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CTRI Number  CTRI/2024/10/075766 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing Two Audio-Visual Techniques to Help Children Feel Calm During Dental Visits behaviour management 
Scientific Title of Study   Comparative evaluation of two different audio-visual distraction techniques for behaviour management: A randomized 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 Oshin Pragya Lepcha 
Designation  Post Graduate Student 
Affiliation  Christian Dental College 
Address  Department of Pedodontics and Preventive Dentistry Christian Dental College Brown Road

Ludhiana
PUNJAB
141008
India 
Phone    
Fax    
Email  oshinpragya217@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mebin George Mathew 
Designation  Associate Professsor 
Affiliation  Christian Dental College 
Address  Department of Pedodontics and Preventive Dentistry Christian Dental College Brown Road

Ludhiana
PUNJAB
141 008
India 
Phone  8951848659  
Fax    
Email  mebingmathew@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abi M Thomas 
Designation  Professor 
Affiliation  Christian Dental College 
Address  Department of Pedodontics and Preventive Dentistry Christian Dental College Brown Road

Ludhiana
PUNJAB
141008
India 
Phone  9417300473  
Fax    
Email  abithomas@gmail.com  
 
Source of Monetary or Material Support  
Dr. Oshin Pragya Lepcha, Department of Pedodontics and Preventive Dentistry, Christian Dental College, Brown Road, Ludhiana, Punjab, India- 141 008 
 
Primary Sponsor  
Name  Dr Oshin Pragya Lepcha 
Address  Christian Dental College, Brown Road, Ludhiana, Punjab, India -141 008  
Type of Sponsor  Other [Self Sponsored] 
 
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 Mebin George Mathew  Christian Dental College  Department of Pedodontics and Preventive Dentistry, Christian Dental College, Brown Road, Ludhiana
Ludhiana
PUNJAB 		 8951748659

mebingmathew@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Health & Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ipad  Oxygen saturation Wong-Baker Faces Pain Rating Scale These measurements will be taken at the following time points: 5 minutes before treatment During administration of local anesthesia During caries removal During biomechanical preparation During obturation During post-obturation restoration 5 minutes post-operatively 
Intervention  Virtual Reality Glass  Virtual reality glasses will be used to provide distraction for children undergoing vital pulp therapy, with specific physiological and psychological measures being recorded at various stages of the treatment. The outcome measures will be: Heart rate Oxygen saturation Wong-Baker Faces Pain Rating Scale These measurements will be taken at the following time points: 5 minutes before treatment During administration of local anesthesia During caries removal During biomechanical preparation During obturation During post-obturation restoration 5 minutes post-operatively 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. A healthy child with bilateral carious primary molars requiring pulp therapy
2. Child aged 7-10 years
3. Exhibiting Frankl positive or definitely positive 
 
ExclusionCriteria 
Details  1. Children with special health care needs
2. Uncooperative child(Frankl negative or definitely negative) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the effectiveness of
virtual reality as an attention distraction technique for pain management and assessment in
children undergoing pulp therapy 		 5 minutes before treatment
During administration of local anesthesia
During caries removal
During biomechanical preparation
During obturation
During post-obturation restoration
5 minutes post-operatively
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and evaluate the changes in
Heart rate
Oxygen saturation
Wong-Baker Faces Pain Rating Scale (pain perception) 		 5 minutes before treatment
During administration of local anaesthesia
During caries removal
During biomechanical preparation
During obturation
During post-obturation restoration
5 minutes post-operatively
 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   Phase 2 
Date of First Enrollment (India)   01/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 split-mouth clinical trial aims to compare the effectiveness of virtual reality (VR) glasses and iPad-based audio-visual distraction techniques in managing anxiety and pain during vital pulp therapy in children aged 7-10 years. The study will be conducted at the Department of Pedodontics and Preventive Dentistry, Christian Dental College, Ludhiana. A total of 25 cooperative children with bilateral carious primary molars requiring pulp therapy will be included. Each child will experience both distraction techniques, with outcomes measured through heart rate, oxygen saturation, and Wong-Baker Faces Pain Rating Scale at various stages of the dental procedure. The study aims to identify which technique better reduces anxiety and pain in pediatric patients, ultimately improving their overall dental experience. 
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