NCT06356246 Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association.
| NCT ID | NCT06356246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2025-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-04-30 with a primary completion date of 2025-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06356246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06356246 currently recruiting?
Yes, NCT06356246 is actively recruiting participants. Contact the research team at marjolaine.gosset@aphp.fr for enrollment information.
Where is the NCT06356246 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France.
Who is sponsoring the NCT06356246 clinical trial?
NCT06356246 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 400 participants.