| CTRI Number |
CTRI/2026/01/101407 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Lignocaine with & without Magnesium Sulphate for Infraorbital Nerve Block in Upper premolar extraction |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of 2 percent lignocaine HCl, 2 percent lignocaine HCl with 0.2 ml 10 percent magnesium sulfate and 2 percent lignocaine HCl with 1:200,000 adrenaline 0.2 ml 10 percent magnesium sulfate in infraorbital nerve block- a randomized controlled trial |
| 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 Sandeep khandaitkar |
| Designation |
Asst Professor |
| Affiliation |
Ranjeet Deshmukh Dental College & Research Centre Nagpur |
| Address |
02, Department of Oral & Maxillofacial Surgery, Ranjeet Deshmukh Dental College & Research Centre , Digdoh Hills, Hingna Road , Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9766992263 |
| Fax |
|
| Email |
iprsandeepkhandaitkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramakrishna Shenoi |
| Designation |
Head of the Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
02 Department of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh hills Hingna Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220505 |
| Fax |
|
| Email |
ramakrishna.shenoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramakrishna Shenoi |
| Designation |
Head of the Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
02 Department of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh hills Hingna Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220505 |
| Fax |
|
| Email |
ramakrishna.shenoi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College & Research Centre Nagpur |
| Address |
02, Department of Oral & Maxilllofacial Surgery, Ranjeet Deshmukh Dental College & Research Centre Digdoh Hills, Hingna Road Nagpur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramakrishna Shenoi |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
02 Department of Oral and Maxillofacial Surgery, Ranjeet Deshmukh Dental College and Research Centre ,Digdoh Hills Hingna Nagpur
Nagpur
MAHARASHTRA |
9822220505
ramakrishna.shenoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine HCl |
2 percent lignocaine HCl during extraction of maxillary premolar |
| Intervention |
Lignocaine with Adrenaline with Magnesium Sulphate |
2 percent lignocaine HCl with adrenaline 1 is to 200000 plus 0 point 2 ml 10 percent magnesium sulfate in Infraorbital Nerve block during extraction of maxillary premolar |
| Intervention |
Lignocaine with Magnesium Sulphate |
2 percent lignocaine HCl with 0 point 2 ml 10 percent magnesium sulfate during extraction of maxillary premolar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients above 18 years of age
2 Patients reporting to the department of Oral and Maxillofacial Surgery for extraction of Maxillary premolar |
|
| ExclusionCriteria |
| Details |
1 Patients allergic to Local Anesthesia
2 Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of action of anesthesia, duration of action of anaesthesia and pain during procedure |
Onset of action of anesthesia duration of action of anaesthesia and pain during procedure will be assessed on the same day during procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pulse rate, systolic & diastolic blood pressure |
assessment of pulse rate, systolic & diastolic blood pressure before administration of anaesthesia i.e baseline & during procedure |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized, double-blind, controlled clinical trial designed to compare the effectiveness of different local anesthetic combinations for infraorbital nerve block (IONB) in patients requiring extraction of maxillary premolars. A total of 90 patients, aged 18–60 years, will be randomly allocated into three groups (n = 30 per group). Group A: 2% lignocaine hydrochloride (plain) Group B: 2% lignocaine hydrochloride + magnesium sulfate Group C: 2% lignocaine hydrochloride with adrenaline + magnesium sulfate
The primary outcomes will include: Onset of anesthesia Duration of anesthesia Pain intensity, assessed using the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) Post-operative analgesic requirement at predefined time intervals
The study aims to identify the most effective anesthetic combination for achieving optimal pain control during extraction of maxillary premolars. |