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临床试验/NCT06119139
NCT06119139尚未招募不适用

Anesthetic Efficacy of 1.8 ml Compared to 3.6 ml of Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 70 人开始时间: 2023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
尚未招募
入组人数
70
主要终点
Anesthetic success

研究概览

简要总结

The aim of the study is to compare the anesthetic efficacy and need for supplemental anesthesia of 1.8 ml compared to 3.6 ml of 4% articaine buccal infiltration in mandibular molars with symptomatic irreversible pulpitis.

详细描述

Patients with moderate-to-severe pain due to symptomatic irreversible pulpitis will be included. Patients will be randomly assigned into two groups to receive either 1.8 ml 4% articaine buccal infiltration or 3.6. ml 4% articaine buccal infiltration before single visit root canal treatments. Intraoperative pain will be assessed using an 11-point numerical rating scale (NRS) so that anesthetic success will be defined as no to mild intraoperative pain. The need for supplemental anesthesia will also be 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists (ASA class I or II).
  • No sex predilection
  • Patients with symptomatic irreversible pulpitis
  • Patient with the ability to understand and use pain scales.
  • Patients who accept to enroll in the study.

排除标准

  • Patients' allergies to any of the drugs or materials used in the study.
  • Pregnant and lactating females.
  • Patients taking analgesics in the last 6-8 hours.
  • Patients having more than one symptomatic tooth in the same quadrant

研究组 & 干预措施

1.8 ml 4% articaine buccal infiltration.

Active Comparator

干预措施: 1.8 ml 4% Articaine hydrochloride (Drug)

3.6 ml 4% articaine buccal infiltration

Experimental

干预措施: 3.6 ml 4% Articaine hydrochloride (Drug)

结局指标

主要结局

Anesthetic success

时间窗: During the procedure

Will be measured by 11-point numerical rating scale NRS. The success will be defined as no or mild pain (NRS 0 or less than 3) and the failure will be defined as moderate to severe pain (NRS more than 3).

次要结局

  • Need for supplemental anesthesia(During the procedure)

研究者

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

Hebatullah Moheb Ibrahim

Principle investigator

Cairo University

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