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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Halitosis
• Intervention / Treatment: Other: Gaseous sampling:

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
H2S measurement	Analysis will be made at Day 0 and Day 7

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Estimated): July 2, 2024

Study Record Updates

• Last Update Posted (Estimated): July 2, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: 9359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No