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
|
|
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
|
|
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. |