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临床试验/NCT03725579
NCT03725579Unknown2 期

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

Cairo University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
66
试验地点
1
主要终点
Pain intensity: Numerical rating scale (NRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

mepivacaine hydrochloride

Experimental

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

干预措施: mepivicane hydrochloride (Drug)

mepivacaine hydrochloride

Experimental

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

干预措施: articane hydrochloride (Drug)

articaine hydrochloride

Active Comparator

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

干预措施: mepivicane hydrochloride (Drug)

articaine hydrochloride

Active Comparator

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

干预措施: articane hydrochloride (Drug)

结局指标

主要结局

Pain intensity: Numerical rating scale (NRS)

时间窗: 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 \[score from 7-10\].

次要结局

  • Pain intensity: Numerical rating scale (NRS)(Twenty-five minutes after injection of the anaesthetic solution)
  • The number of patients who need suplemental anesthesia(Fifteen minutes after injection of the anaesthetic solution)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Mahmoud Bedier

Lecturer in Endodontics Département

Cairo University

研究点 (1)

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