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NCT Number: NCT04822415

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepivacaine

Drug

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

Articaine

Drug

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

Primary outcomes

  1. Anaesthetic success

    Time frame: 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 outcomes

  1. Need for Supplemental anaesthesia

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2021
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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