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NCT Number: NCT06483646

Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Gaseous sampling:

Other

the subject is asked to aspirate the gaseous contents of his oral cavity using a 1ml plastic syringe.

Primary outcomes

  1. H2S measurement

    Time frame: Analysis will be made at Day 0 and Day 7

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Evaluation of the Stability of Volatile Sulfur Compounds in Gas Samples for Halitosis Diagnosis

Acronym: HALITOSIX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Aug 6, 2025

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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