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CTRI Number  CTRI/2019/05/018985 [Registered on: 07/05/2019] Trial Registered Prospectively
Last Modified On: 24/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research work to evaluate the efficacy of two local anesthetic injections given by two different techniques in patients having tooth pain  
Scientific Title of Study   Anesthetic efficacy of supplemental buccal infiltration with 4% Articaine, after a failed inferior alveolar nerve block or Gow Gates nerve block with 2% Lignocaine in mandibular molars diagnosed with symptomatic irreversible pulpitis-A Randomized Double blind trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanaga Priyaa V 
Designation  Post graduate student 
Affiliation  Adhiparasakthi dental college 
Address  Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India 
Phone  9486689653  
Fax    
Email  kanagapriyaa.vellingiri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Srinivasan 
Designation  Reader 
Affiliation  Adhiparasakthi Dental College 
Address  Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India 
Phone  9840479056  
Fax    
Email  srinistatsolutions@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kanaga Priyaa V 
Designation  Post graduate student 
Affiliation  Adhiparasakthi Dental College 
Address  Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Department of conservative dentistry and endodontics, Adhiparasakthi dental college and hospital Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India 
Phone  9486689653  
Fax    
Email  kanagapriyaa.vellingiri@gmail.com  
 
Source of Monetary or Material Support  
Kanaga priyaa V 291-A Shasthiri nagar first street Near GH Dharapuram road KNP colony post Tirupur 641604 Tirupur district Tamil Nadu state 
 
Primary Sponsor  
Name  Kanaga priyaa V 
Address  Kanaga priyaa V 291-A Shasthiri nagar first street Near GH Dharapuram road KNP colony post Tirupur 641604 Tirupur district Tamil Nadu state 
Type of Sponsor  Other [Private dental 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 
Kanaga Priyaa V  Adhiparasakthi dental college and hospital Melmaruvathur  Department of conservative dentistry and endodontics
Kancheepuram
TAMIL NADU 		 9486689653

kanagapriyaa.vellingiri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board and Institutional Ethical Committee of Adhiparasakthi dental college ,Melmaruvathur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Symptomatic irreversible pulpitis in mandibular first or second molars 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gow gates nerve block  3.6 ml of 2% lignocaine in gow gates nerve block, Intraoral injection, Frequency- once. Duration of Treatment - 1 hour 
Comparator Agent  Inferior alveolar nerve block  3.6 ml of 2% lignocaine in inferior alveolar nerve block,intraoral injection,frequency- once,duration of treatment-one hour  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy patients
patients with symptomatic irreversible pulpitis in mandibular molars
Absence of any periapical radiolucency on radiograph except for a widening of periodontal ligament
A vital pulp at access cavity preparation
Ability to understand the use of pain scales  
 
ExclusionCriteria 
Details  Allergy to local anesthetics, pregnancy, the use of any medications such as sedatives,antianxiety,antidepressants or analgesics that might influence pain assessment, the presence of active pathosis in the area of injection, the inability to give written informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assesing the HP-VAS pain score after 2 primary injections  During the treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Assesing the HP-VAS pain score after supplementary secondary injection  During the treatment 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/05/2019 
Date of Study Completion (India) 16/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   A Prospective Randomized Trial of Different Supplementary Local Anesthetic Techniques after Failure of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis in Mandibular Teeth - Mohammad D. Kanaa, DDS, PhD, John M. Whitworth, BChD, PhD,and John Gerard Meechan, BDS, PhD-JOE — Volume 38, Number 4, April 2012  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The aim of this prospective randomized double blind  trial is to  evaluate the anaesthetic efficacy of 4% articaine given as supplementary  buccal infiltration after a failed 2% lignocaine which will be given either as inferior alveolar nerve block or Gow Gates  nerve block. 
114 Patients with symptomatic irreversible pulpitis in mandibular first or second molar will be selected. Patients will be randomly assigned into 2 groups according to the injection method as follows: in group I (n=57) -  patients will receive Inferior alveolar nerve block, in group II (n=57) - patients will receive Gow Gates nerve block. 3.6 ml of 2% lignocaine with 1:80,000 epinephrine will be injected according to their assigned groups. After 15 minutes , the success of the anaesthetic technique will be evaluated in their respective groups and endodontic treatment will be initiated. Pain during the endodontic treatment will be assessed using the Heft -Parker Visual analog scale. Patients having inadequate pulpal anaesthesia will receive 0.9 ml of 4% articaine with 1:1,00,000 epinephrine as buccal infiltration. After 10 minutes, endodontic treatment will be reinitiated and pain scores will be recorded.
 
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