A Phase 2/3 interventional study of mepivicane hydrochloride and articane hydrochloride in Symptomatic Irreversible Pulpitis, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-11-01.
Sponsored by Cairo University · Phase 2/3, Interventional, and Prevention
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.
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's planned enrollment of 66 is close to the median of 62 across 275 interventional studies indexed under Pulpitis.
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Exclusion Criteria:
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 · Drug: articane 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 · Drug: articane hydrochloride
Pain will be assessed during access cavity preparation and instrumentation
Also known as: mepivicane
Pain will be assessed during access cavity preparation and instrumentation
Also known as: articane
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 \[score from 7-10\].
Time frame: Fifteen minutes after injection of the anaesthetic solution
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 \[score from 7-10\].
Time frame: Twenty-five minutes after injection of the anaesthetic solution
The number of patients who need suplemental anesthesia
counting the number of the number of patients who need suplemental anesthesia
Time frame: Fifteen minutes after injection of the anaesthetic solution
Plan to share: Undecided
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Cairo University