Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Clinical Trial.

Study Overview
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Brief Summary
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The extraction of third molars, a frequent treatment in clinical dental practice, can lead patients to painful symptoms during and after surgery. The dental surgeon must correctly indicate the need for extraction and also provide patients who need this treatment greater comfort and control of pain in the trans and postoperative period. Thus, it is necessary to use an effective local anesthetic favoring the factors inherent to the postoperative and achieving good treatment results.

Detailed Description
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This study will compare the use of Articaine at 4% to that of Mepivacaine at 2% for lower third molar surgeries semi-included and / or included. I will select 16 patients who require surgical treatment for extraction of third molars, aged between 16 and 40 years at the São Paulo State University. These will participate simultaneously in the two groups: Group 1 mepivacaine (MEP) and Group 2 articaine (ART), and the division will be performed by randomization, so that each patient will have each side (right or left) allocated in different groups. The primary evaluation variable will be to compare the pain index in the immediate postoperative period, using Visual Analog Scale (VAS), and will also analyze Hemodynamic Parameters, such as Patient and Operator satisfaction. The results will be submitted to qualitative and quantitative statistical analysis. The descriptive data will be compared using the statistical analysis of variance (ANOVA) and Tukey test with a significance level of 5%.

Official Title
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Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Splint-mouth Randomized Double Blind Controlled Clinical Trial.

Conditions
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Pain, Teeth, Impacted

Intervention / Treatment
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* Diagnostic Test: Group 1 -Pain monitor
* Diagnostic Test: Group 2 -Pain monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Classification -(ASA I) patients; Patients with need for extraction of lower third molars included and / or semi-included; Teeth in opposing hemiarch with the same classifications as Pell and Gregory and Winter; Age between 16 and 40 years; Patients who agree to voluntarily participate in the survey. Exclusion Criteria: History of allergic reactions (hypersensitivity) to anesthetics; Patients presenting with local or systemic alterations that contraindicate the procedure; Current use of drugs that may interfere with the action of anesthetics; Need for sedatives or anxiolytic drugs during extraction; Pregnancy or breastfeeding; Third erupted lower third molars.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, double blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely: Group 1 (16 teeth) - using anesthetic mepivacaine in third molar extraction. Group 2 (16 teeth) - using anesthetic articaine in third molar extraction
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1-Pain monitor<br>Use of the anesthetic Mepivacaine 2% in third molar extraction | Diagnostic Test: Group 2 -Pain monitor<br>* Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative<br>|
| Active Comparator: Group 2 -Pain monitor<br>Use of the anesthetic Articaine 4% in third molar extraction | Diagnostic Test: Group 1 -Pain monitor<br>* Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Evaluated in patients in groups 1 and 2. Scale of Visual Analog Scale (VAS), with values from zero to ten, being zero without pain and ten the maximum of pain. This scale will be provided on paper and divided into postoperative hours up to 3 days. | The scale will be provided on paper and divided into postoperative hours up to 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of blood pressure change | Evaluated in patients submitted to the exodontia of third molars, with different types of anesthetics.The investigator evaluated with auscultatory instrument. | Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Third molar, Articaine, Mepivacaine