Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

Study Overview
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Brief Summary
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The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Detailed Description
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Sixty-six patients diagnosed clinically and radiographically with symptomatic irreversible pulpitis in mandibular posterior teeth will received single-visit root canal treatment using ProTaper Universal rotary system for canal preparation, then they will be randomly divided into two groups (n=33) according to the anesthetic solution used, either Group M (3.6 ml Mepivacaine hydrochloride 2% with 1:100000 epinephrine) or Group A (3.4 ml Articaine hydrochloride 4% with 1:100000 epinephrine). The pain will be assessed using numerical rating scale (NRS) during access cavity preparation and instrumentation, then the need for supplemental anesthesia will be also recorded.

Official Title
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Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine for Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial PART 6

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: mepivicane hydrochloride
* Drug: articane hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in good health (American Society of Anesthesiologists Class II or higher) Patients having symptomatic irreversible pulpitis in one of their mandibular molars. Age range is between 20 and 50 years. Patients who can understand Visual Analogue Scales VAS. Patients able to sign informed consent Exclusion Criteria: Patients allergic to articaine and/or mepivacaine and/or sulfur Patients having active sites of pathosis in the area of injection. Patients having active pain in more than one molar. Patients who had taken analgesics in the 12 hours preceding the injection.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mepivacaine hydrochloride<br>2% Mepivacaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle | Drug: mepivicane hydrochloride<br>* Pain will be assessed during access cavity preparation and instrumentation<br>* Other names: mepivicane;Drug: articane hydrochloride<br>* Pain will be assessed during access cavity preparation and instrumentation<br>* Other names: articane;|
| Active Comparator: articaine hydrochloride<br>4 % Articaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle | Drug: mepivicane hydrochloride<br>* Pain will be assessed during access cavity preparation and instrumentation<br>* Other names: mepivicane;Drug: articane hydrochloride<br>* Pain will be assessed during access cavity preparation and instrumentation<br>* Other names: articane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: Numerical rating scale (NRS) | Pain intensity during access cavity preparation using numerical rating scale (NRS). The scale was numerical to facilitate its use by the participants. The Numerical rating scale is an 10-point scale anchored by two extremes No pain and pain as bad as it could be. Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10]. | Fifteen minutes after injection of the anaesthetic solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: Numerical rating scale (NRS) | Pain intensity during root canal negotiation and instrumentation using Numerical rating scale is an 10-point scale anchored by two extremes No pain and pain as bad as it could be. Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10]. | Twenty-five minutes after injection of the anaesthetic solution | 
| The number of patients who need suplemental anesthesia | counting the number of the number of patients who need suplemental anesthesia | Fifteen minutes after injection of the anaesthetic solution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetic efficacy, Inferior alveolar nerve blocks