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临床试验/NCT03942991
NCT03942991Unknown不适用

Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study

Cairo University0 个研究点目标入组 20 人开始时间: 2019年9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
入组人数
20
主要终点
Intra-Operative Pain during Extraction

研究概览

简要总结

parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.

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

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-8 years.
  • Medically fit (ASA I, II).
  • Mentally capable of communication.
  • Having a mandibular first primary molar tooth that require Extraction.
  • Child must give assent prior to participation, as well as parental informed written consent.
  • Body weight >20 kg.
  • it should be the first dental treatment to the child

排除标准

  • Medically and mentally compromised children.
  • Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
  • History of significant behavior management problems.
  • Patients having active sites of pathosis in the area of injection.
  • Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
  • Patients allergic to Articaine and/or Mepivacaine and/or sulfur

研究组 & 干预措施

4% Artpharmadent

Experimental

infiltration injection of 4% Articaine

干预措施: articaine (Drug)

2% Mepecaine-L

Active Comparator

infiltration injection of 2% Mepivacaine

干预措施: Mepivacaine 2% Injection (Drug)

结局指标

主要结局

Intra-Operative Pain during Extraction

时间窗: Immediatly after etxraction

intraoperative pain will be measured using wong baker pain scale,The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain Face

次要结局

未报告次要终点

研究者

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

Nadeen Hossam Eldin Hosny Ahmed

Principal Investigator

Cairo University

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