| CTRI Number |
CTRI/2026/01/100781 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study Comparing How Well Different Amount Of Two Different Dental Anesthesia Work For Painful Lower First Molar Using Cold And Electric Pulp Test |
|
Scientific Title of Study
|
Assessment of anesthetic
success in symptomatic mandibular 1st molar using cold and electric pulp testing following administration of different volumes of lignocaine and articaine-an in vivo 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 |
Dr VISHWA PATEL |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital sankalchand patel university |
| Address |
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road Near
Kamana Char Rasta Visnagar Gujarat
room number 5 department of conservative dentistry and
endodontics
Mahesana
GUJARAT
382440
India |
| Phone |
6354724482 |
| Fax |
|
| Email |
vishwak22170@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and Hod |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital Sankalchand patel
university Visnagar Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and Hod |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital Sankalchand patel
university Visnagar Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of conservative dentistry and endodontics Narsinhbhai Patel Dental
College and Hospital Dental school in Visnagar Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Vishwa Patel |
| Address |
90 K shyam Bunglows Ambaji Road Raj Laxmi Society Part 1 Patan Gujarat 384265 |
| 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 Vishwa Patel |
Narsinhbhai Patel Dental College and Hospita |
Room no 5
Department of
Conservative
Dentistry Narsinhbhai
Patel Dental College
and Hospital Nootan
dental college dental
college Visnagar
Mahesana
GUJARAT |
6354724482
vishwak22170@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient Require Root Canal Treatmnet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of success of inferior alveolar nerve block |
With Different local anesthetic agent with different volume after 15 minutes of administration |
| Comparator Agent |
With using cold and electric pulp test |
To evaluate the success of inferior alveolar nerve block using different volumes of local anesthetic agent after 15 minutes of administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients have mandibular 1st molar diagnose with symptomatic irreversible pulpitis
confirmed with cold test
Intact lamina dura in periapical radiograph
|
|
| ExclusionCriteria |
| Details |
Teeth with acute pulpal periapical lesion
Patients with swelling and sinus tract
Severe needle phobia migraine
Teeth with fracture lines & cracks calcified chambers and canal resorption internal and
external immature apex and periodontal diseases were excluded
Patients having allergy to local anesthesia
Those who have systemic diseases immunocompromised conditions
Patients who use drugs that interfere with sensation in head and face region
Pregnant and lactating women
Patient not report lip numbness after local anesthsia injection |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of inferior alveolar nerve block will be more using articaine |
It would be checked after 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of inferior alveolar nerve block will be more using articaine 3.6 ml volume |
It would be checked after 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Total 60 sample with symptomatic irreversible pulpitis in mandibular 1st molar teeth will be selected after diagnosis confirm with cold test and then devided into 4 group Group I 1.8 ml lignocaine Group II 3.6 ml lignocaine Group III 1.8 ml articaine Group IV 3.6 ml articaine
After 15 min patient with lip numbness will undergo EPT and cold tests and based on response further devided into 4 groups Group A Coldtest Positive EPT Positive Group B Coldtest Negative EPT Negative Group C Coldtest Positive EPT Negative Group D Coldtest Negative EPT Positive
|