Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

NCT ID: NCT03725579

Last Updated: 2018-11-01

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2018-12-31

Brief Summary

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The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Detailed Description

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Sixty-six patients diagnosed clinically and radiographically with symptomatic irreversible pulpitis in mandibular posterior teeth will received single-visit root canal treatment using ProTaper Universal rotary system for canal preparation, then they will be randomly divided into two groups (n=33) according to the anesthetic solution used, either Group M (3.6 ml Mepivacaine hydrochloride 2% with 1:100000 epinephrine) or Group A (3.4 ml Articaine hydrochloride 4% with 1:100000 epinephrine). The pain will be assessed using numerical rating scale (NRS) during access cavity preparation and instrumentation, then the need for supplemental anesthesia will be also recorded.

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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mepivacaine hydrochloride

2% Mepivacaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle

Group Type EXPERIMENTAL

mepivicane hydrochloride

Intervention Type DRUG

Pain will be assessed during access cavity preparation and instrumentation

articane hydrochloride

Intervention Type DRUG

Pain will be assessed during access cavity preparation and instrumentation

articaine hydrochloride

4 % Articaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle

Group Type ACTIVE_COMPARATOR

mepivicane hydrochloride

Intervention Type DRUG

Pain will be assessed during access cavity preparation and instrumentation

articane hydrochloride

Intervention Type DRUG

Pain will be assessed during access cavity preparation and instrumentation

Interventions

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mepivicane hydrochloride

Pain will be assessed during access cavity preparation and instrumentation

Intervention Type DRUG

articane hydrochloride

Pain will be assessed during access cavity preparation and instrumentation

Intervention Type DRUG

Other Intervention Names

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mepivicane articane

Eligibility Criteria

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Inclusion Criteria

1. Patients in good health (American Society of Anesthesiologists Class II or higher)
2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
3. Age range is between 20 and 50 years.
4. Patients who can understand Visual Analogue Scales VAS.
5. Patients able to sign informed consent

Exclusion Criteria

1. Patients allergic to articaine and/or mepivacaine and/or sulfur
2. Patients having active sites of pathosis in the area of injection.
3. Patients having active pain in more than one molar.
4. Patients who had taken analgesics in the 12 hours preceding the injection.
Minimum Eligible Age

20 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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Marwa Mahmoud Bedier

Lecturer in Endodontics Département

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa Bedier, PHD

Role: STUDY_DIRECTOR

Cairo university, faculty of dentistry

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa M Bedier, PHD

Role: CONTACT

0021006611104

Mohamed F Marakby, Master

Role: CONTACT

Facility Contacts

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marwa m bedier, phd

Role: primary

00201006611104

mohamed f marakby, master

Role: backup

Other Identifiers

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CEBD-CU-2014-06-01

Identifier Type: -

Identifier Source: org_study_id

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