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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2018-12-04

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.

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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%.

Conditions

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Pain Teeth, Impacted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Surgical procedures were always performed by the same surgeon and assistant, who was unaware of the group that belonged to the patient, as well as the patient himself. This randomization was performed involving numbers and envelopes, being only the investigator's knowledge.

Study Groups

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Group 1-Pain monitor

Use of the anesthetic Mepivacaine 2% in third molar extraction

Group Type ACTIVE_COMPARATOR

Group 2 -Pain monitor

Intervention Type DIAGNOSTIC_TEST

Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative

Group 2 -Pain monitor

Use of the anesthetic Articaine 4% in third molar extraction

Group Type ACTIVE_COMPARATOR

Group 1 -Pain monitor

Intervention Type DIAGNOSTIC_TEST

Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative

Interventions

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Group 1 -Pain monitor

Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative

Intervention Type DIAGNOSTIC_TEST

Group 2 -Pain monitor

Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Michelle Bianchi de Moraes

Assistant Professor, Department of Diagnosis and Surgery, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brazil.

Responsibility Role PRINCIPAL_INVESTIGATOR