| CTRI Number |
CTRI/2024/07/070287 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Analysis Of Children Pain Reactions And Perception To Injection Using Computer Controlled Local Anesthetic Drug Delivery System And Traditional Injections |
|
Scientific Title of Study
|
A Comparative Analysis Of Children Pain Reactions And Perception To Injection Using Computer Controlled Local Anesthetic Drug Delivery System And Traditional Injections- An In Vivo 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 Sonali Garg |
| Designation |
Post Graduate Student |
| Affiliation |
TEERTHANKER MAHAVEER DENTAL COLLEGE AND RESEARCH CENTRE, MORADABAD |
| Address |
Room No-617, 5th floor, Department of Pedodontics and Preventive
Dentistry, Teerthanker Mahaveer Dental College And Research
Centre, Moradabad
UTTAR PRADESH
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7906712978 |
| Fax |
|
| Email |
dr.sonaligarg16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Dev Gupta |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Dental College And Research Centre |
| Address |
Room No-617, 5th floor, Department of Pedodontics and Preventive
Dentistry, Teerthanker Mahaveer Dental College And Research
Centre, Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9456914922 |
| Fax |
|
| Email |
kapil.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Garg |
| Designation |
Post Graduate Student |
| Affiliation |
TEERTHANKER MAHAVEER DENTAL COLLEGE AND RESEARCH CENTRE, MORADABAD |
| Address |
Room No-617, 5th floor, Department of Pedodontics and Preventive
Dentistry, Teerthanker Mahaveer Dental College And Research
Centre, Moradabad
UTTAR PRADESH
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7906712978 |
| Fax |
|
| Email |
dr.sonaligarg16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-617, 5th floor, Department of Pedodontics and Preventive Dentistry, Teerthanker
Mahaveer Dental College and Research Centre, Moradabad-244001
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Garg |
| Address |
Room No-617, 5th floor, Department of Pedodontics and Preventive
Dentistry, Teerthanker Mahaveer Dental College And Research
Centre, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| 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 Sonali Garg |
Teerthanker Mahaveer Dental College and Research Centre, Moradabad |
Room No. 617, 5th
floor, Department of
Pedodontics and
Preventive Dentistry,
Teerthanker Mahaveer
Dental College and
Research Centre,
Moradabad-244001,
Uttar Pradesh
Moradabad
UTTAR PRADESH |
7906712978
dr.sonaligarg16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Teerthanker Mahaveer Dental College and Research Centre, Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer Controlled Local Anesthetic Drug Delivery System |
Computer Controlled Local Anesthetic Drug Delivery Systems in dentistry enhance precision and patient comfort by automatically adjusting the flow and pressure of anesthetic injection. This technology reduces pain and anxiety, ensuring consistent and controlled delivery, improving the overall experience for patients during various dental procedures, including fillings and extractions. |
| Comparator Agent |
Traditional Injections |
The traditional local anesthetic injection method is widely used. In dental procedures, traditional syringes are crucial for administering local anesthesia to numb specific areas in the mouth. This ensures patients experience minimal discomfort during treatments such as fillings, extractions, and root canals. The syringes precision allows dentists to effectively target nerves. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children in need of dental treatment. Children should be between 5-14 years of age. Children with a good systemic condition. Co-operative patients (Frankel’s III or IV). Healthy patient satisfying the criteria of ASA physical status I. |
|
| ExclusionCriteria |
| Details |
Children who refuse to participate in the study. Children suffering from any systemic disease. Highly uncooperative children. Patient with abscess and fistula. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The pain reaction and perception will be checked in children using computer controlled anesthetic drug delivery system and traditional syringe. |
Pulse rate and Spo2 will be recorded with finger pulse oximeter 5 min. before the administration of Local Anesthesia and again at 10 minutes and 30 minutes after local anesthesia administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check & discover a practical alternative to traditional injections for delivering local anesthetic drugs. |
It will be checked during the procedure. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="2"
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
|
|