HalitosisHALITOSIXNCT06483646
Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air for Halitosis Diagnosis
A study testing Gaseous sampling: in people with Halitosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Halitosis or bad breath is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Halitosis
- What is being tested?
- Gaseous sampling:
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, male or female
- Subject affiliated with a social health insurance plan
- Able to understand the objectives and risks of the research and to give dated and signed informed consent
- Subject presenting for consultation for diagnosis and treatment of periodontal pathology
Who cannot join
- Subject under safeguard of justice
- Subject under guardianship or curatorship
- Pregnancy or breast-feeding
- Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
- Subject currently included in another clinical research protocol or in an exclusion period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Stability of Volatile Sulfur Compounds in Gas Samples for Halitosis Diagnosis
Halitosis or bad breath is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. In addition, a measurement of volatile sulfur compounds (VSC), the main molecules involved in bad breath, is necessary. This is done during the consultation by measuring the concentration of VSCs in exhaled air. However, few private practices or hospitals have the necessary equipment to measure VSC. As a result, patients are often obliged to travel long distances to obtain a consultation including this specific VSC analysis. The aim of this study is to evaluate the stability of VSC values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. The clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.
- Conditions
- Halitosis
- Being tested
- Gaseous sampling:
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaseous sampling:Other
the subject is asked to aspirate the gaseous contents of his oral cavity using a 1ml plastic syringe.
What is being measured
The primary outcome is the main question the study is designed to answer.
H2S measurement
Measured: Analysis will be made at Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
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 (actual)
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
- NCT06483646
- Sponsor's protocol ID
- 9359
- Acronym
- HALITOSIX
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2024
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stability of Volatile Sulfur Compounds in Gas Samples for Halitosis Diagnosis
- ClinicalTrials.gov ID
- NCT06483646
- Acronym / sponsor ID
- HALITOSIX / 9359
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 3 Jul 2024 (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 is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. In addition, a measurement of volatile sulfur compounds (VSC), the main molecules involved in bad breath, is necessary. This is done during the consultation by measuring the concentration of VSCs in exhaled air. However, few private practices or hospitals have the necessary equipment to measure VSC. As a result, patients are often obliged to travel long distances to obtain a consultation including this specific VSC analysis. The aim of this study is to evaluate the stability of VSC values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. The clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.
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, male or female
- Subject affiliated with a social health insurance plan
- Able to understand the objectives and risks of the research and to give dated and signed informed consent
- Subject presenting for consultation for diagnosis and treatment of periodontal pathology
Key exclusion criteria (5 listed)
- Subject under safeguard of justice
- Subject under guardianship or curatorship
- Pregnancy or breast-feeding
- Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
- Subject currently included 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 |
|---|---|---|
| Gaseous sampling:the subject is asked to aspirate the gaseous contents of his oral cavity using a 1ml plastic syringe. | Other | – |
Primary outcome
H2S measurement
Time frame: Analysis will be made at Day 0 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaseous sampling: in people with Halitosis, 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: finished, as of the sponsor's last update on 19 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H2S measurement (time frame: Analysis will be made at Day 0 and 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 19 Aug 2026.