| CTRI Number |
CTRI/2025/03/081928 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect of magnesium sulfate with local anaesthetic injection for tooth pain during and after root canal treatment |
|
Scientific Title of Study
|
Analgesic efficacy of 2% Lignocaine and 4% Articaine with or without
Magnesium Sulfate for inferior alveolar nerve block in irreversible pulpitis and
apical periodontitis -A Randomized Clinical trail |
| Trial Acronym |
LAMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manishaa Jayachandran |
| Designation |
Post graduate student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute
Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
47411000 |
| Fax |
|
| Email |
manishaa0911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Charanya |
| Designation |
Reader |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute
Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
47411000 |
| Fax |
|
| Email |
charanya1711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sadasiva K |
| Designation |
Professor and Head |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute
Rajiv Gandhi Salai, Kelambakkam
TAMIL NADU
603103
India |
| Phone |
47411000 |
| Fax |
|
| Email |
drsadasiva@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute
Rajiv Gandhi Salai, Kelambakkam |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute
Rajiv Gandhi Salai, Kelambakkam |
| 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 C Charanya |
Chettinad dental college and research institute |
Department of conservative dentistry and endodontics, room no 10, 4th floor, E Block, Chettinad dental college and research institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU |
9791146861
charanya1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Dental College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA category I, II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lidocaine with 1:80,000 epinephrine and 4% articaine with 1:1,00,000 epinephrine and 75 mg magnesium sulfate |
Pre-operative vitals and Heft Parker–Visual Analogue
Scale (HP-VAS) pain scores will be recorded before starting the procedure.
Page 2 of 11
The patients are (Block randomization) randomly divided into four groups,each
group containing 11 patients
Group 1- 2% lidocaine with 1:80,000 epinephrine
Group 2- 2% lidocaine with epinephrine 1:80,000 and 75 mg MgSo4
Group 3 -4% articaine with epinephrine 1:1,00,000 and 75mg MgSo4
Group 4-4% articaine with epinephrine 1:1,00,000
The onset of anaesthesia will be evaluated by EPT for every 1 min until the
corresponding vital tooth stops responding. Lip numbness will be considered to
check the aesthetic success within 15 minutes.The duration of anaesthesia will be
evaluated every 15 min using EPT till the adjacent normal tooth responded on the
working side.
In case of pain supplementary injection will be provided and the patient will be
ruled out the study.
Pain data will be collected after access cavity and insertion of files in the canals.
The post-operative analgesia will be examined at intervals of 6, 12, 24, and 48 h. |
| Intervention |
2% lidocaine with 1:80,000 epinephrine and 4% articaine with 1:1,00,000 epinephrine and 75 mg magnesium sulfate |
Pre-operative vitals and Heft Parker–Visual Analogue Scale (HP-VAS) pain scores will be recorded before starting the procedure. Page 2 of 11 The patients are (Block randomization) randomly divided into four groups,each group containing 11 patients Group 1- 2% lidocaine with 1:80,000 epinephrine Group 2- 2% lidocaine with epinephrine 1:80,000 and 75 mg MgSo4 Group 3 -4% articaine with epinephrine 1:1,00,000 and 75mg MgSo4 Group 4-4% articaine with epinephrine 1:1,00,000 The onset of anaesthesia will be evaluated by EPT for every 1 min until the corresponding vital tooth stops responding. Lip numbness will be considered to check the aesthetic success within 15 minutes.The duration of anaesthesia will be evaluated every 15 min using EPT till the adjacent normal tooth responded on the working side. In case of pain supplementary injection will be provided and the patient will be ruled out the study. Pain data will be collected after access cavity and insertion of files in the canals. The post-operative analgesia will be examined at intervals of 6, 12, 24, and 48 h. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients those who will be diagnosed with
symptomatic irreversible pulpitis and symptomatic
apical periodontitis of mandibular molar teeth were
included into the study.
ASA category I, II
Patient age group – 20-60 |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included ASA category III and
above, patients with any prior medications, those
allergic to LA, pregnant, and lactating women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| anesthetic and post operative analgesic efficacy expected with addition of magnesium sulfate |
anesthetic and post operative analgesic efficacy expected with addition of magnesium sulfate. The onset of anaesthesia will be evaluated by EPT for every 1 min until the
corresponding vital tooth stops responding. Lip numbness will be considered to
check the aesthetic success within 15 minutes.The duration of anaesthesia will be
evaluated every 15 min using EPT till the adjacent normal tooth responded on the
working side. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative analgesic efficacy expected with addition of magnesium sulfate |
anesthetic efficacy expected with addition of magnesium sulfate. Pain data will be collected after access cavity and insertion of files in the canals.
The post-operative analgesia will be examined at intervals of 6, 12, 24, and 48 h. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
25/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
AIM: To evaluate the onset, duration, anesthetic efficacy and post operative analgesia of 2% Lignocaine and 4% Articaine with or without Magnesium Sulfate for inferior alveolar nerve block in irreversible pulpitis and apical periodontitis. METHODOLOGY :Patients classified under the American Society of Anaesthesiologists (ASA) categories I and II, within the age groups of 20 to 60 years will be screened in the study. 44 patients diagnosed with symptomatic irreversible pulpitis and apical periodontitis were selected Study protocol will be explained to the patients and informed consent will be obtained from those willing to participate. The patients are free to withdraw anytime during the study. Pre-operative vitals and Heft Parker–Visual Analogue Scale (HP-VAS) pain scores will be recorded before starting the procedure.Page 2 of 11 The patients are (Block randomization) randomly divided into four groups,each group containing 11 patients Group 1- 2% lidocaine with 1:80,000 epinephrine Group 2- 2% lidocaine with epinephrine 1:80,000 and 75 mg MgSo4 Group 3 -4% articaine with epinephrine 1:1,00,000 and 75mg MgSo4 Group 4-4% articaine with epinephrine 1:1,00,000 The onset of anaesthesia will be evaluated by EPT for every 1 min until the corresponding vital tooth stops responding. Lip numbness will be considered to check the aesthetic success within 15 minutes.The duration of anaesthesia will be evaluated every 15 min using EPT till the adjacent normal tooth responded on the working side. In case of pain supplementary injection will be provided and the patient will be ruled out the study. Pain data will be collected after access cavity and insertion of files in the canals. The post-operative analgesia will be examined at intervals of 6, 12, 24, and 48 h. STATISTICAL ANALYSIS Statistical analysis will be done by IBM SPSS (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp). Mean and SD will be used to summarize the data. A ‘P’ value of <0.05 will be considered as statistically significant difference. |