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CTRI Number  CTRI/2023/07/055438 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to compare the effectiveness of three pain reducing methods and two needle gauges in reducing pain and anxiety in children during local anesthesia injection . 
Scientific Title of Study   Comparative evaluation of pain perception and anxiety levels in children during local anesthesia procedure using three different pain alleviating methods in combination with two needle gauges. 
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 Sai Vaishnavi Alahari 
Designation  pedodontic post graduate student 
Affiliation  sri sai college of dental surgery. 
Address  Department of Pedodontics and Preventive Dentistry Sri Sai College of Dental Surgery 1-2-64 kotherepally oppo shivsagar lake vikarabad 501102

Hyderabad
TELANGANA
501102
India 
Phone  8008733770  
Fax    
Email  saivaishnavialahari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr CH Sampath Reddy 
Designation  Head Of The Department 
Affiliation  sri sai college of dental surgery. 
Address  Department of Pedodontics and Preventive Dentistry Sri Sai College of Dental Surgery 1-2-64 kotherepally oppo shivsagar lake vikarabad 501102

Hyderabad
TELANGANA
501102
India 
Phone  9246371730  
Fax    
Email  sampathcheruku@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sai Vaishnavi Alahari 
Designation  pedodontic post graduate student 
Affiliation  sri sai college of dental surgery. 
Address  Department of Pedodontics and Preventive Dentistry Sri Sai College of Dental Surgery 1-2-64 kotherepally oppo shivsagar lake vikarabad 501102

Hyderabad
TELANGANA
501102
India 
Phone  8008733770  
Fax    
Email  saivaishnavialahari@gmail.com  
 
Source of Monetary or Material Support  
Sri Sai college of Dental Surgey, opp.shiv sagar lake, kothrepally,Vikarabad, Telangana 501102. 
 
Primary Sponsor  
Name  Dr Sai Vaishnavi Alahari 
Address  Sri Sai College Of Dental Surgery, 1-2-64/1, Kotherepally,opp.shiv sagar lake,vikarabd,Telangana 501102. 
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 Sai Vaishnavi Alahari  Sri sai college of dental surgery  Room No 9,Department of pedodontics and preventive Dentistry,Sri sai college of dental surgery, opp shiv sagar lake, kothrepally, vikarabad,501102.
Hyderabad
TELANGANA 		 8008733770

saivaishnavialahari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 2022-23, Sri Sai College of Dental Surgery.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Eutectic Mixture of Local Anesthetics (EMLA)  using Eutectic Mixture of Local Anesthetics (EMLA) for 30-60 seconds as a pain alleviating method during local anesthesia procedure . 
Comparator Agent  NIL  nil 
Intervention  Topical lignocaine spray  using Topical lignocaine spray for 30-60 seconds as a pain alleviating method during local anesthesia procedure . 
Intervention  Transcutaneous Electrical Nerve Stimulation (TENS)  using Transcutaneous Electrical Nerve Stimulation for 30-60 seconds as a pain alleviating method during local anesthesia procedure . 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Healthy children with no systemic illness , allergies,etc.
children requiring local anesthesia administration for dental treatment .
children with informed parental consent. 
 
ExclusionCriteria 
Details  Children with known systemic disease.
Children without parental consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare effect of three pain alleviating methods on pain & anxiety levels in children during local anesthesia procedure.  pain & anxiety will be recorded before & after local anesthesia procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To compare effect of two needle gauges on pain & anxiety levels in children during local anesthesia procedure.  after local anesthesia procedure 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 25/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/03/2025 
Estimated Duration of Trial   Years="2"
Months="0"
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  

In clinical pediatric dental practice local anesthesia is of utmost importance as it relieves the pain sensation during dental procedures, making the experience comfortable for the patient. The fear of needles is shown to be one of the main obstacles for avoidance of dental treatment which has no exception in children.  The challenge of  reducing the pain during administering local anesthesia can help reduce fear and anxiety in the child, also helps him to trust the dentist and build a positive attitude towards dental treatment. The current trial aims at comparing three pain alleviating methods TENS, EMLA cream to conventionally used topical spray in combination with two different needle gauges (25 gauge and 30-gauge) as pain alleviating methods during the administration of local anesthesia.

 
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