| CTRI Number |
CTRI/2024/04/065122 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the anesthetic efficacy of lidocaine 2% with articaine 4% in dental pain anesthesia. |
|
Scientific Title of Study
|
Comparative Evaluation of Anesthetic Efficacy of two different Local Anesthetic Agents in Maxillary Posterior Teeth with Irreversible Pulpitis: A Prospective Randomized Double-Blind Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EDE Sumit Nagaraj |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh |
| Address |
Department of Conservative Dentistry and Endodontics, Dr Z. A. Dental college, Aligarh Muslim University, Aligarh.
Department of Conservative Dentistry and Endodontics, Dr Z. A. Dental college, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9552489345 |
| Fax |
|
| Email |
edesumit11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor |
| Affiliation |
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh |
| Address |
Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh
Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412732327 |
| Fax |
|
| Email |
ashokoperative@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Mukhtar ArUnNisar Andrabi |
| Designation |
Assistant Professor |
| Affiliation |
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh |
| Address |
Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh
Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7599112249 |
| Fax |
|
| Email |
mukhtarandrabi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh, Uttar Pradesh, India. 202002 |
|
|
Primary Sponsor
|
| Name |
EDE Sumit Nagaraj |
| Address |
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh |
| 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 |
| Dr Sumit Nagaraj EDE |
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh, |
OPD NO. 7, Post Graduate Clinic, Department of Conservative Dentistry and Endodontics,
Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh, Uttar Pradesh, India, 202002
Aligarh
UTTAR PRADESH |
9552489345
edesumit11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawahrlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim Universiity, Aligarh, Uttar Pradesh 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
4% articaine with 1:100,000 epinephrine. |
(1) 26 patients shall receive PSA nerve block injection using 1.8 ml of 4% articaine with 1:100,000 epinephrine 15 minutes before the start of the root canal treatment.
(2) 26 patients shall receive infiltration injection of 1.8 ml of 4% articaine with 1:100,000 epinephrine 15 minutes before the start of the root canal treatment. |
| Intervention |
2% lidocaine with 1:100,000 |
(1) 26 patients shall receive PSA nerve block injections using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine, 15 minutes before the start of the root canal treatment
(2)26 patients shall receive infiltration using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine 15 minutes before the start of the root canal treatment
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Those Patients who are at least 18 years old, having good oral and general health, possessing vital symptomatic maxillary posterior teeth,moderate to severe pain in the maxillary molar, a prolonged response to cold testing with an endofrost spray and an exaggerated response to electric pulp testing,the absence of any periapical radiolucency on radiographs except for a widened periodontal ligament, a vital coronal pulp on access opening, and the ability of subject to understand the use of pain scales.
|
|
| ExclusionCriteria |
| Details |
Subjects younger than 18 years of age or older than 50 years of age, patients having active pain in more than 1 maxillary molar, subjects taking any pain-relieving medication including over-the-counter analgesics at least 12 hours before enrolment in the study and swelling near the tooth in question. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective and Objective Signs of onset of complete pulpal anesthesia after the injection of the anesthetic agent |
15 minutes after the injection of the anesthetic agent, and the same shall be verified by negative response to electric pulp testing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patients who have received the injection of the anesthetic agent must feel no pain during endodontic access opening & instrumentation |
complete pulpal anesthesia 15 minutes after the injection & no sensation of pain up to 1 hour. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
05/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study aims to evaluate the efficacy of two different local anesthetic agents (Lidocaine 2% and Articaine 4%) in maxillary posterior teeth with irreversible pulpitis. The study is a Double Blind Randomized Clinical Trial with participant and outcome assessor blinded. The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, AMU. Patients will be selected from the pool of patients visiting the department of Conservative Dentistry and Endodontics, seeking endodontic treatment. Patients will be selected from the pool of patients visiting the department of conservative dentistry and endodontics with the chief complaints of pain in maxillary posterior teeth. A quorum of at least 104 volunteer patients fulfilling the inclusion criteria will be included in the study. The study will be conducted for about 1 and half years from the date of recruitement.
|