| CTRI Number |
CTRI/2023/04/051267 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Dentistry
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare PAIN PERCEPTION in children WITH AN ELECTRONICALLY ASSISTED INJECTION SYSTEM AND CONVENTIONAL NEEDLE METHOD. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PAIN PERCEPTION in children WITH AN ELECTRONICALLY ASSISTED INJECTION SYSTEM AND CONVENTIONAL NEEDLE METHOD: A SPLIT MOUTH RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devyani Sharma |
| Designation |
PG Student |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
Sinhgad Dental college and hospital, vadgaon budruk Pune.
Dept of Pediatric and preventive dentistry, dept no-6.
Pune
MAHARASHTRA
411041
India |
| Phone |
09860528691 |
| Fax |
02024351308 |
| Email |
devyani.sharma1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raju Patil |
| Designation |
Head of Department |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
Sinhgad Dental college and hospital, Pune.
Dept of Pediatric and preventive dentistry, dept no-6.
Pune
MAHARASHTRA
411041
India |
| Phone |
8871963896 |
| Fax |
02024351308 |
| Email |
Pedodontics.sdch@sinhgad.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raju Patil |
| Designation |
Head of Department |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
Sinhgad Dental college and hospital, Pune.
Dept of Pediatric and preventive dentistry, dept no-6.
Pune
MAHARASHTRA
411041
India |
| Phone |
8871963896 |
| Fax |
02024351308 |
| Email |
Pedodontics.sdch@sinhgad.edu |
|
|
Source of Monetary or Material Support
|
| Sinhgad dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Devyani Sharma |
| Address |
Sinhgad Dental college and hospital, Pune. |
| 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 Raju Patil |
Sinhgad Dental college and hospital, Pune. |
Department of Pediatric and Preventive Dentistry, dept no 06.
Pune
MAHARASHTRA |
08871963896
02024351308
Pedodontics.sdch@sinhgad.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee of Sinhgad dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARTICAINE |
Infiltration in mandibular region using electronically assisted needle. |
| Comparator Agent |
ARTICAINE. |
Infiltration in mandibular region using conventional needle method. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
-No previous experience of dental needles.
-Patients with Frankl ++ during opd.
-Need for extraction and LA administration through infiltration.
|
|
| ExclusionCriteria |
| Details |
-Patient with any allergy.
-History of swelling associated with the tooth
-Patient Unwilling to participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To clinically evaluate pain perception by LA administration using electronically assisted injection system and conventional needle in children.
|
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare pain perception using electronically assisted injection system and conventional needle method during LA administration in children.
|
18months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
11/04/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study has been taken up to clinically compare pain perception between Electronically assisted syringe system and Conventional needle method in children. And also by evaluating effectiveness of Electronically assisted syringe system in dental extraction procedure in children as an alternative to the Conventional needle method of local anesthesia (LA) administration. |