Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

Study Overview
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Brief Summary
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the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars

Official Title
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Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

Conditions
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Success of Inferior Alveolar Nerve Block

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Mepivacaine-Levonordefrin Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-55 years old. Systemically healthy patient (ASA I or II). Mandibular molar teeth with: Preoperative sharp pain. No widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1. Fully formed roots. Positive patient's acceptance for participation in the study. Exclusion Criteria: Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment. Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Drug abusers and subjects who were on antidepressant medication. Re-treatment cases. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: megnesium sulphate<br>Injection of 1.8 mL of an anaesthetic solution containing 1% magnesium sulphate , and 1.8% mepivacaine HCL with .06mg Levonordefrin HCl during inferior alveolar nerve block. | Drug: Magnesium sulfate<br>* patients will be given an IANB injection by adding 0.18 mL of 10% magnesium sulphate to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe<br>* Other names: magnisol;|
| Active Comparator: mepivacaine HCl<br>Injection of 1.8 mL of a local anaesthetic solution containing 1.8% mepivacaine HCL with .06mg Levonordefrin HCL during inferior alveolar nerve block | Drug: Mepivacaine-Levonordefrin Hydrochloride<br>* patients will be given an IANB injection by adding 0.18 mL of sterile distilled water to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe<br>* Other names: Mepecaine - L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of inferior alveolar nerve block measured using a numerical rating scale (NRS) | Intensity of pain 15 minutes after injection during access cavity and initial file placement is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain ) | 15 minutes after injection |