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

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

Study Overview

• Status: Completed
• Conditions: Pain; Teeth, Impacted
• Intervention / Treatment: Diagnostic test: Group 2 -Pain monitor; Diagnostic test: Group 1 -Pain monitor

Detailed Description

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%.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São José dos Campos, SP, Brazil, 12245000
      • Michelle Bianchi de Moraes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1-Pain monitor; Use of the anesthetic Mepivacaine 2% in third molar extraction	Diagnostic test: Group 2 -Pain monitor; Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative
ACTIVE_COMPARATOR: Group 2 -Pain monitor; Use of the anesthetic Articaine 4% in third molar extraction	Diagnostic test: Group 1 -Pain monitor; Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of heart rate change	Evaluated in patients submitted to the exodontia of third molars.	Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
Assessment of oxygen saturation change	Evaluated in patients submitted to the exodontia of third molars	Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Collaborators: Prof. Dr. Fernando Vagner Raldi; Paula Carolina de Almeida
• Investigators: Principal Investigator: Michelle B Moraes, PHD, Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp

Publications and helpful links

General Publications

• Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76.
• Colombini BL, Modena KC, Calvo AM, Sakai VT, Giglio FP, Dionisio TJ, Trindade AS Jr, Lauris JR, Santos CF. Articaine and mepivacaine efficacy in postoperative analgesia for lower third molar removal: a double-blind, randomized, crossover study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):169-74. doi: 10.1016/j.tripleo.2005.09.003. Epub 2006 Mar 24.
• Gregorio LV, Giglio FP, Sakai VT, Modena KC, Colombini BL, Calvo AM, Sipert CR, Dionisio TJ, Lauris JR, Faria FA, Trindade Junior AS, Santos CF. A comparison of the clinical anesthetic efficacy of 4% articaine and 0.5% bupivacaine (both with 1:200,000 epinephrine) for lower third molar removal. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):19-28. doi: 10.1016/j.tripleo.2007.11.024. Epub 2008 Apr 16.
• Holliday R, Jackson I. Superior position of the mandibular foramen and the necessary alterations in the local anaesthetic technique: a case report. Br Dent J. 2011 Mar 12;210(5):207-11. doi: 10.1038/sj.bdj.2011.145.
• McCoy JM. Complications of retention: pathology associated with retained third molars. Atlas Oral Maxillofac Surg Clin North Am. 2012 Sep;20(2):177-95. doi: 10.1016/j.cxom.2012.06.002. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2017
• Primary Completion (ACTUAL): October 30, 2018
• Study Completion (ACTUAL): December 4, 2018

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): December 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Mepivacaine; Third molar; Articaine
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: ICT-UNESP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes