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临床试验/NCT02726737
NCT02726737已完成3 期

Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in the Mandibular First Molar With Symptomatic Irreversible Pulpitis: a Prospective, Randomized Double-blind Study

Masoud Saatchi1 个研究点 分布在 1 个国家目标入组 100 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
3 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis

研究概览

简要总结

The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic

详细描述

Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

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

sodium bicarbonate

Experimental

0.7 mL of 8.4% sodium bicarbonate & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

干预措施: sodium bicarbonate (Drug)

sodium bicarbonate

Experimental

0.7 mL of 8.4% sodium bicarbonate & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

干预措施: Lidocaine (Drug)

Non-sodium bicarbonate

Active Comparator

Sterile distilled water & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

干预措施: Lidocaine (Drug)

Non-sodium bicarbonate

Active Comparator

Sterile distilled water & 0.3 mL of 2% lidocaine with 1:100,000 epinephrine

干预措施: sterile distilled water (Drug)

结局指标

主要结局

success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis

时间窗: Baseline

次要结局

  • Heft-Parker visual analog scale recording of pain(Baseline)

研究者

发起方
Masoud Saatchi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Masoud Saatchi

Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences

Isfahan University of Medical Sciences

研究点 (1)

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