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临床试验/NCT04303234
NCT04303234Unknown不适用

Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 46 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
主要终点
Intraoperative Pain: Wong Baker rating scale

研究概览

简要总结

The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

详细描述

Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.

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
Single (Participant)

盲法说明

single ( participant ) because the two interventions used in this trial are easily recognized by the investigator but the participant and the statistician will be blinded.

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 8-10 years old
  • Mentally capable of communication
  • Cooperative children need restorative treatment

排除标准

  • Medically compromised patient
  • Primary teeth requiring pulpotomy or pulpectomy
  • Parent or guardians who refuse participating in the study

结局指标

主要结局

Intraoperative Pain: Wong Baker rating scale

时间窗: During the procedure.

Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.

次要结局

  • Time of numbness disappear(2 hours postoperatively after the procedure.)
  • Onset of anesthesia(Immediately after the injection.)
  • The sensation after injection(Immediately after the injection.)

研究者

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

Amani Hamed Hashem AL-Aidaros

Principle Investigator

Cairo University

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