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

NCT ID: NCT04822415

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mepivacaine

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

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Articaine

Intervention Type DRUG

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

Interventions

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Mepivacaine

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

Intervention Type DRUG

Articaine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Suzan AW Amin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randa ElBoghdadi, PhD

Role: STUDY_DIRECTOR

Cairo University

References

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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.

Reference Type BACKGROUND
PMID: 27652697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30638269 (View on PubMed)

Other Identifiers

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ENDO-CU-2014-06-09

Identifier Type: -

Identifier Source: org_study_id

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