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Anesthetic Efficacy in Irreversible Pulpitis

Primary Purpose

Anesthesia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Intervention: inferior alveolar nerve block injection
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring articaine, lidocaine, mepivacaine, inferior alveolar nerve block, irreversible pulpitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Emergency Center of the School of Dentistry at the University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

lidocaine

mepivacaine

articaine

Arm Description

injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

Outcomes

Primary Outcome Measures

pulpal anesthesia
pulpal anesthesia was tested with an electric pulp stimulator

Secondary Outcome Measures

analgesia
To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted

Full Information

First Posted
September 3, 2013
Last Updated
January 31, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02054767
Brief Title
Anesthetic Efficacy in Irreversible Pulpitis
Official Title
Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
Keywords
articaine, lidocaine, mepivacaine, inferior alveolar nerve block, irreversible pulpitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine
Arm Type
Experimental
Arm Description
injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Arm Title
mepivacaine
Arm Type
Experimental
Arm Description
injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Arm Title
articaine
Arm Type
Experimental
Arm Description
injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Intervention Type
Drug
Intervention Name(s)
Intervention: inferior alveolar nerve block injection
Intervention Description
-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
Primary Outcome Measure Information:
Title
pulpal anesthesia
Description
pulpal anesthesia was tested with an electric pulp stimulator
Time Frame
Ten minutes after the inferior alveolar nerve block
Secondary Outcome Measure Information:
Title
analgesia
Description
To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted
Time Frame
the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal
Other Pre-specified Outcome Measures:
Title
lip anesthesia
Description
The investigators evaluated the subjective lip anethesia by asking the patient whether his/her lip was numb
Time Frame
ten minutes after the inferior alveolar nerve block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel P Tortamano, PhD
Organizational Affiliation
USão Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Center of the School of Dentistry at the University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-900
Country
Brazil

12. IPD Sharing Statement

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Anesthetic Efficacy in Irreversible Pulpitis

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