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CTRI Number  CTRI/2024/09/074190 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The onset of loss of pain sensation using 2 anesthetic solutions by injection techniques in children 
Scientific Title of Study   The onset of anesthetic action using 2 percent Lidocaine and 4 percent Articaine for infiltration anesthetic in children 
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 Bankuru Himabindu 
Designation  III MDS 
Affiliation  Vishnu Dental College 
Address  Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Bhimavaram West Godavari District Andhra Pradesh

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7989846647  
Fax    
Email  himabindubankuru@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chaitanya Penmatsa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Bhimavaram West Godavari District Andhra Pradesh

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9908217142  
Fax    
Email  chaitanyap@vdc.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Chaitanya Penmatsa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Block 3 Room 5 Department of Pedodontics and Preventive Dentistry Vishnu Dental College Bhimavaram West Godavari District Andhra Pradesh


ANDHRA PRADESH
534202
India 
Phone  9908217142  
Fax    
Email  chaitanyap@vdc.edu.in  
 
Source of Monetary or Material Support  
Room No. 5, Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, West Godavari, Andhra Pradesh, India 534202 
 
Primary Sponsor  
Name  Dr Bankuru Himabindu 
Address  Block 3, Room no.5,Department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram, West Godavari District, Andhra Pradesh  
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 Bankuru Himabindu  Vishnu Dental College  Block 2 Room 5 Department of Pedodontics and Preventive Dentistry Vishnupur Bhimavaram 534202
West Godavari
ANDHRA PRADESH 		 7989846647

himabindubankuru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Onset of action with 2% Lidocaine  administration of 1ml of 2% Lidocaine one time in the Posterior buccal Vestibular region in either upper and lower arches by infiltration for 60secs and recording buccal and palatal mucosa onset of action by periosteal elevator by every 20secs till loss of pain sensation for total duration of 15mins 
Intervention  Onset of action with 4% Articaine  administration of 1ml of 4% Articaine one time in the buccal vestibular mucosa by infiltration of 60 secs and recording buccal and palatal mucosa onset of action by periosteal elevator for every 20secs till loss of pain sensation for total duration of 15mins  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children of age 6 to 10 years.
2.Teeth requiring LA administration for treatment.
3.Children willing to participate in the study with signed consent from parents 
 
ExclusionCriteria 
Details  1.Participation in another trial.
2.Children with systemic problems and special health care needs.
3.Children requiring emergency dental treatments.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Recording the onset time of soft tissue anesthesia using 2% Lidocaine and 4% Articaine
 		 one time (baseline) immediately after drug administration of local anesthesia  
 
Secondary Outcome     
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   01/10/2024 
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="5" 
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   It is a split-mouth randomized control trial, Details of the study will be explained to the Parents , teeth requiring LA administration for treatment will be selected bilaterally , During - 1 st visit, to one of the quadrants by buccal infiltration 4% Articaine will be administered and the onset of anesthesia will be noted palatally/lingually by elevator. In next visit on other quandrant onset of anesthesia will be noted by using 2% lidocaine for buccal infiltration.  
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