Anesthetic Efficacy in Irreversible Pulpitis

January 31, 2014 updated by: Isabel Peixoto Tortamano, University of Sao Paulo

Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar

The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-900
        • Emergency Center of the School of Dentistry at the University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of irreversible pulpitis
  • good health
  • had at least 1 adjacent tooth plus a healthy canine

Exclusion Criteria:

  • took medication could be interacting with any of the anesthetics used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lidocaine
injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Drug: Intervention: inferior alveolar nerve block injection
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
Experimental: mepivacaine
injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Drug: Intervention: inferior alveolar nerve block injection
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
Experimental: articaine
injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Drug: Intervention: inferior alveolar nerve block injection
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulpal anesthesia
Time Frame: Ten minutes after the inferior alveolar nerve block
pulpal anesthesia was tested with an electric pulp stimulator
Ten minutes after the inferior alveolar nerve block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesia
Time Frame: the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal
To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted
the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
lip anesthesia
Time Frame: ten minutes after the inferior alveolar nerve block
The investigators evaluated the subjective lip anethesia by asking the patient whether his/her lip was numb
ten minutes after the inferior alveolar nerve block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Isabel P Tortamano, PhD, USao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDAAA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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