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CTRI Number  CTRI/2022/06/043611 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 01/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
To Compare 2LA in dentistry  
Scientific Title of Study   Anesthetic efficacy of 4 % Articaine buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower primary molars indicated for endodontic treatment. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snigdha Trivedi 
Designation  PG student 
Affiliation  SGT University 
Address  Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9811105319  
Fax    
Email  trivedi.snigdha0110@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankit Srivastav 
Designation  Professor 
Affiliation  SGT University 
Address  Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  8130023844  
Fax    
Email  ankit.srivastav@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Snigdha Trivedi 
Designation  PG student 
Affiliation  SGT University 
Address  Room No-6,Department of Pediatric and Preventive dentistry, Faculty of Dental Sciences, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9811105319  
Fax    
Email  trivedi.snigdha0110@gmail.com  
 
Source of Monetary or Material Support  
SGT University, Budhera, Gurgaon,122505 
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Sciences, SGT University,Gurgaon-122505  
Type of Sponsor  Research institution and hospital 
 
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 
Snigdha Trivedi  SGT University  Room No-6.Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences
Gurgaon
HARYANA 
9811105319

trivedi.snigdha0110@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY,GURGAON  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2 % Lignocaine Inferior alveolar Nerve block injection for endodontic treatment of lower primary molars  1.8 ml Lignocaine with 1:80,000 adrenaline via Inferior Alveolar Nerve Block with a standard aspirating syringe with 26-gauge 1.5-inch needle single injection just before the procedure  
Intervention  4 % Articaine buccal infiltration injection for endodontic treatment of lower primary molars  1.8ml of 4% articaine with 1:100,000 adrenaline as Buccal infiltration with a standard aspirating syringe and 26-gauge 0.5-inch needle single injection just before the procedure 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children of age 4-8 years
2.Indicated for pulpotomy/pulpectomy in mandibular primary molars
 
 
ExclusionCriteria 
Details  1.Medically compromised patient
2.Any known allergy to local anesthetic agents
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the anaesthetic efficacy of 4 % articaine buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower primary molars indicated for endodontic treatment  Clinical evaluation at baseline,4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate pain and discomfort of the patient during anaesthesia with 4% articaine buccal infiltration and 2% lidocaine inferior alveolar nerve block   Clinical Evaluation at baseline,4 weeks 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/07/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Successful anaesthesia is the hallmark of painless endodontic treatment. Pulpal anaesthesia commences with the administration of traditional nerve blocks or infiltration anaesthesia. 

Conventionally it was thought that the Inferior alveolar nerve bock (IANB) is the local anaesthesia technique of choice over when treating mandibular primary or permanent molars for endodontic treatment. The primary advantage of this block is the depth of anaesthesia6. All the molars, canines and incisors on the injected side are anesthetized and hence allows for treatment of   multiple teeth of the same quadrant at one appointment . 2 % lignocaine is considered as the gold standard among local anaesthetic agents

Unfortunately, IANB is associated with several complications such as transient facial paralysis, trismus, local anaesthetic getting injected into the blood vessel and prolonged soft tissue anaesthesia which results in self-inflicted trauma such as biting of lip and cheek specially in paediatric population.

Buccal infiltration (BI) has been suggested as a simpler modality than IANB and is being widely advocated in recent studies. Due to low penetration of lidocaine through the buccal cortical plate, BI using lidocaine is not as effective as IANB for achieving profound anaesthesia in mandibular primary molars. 4 percent Articaine for BI in mandibular primary molar, has increased lipid solubility and high tissue permeability  enables it to diffuse through the mandibular dense cortical bone as well as maxillary cortical plates (11)

 Hence the present study aims to compare the anaesthetic efficacy of 4 % articaine buccal infiltration versus 2% lignocaine inferior alveolar nerve block in lower primary molars indicated for endodontic treatment

 

 
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