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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03384160
Enrollment
7
Registered
2017-12-27
Start date
2017-12-07
Completion date
2018-12-04
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Teeth, Impacted

Keywords

Pain, Third molar, Articaine, Mepivacaine

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%.

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

Sponsors

Prof. Dr. Fernando Vagner Raldi
CollaboratorUNKNOWN
Paula Carolina de Almeida
CollaboratorUNKNOWN
Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

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.

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

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain assessmentThe scale will be provided on paper and divided into postoperative hours up to 3 days.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

MeasureTime frameDescription
Assessment of blood pressure changeObserved and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesiaEvaluated in patients submitted to the exodontia of third molars, with different types of anesthetics.The investigator evaluated with auscultatory instrument.

Other

MeasureTime frameDescription
Assessment of heart rate changeObserved and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesiaEvaluated in patients submitted to the exodontia of third molars.
Assessment of oxygen saturation changeObserved and recorded immediately before application of the anesthetic solution, at 5, 20 and 70 minutes after the application of anesthesiaEvaluated in patients submitted to the exodontia of third molars

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026