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

NCT04822415 | Completed

• 1 other identifier: ENDO-CU-2014-06-09
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative

Secondary Outcomes (1)

• Need for Supplemental anaesthesia

  Intraoperative

Study Arms (2)

Mepivacaine

EXPERIMENTAL

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

Drug: Mepivacaine

Articaine

ACTIVE COMPARATOR

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

Drug: Articaine

Interventions

Mepivacaine DRUG

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

Mepivacaine

Articaine DRUG

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

Articaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 27652697 BACKGROUND

• 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.

  PMID: 30638269 BACKGROUND

MeSH Terms

Interventions

Mepivacaine; Carticaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals

Study Officials

• Randa ElBoghdadi, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 2, 2021

Record last verified: 2021-07