Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis (Malodorix)
Relevance of Using Tedlar Bags for the Remote Evaluation of the Stability of Volatile Sulfur Compounds in Gaseous Samples for the Diagnosis of Halitosis
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Les Hôpitaux Universitaires de Strasbourg
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Strasbourg, Les Hôpitaux Universitaires de Strasbourg, Frankrig, 6700
- Clinique Dentaire
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Ledende efterforsker:
- olivier HUCK, MD
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Kontakt:
- Sarah Hustache, MD
- E-mail: dpidrci@chru-strasbourg.fr
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Ledende efterforsker:
- Pierre-Yves GEGOUT, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
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
Exclusion Criteria:
- - 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of patient showing a decrease of 20% of H2S level at day 7
Tidsramme: The measurement will be performed at baseline (day 0) and seven days later (day 7)
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Analysis of difference in H₂S levels measured in exhaled air between the time of sampling and at 7 days of less than 20% of the baseline value
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The measurement will be performed at baseline (day 0) and seven days later (day 7)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC25_0120
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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