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Clinical Trials/NCT01912755
NCT01912755
Completed
Phase 4

Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits

University of Campinas, Brazil1 site in 1 country50 target enrollmentFebruary 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Irreversible Pulpitis
Sponsor
University of Campinas, Brazil
Enrollment
50
Locations
1
Primary Endpoint
Pain perception 3
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

Detailed Description

Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
January 2011
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Campinas, Brazil
Responsible Party
Principal Investigator
Principal Investigator

Francisco Groppo

Professor of Physiological Sciences Department

University of Campinas, Brazil

Eligibility Criteria

Inclusion Criteria

  • long-lasting moderate to severe pain during cold test
  • absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
  • vital coronal pulp on access opening

Exclusion Criteria

  • Previous history of allergy to local anesthetics
  • Subjects with systemic diseases
  • Pregnancy and lactation
  • Subjects taking any kind of medication that could change or influence the outcome of this research
  • Subjects without painful symptoms
  • Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures

Outcomes

Primary Outcomes

Pain perception 3

Time Frame: 10 minutes after injection

Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

Secondary Outcomes

  • Buccal cortical bone thickness(one week after injection)
  • Basal pain perception(10 minutes before injection)
  • Pain perception 2(5 minutes before injection)
  • Root distance to the bone(one week after injection)

Study Sites (1)

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