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CTRI Number  CTRI/2025/02/081335 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing 4% Articaine and 2% Lignocaine for Pain Relief in Childrens Lower Back Teeth, with assessment of Parent Satisfaction. 
Scientific Title of Study   Comparison of 4% Articaine Buccal Infiltration and 2% Lignocaine Inferior Alveolar Nerve Block for Invasive Dental Procedures in Primary Mandibular Molars along with Assessment of Parental Satisfaction: An Equivalence Parallel Prospective 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 Shreya Pandey 
Designation  Post Graduate 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Science 
Address  Department no 5, Sardar Patel Post Graduate Institute of Dental and Medical Science, Lucknow

Lucknow
UTTAR PRADESH
226001
India 
Phone  7000816234  
Fax    
Email  spshreyapandey123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gunjan Yadav 
Designation  Professor and Head of Department 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Science 
Address  Department no 5, Sardar Patel Post Graduate Institute of Dental and Medical Science, Lucknow

Lucknow
UTTAR PRADESH
226001
India 
Phone  9454109142  
Fax    
Email  drgunjany@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gunjan Yadav 
Designation  Professor and Head of Department 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Science 
Address  Department no 5, Sardar Patel Post Graduate Institute of Dental and Medical Science, Lucknow

Lucknow
UTTAR PRADESH
226001
India 
Phone  9454109142  
Fax    
Email  drgunjany@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Postgraduate Institute of Dental and Medical Sciences, Lucknow 
 
Primary Sponsor  
Name  Dr Shreya Pandey 
Address  Department no 5, Sardar Patel Post Graduate Institute of Dental and Medical Science Lucknow  
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 Shreya Pandey  Sardar Patel Post Graduate Institute of Dental and Medical Science, Lucknow  Room no 5 Department of Pediatric and Preventive Dentistry
Lucknow
UTTAR PRADESH 		 7000816232

spshreyapandey123@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 
Healthy Human Volunteers  Carious lower posterior teeth, Decayed lower posterior teeth, traumatic lower posterior teeth or lower posterior teeth with faulty restoration  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% Lignocaine   primary mandibular molars undergoing extraction or pulp therapy will be administered inferior alveolar nerve block using 2% Lignocaine 
Comparator Agent  4% Articaine  primary mandibular molars undergoing extraction and pulp therapy will be administered buccal infiltration using 4% Articaine 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  patients medically healthy
patients requiring invasive dental procedure
patients showing understanding of pain scale
co-operative patients
primary molars requiring pulp therapy and extraction 
 
ExclusionCriteria 
Details  medically compromised
known allergy to local anesthesia
uncooperative patients
tooth other than primary molars
children younger than 5 and older than 10 years of age 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To improve patient co-operation and make dental procedure less traumatic by using articaine buccal infiltration instead of IANB with lignocaine  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="134" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/03/2025 
Date of Study Completion (India) 06/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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 study compares two local anesthesia techniques—2% lignocaine inferior alveolar nerve block (IANB) and 4% articaine buccal infiltration (BI)—for pediatric dental procedures, specifically pulp therapy and extractions of primary mandibular molars. The key points are:

  1. Purpose: Evaluate the effectiveness of both techniques in pain control, children’s reactions to pain, and parental satisfaction.

  2. Relevance: Effective, less stressful anesthesia techniques are essential for pediatric patients, especially given their heightened pain sensitivity and need for behavior management.

  3. Novelty: The study addresses the limited research on articaine in children, particularly its potential to replace IANB for primary mandibular molars.

  4. Applicability: If articaine proves effective, it could shift pediatric dental practices by reducing discomfort and complications associated with IANB.

  5. Outcome: Articaine infiltration may provide effective pain control with less stress, improving patient cooperation and parent satisfaction.

Validated pain scales (MBPS and WBFS) and a parental satisfaction scale (PSLAS) will assess pain and satisfaction levels, helping determine whether articaine is a viable alternative to IANB.

 
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