Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

NCT07602309 | Not Yet Recruiting Phase 4

• 1 other identifier: RC25_0120
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Halitosis; Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Proportion of patient showing a decrease of 20% of H2S level at 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

  The measurement will be performed at baseline (day 0) and seven days later (day 7)

Interventions

Breath sample collection with Tedlar bags PLV 0.6L and plastic syringe 1cc DIAGNOSTIC_TEST

Patients will be asked to collect their own breath sample with two different devices : Tedlar bag 0.6L and plastic syringe 1cc

Eligibility Criteria

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

You may qualify if:

• Adult subject, male or female
• Subject affiliated with a health insurance system
• Subject able to sign the non-opposition form
• Subject attending a consultation at UF8607 for diagnosis and treatment of a periodontal condition

You may not qualify if:

• \- Subject under legal protection (judicial safeguard)
• Subject under guardianship or curatorship
• Pregnancy or breastfeeding
• Inability to provide the subject with informed information (e.g., emergency situation, comprehension difficulties)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Clinique Dentaire

Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 6700, France

Location

MeSH Terms

Conditions

Halitosis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)