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

Primary Purpose

Pain, Teeth, Impacted

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group 1 -Pain monitor
Group 2 -Pain monitor
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Pain, Third molar, Articaine, Mepivacaine

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Michelle Bianchi de Moraes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1-Pain monitor

Group 2 -Pain monitor

Arm Description

Use of the anesthetic Mepivacaine 2% in third molar extraction

Use of the anesthetic Articaine 4% in third molar extraction

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2017
Last Updated
February 5, 2019
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Prof. Dr. Fernando Vagner Raldi, Paula Carolina de Almeida
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1. Study Identification

Unique Protocol Identification Number
NCT03384160
Brief Title
Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Clinical Trial.
Official Title
Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Splint-mouth Randomized Double Blind Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Prof. Dr. Fernando Vagner Raldi, Paula Carolina de Almeida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Teeth, Impacted
Keywords
Pain, Third molar, Articaine, Mepivacaine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1-Pain monitor
Arm Type
Active Comparator
Arm Description
Use of the anesthetic Mepivacaine 2% in third molar extraction
Arm Title
Group 2 -Pain monitor
Arm Type
Active Comparator
Arm Description
Use of the anesthetic Articaine 4% in third molar extraction
Intervention Type
Diagnostic Test
Intervention Name(s)
Group 1 -Pain monitor
Intervention Description
Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative
Intervention Type
Diagnostic Test
Intervention Name(s)
Group 2 -Pain monitor
Intervention Description
Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative
Primary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
The scale will be provided on paper and divided into postoperative hours up to 3 days.
Secondary Outcome Measure Information:
Title
Assessment of blood pressure change
Description
Evaluated in patients submitted to the exodontia of third molars, with different types of anesthetics.The investigator evaluated with auscultatory instrument.
Time Frame
Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
Other Pre-specified Outcome Measures:
Title
Assessment of heart rate change
Description
Evaluated in patients submitted to the exodontia of third molars.
Time Frame
Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
Title
Assessment of oxygen saturation change
Description
Evaluated in patients submitted to the exodontia of third molars
Time Frame
Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle B Moraes, PHD
Organizational Affiliation
Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michelle Bianchi de Moraes
City
São José dos Campos
State/Province
SP
ZIP/Postal Code
12245000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25369391
Citation
Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76.
Results Reference
result
PubMed Identifier
16876058
Citation
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.
Results Reference
result
PubMed Identifier
18420431
Citation
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.
Results Reference
result
PubMed Identifier
21394145
Citation
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.
Results Reference
result
PubMed Identifier
23021395
Citation
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.
Results Reference
result

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

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