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CTRI Number  CTRI/2026/03/106990 [Registered on: 27/03/2026] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of effect of topical anesthetic gel, pre-cooled topical anesthetic gel and ice application in reducing pain during local anesthesia injections in children. 
Scientific Title of Study   Comparing the effectiveness of topical, pre-cooled topical anesthetic gel and ice during local anesthesia administration in pediatric dental patients: a randomized 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  Dr Yukti Sakharwade 
Designation  Mds post graduate student 
Affiliation  Maitri college of dentistry and research center 
Address  302, Department of pediatric and preventive dentistry, Maitri college of dentistry and research center, anjora, durg, chhattisgarh

Durg
CHHATTISGARH
491001
India 
Phone  9579434557  
Fax    
Email  yuktisakharwade46@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratik Surana 
Designation  Reader 
Affiliation  Maitri college of dentistry and research center 
Address  302, Department of pediatric and preventive dentistry, Maitri college of dentistry and research center, anjora, durg, chhattisgarh

Durg
CHHATTISGARH
491001
India 
Phone  8871310111  
Fax    
Email  suranadrpratik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yukti Sakharwade 
Designation  Mds post graduate student 
Affiliation  Maitri college of dentistry and research center 
Address  302, pediatric and preventive dentistry,Maitri college of dentistry and research center, anjora, durg, chhattisgarh

Durg
CHHATTISGARH
491001
India 
Phone  9579434557  
Fax    
Email  yuktisakharwade46@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Yukti Sakharwade 
Address  Maitri college of dentistry and research centre, GE road, anjora, durg, chhattisgarh, 491001 
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 Pratik Surana  Maitri college of dentistry and research centre  302, department of pediatric and preventive dentistry, maitri college of dentistry and research centre, anjora, durg, chhattisgarh
Durg
CHHATTISGARH 		 8871310111

suranadrpratik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ice  Ice will be prepared by filling a 2.5ml plastic syringe with mineral water and freezing it in freezer. The temperature will be maintained at -4°C to 0°C. Before the application the tip of the syringe will be cut off with a scalpel allowing the ice to be pressed on to the mucosa while it melts at injection site for one minute before administering local anesthesia. 
Intervention  Pre cooled topical anesthetic gel  The Lignocaine hydrochloride topical anesthetic gel will be placed in refrigerator 15 min prior to application. A laboratory thermometer will be used to confirm the temperature at 2 - 4°C. Precooled topical anesthetic gel at temperature between 2 - 4°C will be applied followed by local anesthesia administration. 
Comparator Agent  Topical anesthetic gel  Lignocaine hydrochloride topical anesthetic gel at room temperature will be applied on the site using a cotton tip applicator. After one minute of applying the topical gel, local anesthesia will be administered. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1)Children of 6 to 10 years of age with treatment requiring la administration either in mandibular arch, 2)children who demonstrated positive or definitely positive behavior during pretreatment evaluation(ranking 3 or 4 on the Frankel scale), 3)children having first dental visit.
 
 
ExclusionCriteria 
Details  1)Children with any systemic illness(ASA II & ASA III), 2)children with a history of allergy to any form of local anesthetic agent, 3)children requiring an emergency dental treatment.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception during local anesthesia administration  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/04/2026 
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="1"
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  

This randomized controlled clinical trial will be conducted to compare the effectiveness of topical anesthetic gel, pre-cooled topical anesthetic gel, and ice application in reducing pain during local anesthesia administration in pediatric dental patients. A total of 45 children aged 6–10 years requiring inferior alveolar nerve block will be randomly allocated into three groups of 15 each. The assigned intervention will be applied at the injection site for 1 minute prior to local anesthesia administration. Pain perception will be assessed using the wong baker faces pain rating scale and flacc scale. The findings of the study will help determine the most effective noninvasive method for reducing injection pain and improving cooperation in children.

 
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