Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air for Halitosis Diagnosis

NCT06483646 | Recruiting

• 1 other identifier: 9359
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• H2S measurement

  Analysis will be made at Day 0 and Day 7

Interventions

Gaseous sampling: OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Clinique dentaire

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)