HalitosisMalodorixNCT07602309
Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis
A study testing Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc in people with Halitosis and Periodontal Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Halitosis, Periodontal Diseases
- What is being tested?
- Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique Dentaire
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 6700
Sarah Hustache, MD, dpidrci@chru-strasbourg.fr
Pierre-Yves GEGOUT, MD
About this study
Official 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
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.
- Conditions
- Halitosis, Periodontal Diseases
- Being tested
- Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc
- Medical subject headings
- Halitosis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1ccDiagnostic test
Patients will be asked to collect their own breath sample with two different devices :
Tedlar bag 0.6L and plastic syringe 1cc
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The measurement will be performed at baseline (day 0) and seven days later (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602309
- Sponsor's protocol ID
- RC25_0120
- Acronym
- Malodorix
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07602309
- Acronym / sponsor ID
- Malodorix / RC25_0120
- Conditions
- Halitosis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1ccPatients will be asked to collect their own breath sample with two different devices : Tedlar bag 0.6L and plastic syringe 1cc | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc in people with Halitosis and Periodontal Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.