| CTRI Number |
CTRI/2025/05/086337 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the level of pain in Children during giving injection using Special Electronic Device and Needle. |
|
Scientific Title of Study
|
Evaluation of Pain Perception during Local Anesthetic Procedure using Electronic Anesthetic Device with Transcodent needle in 5-10 years old Children: A Randomized Clinical Study. |
| 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 Neha Gajewar |
| Designation |
Post Graduate Student |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
1 floor number 3 department of pediatric and preventive dentistry, K. M. Shah Dental College and Hospital, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
7774007208 |
| Fax |
|
| Email |
nehagajewar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Kariya |
| Designation |
Professor |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
1 floor number 3 department of pediatric and preventive dentistry, K. M. Shah Dental College and Hospital, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Kariya |
| Designation |
Professor |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
1 floor number 3 department of pediatric and preventive dentistry, K. M. Shah Dental College and Hospital, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9558330199 |
| Fax |
|
| Email |
prateek.kariya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Neha Gajewar |
| Address |
1 floor number 3 department of pediatric and preventive dentistry,
K.M. Shah dental college and hospital, Sumandeep vidyapeeth an
deemed to be university, Vadodara Gujarat |
| 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 Neha Gajewar |
K. M. Shah Dental College and Hospital |
1 floor, number 3,
department of pediatric
and preventive dentistry,
K.M.SHAH dental college
and hospital, sumandeep
vidyapeeth an deemed to
be university, Vadodara
GUJARAT
Vadodara
GUJARAT |
07774007208
nehagajewar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children requiring bilateral local anaesthesia in their dental treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Starpen Anaesthetic device with painless transcodent needle |
Administration of local anaesthetic injection using painless trancodent needle through Starpen electronic device |
| Comparator Agent |
Starpen electronic device with conventional needle |
Administration of local anaesthesia injection using conventional needle through starpen electronic device |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children requiring bilateral inferior alveolar nerve block for any dental procedures.
2.Children exhibiting a 3 or 4 rating according to Frankl’s behaviour rating scale.
3.Children refrained from medication (antibiotics and analgesics) for the previous 48h that
could impact their response to local anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Children with systemic condition.
2. Children with asthma and / or any known allergy of lignocaine.
3. Parent who do not give consent for their child to participate in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Administring local anaesthesia for inferior alveolar nerve block using painless transcodent needle having three edge lancet bevel through starpen anaesthetic device. |
pain assessment on day 1 and day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there will be no difference in administring local anaesthesia for inferior alveolar nerve block block through conventional needle or painless transcodent needle |
pain assessment on day 1 and day 15 |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="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
|
The study aims to assess and compare pain perception using Starpen with Transcodent needle and Starpen with Conventional needle in children between 5 to 10 years of age undergoing inferior alveolar nerve block procedure.
1. To assess pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Transcodent needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2). 2. To assess pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Conventional needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2). 3. To compare pain perception of 5 to 10 years old child during inferior alveolar nerve block by Starpen with Transcodent needle and Starpen with conventional needle using Visual Analog Scale (VAS) , Face, Legs, Activity, Cry, Consolability Scale (FLACC) and physiological parameter (pulse rate and SpO2).
|