| CTRI Number |
CTRI/2025/07/091393 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Electronic Pen versus Cold Spray During Dental Injections in 12-16-year-old children participants for reducing pain |
|
Scientific Title of Study
|
Pain Alleviation by Electronic Acupuncture Pen versus Ethyl Chloride Spray during Local Anaesthetic Injection Procedures: A Randomised Split-Mouth Clinical 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 |
Meghna Bhargava |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room No-309, Department of Pediatric and Preventive Dentistry, Institute of Dental Sciences, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
07300860267 |
| Fax |
|
| Email |
meghna199809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Vashisth |
| Designation |
professor |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room No-301, Department of Pediatric and Preventive Dentistry, Institute of Dental Sciences, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7017922134 |
| Fax |
|
| Email |
pallavivashisth@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Vashisth |
| Designation |
professor |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room No-301, Department of Pediatric and Preventive Dentistry, Institute of Dental Sciences, Pilibhit bypass road, Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7017922134 |
| Fax |
|
| Email |
pallavashisth@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences, Pilibhit by pass road,Opposite to Suresh sharma nagar Chandpur Bichpuri, Bareilly, UP-243006 |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences |
| Address |
Room No 309 department of pediatric and preventive dentistry pilibhit by pass road, opposite to suresh sharma nagar Bareilly-243006 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Meghna Bhargava |
INSTITUTE OF DENTAL SCIENCES |
Room No 309 department of pediatric and preventive dentistry PILIBHIT BY PASS ROAD, OPPOSITE TO SURESH SHARMA NAGAR
Bareilly
UTTAR PRADESH |
07300860267
meghna199809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IDS, Bareilly, UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
electronic acupuncture pen |
the electronic pen will be used in circular motions on the site for 2minutes where local anaesthesia has to be administered. |
| Intervention |
ethyl chloride spray |
a cotton sprayed with ethyl chlroide srpray ranging from 0 to -2 degree celsius will be applied on the area for 1 minute where local anaesthesia has to be administered |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 12-16 years
Children graded 2 or 3 on Frankls behaviour rating scale
Children requiring anaesthesia in mandibular or maxillary arch |
|
| ExclusionCriteria |
| Details |
Patients with systemic illness, compromised circulation, skin conditions or open wounds
Frankl rating behaviour scale grading 1 or 4
Patient allergic to LA or electrode or tape gel
Specially abled children
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study may conclude which method—electronic acupuncture pen or ethyl chloride spray—is more effective and acceptable for reducing injection pain in dental procedures using pulse oximeter and wong baker facial pain sacles |
pulse oximeter readings will be taken at baseline, after administering the injection and 1 minute post injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2025 |
| 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="3"
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
|
A total of 24 children who meet the inclusion/exclusion criteria will participate in the study. The patient will be well-informed prior to any involvement in the study, as outlined in the patient information sheet. A proper consent will be taken duly signed by him/her. Pulse oximeter reading will be taken using a fingertip pulse oximeter prior, during and post injection prick. The participant will be divided randomly into 2 groups using lottery method. A. Group ‘A’- Electronic acupuncture pen will be used first and in the subsequent visit, cryotherapy using ethyl chloride spray for alleviating pain during LA administration. B. In group ‘B’- Cryotherapy using ethyl chloride spray will be used first and in the subsequent visit, electronic acupuncture pen will be used for alleviating pain during LA administration. Following which LA will be administered in a bilateral split-mouth technique. The evaluation of pain perceived by the patient will be recorded using numerical rating scale whereas the investigator will rate using Wong Baker Facial Pain Scale in a customised case history performa. |