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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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