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.

Phase 3

Completed

• Conditions: Patients with symptomatic irreversible pulpitis with symptomatic apical periodontitis under ASA I & II category.

• Registration Number: CTRI/2018/01/011569
• Lead Sponsor: SRM Dental College Ramapuram

Brief Summary

Achieving profound anesthesia in symptomaticirreversible pulpitis is a cornerstone in endodontic practice as literaturestates that a single inferior alveolar nerve block is ineffective in 30-80% ofpatients due to anatomical variations, blood flow, local tissue pH, centralsensitization, psychological factors and various reasons.

In Dentistry, the combination of adjuvant with lignocaine hasprovided better anesthetic and analgesic effect to overcome the failure ofanesthesia. Magnesium sulfate (MgSO4) acts as anantagonist at the N-methyl D-aspartate (NMDA) glutamate receptor resulting ineffective anesthesia. Hence, the aim of this prospective randomized doubleblind clinical controlled trial is to evaluate the onset, anesthetic efficacy,duration and post-operative analgesia of 2% lignocaine combined with andwithout magnesium sulfate in patients with symptomatic irreversible pulpitisand apical periodontitis.

After obtaining ethical clearance, 42 patients wererandomly 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. Theonset of anesthesia was recorded by EPT at every one-minute interval. Once thetooth was anesthetized, access cavity was performed under isolation andanesthetic efficacy was recorded on the placement of first file. Subsequentroot canal treatment was carried out. The duration of anesthesia was evaluatedbased on normalcy in lip numbness. The postoperative analgesia was examined atan interval of 2, 6, 12, 24 and 48 hours. All the data were compiled andnon-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 wassignificantly higher in group 3 (247.07mins) when compared to that of group 2and group 1. Group 3 showed improved post-operative analgesic efficacy at 6thhour when compared to the other 2 groups and postoperative analgesia wasobserved to be significantly similar in group 2 and group 3 after 24 hours.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-20
• Study Completion: 2018-08-31
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Onset and duration of anaesthesia	1. Onset of anaesthesia: Within 3-5 minutes

Trial Locations

Locations (1)

SRM DENTAL COLLEGE; 🇮🇳 Chennai, TAMIL NADU, India

SRM DENTAL COLLEGE

🇮🇳Chennai, TAMIL NADU, India

DR C CHARANYA

Principal investigator

9791146861

charanya1711@gmail.com