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Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07602309
Acronym
Malodorix
Enrollment
100
Registered
2026-05-22
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Halitosis, Periodontal Diseases

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBreath 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

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patient showing a decrease of 20% of H2S level at day 7The measurement will be performed at baseline (day 0) and seven days later (day 7)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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026