| CTRI Number |
CTRI/2025/07/090416 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effectiveness of Three Pre-Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children- A Randomized crossover study |
|
Scientific Title of Study
|
Effectiveness of Three Pre-Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children: A Randomized crossover 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 |
POONAM SHUKLA |
| Designation |
Junior Resident |
| Affiliation |
KING GEORGE MEDICAL COLLEGE |
| Address |
4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, FACULTY OF DENTAL SCIENCES, KING GEORGE MEDICAL COLLEGE, LUCKNOW, UTTAR PRADESH
4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, FACULTY OF DENTAL SCIENCES, KING GEORGE MEDICAL COLLEGE, LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7042704837 |
| Fax |
|
| Email |
poonamshukla231996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Singh |
| Designation |
Head of department and Professor |
| Affiliation |
KING GEORGE MEDICAL COLLEGE |
| Address |
4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, FACULTY OF DENTAL SCIENCES, KING GEORGE MEDICAL COLLEGE, LUCKNOW UTTAR PRADESH
4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, FACULTY OF DENTAL SCIENCES, KING GEORGE MEDICAL COLLEGE, LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajeevkumarsingh@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
POONAM SHUKLA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGE MEDICAL COLLEGE |
| Address |
RESIDENT HOSTEL, SHAHMINA CHOWK KGMU , LUCKNOW, UTTAR PRADESH
4TH Floor DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, FACULTY OF DENTAL SCIENCES, KING GEORGE MEDICAL COLLEGE, LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7042704837 |
| Fax |
|
| Email |
poonamshukla231996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty Of Dental Sciences, King Georges medical university |
|
|
Primary Sponsor
|
| Name |
Poonam Shukla |
| Address |
4th FLOOR Department Paediatric And Preventive Dentistry Faculty of Dental Sciences King Georges Medical college Lucknow uttar pradesh |
| 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 POONAM SHUKLA |
KING GEORGE MEDICAL COLLEGE |
4TH FLOOR DEPARTMENT OF PAEDIATRIC AND PREVENTIVE DENTISTRY , FACULTY OF DENTAL SCIENCES, KGMU LUCKNOW
Lucknow
UTTAR PRADESH |
7042704837
poonamshukla231996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical College Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryotherapy
|
Application of an ice cube at the injection site for about 30 seconds before administering local anesthesia to reduce pain via nerve desensitization and vasoconstriction. |
| Intervention |
Low-Level Laser Therapy (LLLT) |
Use of a diode laser on the injection site prior to anesthesia. This photobiomodulation technique aims to reduce pain through cellular and neural modulation without tissue damage. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Vibrational Stimulus |
Application of a vibratory device at the injection site starting 10 seconds before and continuing during the injection. Based on the gate control theory, vibration interferes with pain signal transmission, reducing perceived pain and anxiety. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Requiring buccal infiltration anesthesia for dental treatment.
2. Requiring multiple dental appointments.
3. Classified as "negative" or "positive" on the Frankl Behavior Rating Scale (Annexure1).
4. Free of allergies to topical anesthetics used in the study.
5. Free from neurological or psychological disorders.
6. Parents provide informed consent, and children above 7 years provide assent.
|
|
| ExclusionCriteria |
| Details |
1. Children classified as "definitely negative" or "definitely positive" on the Frankl Behavior Rating Scale.
2. Patients where local anesthesia is contraindicated.
3. Children with special healthcare needs.
4. Patients unable to follow instructions due to psychological or developmental impairments.
5. Patients who decline to participate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain perception during local anesthesia injection (measured by VAS, Wong-Baker Faces).
Anxiety levels before and after injection (measured by Venham’s Picture Scale).
|
at baseline, after 10 days then again after 10 days
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="5"
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
|
Title
Effectiveness of Three Pre Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children A Randomized Crossover Study
Objective
To compare the effectiveness of cryotherapy low level laser therapy and vibrational stimulus in reducing pain and anxiety during intraoral local anesthesia injections in children aged 6 to 11 years
Design
Randomized crossover study where each child receives all three interventions across different appointments
Interventions
1 Cryotherapy Ice application at the injection site
2 Low Level Laser Therapy Diode laser exposure before injection
3 Vibrational Stimulus Vibration applied before and during injection
Primary Outcomes
Pain perception during injection
Anxiety levels before and after injection
Secondary Outcomes
Changes in physiological parameters pulse rate and SpO2
Patient satisfaction and preference
Tools Used
Visual Analogue Scale
Wong Baker Faces Scale
Venham Picture Scale
FLACC scale
SEM scale
Likert scale
Expected Benefit
To identify the most effective non pharmacological method to improve comfort and reduce distress in pediatric dental patients undergoing local anesthesia
|