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临床试验/NCT04822415
NCT04822415已完成不适用

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

Cairo University0 个研究点目标入组 330 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
330
主要终点
Anaesthetic success

研究概览

简要总结

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.

详细描述

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.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 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 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.

排除标准

  • 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.

研究组 & 干预措施

Mepivacaine

Experimental

IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.

干预措施: Mepivacaine (Drug)

Articaine

Active Comparator

IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.

干预措施: Articaine (Drug)

结局指标

主要结局

Anaesthetic success

时间窗: Intraoperative

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.

次要结局

  • Need for Supplemental anaesthesia(Intraoperative)

研究者

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

Suzan AW Amin

Professor

Cairo University

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