Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association.
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT06356246
- Status
- Recruiting
Conditions
- Cystic Fibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Apr 10, 2024
- Start date
- Apr 30, 2025
- Status verified
- May 2025
- Primary completion
- Jul 30, 2025
- Completion
- Jul 31, 2025
Study Design
- Enrollment
- 400 participants (estimated)
Primary Outcome Measure
Periodontal Risk Screening Score PESS [ Time Frame: 3 months ]
Central Contacts
- Marjolaine GOSSET, MD, PhD+33 (0)1 49 59 48 20
- Anne Sophie Duflos, Vaincre La Mucoviscidose+33 (0)1 40 78 91 97
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