| CTRI Number |
CTRI/2025/02/081163 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Popsicles to Reduce Pain from Dental Injections in Children: A Study on Pain Perception and Post-Treatment Comfort |
|
Scientific Title of Study
|
A comparative evaluation of pain perception and postoperative pain in children with pre cooled injection sites using popsicles for local anaesthesia: a randomized controlled 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 |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,Chennai, Tamil nadu 600077
India.
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,Chennai, Tamil nadu 600077
India.
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental college and hospital |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,Chennai, Tamil nadu 600077
India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, SIMATS University |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| harsh baldawa |
saveetha dental college and hospital |
clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital, Chennai 600077
Chennai
TAMIL NADU |
08485841420
baldawaharsh.hb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ice popsicles |
Participant has choice of flavoour of popsicle, Popsicles is then placed on the injection site for 1 minute and then local anaesthesia is administered |
| Intervention |
ice popsicles |
Precooled Popsicles is placed on the injection site for 1 minute and then local anaesthesia is administered |
| Comparator Agent |
topical anaesthetic spray |
Injection site is cleaned by cotton and then topical anaesthetic spray is applied on injection site. After 1 minute LA is administered |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.children age 4-10 years
2. frankles behavior rating scale 3 and 4
3. child with first dental visit
4. With no significant medical condition
5. Child undergoing only extraction treatment |
|
| ExclusionCriteria |
| Details |
1. Treatment other than extraction
2. Frankles behavior rating scale 1 and 2
3. Medically compromised individuals
4. Parents who didnt give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
baseline |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Months="0"
Days="7" |
|
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
|
Title: A Comparative Evaluation of Pain Perception and Postoperative Pain in Children with Pre-Cooled Injection Sites Using Popsicles for Local Anaesthesia: A Randomized Controlled Trial
Objective: This study aims to assess the effectiveness of pre-cooling injection sites using popsicles in reducing pain perception during local anaesthesia administration and postoperative pain post extraction in children.
Study Design: A randomized controlled trial with two groups—one receiving pre-cooling with popsicles before local anaesthesia and the other receiving standard local anaesthesia without pre-cooling.
Participants: Children requiring dental procedures under local anaesthesia.
Intervention: The experimental group will receive popsicle application to the injection site before local anaesthesia, while the control group will receive local anaesthesia without pre-cooling.
Outcome Measures: Pain perception during injection (assessed using a standardized pain scale) and postoperative pain levels (measured at different time intervals).
Significance: The study aims to determine whether pre-cooling with popsicles is an effective, non-invasive, and child-friendly method for pain management in pediatric dental procedures. |