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
|
|
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
|
|
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
|
|
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 . |