Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc
  Patients will be asked to collect their own breath sample with two different devices : Tedlar bag 0.6L and plastic syringe 1cc

Первичные конечные точки

• Proportion of patient showing a decrease of 20% of H2S level at day 7 [Срок оценки: The measurement will be performed at baseline (day 0) and seven days later (day 7)]

Критерии участия

Критерии включения

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

Критерии исключения

• \- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Clinique Dentaire — Strasbourg

Идентификаторы

NCT: NCT07602309 · RC25_0120

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗