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临床试验/NCT03186352
NCT03186352Unknown不适用

Clinical Effect of Photoactivated Disinfection on Primary Root Carious Lesions After Partial Caries Removal

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年7月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
elimination of bacteria

研究概览

简要总结

The problem of root caries has been increasing in last decades as the an average life expectancy is rising. Due to progress of medicine and dentistry humans also maintain natural dentition longer.

The aim of the study is to determine the effectiveness of photoactivated disinfection / photodynamic therapy / photodynamic antimicrobial therapy in elimination of cariogenic bacteria after manual root caries removal.

If proved to be effective in eliminating bacteria from prepared cavity PAD could be incorporated in the protocol of treatment of root cavities.

详细描述

Elimination of cariogenic bacteria is to be determined in this study - Mutans streptococci, Lactobacillus spp. and Actinomyces spp.

After manual preparation of the cavity with an excavator and taking a sample for a microbial analysis with a rose bur on micro motor (size 014) the cavity undergoes the procedure of photodynamic disinfection:

  • application of photosensitizer 'Fotosan Agent' (CMS Dental, Denmark) for 5 minutes,
  • radiation with low power laser, wavelength 635 nm power 200mW 120 s. ('Lasotronix', DiodeLX model SMART)
  • rinsing with water and drying

After photodynamic disinfection another sample for microbial analysis is taken form the neighboring area to get the material for a comparison analysis.

Filling the cavity with a material for permanent fillings (glass-ionomer cement)

研究设计

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

入排标准

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

入选标准

  • more than 10 teeth
  • at least one tooth with primary caries lesion with contraindicated non-invasive treatment (lesion which needs to be prepared and filled with material for permanent fillings); tooth with no clinical and/or radiological symptoms of pulp involvement.
  • no systemic disease

排除标准

  • systemic diseases (may affect saliva flow and properties)
  • antibiotic therapy in previous 3 months before the appointment

结局指标

主要结局

elimination of bacteria

时间窗: 7 day

determination of amount of Colony Forming Units per ml

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

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