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

NCT03384160 | Completed DMC

• 1 other identifier: ICT-UNESP
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Teeth, Impacted

Keywords

Pain; Third molar; Articaine; Mepivacaine

Outcome Measures

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.

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

Secondary Outcomes (1)

• Assessment of blood pressure change

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

Other Outcomes (2)

• Assessment of heart rate change

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

• Assessment of oxygen saturation change

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

Study Arms (2)

Group 1-Pain monitor

ACTIVE COMPARATOR

Use of the anesthetic Mepivacaine 2% in third molar extraction

Diagnostic Test: Group 2 -Pain monitor

Group 2 -Pain monitor

ACTIVE COMPARATOR

Use of the anesthetic Articaine 4% in third molar extraction

Diagnostic Test: Group 1 -Pain monitor

Interventions

Group 1 -Pain monitor DIAGNOSTIC_TEST

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

Group 2 -Pain monitor

Group 2 -Pain monitor DIAGNOSTIC_TEST

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

Group 1-Pain monitor

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Prof. Dr. Fernando Vagner Raldi: collaborator
• Paula Carolina de Almeida: collaborator

Study Sites (1)

Michelle Bianchi de Moraes

São José dos Campos, São Paulo, 12245000, Brazil

Location

Related 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.

  PMID: 25369391 RESULT

• 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.

  PMID: 16876058 RESULT

• 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.

  PMID: 18420431 RESULT

• 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.

  PMID: 21394145 RESULT

• 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.

  PMID: 23021395 RESULT

MeSH Terms

Conditions

Pain; Tooth, Impacted

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Michelle B Moraes, PHD

  Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Diagnosis and Surgery, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brazil.

Model Details: 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

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: December 27, 2017
• Study Start: December 7, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 4, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)