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临床试验/NCT04430387
NCT04430387撤回不适用

Evaluation of Impact on Environmental Spatter Using Different Isolation Methods During Hygiene Appointment Among Pediatric Patients

The University of Texas Health Science Center, Houston0 个研究点开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry

研究概览

简要总结

The purpose of this study is to collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry, to compare the effectiveness of aerosol reduction between these methods, to identify the most effective way to manage aerosol during dental prophylaxis for pediatric patients and to provide clinical evidence to facilitate practice guidelines in dentistry related to COVID-19.

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 (Outcomes Assessor)

盲法说明

The assessor will be blind to group assignment of the patients

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA 1 patients
  • Receiving dental prophylaxis or restorative procedure not requiring sedation or nitrous oxide
  • Ability to cooperate in the dental chair
  • Parents speak/read either English or Spanish and consent to study
  • Child, when age appropriate, can assent to study

排除标准

  • Patients that do not meet the above criteria (including inability to cooperate or special health care need)
  • Parents that do not speak/read either English or Spanish
  • Children that do not assent (when age appropriate) to the study

结局指标

主要结局

To collect, measure, and assess the environmental spatter produced during dental appointments under different isolation methods used in pediatric dentistry

时间窗: Through case completion, an average a year

The image of the spots of fluorescence from the spatter collected will be captured using a digital camera (Nikon D3100, Nikon, Tokyo, Japan) with an amber-colored lens cover. The image will be processed by a digital imaging software, ImageJ (National Institutes of Health, the Laboratory for Optical and Computational Instrumentation, University of Wisconsin) to get the number of the spots on each mask and film. The number of fluorescent spots is recorded to determine the amount of spatter produced.

次要结局

未报告次要终点

研究者

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

Di Wu, DDS MS PhD

Assistant Professor

The University of Texas Health Science Center, Houston

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