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Recruiting Observational

Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association.

NCT06356246 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-04-30
Last updated
2025-05-14

Condition(s) studied

Cystic Fibrosis

Study summary

Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied.

Today, emerging challenges arise due to the increased life expectancy of CF patients, attributed to the rise of modulators such as Kaftrio®, resulting in an adult-majority population in France. The study of periodontal diseases, associated with oral dysbiosis, becomes relevant as they represent bacterial reservoirs that could impact respiratory complications in CF patients.

To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult patient (\> 18 years old) 2. Cystic fibrosis patient 3. Patient who speaks and understands French well enough to read and understand the study information leaflet. 4. Patient does not object to participation in the study Exclusion Criteria: NA

Primary outcome measure(s)

  • Periodontal Risk Screening Score PESS — 3 months
    The Periodontal Screening Score (PESS) is a simple screening method based on 10 questions that helps identify individuals who may be at risk of periodontitis. It was developped and published by Carra et al in 2018. Score values: 0 up to 13, higher scores mean a worse outcome.

Trial sites (1)

FacilityCityRegionStatus
Marjolaine GOSSET Ivry-sur-Seine Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06356246 on ClinicalTrials.gov ↗ ← All trials in France