Clinical trial NCT03384160: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Teeth, Impacted
Keywords: Pain
Third molar
Articaine
Mepivacaine
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Fernando Vagner Raldi
name: Paula Carolina de Almeida
First posted: 2017-12-27
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: Pain assessment
timeFrame: The scale will be provided on paper and divided into postoperative hours up to 3 days.
Secondary outcomes:
measure: Assessment of blood pressure change
timeFrame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
Other outcomes:
measure: Assessment of heart rate change
timeFrame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
measure: Assessment of oxygen saturation change
timeFrame: Observed and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesia
Locations:
city: São José dos Campos
country: Brazil
facility: Michelle Bianchi de Moraes
state: SP
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp
name: Michelle B Moraes, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76.
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.
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.
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.
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.