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临床试验/NCT03531970
NCT03531970已完成2 期

Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
success of IAN Block anesthesia for the Dexamethasone group

研究概览

简要总结

The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

详细描述

Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block

研究设计

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

入排标准

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

入选标准

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

排除标准

  • younger than 18 years old
  • history of significant medical conditions
  • allergies to local anesthetics or sulfites
  • pregnancy
  • taking any medications that might influence anesthetic assessment
  • active sites of pathosis in area of injection
  • inability to give informed consent

研究组 & 干预措施

Dexamethasone

Experimental

lidocaine & Dexamethasone

干预措施: Dexamethasone (Drug)

Non-dexamethasone

Placebo Comparator

lidocaine & Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

success of IAN Block anesthesia for the Dexamethasone group

时间窗: 15 minutes after the local anesthetic injection (at time of access cavity preparation)

The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as \>0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.

success of IAN Block anesthesia for the Non-dexamethasone group

时间窗: 15 minutes after the local anesthetic injection (at time of access cavity preparation)

The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as \>0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. A score \>54 mm and \<114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.

次要结局

  • initial pain(Baseline)

研究者

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

Masoud Saatchi, DDS MSc

Professor of Endodontics

Isfahan University of Medical Sciences

研究点 (1)

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