Clinique Dentaire
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 6700, France
Location contact
Pierre-Yves GEGOUT, MD
PRINCIPAL_INVESTIGATOR
Sarah Hustache, MD
CONTACT
olivier HUCK, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07602309
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 6700, France
Pierre-Yves GEGOUT, MD
PRINCIPAL_INVESTIGATOR
Sarah Hustache, MD
CONTACT
olivier HUCK, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult subject, male or female
Exclusion criteria
Patients will be asked to collect their own breath sample with two different devices :
Tedlar bag 0.6L and plastic syringe 1cc
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
University Hospital, Strasbourg, France
Other
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
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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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