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临床试验/NCT05239078
NCT05239078已完成不适用

Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study

Dr. Vivek Aggarwal0 个研究点目标入组 120 人开始时间: 2016年3月1日最近更新:
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
120
主要终点
Anesthetic Success

研究概览

简要总结

Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • active pain in a mandibular molar
  • prolonged response to cold testing with an ice stick and an electric pulp tester
  • absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
  • vital coronal pulp on access opening and ability to understand the use of pain scales

排除标准

  • known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
  • history of active peptic ulcer within the preceding 12 months
  • history of bleeding problems or anticoagulant use within the last month
  • patients who were pregnant or breast-feeding
  • a history of known or suspected drug abuse
  • patients who had taken NSAIDs within 12 h before administration of the study drugs

研究组 & 干预措施

Inferior Alveolar nerve block with 2% lidocaine with epinephrine

Active Comparator

An inferior alveolar nerve block was given with 2% lidocaine with epinephrine

干预措施: local anaesthetic injection (Drug)

Inferior Alveolar nerve block with 4% articaine with epinephrine

Experimental

An inferior alveolar nerve block was given with 4% articaine with epinephrine

干预措施: local anaesthetic injection (Drug)

Inferior Alveolar nerve block with 3% plain mepivacaine

Experimental

An inferior alveolar nerve block was given with 3% plain mepivacaine

干预措施: local anaesthetic injection (Drug)

结局指标

主要结局

Anesthetic Success

时间窗: 15 minutes after the inferior alveolar nerve block

Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.

次要结局

未报告次要终点

研究者

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

Dr. Vivek Aggarwal

Professor

Jamia Millia Islamia

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