Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

Study Overview
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Brief Summary
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To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.

Detailed Description
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Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.

Official Title
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Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: 1.8 ml mepivacaine hydrochloride
* Drug: 3.6 ml mepivacaine hydrochloride
* Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in good health (ASA Class I, II). Age between 18-60 years old. Males or females. Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis. Patients who can understand NRS scale and sign the informed consent. Exclusion Criteria: Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment. Pregnant or nursing females. Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.8 ml mepivacaine IANB<br> | Drug: 1.8 ml mepivacaine hydrochloride<br>* 1.8 ml mepivacaine IANB<br>|
| Experimental: 3.6 ml mepivacaine IANB<br> | Drug: 3.6 ml mepivacaine hydrochloride<br>* 3.6 ml mepivacaine IANB<br>|
| Experimental: 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI<br> | Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI<br>* 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic success | Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain. Success will be defined as no to mild pain. | During the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative pain | Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain. | During the treatment | 
| Need for supplemental anesthesia | Whether the patient requires supplemental anesthesia or not | During the treatment |