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

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: Articaine; Drug: Mepivacaine

• Registration Number: NCT04822415
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Articaine	Articaine	IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
Mepivacaine	Mepivacaine	IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.

Primary Outcome Measures

Name	Time	Method
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

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