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临床试验/NCT07210814
NCT07210814尚未招募不适用

Pilot Study on the Activity of Commercially Available Mouthwashes Againgst Entamoeba Spp.

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Change in E. gingivalis DNA quantity after using the mouthwash octenident®.

研究概览

简要总结

The amoeba Entamoeba gingivalis colonizes the human oral cavity, where it can actively destroy tissue and cause local inflammation. Currently, there is no standard treatment for E. gingivalis infection. Even during treatment for periodontitis, there is no specific treatment targeting E. gingivalis, although this could significantly improve the effectiveness and long-term results of periodontitis therapy. Octenidine is an antiseptic agent used for disinfecting skin, mucous membranes, and wounds. It is effective against bacteria, fungi, and some viruses. octenident® is a commercially available cosmetic mouthwash containing octenidine as the active ingredient. Its efficacy against Entamoeba spp. will be tested in vitro. Because E. gingivalis is very difficult to cultivate under laboratory conditions, and in vitro testing may not be feasible, the effect of using the mouthwash octenident® (cosmetic product) twice daily for 30 seconds over a 7-day period on the quantity of E. gingivalis will be evaluated in healthy volunteers using quantitative real-time PCR, a technique enabling the comparison of E. gingivalis DNA before and after the use of octenident®.

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

  • Adults aged 18 years or older
  • Able and willing to provide written informed consent
  • Positive identification of Entamoeba gingivalis in oral samples collected during screening, confirmed by specific PCR

排除标准

  • Antibiotic therapy or periodontal treatment within the last 6 months
  • Current orthodontic treatment
  • Underlying systemic diseases (e.g., diabetes mellitus)
  • Autoimmune diseases
  • Acute infections and other conditions requiring medication
  • Pregnancy

结局指标

主要结局

Change in E. gingivalis DNA quantity after using the mouthwash octenident®.

时间窗: 8 days, pre-treatment (day one, first sampling), 7 days using mouthwash, final sampling (day 8)

Quantification of E. gingivalis DNA levels using quantitative polymerase chain reaction (qPCR) before (day 1) and after (day 8) using the mouthwash octenident® twice daily for seven days. Total DNA will be isolated from plaque and saliva samples on day 1 and day 8. The outcome will be reported as the absolute change in E. gingivalis DNA concentration from baseline to post-treatment. A standard curve will be generated using a dilution series of DNA with known concentrations. DNA concentrations in study samples will be interpolated from this curve to assess absolute changes in DNA quantity before and after treatment.

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

Martina Koehsler

Principal Investigator

Medical University of Vienna

研究点 (2)

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