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临床试验/NCT07602309
NCT07602309尚未招募不适用

Relevance of Using Tedlar Bags for the Remote Evaluation of the Stability of Volatile Sulfur Compounds in Gaseous Samples for the Diagnosis of Halitosis

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Halitosis, or bad breath, affects about 30% of people worldwide and is most often caused by oral diseases such as periodontitis. To diagnose it, dentists usually perform a clinical examination and measure specific gases in the breath called volatile sulfur compounds (VSCs), which are responsible for bad odor. However, the equipment needed for this analysis is not widely available, forcing many patients to travel long distances. This study aims to determine whether breath samples can be collected and analyzed later, making remote diagnosis possible. Specifically, it evaluates whether the levels of these gases remain stable for up to 7 days after collection, with a variation of less than 20% considered acceptable. To do this, 100 adult patients with periodontal conditions will be included in a single-center study.

During a single visit, patients will provide breath samples by exhaling into a special Tedlar bag and a syringe, which will then be analyzed immediately and again after 7 days using a device called OralChroma. Afull periodontal examination will also be performed, and patient information such as age and risk factors will be collected. The study will also examine how gas levels change over time and whether they are linked to gum disease. If the results confirm that the samples remain stable, this approach could allow patients to collect their breath at home and receive a diagnosis remotely, reducing the need for travel and improving access to care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Adult subject, male or female
  • Subject affiliated with a health insurance system
  • Subject able to sign the non-opposition form
  • Subject attending a consultation at UF8607 for diagnosis and treatment of a periodontal condition

排除标准

  • - Subject under legal protection (judicial safeguard)
  • Subject under guardianship or curatorship
  • Pregnancy or breastfeeding
  • Inability to provide the subject with informed information (e.g., emergency situation, comprehension difficulties)
  • Subject currently enrolled in another clinical research protocol or in an exclusion period

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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