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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384160
• Other study ID #: ICT-UNESP
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: December 4, 2018

Study information

• Verified date: February 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 4, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Teeth, Impacted
• Tooth, Impacted

Intervention

Diagnostic Test:
• Group 1 -Pain monitor
Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative
• Group 2 -Pain monitor
Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative

Locations

Country	Name	City	State
Brazil	Michelle Bianchi de Moraes	São José dos Campos	SP

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Paula Carolina de Almeida, Prof. Dr. Fernando Vagner Raldi

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Brockmann WG. Mepivacaine: a closer look at its properties and current utility. Gen Dent. 2014 Nov-Dec;62(6):70-5; quiz 76. Review. — View Citation

Colombini BL, Modena KC, Calvo AM, Sakai VT, Giglio FP, Dionísio 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 — View Citation

Gregorio LV, Giglio FP, Sakai VT, Modena KC, Colombini BL, Calvo AM, Sipert CR, Dionísio 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 epi — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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