FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094908 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing anxiety and pain in children during dental injections using a Traditional Syringe and Electronic syringe 
Scientific Title of Study   Comparative evaluation of anxiety and pain during local anesthesia administration by Conventional Syringe and Electronic Dental Anesthesia Device in children : 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 Sharvari Itankar 
Designation  Post Graduate Student  
Affiliation  K.L.E.V.K Institute of Dental Science 
Address  Department of Pediatric and Preventive Dentistry, Room no 6, KLE V.K Institute of Dental Science, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7038645367  
Fax    
Email  sharvariitankar03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrashekhar Badakar 
Designation  Professor and Head of Department 
Affiliation  K.L.E.V.K Institute of Dental Science 
Address  Department of Pediatric and Preventive Dentistry, Room no 6, KLE V.K Institute of Dental Science, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9902773259  
Fax    
Email  badakar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharvari Itankar 
Designation  Post Graduate Student  
Affiliation  K.L.E.V.K Institute of Dental Science 
Address  Department of Pediatric and Preventive Dentistry, Room no 6, KLE V.K Institute of Dental Science, Nehru nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7038645367  
Fax    
Email  sharvariitankar03@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental Sciences, belagavi, Karnataka, India 590010. 
 
Primary Sponsor  
Name  Dr Sharvari Itankar 
Address  Department of Pediatric and Preventive Dentistry, Room No 6 KLE VK Institute of Dental Sciences, Nehru nahar, Belagavi 
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 Sharvari Itankar  KLE VK Institute of Dental Sciences  Department of Pediatric and Preventive Dentistry,Room no 6,First floor,KLE V.K Institute of Dental Science,Nehru nagar,Belagavi
Belgaum
KARNATAKA 
7038645367

sharvariitankar03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Syringe  Local anesthesia will be delivered using Conventional Syringe. 27 guage needle and 2% lignocaine 1:80,000 will be used for the injection 
Intervention  Electronic Denatal Anesthesia Device  Local anesthesia will be delivered using An electronic assisted time and pressure control system, Electronic Dental Anesthesia Device which consists of a handpiece, cartridge holder, and power adapter. The device offers three different modes, each with nine adjustable injection speeds. 27 guage needle and 2% lignocaine 1:80,000 will be used for the injection  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children undergoing dental treatment requiring local anesthesia
Children in the age group of 6 to 12 years
Children with Frankls behavior rating scale of positive and definitely positive
Children who are willing to undergo treatment
 
 
ExclusionCriteria 
Details  Children with a diagnosed systemic disease and special healthcare needs.
Children with a known history of allergy to local anesthetic agents.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of Anxiety and Pain during local anesthesia administration using Electronic Dental Anesthesia Device (Star Pen®) as compared to Conventional Syringe in Children.
 
Anxiety will be recorded before and immediately after the local anesthesia administration using pulse oximeter and Venham’s picture scale.
Pain will be assessed during the local anesthesia administration by SEM Scale by a trained pediatric dentist
Self administered Wong Baker Faces Pain Rating scale will be used immediately after local anesthesia administration.
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of Anxiety and Pain during local anesthesia administration using Electronic Dental Anesthesia Device as compared to Conventional Syringe in Children.  Anxiety will be recorded before and immediately after the local anesthesia administration using pulse oximeter and Venham’s picture scale. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/01/2026 
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)  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  

Pediatric dental anxiety is often triggered by injections, which are feared due to their psychological and visual impact. While local anesthesia alleviates discomfort, its administration can still be distressing for children, as anxious patients tend to perceive more pain. Various techniques, such as topical anesthetics, slow injection methods, and distraction, aim to reduce this pain. However, some discomfort persists, even with these methods. The Electronic Dental Anesthesia device, which offers adjustable speeds and time/pressure control, presents a promising alternative to traditional syringes, potentially minimizing pain. This study aims to compare anxiety and pain levels in children receiving local anesthesia via the conventional syringe versus the Electronic Dental Anesthesia device. Objective of the study is to evaluate  and compare the anxiety and pain during local anesthesia administration by Conventional syringe and Electronic Dental Anesthesia device in children

This is a parallel arm randomized control trial evaluating anxiety and pain during local anesthesia administration by Conventional syringe and Electronic Dental Anesthesia device in children. The pre-procedural pulse rate will be monitored using pulse oximeter and anxiety score by Venhams Picture Scale will be measured prior to procedure. Topical anaesthetic will be applied and local anesthesia will be given with 2% lignocaine 1:80,000 by Conventional Syringe and Electronic Dental Anesthesia Device in Group I and Group II respectively. The Pain will be assessed during the local anesthesia administration by SEM Scale by a trained pediatric dentist. Immediately after local anesthesia administration Anxiety will be recorded using pulse oximeter and Venham’s picture scale. The Self-administered Wong Baker Faces Pain Rating scale will be used to record pain. Expected outcome of the study is reduction in anxiety and pain during local anaesthesia administration using Electronic dental anesthesia device as compared to Conventional syringe in children

 
Close