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

NCT06356246 | Recruiting DMC

• 1 other identifier: APHP240363
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Oral quality of life; Periodontal disease; Oral health habits; Dental diseases

Outcome Measures

Primary Outcomes (1)

• Periodontal Risk Screening Score PESS

  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.

  3 months

Secondary Outcomes (4)

• Assess the adherence to good oral hygiene practices and dental follow-up in adult CF patients according to French Union for Oral Health (UFSBD) 2021

  3 months

• Evaluate the risk of dental caries and tooth wear

  3 months

• Assess the oral quality of life

  3 months

• Evaluate oral dryness

  3 months

Eligibility Criteria

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

Study Population

adults with cystic fibrosis treated in France

You may qualify if:

• Adult patient (\> 18 years old)
• Cystic fibrosis patient
• Patient who speaks and understands French well enough to read and understand the study information leaflet.
• Patient does not object to participation in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Vaincre la Mucoviscidose: collaborator

Study Sites (1)

Marjolaine GOSSET

Ivry-sur-Seine, Île-de-France Region, 94270, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Periodontal Diseases; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Mouth Diseases

Central Study Contacts

Marjolaine GOSSET, MD, PhD

CONTACT

+33 (0)1 49 59 48 20; marjolaine.gosset@aphp.fr

Anne Sophie Duflos, Vaincre La Mucoviscidose

CONTACT

+33 (0)1 40 78 91 97; asduflos@vaincrelamuco.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: April 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)