| CTRI Number |
CTRI/2025/07/090744 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reducing Pain in Children During Dental Injections: A Study Using Vibration and Cooling Together |
|
Scientific Title of Study
|
Effectiveness of Combined Extraoral Vibration and Cooling on Pain Perception during IANB administration in Children: a split mouth randomised 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 |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
08485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunny Priyatham Tirupathi |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9490549454 |
| Fax |
|
| Email |
dr.priyatham@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
post graduate |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
08485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai 600077, India |
|
|
Primary Sponsor
|
| Name |
Harsh Baldawa |
| Address |
Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai |
| 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 |
| Harsh Sanjaykumar Baldawa |
Saveetha Dental College and Hospital, Chennai |
Clinic 28, Department of Pedodontics, Saveetha Dental College and Hospital, Chennai
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: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
extraoral vibration and cooling device |
The extraoral vibration and cooling device was activated 30 seconds before administration of the local anesthetic and remained operational throughout the procedure. It was positioned extraorally over the area adjacent to the intended injection site (mandibular or maxillary) and functioned in a hands-free manner, requiring no manual stabilization.
Duration is 2 minutes until local anesthesia is administered. |
| Comparator Agent |
topical anesthesia |
LA was administered using the conventional method, with prior application of topical anesthetic for surface desensitization for 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children aged four to nine years
Requiring bilateral LA for dental procedures such as pulp therapy, extraction, or restorative treatment
Medically healthy children with no systemic conditions affecting pain perception
Cooperative behavior rated as three or four on the Frankl Behavior Rating Scale |
|
| ExclusionCriteria |
| Details |
Neurological or cognitive impairments
History of adverse reactions to local anesthetics
Presence of intraoral soft tissue lesions or infections at the injection site
Use of analgesics or sedatives within 24 hours prior to the procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception that is subjective and objective pain |
baseline - while local anesthesia administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
baseline - during administration of local anesthesia |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/07/2025 |
| 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="15" |
|
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
|
This study investigated the effectiveness of a novel EVC device in reducing pain perception and physiological stress during IANB administration in children. Pain and anxiety are significant concerns in pediatric dentistry, often impacting cooperation and long-term dental attitudes. |