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NCT Number: NCT07602309

Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Dentaire

Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 6700, France

Location contact

Pierre-Yves GEGOUT, MD

PRINCIPAL_INVESTIGATOR

Sarah Hustache, MD

CONTACT

[email protected]

olivier HUCK, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc

Diagnostic Test

Patients will be asked to collect their own breath sample with two different devices :

Tedlar bag 0.6L and plastic syringe 1cc

Primary outcomes

  1. Proportion of patient showing a decrease of 20% of H2S level at day 7

    Time frame: The 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: Malodorix

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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