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CTRI Number  CTRI/2018/01/011569 [Registered on: 25/01/2018] Trial Registered Retrospectively
Last Modified On: 23/12/2019
Post Graduate Thesis  Yes 
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 study the effects of adding magnesium sulfate with local anesthetic injection on evaluating shooting tooth pain during and after the treatment. 
Scientific Title of Study   Evaluation of Onset, Duration, Anesthetic Efficacy and Post-Operative Analgesia of 2% Lidocaine with or without Magnesium Sulfate for Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis. – A Prospective Randomized Double Blind Controlled Clinical Trial. 
Trial Acronym  LAMG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Charanya 
Designation  Post Graduate Student 
Affiliation  SRM Dental College Ramapuram 
Address  Department of Conservative Dentistry and Endodontics SRM Dental College Ramapuram Chennai

Chennai
TAMIL NADU
600089
India 
Phone  9791146861  
Fax    
Email  charanya1711@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  S Mahalaxmi 
Designation  Head of the Department 
Affiliation  SRM Dental College Ramapuram 
Address  Department of Conservative Dentistry and Endodontics SRM Dental College Ramapuram Chennai

Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax    
Email  researchmaha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  L Vijay Amirtharaj 
Designation  Reader 
Affiliation  SRM Dental College Ramapuram 
Address  Department of Conservative Dentistry and Endodontics SRM Dental College Ramapuram Chennai

Chennai
TAMIL NADU
600089
India 
Phone  9884111167  
Fax    
Email  vijuendo@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, 2nd floor, SRM Dental College, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089 
 
Primary Sponsor  
Name  SRM Dental College Ramapuram 
Address  Department of Conservative Dentistry and Endodontics, SRM Dental College,Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  SRM DENTAL COLLEGE  Department of conservative dentistry and endodontics, 2nd floor, SRM Dental College, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU 
9791146861

charanya1711@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, SRM Dental College, Ramapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with symptomatic irreversible pulpitis with symptomatic apical periodontitis under ASA I & II category. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% Lignocaine Hydrochloride and Magnesium Sulfate 75mg and 150mg  Groups: 1. 2% Lignocaine hydrochloride (1.5ml) 2. 1.5ml 2% Lignocaine hydrochloride with 0.15ml (75mg) of magnesium sulfate 3. 1.5ml of 2% lignocaine hydrochloride with 0.3ml (150mg) of magnesium sulfate The above mentioned concentrations is randomly allocated and given in patients with age group between 20 to 60 years who are diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis. Endodontic therapy is carried out and completed.The following factors were evaluated during and after the procedure. 1. Onset and duration of anesthesia 2. Anesthetic Efficacy 3. Post operative analgesia for a period of 2, 6, 12, 24 and 48 hours. 
Intervention  Lignocaine Hydrochloride and Magnesium Sulfate  Groups: 1. 2% Lignocaine hydrochloride (1.5ml) 2. 1.5ml 2% Lignocaine hydrochloride with 0.15ml (75mg) of magnesium sulfate 3. 1.5ml of 2% lignocaine hydrochloride with 0.3ml (150mg) of magnesium sulfate The above mentioned concentrations is randomly allocated and given in patients with age group between 20 to 60 years who are diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis. Endodontic therapy is carried out and completed.The following factors were evaluated during and after the procedure. 1. Onset and duration of anesthesia 2. Anesthetic Efficacy 3. Post operative analgesia for a period of 2, 6, 12, 24 and 48 hours. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis in mandibular posterior teeth (premolar or molar) of moderate to severe intensity (AAE).
2.Age group between 20 – 60 years.
3.Immediate response to electric pulp testing.
4.Ability to understand the use of pain scales.
5.Patients satisfying American Society of Anesthesiologist (ASA) category I and II.
 
 
ExclusionCriteria 
Details  1.Had taken any medications within 8 hours before treatment.
2.Allergic to local anesthesia.
3.ASA category of III or greater.
4.Pregnancy and Nursing.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anesthetic Efficacy, post operative analgesia onset and duration of 2% Lidocaine with Magnesium Sulfate ( 75mg, 150mg)  1. Immediate complete anaesthesia without supplementary injections in 5 to 15 minutes.
2.Duration of anesthesia from the onset upto 3 hours.
3. Post operative analgesia upto 48 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
Onset and duration of anaesthesia  1. Onset of anaesthesia: Within 3-5 minutes
2. Duration of anaesthesia: More than 1.5 hours.  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/08/2017 
Date of Study Completion (India) 31/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2018 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Achieving profound anesthesia in symptomatic irreversible pulpitis is a cornerstone in endodontic practice as literature states that a single inferior alveolar nerve block is ineffective in 30-80% of patients due to anatomical variations, blood flow, local tissue pH, central sensitization, psychological factors and various reasons.

In Dentistry, the combination of adjuvant with lignocaine has provided better anesthetic and analgesic effect to overcome the failure of anesthesia. Magnesium sulfate (MgSO4) acts as an antagonist at the N-methyl D-aspartate (NMDA) glutamate receptor resulting in effective anesthesia. Hence, the aim of this prospective randomized double blind clinical controlled trial is to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine combined with and without magnesium sulfate in patients with symptomatic irreversible pulpitis and apical periodontitis.

After obtaining ethical clearance, 42 patients were randomly divided into 3 groups following block randomization. Group 1: 2% lignocaine (LA) (1.5mL), 2% LA with MgSO4 (75mg)(0.15mL) and (150mg)(0.3mL) in Group 2 and 3 respectively. Pre-operative vitals and HP-VAS pain score were recorded. Consent forms were obtained from patients willing to participate in the study. 42 patients randomly received IANB injection of the experimental solutions. The onset of anesthesia was recorded by EPT at every one-minute interval. Once the tooth was anesthetized, access cavity was performed under isolation and anesthetic efficacy was recorded on the placement of first file. Subsequent root canal treatment was carried out. The duration of anesthesia was evaluated based on normalcy in lip numbness. The postoperative analgesia was examined at an interval of 2, 6, 12, 24 and 48 hours. All the data were compiled and non-parametric tests were employed for statistical analysis.

In this study group 3 (2% LA with 150mg MgSO4) hastens the onset (1.29min) and produced better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2% LA with 75mg MgSO4) (2.07min) (9.14 HP-VAS) and group 1 (2% LA) (3.29min) (35.79 HP-VAS). The duration of anesthesia was significantly higher in group 3 (247.07mins) when compared to that of group 2 and group 1. Group 3 showed improved post-operative analgesic efficacy at 6th hour when compared to the other 2 groups and postoperative analgesia was observed to be significantly similar in group 2 and group 3 after 24 hours.

 Within the limitations of this study, it can be concluded that 2% LA with MgSO4 (150mg) as an adjuvant showed faster onset, pronounced anesthetic efficacy, marked duration of anesthesia and significantly higher postoperative analgesia than 2% lignocaine. MgSO4 affirms to be a potent adjuvant with 2% lignocaine in subsiding the endodontic pain intra-operatively and post-operatively.

 
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