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
|
|
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
|
|
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. |