Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine (Anesthesia)

October 31, 2018 updated by: Marwa Mahmoud Bedier, Cairo University

Anesthetic 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 PART 6

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: mepivicane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
Other Names:
  • mepivicane
Drug: articane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
Other Names:
  • articane
Active Comparator: 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
Drug: mepivicane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
Other Names:
  • mepivicane
Drug: articane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
Other Names:
  • articane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity: Numerical rating scale (NRS)
Time Frame: Fifteen minutes after injection of the anaesthetic solution

Pain intensity during access cavity preparation using numerical rating scale (NRS). The scale was numerical to facilitate its use by the participants. The Numerical rating scale is an 10-point scale anchored by two extremes "No pain" and "pain as bad as it could be".

Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10].
Fifteen minutes after injection of the anaesthetic solution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity: Numerical rating scale (NRS)
Time Frame: Twenty-five minutes after injection of the anaesthetic solution

Pain intensity during root canal negotiation and instrumentation using Numerical rating scale is an 10-point scale anchored by two extremes "No pain" and "pain as bad as it could be".

Pain was categorized into four categorical scores: (1) none [score 0], (2) mild [score from 1-3], (3) moderate [score from 4-6], (4) severe [score from 7-10].
Twenty-five minutes after injection of the anaesthetic solution
The number of patients who need suplemental anesthesia
Time Frame: Fifteen minutes after injection of the anaesthetic solution
counting the number of the number of patients who need suplemental anesthesia
Fifteen minutes after injection of the anaesthetic solution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Marwa Bedier, PHD, Cairo University, faculty of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2014-06-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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