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临床试验/NCT05473858
NCT05473858招募中3 期

Comparative Study of the Effect of Diode Laser and Oraverse on Reversing the Effect of Articaine 4% Soft Tissue Anasthesia in Children

sara nabil1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年12月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
36
试验地点
1
主要终点
reversal of local anasthesia

研究概览

简要总结

clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

详细描述

Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into:

subgroup 1: Articaine 4% with 1:100000 epinephrin &Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
  • Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -

排除标准

  • 未提供

研究组 & 干预措施

laser group

Experimental

Patients will be undergoing anesthesia revision by diode laser

干预措施: diode laser (Device)

Control group

Experimental

Patient exposed to anaesthesia only

干预措施: Anaesthesia only (Other)

oraverse group

Experimental

Patients will be undergoing anesthesia revision by oraverse

干预措施: OraVerse Injectable Product (Drug)

结局指标

主要结局

reversal of local anasthesia

时间窗: 30 minute

patient free of lip numbness

次要结局

未报告次要终点

研究者

发起方
sara nabil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

sara nabil

Lecturer of pediatric dentistry

Al-Azhar University

研究点 (1)

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