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

Symptomatic Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822415
• Other study ID #: ENDO-CU-2014-06-09
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for Supplemental anaesthesia	The need for supplemental anaesthesia to complete treatment (Yes/No).	Intraoperative