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CTRI Number  CTRI/2025/08/093134 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of efficacy, hemodynamic changes, and postoperative complications of 2% lidocaine using inferior alveolar nerve block and 4% articaine using intraosseous anaesthesia in mandibular primary molars of children aged 6 to 8 years: An in vivo, randomized, controlled study 
Scientific Title of Study   Comparative evaluation of efficacy, hemodynamic changes, and postoperative complications of 2 percent lidocaine using inferior alveolar nerve block and 4 percent articaine using intraosseous anaesthesia in mandibular primary molars of children aged 6 to 8 years: An in vivo, randomized, controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hinal Kanabar 
Designation  Post graduate student 
Affiliation  Pacific Dental College And Hospital 
Address  Pacific Dental College And Hospital Debari Udaipur
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  09265289652  
Fax    
Email  heenalkanabar123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao 
Designation  HOD PG guide 
Affiliation  Pacific Dental College And Hospital 
Address  Department of pediatric and preventive dentistry Pacific Dental College And Hospital Debari Udaipur
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  09265289652  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Hinal Kanabar 
Designation  Post graduate student 
Affiliation  Pacific Dental College And Hospital 
Address  Department of pediatric and preventive dentistry Pacific Dental College And Hospital Debari Udaipur
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  09265289652  
Fax    
Email  heenalkanabar123@gmail.com  
 
Source of Monetary or Material Support  
Pacific Dental College and Hospital Debari Udaipur 313024 
 
Primary Sponsor  
Name  Hinal Kanabar 
Address  Pacific Dental College And Hospital Debari Udaipur 313024 
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 
DrHinal Kanabar  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN
Udaipur
RAJASTHAN 
9265289652

heenalkanabar123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inferior alveolar nerve block  Injecting 2% lidocaine in primary mandibular molars that require pulp therapy duration of anesthesia pain during procedures and pstoperative complications within 24 hours 
Comparator Agent  Intraosseous anaesthesia   Injecting 4% Articaine in primary mandibular molars that require pulp therapy and it will be assessed duration of anesthesia pain during procedures and pstoperative complications within 24 hours 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Aged 6-8 years
Medically fit children
Mentally capable of communication
Having mandibular primary molar tooth that require pulp therapy
Tooth without having any kind of history of infection (abscess) or swelling and no evidence of periapical pathosis or soft tissue infection/inflammation near the site of injection.
Children, who are cooperative enough to undergo dental procedures and parental informed written consent provided.
Tooth, which will give a baseline reading on pulp tester before administration of local anaesthetics.
 
 
ExclusionCriteria 
Details  Medically and mentally compromised children.
History of significant behaviour management problems.
Evidence of infection near the proposed injection site as this might affect the efficacy of local anaesthesia like periodontal (periodontal pockets or tooth mobility), radiological alterations (bone loss or periapical radio transparencies).
Children who did not speak or understand local language.
Children who are allergic to 4% articaine.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraosseous Anaesthesia using 4% articaine with needle guide system shows:
Faster onset of action in mins
Better pain control during procedures using WBFS, VAS and SEM scale
 
Evaluation will be done at the baseline and one week 
 
Secondary Outcome  
Outcome  TimePoints 
Intraosseous Anaesthesia using 4% articaine with needle guide system showed:
Minimal hemodynamic changes like increase in heart rate
Lower incidence of postoperative complications like soft tissue injuries within 24 hours
 
Evaluation will be done at the baseline & one week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   29/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

Effective pain management is crucial in pediatric dentistry to ensure a positive experience for young patients. The inferior alveolar nerve block (IANB) is commonly used to anesthetize mandibular teeth but has a notable failure rate, especially in children, due to anatomical variations and technical challenges. Studies indicate that IANB can fail in approximately 30% to 45% of cases, even when proper techniques are employed.

Intraosseous anesthesia (IOA) presents an alternative, involving the direct injection of anesthetic into the cancellous bone, potentially offering more reliable anesthesia for mandibular procedures. Recent advancements, such as the TuttleNumbNow (TNN) system, utilize specialized needles to facilitate this technique. Comparative studies have explored the efficacy of 4% articaine versus 2% lidocaine in pediatric patients. Some findings suggest that articaine may provide superior anesthetic success rates and faster onset compared to lidocaine.

However, very few studies have found no significant difference in efficacy between the two anesthetics when used for primary molar extractions in children. The proposed research aims to further evaluate these findings by comparing the efficacy, hemodynamic responses, and postoperative complications of 2% lidocaine via IANB and 4% articaine via IOA in children aged 6–8 undergoing mandibular primary molar procedures. The outcomes could inform best practices in pediatric dental anesthesia, potentially leading to improved patient comfort and treatment outcomes.

 
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