
Dhankawadi
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9970667338 |
| Fax |
|
| Email |
shweta.jajoo@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushikee Yadav |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital , Pune |
| Address |
208, Department of Pediatric And Preventive Dentistry
BVDUDCH
Pune Satara Road
Dhankawadi
Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
90212384755 |
| Fax |
|
| Email |
yadav.kaushikee1901@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY DENTAL COLLEGE AND HOSPITAL
PUNE SATARA ROAD
DHANKAWADI
PUNE , MAHARASHTRA
411043
INDIA |
|
|
Primary Sponsor
|
| Name |
DR KAUSHIKEE YADAV |
| Address |
208, DEPT. OF PEDIATRIC AND PREVENTIVE DENTISTRY
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY DENTAL COLLEGE AND HOSPITAL
PUNE |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kaushikee Yadav |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital |
208, Department of Pediatric And Preventive Dentistry
BVDUDCH
Pune Satara Road
Dhankawadi
Pune
Pune
MAHARASHTRA |
90212384755
yadav.kaushikee1901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Binaural Beats and Virtual Reality |
Group II: Patient will be presented with pure binaural beats throughout the restorative procedure.
Group III: Patients will be presented with VR goggle connected to a mobile phone from which MP4 audio-visual files selected by the patient will be played throughout the restorative procedure.After presentation of the distraction technique, Class 1 cavity will be prepared using high speed airotor and restoration of the tooth will be done under relative isolation. |
| Comparator Agent |
TELL SHOW DO |
Group I: Patient will be treated with conventional tell-show-do method.After presentation of the respective distraction technique, Class 1 cavity will be prepared using high speed airotor and restoration of the tooth will be done under relative isolation |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children ASA 1 between 4-12 years.
First dental visit
Patients with ICDAS and ICDAS II code 3 and 4
Patients whose parents give consent for the treatment |
|
| ExclusionCriteria |
| Details |
Presence of any systemic disorder.
Special healthcare children
Visual and auditory impaired children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self measurement of pain
Meaurement of physiological parameter of anxiety by pulse rate and oxygen saturation |
before , during and after |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/08/2025 |
| 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="2"
Months="0"
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
|
This randomized controlled trial aims to compare the effectiveness of two distraction techniques binaural beats and virtual reality in reducing pain perception and anxiety among pediatric patients undergoing dental restorative procedures. By evaluating physiological and psychological responses, the study seeks to determine which technique offers better patient comfort and cooperation, ultimately contributing to improved pediatric dental care outcomes. |