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CompletedNCT03384160Updated Feb 6, 2019

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

An interventional study of Group 1 -Pain monitor and Group 2 -Pain monitor in Pain and Teeth, Impacted, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-06.

Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
16 Years to 40 Years
Sex
All
01

Study 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.

Read the 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%.

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Conditions studied

  • Pain
  • Teeth, Impacted

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Keywords

  • Pain
  • Third molar
  • Articaine
  • Mepivacaine
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Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
7 participants (actual)

Study arms

  • Active comparator
    Group 1-Pain monitor

    Use of the anesthetic Mepivacaine 2% in third molar extraction

    Diagnostic Test: Group 2 -Pain monitor

  • Active comparator
    Group 2 -Pain monitor

    Use of the anesthetic Articaine 4% in third molar extraction

    Diagnostic Test: Group 1 -Pain monitor

Interventions

  • Diagnostic testGroup 1 -Pain monitor

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

  • Diagnostic testGroup 2 -Pain monitor

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

05

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

Other outcomes

  1. Assessment of heart rate change

    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

  2. Assessment of oxygen saturation change

    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

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Study locations

1 site
  • Michelle Bianchi de Moraes
    São José dos Campos, SP 12245000, Brazil
07

References and documents

Publications

  • Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76. PubMed 25369391 ↗
  • 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. PubMed 16876058 ↗
  • 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. PubMed 18420431 ↗
  • 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. PubMed 21394145 ↗
  • 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. PubMed 23021395 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03384160
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Prof. Dr. Fernando Vagner Raldi, Paula Carolina de Almeida
Responsible party
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., Universidade Estadual Paulista Júlio de Mesquita Filho) — Principal investigator
First posted
Dec 27, 2017
Start date
Dec 7, 2017
Primary completion
Oct 30, 2018
Completion
Dec 4, 2018
Last update
Feb 6, 2019

Study contacts

Michelle B Moraes, PHD
principal investigator · Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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