| CTRI Number |
CTRI/2025/11/098100 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare if change in the temperature of the local anaesthetic solution will help in enhancing the property of the solution |
|
Scientific Title of Study
|
To evaluate the effectiveness, pain perception and onset of action of local anesthesia at different temperatures among children |
| 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 R Priyanka |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Room number 4
Department of Pediatric and Preventive Dentistry
Sathyabama Dental College and Hospital
Sathyabama Institute of science and technology
Jeppiaar Nagar
Seemencherri
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
8825549560 |
| Fax |
|
| Email |
priyankaravi112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Priyanka |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Room number 4
Department of Pediatric and Preventive Dentistry
Sathyabama Dental college and hospital
Sathyabama Institute of science and technology
Jeppiaar nagar
Seemencheri
Sathyabama Institute of science and technology
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
8825549560 |
| Fax |
|
| Email |
priyankaravi112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Priyanka |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Room number 4
Department of Pediatric and Preventive Dentistry
Sathyabama Dental college and hospital
Sathyabama institute of science and technology
Jeppiaar nagar
Seemencheri
Sathyabama Institute of science and technology
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
8825549560 |
| Fax |
|
| Email |
priyankaravi112@gmail.com |
|
|
Source of Monetary or Material Support
|
| All those supports for patients will be from the college, Sathyabama dental collegeand hospital chennai |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NO] |
|
|
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 R Priyanka |
athyabama Dental College and Hospital |
Room number 4
Department of Pediatric and Preventive Dentistry
Sathyabama Dental college and hospital
Sathyabama Institute of science and technology
Kancheepuram
TAMIL NADU |
08825549560
priyankaravi112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Temperature |
Pulse rate |
| Intervention |
Temperature |
Pulse rate |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Those who require local anaesthesia for any of the procedure all the four sides of the mouth but should be cooperative |
|
| ExclusionCriteria |
| Details |
those who does not require anesthesia in any one of the side uncooperative children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in temperature and its influence on pain perception and onset of action |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aim of the study is to identify does change in the temperature has any influence in the reduction of the level of pain perception and onset of action, for this study vials will be used and heating will be done with the hot plat based on the previous study no change in the property of the anesthetic solution happens in 2 mins |