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Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mepivacaine
Articaine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in good health (American Society of Anesthesiologists Class I or II).
  • Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
  • Age range between 18 to 50 years.
  • Patients who can understand Numerical Rating Scale (NRS).
  • Positive patient acceptance and the ability to sign an informed consent.

Exclusion Criteria:

  • Pregnant females.
  • Patients allergic to articaine, mepivacaine and/or any used medication or material.
  • Patients having active sites of pathosis in the area of injection.
  • Patients having active pain in more than one molar.
  • Patients who had taken analgesics in the 12 hours preceding treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mepivacaine

    Articaine

    Arm Description

    IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.

    IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.

    Outcomes

    Primary Outcome Measures

    Anaesthetic success
    Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation measured using the 11-point numerical rating scale (NRS) so that no-or-mild pain is considered as anesthetic success and moderate-to-severe pain is considered anesthetic failure.

    Secondary Outcome Measures

    Need for Supplemental anaesthesia
    The need for supplemental anaesthesia to complete treatment (Yes/No).

    Full Information

    First Posted
    March 26, 2021
    Last Updated
    July 27, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04822415
    Brief Title
    Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis
    Official Title
    Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine for Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars.
    Detailed Description
    The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars. Patients were clinically and radiographically examined and their eligibility assessed and preoperative pain was measured using the numerical rating scale (NRS). Patients were randomly assigned to one of 2 groups: experimental group (2% mepivacaine) and the control group (4% articaine). After 15 minutes of the inferior alveolar nerve block (IANB), patients reporting lip numbness had their molars accessed. No-to-mild pain response was considered success during root canal preparation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    330 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mepivacaine
    Arm Type
    Experimental
    Arm Description
    IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
    Arm Title
    Articaine
    Arm Type
    Active Comparator
    Arm Description
    IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
    Intervention Type
    Drug
    Intervention Name(s)
    Mepivacaine
    Intervention Description
    IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
    Intervention Type
    Drug
    Intervention Name(s)
    Articaine
    Intervention Description
    IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
    Primary Outcome Measure Information:
    Title
    Anaesthetic success
    Description
    Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation measured using the 11-point numerical rating scale (NRS) so that no-or-mild pain is considered as anesthetic success and moderate-to-severe pain is considered anesthetic failure.
    Time Frame
    Intraoperative
    Secondary Outcome Measure Information:
    Title
    Need for Supplemental anaesthesia
    Description
    The need for supplemental anaesthesia to complete treatment (Yes/No).
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in good health (American Society of Anesthesiologists Class I or II). Patients having symptomatic irreversible pulpitis in one of their mandibular molars. Age range between 18 to 50 years. Patients who can understand Numerical Rating Scale (NRS). Positive patient acceptance and the ability to sign an informed consent. Exclusion Criteria: Pregnant females. Patients allergic to articaine, mepivacaine and/or any used medication or material. Patients having active sites of pathosis in the area of injection. Patients having active pain in more than one molar. Patients who had taken analgesics in the 12 hours preceding treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Randa ElBoghdadi, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27652697
    Citation
    Allegretti CE, Sampaio RM, Horliana AC, Armonia PL, Rocha RG, Tortamano IP. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial. Braz Dent J. 2016 Jul-Aug;27(4):381-6. doi: 10.1590/0103-6440201600663.
    Results Reference
    background
    PubMed Identifier
    30638269
    Citation
    Nagendrababu V, Pulikkotil SJ, Suresh A, Veettil SK, Bhatia S, Setzer FC. Efficacy of local anaesthetic solutions on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a systematic review and network meta-analysis of randomized clinical trials. Int Endod J. 2019 Jun;52(6):779-789. doi: 10.1111/iej.13072. Epub 2019 Feb 12.
    Results Reference
    background

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    Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis

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