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Not yet recruitingNCT07602309MalodorixUpdated Jun 3, 2026

Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

An interventional study of Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc in Halitosis and Periodontal Diseases, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Halitosis
  • Periodontal Diseases
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In context

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's planned enrollment of 100 is above the median of 45 across 79 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

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

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What researchers measure

Primary outcomes

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

    Time frame: The measurement will be performed at baseline (day 0) and seven days later (day 7)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07602309
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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