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CTRI Number  CTRI/2024/09/073413 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 24/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the efficacy of two behaviour management techniques, Virtual Reality eyeglasses (3D) and conventional Tell-Show-Do in reducing dental anxiety in children during dental extractions. 
Scientific Title of Study   Comparative evaluation of efficacy of Virtual Reality eyeglasses (3D) as distraction aid and conventional Tell- Show-Do technique in reducing dental anxiety in children during dental extractions: A Randomized Controlled 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  Amina Zulfiquar 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute Bangalore 
Address  Department of Pediatric and Preventive Dentistry,Government Dental College and Research Institute Bangalore, Karnataka -560002

Bangalore
KARNATAKA
560002
India 
Phone  8921216387  
Fax    
Email  aminazulfiquar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. S K Srinath 
Designation  Professor and HOD 
Affiliation  Government Dental College and Research Institute Bangalore 
Address  Department of Pediatric and Preventive Dentistry,Government Dental College and Research Institute Bangalore, Karnataka -560002


KARNATAKA
560002
India 
Phone  9845592166  
Fax    
Email  srinath.krishnappa@yahoo.com  
 
Details of Contact Person
Public Query  
Name  AMINA ZULFIQUAR 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Research Institute Bangalore 
Address  Department of Pediatric and Preventive Dentistry,Government Dental College and Research Institute Bangalore, Karnataka -560002

Bangalore
KARNATAKA
560002
India 
Phone  8921216387  
Fax    
Email  aminazulfiquar@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventice Dentistry, Government Dental College and Research Institute , Bangalore ,Victoria Hospital, Kalasipalya,560002 
 
Primary Sponsor  
Name  AMINA ZULFIQUAR 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE BANGALORE,KARNATAKA -560002 
Type of Sponsor  Other [Self] 
 
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 Amina Zulfiquar  Government Dental College and Research Institute, Bangalore  Room Number 5,Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Bangalore, Victoria hospital ,Kalasipalya PIN 560002
Bangalore
KARNATAKA 		 8921216387

aminazulfiquar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  tell-show-do technique  use of conventional tell-show-do technique as distraction aid during extraction of non restorable primary molars in 6-9 year old children. 
Intervention  virtual reality eyeglasses (3D)  use of virtual reality eyeglasses (3D) as distraction aid in extraction of non restorable primary molar in 6-9 year old children. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) Healthy children in the age group of 6-9 years who can read and understand Kannada/English/Hindi.
2)Children with dft/DMFT score of less than 5 and requiring extraction of primary molars under local anesthesia.
3)Children with Frankl behavior rating in category 2 and 3.
4)No known history of medical allergy 
 
ExclusionCriteria 
Details  1) Children presenting with acute pain and requiring emergency dental treatment.

2) Primary molars with any eruptive abnormality (ankylosis) and preshedding mobility.
3) Children who had previous unpleasant experience in dental/medical settings and experience with local anesthesia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of participants successful completion of dental extractions done using Virtual Reality eyeglasses (3D) as an audiovisual distraction aid and Tell-Show- Do technique.  no follow up 
 
Secondary Outcome  
Outcome  TimePoints 
: Parental and child acceptance of Virtual Reality eyeglasses (3D) as an audiovisual distraction aid.  no follow up 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   10/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   It is a randomized controlled clinical trial, aimed to assess dental fear, anxiety and pain perception in children after dental extraction using virtual reality eyeglasses (3D). Children between the age group of 6-9 years fulfilling the inclusion criteria will be selected for the study. Group 1 (experimental group) will undergo extraction along with virtual reality eyeglasses and group 2 (control group) will undergo extraction after tell show do technique. Pretreatment and post treatment pulse rate, respiratory rate and oxygen saturation level will be estimated along with anxiety assessment by venhams picture test and venhams clinical anxiety scale and pain assessment by Wong Baker Faces Pain Scale. 
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