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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04822415
Collaborator
(none)
330
2
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mepivacaine

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

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

Active Comparator: Articaine

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

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

Outcome Measures

Primary Outcome Measures

  1. Anaesthetic success [Intraoperative]

    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

  1. Need for Supplemental anaesthesia [Intraoperative]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Randa ElBoghdadi, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Suzan AW Amin, Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04822415
Other Study ID Numbers:
  • ENDO-CU-2014-06-09
First Posted:
Mar 30, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021