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临床试验/NCT04181099
NCT04181099已完成不适用

Influence of Different Zirconia Surface Treatments on Biofilm Formation

University of Basel2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Safranin Staining

研究概览

简要总结

The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • No systematic antibiotic therapy during the last 3 months
  • Good oral health and compliance (PI and BI <20%)
  • No sign of parodontal disease or other inflammatory changes in the mouth
  • Non-smoker

排除标准

  • Disease that requires antibiotic therapy
  • Pressure marks due to the orthodontic apparatus that can not be eliminated
  • Other unexpected complications that could be related to the orthodontic apparatus

结局指标

主要结局

Safranin Staining

时间窗: 3 months

The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer

次要结局

  • SEM(3 months)

研究者

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

Nadja Rohr

Principal Investigator

University of Basel

研究点 (2)

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