Clinical trial NCT04822415: 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
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Anaesthetic success
timeFrame: Intraoperative
Secondary outcomes:
measure: Need for Supplemental anaesthesia
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Randa ElBoghdadi, PhD
role: STUDY_DIRECTOR
References:
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.
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.