Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

Study Overview
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Brief Summary
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The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

Detailed Description
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Patients with moderate-to-severe pain due to symptomatic irreversible pulpitis will be included. Patients will be randomly assigned into two groups to receive either 1.8 ml 4% articaine buccal infiltration or 3.6. ml 4% articaine buccal infiltration before single visit root canal treatments. Intraoperative pain will be assessed using an 11-point numerical rating scale (NRS) so that anesthetic success will be defined as no to mild intraoperative pain. The need for supplemental anesthesia will also be recorded.

Official Title
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Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: 3.6 ml 4% Articaine hydrochloride
* Drug: 1.8 ml 4% Articaine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II). No sex predilection Patients with symptomatic irreversible pulpitis Patient with the ability to understand and use pain scales. Patients who accept to enroll in the study. Exclusion Criteria: Patients' allergies to any of the drugs or materials used in the study. Pregnant and lactating females. Patients taking analgesics in the last 6-8 hours. Patients having more than one symptomatic tooth in the same quadrant

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
Interventional Model Description: Parallel, randomized, clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.8 ml 4% articaine buccal infiltration.<br> | Drug: 1.8 ml 4% Articaine hydrochloride<br>* 1.8 ml 4% articaine buccal infiltration<br>|
| Experimental: 3.6 ml 4% articaine buccal infiltration<br> | Drug: 3.6 ml 4% Articaine hydrochloride<br>* 3.6 ml 4% articaine buccal infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic success | Will be measured by 11-point numerical rating scale NRS. The success will be defined as no or mild pain (NRS 0 or less than 3) and the failure will be defined as moderate to severe pain (NRS more than 3). | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for supplemental anesthesia | Whether the patient requires supplemental anesthesia or not. It will be recorded by the questionnaire (yes or no). | During the procedure |