跳至主要内容
临床试验/NCT04215055
NCT04215055Unknown不适用

Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe in Decreasing Children Pain and Anxiety Perception During Local Anesthetic Injection ) Randomized Controlled Clinical Trial (

Cairo University0 个研究点目标入组 46 人开始时间: 2020年2月8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
Pain rating scale

研究概览

简要总结

The study will be conducted to evaluate the effect of the vibration assisted syringe on pain perception and anxiety in children during intra oral injection of local anesthesia in comparison with conventional syringe.

详细描述

As for granted the main concern in pediatric dentistry is to guarantee a positive response from child for any further appointments, that's why we aim to manage a successful dental procedure keeping a stress free situation. Conventional local anesthetic technique is the most commonly used technique for anesthetizing teeth but in turn it has shown the highest levels of discomfort in comparison with other techniques. VibraJect is vibration associated syringe device, it is simple and cost effective solution to alleviate injection discomfort. It works because the light pressure of a Vibraject injection is carried rapidly to the brain by thicker insulated nerve tissues. In contrast, the needle prick travels on thinner nerve tissues, arriving too late for the brain to register the sensation. Vibraject is good news for the patient, because the anesthetic itself causes virtually no discomfort and good news for the dentist, who can work easily knowing that patient, is comfortable.

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
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Medically compromised patients.
  • Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia.
  • Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
  • Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.

结局指标

主要结局

Pain rating scale

时间窗: baseline

Visual linear analogue scale

次要结局

  • anxiety(baseline)

研究者

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

Mohamed Abdallah Mohamed Abdallah

dentist

Cairo University

相似试验