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Anesthetic Efficacy in Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT02054767
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Isabel Peixoto Tortamano, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Intervention: inferior alveolar nerve block injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar
Study Start Date : August 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. pulpal anesthesia [ Time Frame: Ten minutes after the inferior alveolar nerve block ]
    pulpal anesthesia was tested with an electric pulp stimulator


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054767


Locations
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Brazil
Emergency Center of the School of Dentistry at the University of São Paulo
São Paulo, Brazil, 05508-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Isabel P Tortamano, PhD USão Paulo

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Responsible Party: Isabel Peixoto Tortamano, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02054767    
Other Study ID Numbers: FDAAA
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: September 2013
Keywords provided by Isabel Peixoto Tortamano, University of Sao Paulo:
articaine
lidocaine
mepivacaine
inferior alveolar nerve block
irreversible pulpitis
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lidocaine
Carticaine
Mepivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action