Skip to main content
OpenTrials
Completed

NCT Number: NCT03384160

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michelle Bianchi de Moraes

São José dos Campos, São Paulo, 12245000, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1 -Pain monitor

Diagnostic Test

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

Group 2 -Pain monitor

Diagnostic Test

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

Primary outcomes

  1. Pain assessment

    Time frame: The scale will be provided on paper and divided into postoperative hours up to 3 days.

    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.

Secondary outcomes

  1. Assessment of blood pressure change

    Time frame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

    Evaluated in patients submitted to the exodontia of third molars, with different types of anesthetics.The investigator evaluated with auscultatory instrument.

Other outcomes

  1. Assessment of heart rate change

    Time frame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

    Evaluated in patients submitted to the exodontia of third molars.

  2. Assessment of oxygen saturation change

    Time frame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

    Evaluated in patients submitted to the exodontia of third molars

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Paula Carolina de Almeida
  • Prof. Dr. Fernando Vagner Raldi

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2017
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.