| CTRI Number |
CTRI/2025/05/087907 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of pain perception in 6-10 year old children during inferior alveolar nerve block injection using Star pen vs Conventional injection technique. |
|
Scientific Title of Study
|
Comparative evaluation of pain assessment using Star Pen and Conventional injection technique during inferior alveolar nerve block injection in children aged between 6-10 years. -A Split mouth Randomised 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 Swanandi Kelkar |
| Designation |
Post Graduate student |
| Affiliation |
Bharati VidyapeethDeemed to be University Dental College and Hospital Pune |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 208 Satara Road Katraj Ambegaon BK Rd Dhankawadi Pune Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9403459072 |
| Fax |
|
| Email |
swanandik97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetam Shah |
| Designation |
PG Guide |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital Pune |
| Address |
Department of Pediatric and Preventive Dentistry, Room no 208 Satara Road Katraj Ambegaon BK Rd Dhankawadi Pune Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9403459072 |
| Fax |
|
| Email |
preetamshah9009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swanandi Kelkar |
| Designation |
Post Graduate student |
| Affiliation |
Bharati VidyapeethDeemed To Be University Dental College and Hospital Pune |
| Address |
Department of Pediatric and Preventive Dentistry, Room no 208 Satara Road Katraj Ambegaon BK Rd Dhankawadi Pune Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
9403459072 |
| Fax |
|
| Email |
swanandik97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed To Be University Dental College and Hospital Pune, Maharashtra 411043 India |
|
|
Primary Sponsor
|
| Name |
Dr. Swanandi Kelkar |
| Address |
Bharati Vidyapeeth Educational Complex Pune- Satara Road Katraj - Dhankawadi Pune - 411043 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Preetam Shah |
Bharati Vidyapeeth Educational Complex, Pune- Satara Road, Katraj - Dhankawadi, Pune-411043 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swanandi Kelkar |
Bharati Vidyapeeth Deemed To be University Dental college and hospital |
Department of Pediatric and Preventive Dentistry, Room no 208 Bharati Vidyapeeth Educational Complex, Pune- Satara Road, Katraj - Dhankawadi, Pune 411043
Pune
MAHARASHTRA |
9403459072
swanandik97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Pune India Dental College and Hospital Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M26-M27||Dentofacial anomalies [including malocclusion] and other disorders of jaw, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cartridge syringe |
Conventional Cartridge syringe by Septodont.
The duration of action of delivering local anaesthesia will be approximately one minute for conventional local anaesthesia delivery system using cartridge. |
| Intervention |
Star Pen |
Star Pen Eletrconic local anesthesia device by Woodpecker.
The hybrid mode of Star Pen device will be selected for local anaesthesia delivery. The duration of delivery of local anaesthesia will be approximately one minute. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients requiring bilateral inferior alveolar nerve block injection for further dental treatment. 2)Healthy (ASA-I) patients in the age group 3)Cooperative patients (Frankel behaviour rating 3 and 4)
|
|
| ExclusionCriteria |
| Details |
1)Children with special health care needs. 2)Children with any systemic complications. 3)Very uncooperative patients (Frankel behaviour rating 1 and 2) 4)Children with known allergies to local anesthesia solution. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the most efficient local anesthesia administration technique in children aged between 6-10 years. |
There will be a wash out period of 2 weeks between both injection techniques |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of pain perception for Star Pen device during IANB injection in children.
|
Evaluation of pain perception will be done during injection
|
Evaluation of pain perception for conventional cartridge syringe during IANB injection in children.
|
Pain perception will be evaluated during injection |
| Evaluation of pain reaction for Star Pen device during IANB injection in children. |
Pain reaction will be recorded right after the injection |
| Evaluation of pain reaction for conventional cartridge syringe during IANB injection in children. |
Pain reaction will be evaluated right after the injection |
| To compare pain perception and reaction for star pen device and conventional local anaesthesia technique during IANB injection in children |
There will be a wash out period of 2 weeks between both injection techniques |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="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
|
This is a split mouth randomised control trial comparing pain perception and pain reaction using Star Pen and Conventional injection technique during inferior alveolar nerve block injection in children aged between 6-10 years. The study will be conducted inBharati Vidyapeeth Dental College and Hospital Pune, India. The purpose of this study is to assess the utilisation of Star Pen : Advanced Dental Anaesthesia Device in routine pediatric dental practice for administration of local anaesthesia. The primary outcome will be To find out the most efficient local anaesthesia administration technique in children aged between 6-10 years. While the secondary outcomes will include Evaluation of pain perception for Star Pen device during IANB injection in children, Evaluation of pain perception for conventional cartridge syringe during IANB injection in children, Evaluation of pain reaction for Star Pen device during IANB injection in children, Evaluation of pain reaction for conventional cartridge syringe during IANB injection in children, To compare pain perception and pain reaction of Star pen device and conventional cartridge syringe during IANB injection in children. |