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临床试验/NCT05988359
NCT05988359已完成不适用

Assessment of Aerosol Quantity Generated During Caries Treat-ment With Er:YAG Laser. A Randomized Clinical Trial.

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月28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
60
试验地点
1
主要终点
Aerosols measurment

研究概览

简要总结

Background: Maintaining biosafety in dental practice requires an efficient elimination of aerosols produced during dental treatment. The objective of this research was to assess the quantity of aerosols and aerobic bacteria present in the air during the treatment of caries. Methods: This study was divided into two groups based on the caries treatment method involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a conventional dental turbine W&H Synea TA-98LC (W&H, Bürmoos, Austria), while Group 2 (n=30) received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with 5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming units) before each treatment.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subjects were chosen for the study under the subsequent inclusion criteria: occurrence of medium or profound caries on Black class I, ICDAS 3,4

排除标准

  • Patients with systematic diseases that can influence the treatment of periodontitis
  • Patients under or took antibiotics 2 months.
  • Patients under or took immunosuppressors the last 6 months.
  • Pregnant or lactating woman.

结局指标

主要结局

Aerosols measurment

时间窗: immediately after the procedure

The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).

次要结局

  • Bacteriological study(immediately after the procedure)

研究者

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

Jacek Matys

Principal Investigator

Wroclaw Medical University

研究点 (1)

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