Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits

July 29, 2013 updated by: Francisco Groppo, University of Campinas, Brazil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

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
    • SP
      • Piracicaba, SP, Brazil, 13414-903
        • Piracicaba Dental School - UNICAMP

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Articaine
injection of 1.8 mL buccal infiltrations of 4% articaine with 1:100,000 epinephrine in one tooth with a clinical diagnosis of symptomatic irreversible pulpitis.
Drug: 4% articaine with 1:100,000 epinephrine
If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.
Other Names:
  • articaine
Drug: 2% lidocaine with 1:100,000 epinephrine
If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.
Other Names:
  • Lidocaine
Active Comparator: Lidocaine
1.8 mL 2% lidocaine with 1:100,000 epinephrine injected as inferior alveolar nerve block in the mandible side with one tooth with a clinical diagnosis of symptomatic irreversible pulpitis.
Drug: 4% articaine with 1:100,000 epinephrine
If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.
Other Names:
  • articaine
Drug: 2% lidocaine with 1:100,000 epinephrine
If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.
Other Names:
  • Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccal cortical bone thickness
Time Frame: one week after injection
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness.
one week after injection
Root distance to the bone
Time Frame: one week after injection
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone.
one week after injection
Basal pain perception
Time Frame: 10 minutes before injection
Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.
10 minutes before injection
Pain perception 2
Time Frame: 5 minutes before injection
Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing).
5 minutes before injection

Collaborators and Investigators

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

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Chair: José FA Almeida, DDS, PhD, Endodontics Area - FOP-UNICAMP
  • Principal Investigator: Maria RF Monteiro, DDS, MSc, Endodontics Area - FOP-UNICAMP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

July 31, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-10834-4

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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