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CTRI Number  CTRI/2018/03/012678 [Registered on: 20/03/2018] Trial Registered Prospectively
Last Modified On: 20/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparative pain management of local anesthetic drugs when placed at the site. 
Scientific Title of Study   Comparing the anesthetic efficacy of 4% Articaine and 3% Mepivacaine for mandibular intraligamentary technique in patients with irreversible pulpitis- A Randomized Double - blinded clinical control trial 
Trial Acronym  ARME 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R Seshan Rakkesh 
Designation  Post graduate student 
Affiliation  SRM dental college 
Address  SRM Dental College Bharathi salai Ramapuram

Chennai
TAMIL NADU
600089
India 
Phone  9952841991  
Fax    
Email  drseshanendo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  R Seshan Rakkesh 
Designation  Post graduate student 
Affiliation  SRM dental college 
Address  SRM Dental college Bharathi salai Ramapuram

Chennai
TAMIL NADU
600089
India 
Phone  9952841991  
Fax    
Email  drseshanendo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR S Kavitha 
Designation  Professor 
Affiliation  SRM Dental college 
Address  SRM Dental college Bharathi salai Ramapuram

Chennai
TAMIL NADU
600089
India 
Phone  9940048022  
Fax    
Email  kavithasanjeev02@gmail.com  
 
Source of Monetary or Material Support  
SRM Dental College,II floor, Department of Conservative Dentistry and Endodontics, Bharathi Salai, Ramapuram, Chennai - 600089  
 
Primary Sponsor  
Name  R Seshan Rakkesh 
Address  SRM Dental College, Bharathi salai, Ramapuram, Chennai -600089 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
R SESHAN RAKKESH  SRM DENTAL COLLEGE  II floor, Department of Conservative Dentistry and Endodontics, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU 
9952841991

drseshanendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board SRM Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ACUTE IRREVERSIBLE PULPITIS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3% Mepivacaine  Mepivacaine hydrochloride 3% 
Comparator Agent  4% Articaine  4% Articaine with 1:100,000 Epinephrine 
Intervention  Intrligamentary technique  Ultra Saftey Plus disposable 30 gauge needles, inseted at all the 4 axial angles and buccal and lingual surfaces of mandibular molar with 30 degree angulation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Acute irreversible pulpitis
 
 
ExclusionCriteria 
Details  Systemic diseases and systemic conditions, Medically compromised, Mentally retarded patients, Local periapical pathologies, Hypersensitivity, Referred pain 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Heft Parkers Visual Analogue Scale score below 10  30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Heft Parkers Visual Analogue Scale score below 10  24 hours following the procedure 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1 
Date of First Enrollment (India)   23/03/2018 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Profound pulpal anesthesia is critical and is essential to prevent pain during endodontic treatment of diseased teeth with vital pulps. Inferior alveolar nerve block (IANB) is the most commonly used anesthetic technique for endodontic procedures in mandibular molars. Various reasons could be attributed to the failure of IANB in achieving profound pulpal anesthesia. Intraligamentary anesthetic technique has been proved to be an effective alternative to counteract this problem. Studies have shown that articaine, a long-acting amide anesthetic has better bone absorption when used as an intraligamentary injection. Similarly a short-acting local anesthetic, mepivacaine is known to produce effective pulpal anesthesia, but its efficacy, when used as an intraligamentary injection in achieving pulpal anesthesia, is not yet explored. Hence the aim of this study is to compare the efficacy of mepivacaine and articaine when used as an intraligamentary injection in achieving pulpal anesthesia of mandibular molars. Study design: 40 patients requiring root canal treatment of mandibular molars diagnosed with acute irreversible pulpitis will be selected. Patients will be randomly assigned to receive intraligamentary injections with either mepivacaine or articaine. Heft-Parker Visual Analogue Score (HP-VAS) will be used to assess pain before and after the procedure. Results: The study will be conducted and the results will be collected and statistically analysed. The primary outcome is to eliminate the pain immediately during the procedure and the secondary outcome is to observe the time taken for the anesthetic effect to wear off.

 
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