Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mepivacaine
Articaine
Sponsored by
About this trial
This is an interventional prevention trial for Symptomatic Irreversible Pulpitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mepivacaine
Articaine
Arm Description
IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Need for Supplemental anaesthesia
The need for supplemental anaesthesia to complete treatment (Yes/No).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04822415
Brief Title
Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mepivacaine
Arm Type
Experimental
Arm Description
IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
Arm Title
Articaine
Arm Type
Active Comparator
Arm Description
IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Intervention Description
IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
Intervention Type
Drug
Intervention Name(s)
Articaine
Intervention Description
IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
Primary Outcome Measure Information:
Title
Anaesthetic success
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Need for Supplemental anaesthesia
Description
The need for supplemental anaesthesia to complete treatment (Yes/No).
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa ElBoghdadi, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27652697
Citation
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.
Results Reference
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PubMed Identifier
30638269
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.
Results Reference
background
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Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis
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