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

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
mepivicane hydrochloride
articane hydrochloride
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis focused on measuring Anesthetic efficacy, Inferior alveolar nerve blocks

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mepivacaine hydrochloride

articaine hydrochloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain intensity: Numerical rating scale (NRS)
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].

Secondary Outcome Measures

Pain intensity: Numerical rating scale (NRS)
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].
The number of patients who need suplemental anesthesia
counting the number of the number of patients who need suplemental anesthesia

Full Information

First Posted
October 23, 2018
Last Updated
October 31, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03725579
Brief Title
Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine
Acronym
Anesthesia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Anesthetic efficacy, Inferior alveolar nerve blocks

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mepivacaine hydrochloride
Arm Type
Experimental
Arm Description
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
Arm Title
articaine hydrochloride
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
mepivicane hydrochloride
Other Intervention Name(s)
mepivicane
Intervention Description
Pain will be assessed during access cavity preparation and instrumentation
Intervention Type
Drug
Intervention Name(s)
articane hydrochloride
Other Intervention Name(s)
articane
Intervention Description
Pain will be assessed during access cavity preparation and instrumentation
Primary Outcome Measure Information:
Title
Pain intensity: Numerical rating scale (NRS)
Description
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].
Time Frame
Fifteen minutes after injection of the anaesthetic solution
Secondary Outcome Measure Information:
Title
Pain intensity: Numerical rating scale (NRS)
Description
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].
Time Frame
Twenty-five minutes after injection of the anaesthetic solution
Title
The number of patients who need suplemental anesthesia
Description
counting the number of the number of patients who need suplemental anesthesia
Time Frame
Fifteen minutes after injection of the anaesthetic solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in good health (American Society of Anesthesiologists Class II or higher) Patients having symptomatic irreversible pulpitis in one of their mandibular molars. Age range is between 20 and 50 years. Patients who can understand Visual Analogue Scales VAS. Patients able to sign informed consent Exclusion Criteria: Patients allergic to articaine and/or mepivacaine and/or sulfur 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 the injection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa M Bedier, PHD
Phone
0021006611104
Email
m.bedier81@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Marakby, Master
Email
elmarakby_200200@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Bedier, PHD
Organizational Affiliation
Cairo university, faculty of dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marwa m bedier, phd
Phone
00201006611104
Email
m.bedier81@gmail.com
First Name & Middle Initial & Last Name & Degree
mohamed f marakby, master
Email
elmarakby_200200@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

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