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Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

Phase 2
Conditions
Symptomatic Irreversible Pulpitis
Interventions
Drug: mepivicane hydrochloride
Drug: articane hydrochloride
Registration Number
NCT03725579
Lead Sponsor
Cairo University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
66
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
articaine hydrochloridearticane hydrochloride4 % 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
mepivacaine hydrochloridemepivicane hydrochloride2% 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
mepivacaine hydrochloridearticane hydrochloride2% 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
articaine hydrochloridemepivicane hydrochloride4 % 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
Primary Outcome Measures
NameTimeMethod
Pain intensity: Numerical rating scale (NRS)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 \[score from 7-10\].

Secondary Outcome Measures
NameTimeMethod
Pain intensity: Numerical rating scale (NRS)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 \[score from 7-10\].

The number of patients who need suplemental anesthesiaFifteen minutes after injection of the anaesthetic solution

counting the number of the number of patients who need suplemental anesthesia

Trial Locations

Locations (1)

Faculty of Dentistry

🇪🇬

Cairo, Egypt

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