| 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 |
|
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Details of Secondary Sponsor
|
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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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.
|
|
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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.
|
|
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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. |
|
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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 |