跳至主要内容
临床试验/NCT04243811
NCT04243811撤回不适用

Efficacy of Low Level Laser Therapy in the Management of Injection Pain During Supraperiosteal Anesthesia in Children: A Randomize Clinical Trial

Okan University2 个研究点 分布在 1 个国家开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Face, Legg, Cry, Consolability Scale (FLACC)

研究概览

简要总结

The purpose of this study was to compare the pain during needle insertion and injection in supraperiosteal anesthesia with either topical anesthesia (control) or LLTT (experimental).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • In need of treatment of right and left molar teeth of maxilla,
  • Does not have any systemic disorder,
  • High level of communication that can provide logical answers to the questions we ask
  • With parental consent,
  • Volunteers who want to participate in the research
  • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

排除标准

  • No need for treatment of right and left molar teeth of maxilla,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group

结局指标

主要结局

Face, Legg, Cry, Consolability Scale (FLACC)

时间窗: 1 year

The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain \[Willis et al., 2003\]. Behavioural parameters were recorded.

Wong-Baker Faces Pain Rating Scale (PRS)

时间窗: 1 year

The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").

次要结局

未报告次要终点

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sinem yildirim

Assist. Prof. Dr.

Okan University

研究点 (2)

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