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CTRI Number  CTRI/2017/03/008204 [Registered on: 24/03/2017] Trial Registered Retrospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Anesthesia of lower teeth with different methods 
Scientific Title of Study   Evaluation of different type of anesthetic techniques on anesthetic success rates in mandibular premolars with symptomatic irreversible pulpitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Aggarwal 
Designation  Assistant Professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia. New Delhi

South
DELHI
110025
India 
Phone  9818188358  
Fax    
Email  drvivekaggarwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Aggarwal 
Designation  Assistant Professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia. New Delhi


DELHI
110025
India 
Phone  9818188358  
Fax    
Email  drvivekaggarwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Aggarwal 
Designation  Assistant Professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia. New Delhi


DELHI
110025
India 
Phone  9818188358  
Fax    
Email  drvivekaggarwal@gmail.com  
 
Source of Monetary or Material Support  
Self Funded 
 
Primary Sponsor  
Name  Self funded 
Address  Dr. Vivek Aggarwal, Faculty of Dentistry, Jamia Millia Islamia 
Type of Sponsor  Government medical college 
 
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 Vivek Aggarwal  Faculty of Dentistry, Jamia Millia Islamia  Room No 311, Third Floor, Department of Conservative Dentistry and Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi
South
DELHI 
9818188358

drvivekaggarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Millia Islamia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Patients should be actively experiencing pain in a mandibular premolar 
Patients  Patients should be actively experiencing pain in a mandibular premolar.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buccal Infiltration/ mental nerve block  It is an alternate technique, especially for mandibular premolars 
Intervention  Inferior alveolar nerve block  Inferior alveolar nerve block is a standard anesthesia technique for mandibular teeth 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  The subjects should be actively experiencing pain and in good health, and none will be taking any medication that would alter pain perception. 
 
ExclusionCriteria 
Details  Patients with underlying systemic diseases.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ability to undertake pulp access and canal instrumentation with no or mild pain   The primary outcome shall be assessed after the administration of local anesthetic solution and during the procedure. If the patient experiences pain during any point of the procedure the anesthesia will be considered as failure. 
 
Secondary Outcome  
Outcome  TimePoints 
ability to undertake pulp access and canal instrumentation with no or mild pain   It will assessed at the end of the endodontic treatment.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia for posterior mandibular endodontic procedures. In mandibular premolars, buccal infiltration provides adequate anesthesia. The purpose of this prospective randomized study is to compare IANB and buccal infiltration on anesthetic success rates. Adult volunteer subjects will be selected from dental OPD and included in this prospective, randomized study. The success is defined as the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker VAS score<55mm). The subjects should be actively experiencing pain and in good health, and none will be taking any medication that would alter pain perception, as determined by oral questioning and written questionnaire. An informed written consent will be obtained from each subject. The patients will be randomly allocated to the treatment groups. Patients will receive standard inferior alveolar nerve block or buccal infiltrations. A conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hand if any pain was felt during the procedure. In case of pain during the treatment, the procedure will be stopped, and patients asked to rate the pain on HP VAS. Success will be defined as no pain or weak/mild pain during endodontic access preparation and instrumentation .

 
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