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临床试验/NCT05899296
NCT05899296已完成不适用

Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe (A Randomized Clinical Trial)

Duaa Kamal Naji2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
pain perception

研究概览

简要总结

The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia:

  1. Pain perception.
  2. Pain related behaviors.
  3. Dental anxiety
  4. Anesthetic efficiency.
  5. Patient acceptance and preference

详细描述

The prevalent phobia of needles and the associated rise in dental anxiety when using the traditional needle method of LA infiltration, the development of needle-free alternatives for local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new gadget that promises less pain administration of local anesthetic without the use of a hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for intraligmentary injection without penetrating the periodontal ligament. This study was performed due to the lack of sufficient research on NumBee and since it meets a number of exceptional criteria, including being able to anesthetize just one tooth without having to do so for the entire alveolar dental nerve and having a needleless design that may be more appealing to children than the distressing appearance of traditional dental syringes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
Single (Participant)

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

  • Patients with American Society of Anesthesiologists-1(ASA 1) health status (A completely healthy fit patient).
  • Not mentally retarded patient.
  • Cooperative patient, as determined by a behavioral rating of "positive" or "definitely positive" according to the Frankle behavior classification scale.
  • Without a history of dental visits.

排除标准

  • Mentally and medically compromised child.
  • Patient on medication that effect on the pain perception.
  • History of allergy to L.A.

结局指标

主要结局

pain perception

时间窗: five months

checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment

次要结局

未报告次要终点

研究者

发起方
Duaa Kamal Naji
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Duaa Kamal Naji

Bachelor of dental surgery

University of Baghdad

研究点 (2)

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