| CTRI Number |
CTRI/2025/03/083317 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Light, Ice and Numbing Cream in Reducing Pain Before Giving Local Anaesthesia in Children Aged 8-12 Years |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Photobiomodulation, Cryo-Anaesthesia and Topical Anaesthesia Gel in Reduction of Pain Perception During Local Anaesthesia Administration in Children Aged 8-12 Years: A Randomized 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 |
Dr Aishwarya Arunkumar Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru
Nagar, Belagavi-590010
Belgaum KARNATAKA 590010 India |
| Phone |
9845585416 |
| Fax |
|
| Email |
aishwaryaarunpatil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vidyavathi H Patil |
| Designation |
Reader |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru
Nagar, Belagavi-590010
Belgaum KARNATAKA 590010 India |
| Phone |
9611835828 |
| Fax |
|
| Email |
nisarga_vhp@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vidyavathi H Patil |
| Designation |
Reader |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru
Nagar, Belagavi-590010
Belgaum KARNATAKA 590010 India |
| Phone |
9611835828 |
| Fax |
|
| Email |
nisarga_vhp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institue of Dental Sciences,
Nehru Nagar, Belagavi-590010, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Arunkumar Patil |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010 |
| 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 Aishwarya Patil |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
Department of Pediatric
and Preventive Dentistry, Department No. 6, 1st Floor, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010 Belgaum KARNATAKA |
09845585416
aishwaryaarunpatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryo-Anaesthesia |
Evaluation of effectiveness of cryo-anaesthesia in reduction of pain perception during local anaesthesia administration in children aged 8-12 years. Ice pack will be applied at the injection site for 2 minutes duration.
|
| Intervention |
Photobiomodulation |
Evaluation of effectiveness of photobiomodulation in reduction of pain perception
during local anaesthesia administration in children aged 8-12 years. It will be applied at the injection site for 1 minute duration. |
| Comparator Agent |
Topical Anaesthesia Gel |
Evaluation of effectiveness of topical anaesthesia gel in reduction of pain perception
during local anaesthesia administration in children aged 8-12 years. It will be applied at the injection site for 1 minute duration. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 8-12 years of age.
2. Children requiring dental treatment under inferior alveolar nerve block technique.
3. Children classified as positive and definitely positive on Frankl’s behaviour rating
scale.
4. Parents and patients who willingly give informed consent and assent respectively. |
|
| ExclusionCriteria |
| Details |
1. Parents/ patients who do not give their consent/ assent respectively.
2. Children experiencing local inflammation or tenderness at the injection site.
3. Children exhibiting acute symptoms necessitating immediate medical attention.
4. Children with systemic conditions or special health care needs.
5. Children classified as negative and definitely negative on Frankl’s behaviour rating scale.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Reduction in Pain Perception during Local Anaesthesia Administration using Photobiomodulation, Cryo-Anaesthesia and Topical Anaesthesia Gel in Children Aged 8-12 Years. |
Baseline and Post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the Reduction in Pain Perception during Local Anaesthesia Administration using Photobiomodulation, Cryo-Anaesthesia & Topical Anaesthesia Gel in Children Aged 8-12 Years. |
Baseline & post operative |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/04/2025 |
| Date of Study Completion (India) |
06/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/09/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 is an in-vivo, randomized parallel group, three-arm clinical study evaluating the effectiveness of Photobiomodulation, Cryo- Anaesthesia and Topical Anaesthesia Gel in reduction of pain perception during local anaesthesia administration in children aged 8-12 years. The study will be conducted at the Department of Pediatric and Preventive Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, Belagavi, and will include 48 children requiring dental treatment under the inferior alveolar nerve block anaesthesia technique. The principal investigator will perform the procedure under standard operating protocols. The selected child will be made to sit comfortably on the dental chair, the procedure will be completely explained to the parent as well as the child by the principal investigator. A case history will be recorded for the present study so as to have a systematic and methodological recording of all the observations and information. After recording the preliminary information, clinical examination will be carried out on a dental chair under standard operating protocol. Patients allocated to Group I will be treated with Photobiomodulation, Group II with Cryo-Anaesthesia, and Group III with Topical Anaesthesia Gel. The procedure will be carried out in approximately 5 minutes for each patient in all the three followed by the administration of local anaesthesia. Objective pain will be assessed by a trained pediatric dentist, who will be blinded during the intervention, using Sound, Eye, Body Movement (SEM) Scale during local anaesthesia administration. Subjective pain will be assessed using self-administered Wong–Baker Faces Pain Rating Scale immediately after local anaesthesia administration. Further necessary dental treatment will be provided following standard operating protocols. |