Cystic Fibrosis and Periodontal Diseases

NCT06133335 | Unknown

• 1 other identifier: PO23074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The number of CF adults is increasing year after year (61.7% in 2021) confirming that patients are living longer. These data do not leave aside the desire to see CF patients "age well" considering of all the comorbidities linked to aging. Among these comorbidities, the oral repercussions of cystic fibrosis and its treatments remain to this day little investigated. We know, however, that oral health, and periodontal health, is closely linked to general health. Indeed, the oral cavity presents one of the richest microbiota in the body, made up of bacteria, viruses, yeasts and archae organized into a biofilm at the interface of periodontal tissues. Periodontal diseases are partly linked to an imbalance in and loss of diversity within the commensal periodontal flora, aggravated by risk factors such as diabetes, which affects many CF adults. Early detection and treatment of periodontal diseases are therefore of primary interest in patients at increased risk of respiratory infections such as CF patients. This transversal research project aims to study the oral repercussions, notably periodontal disease prevalence in cystic fibrosis (CF) adult patients. Thus, this program will allow, on the one hand, the acquisition of clinical and biological data on periodontal and/or dental pathologies from which adult CF patients may suffer. These data will be accessible through an oral and periodontal clinical examination that will allow the identification of diagnostic clues. The quality of life related to oral health will also be investigated using a self-administered questionnaire. Clinical and biological data commonly recorded in the context of the medical follow-up of CF patients (ventilatory capacity, glycemic status, cytobacteriological examination of sputum, etc.) will also be taken into account in order to study any correlations with periodontal status. On the other hand, on a more fundamental level, this work aims to investigate the impact of CFTR protein dysfunction on the local immunity of the oral cavity and more particularly on the expression of antimicrobial peptides at the level of the periodontium. Thus this project is articulated around a strong axis which is "aging well" for adult CF patients thanks to the improvement of knowledge and ultimately the prevention of comorbidities linked to aging in CF adult patients and particularly those related to oral health.

Conditions

Cystic Fibrosis; Periodontitis; Gingivitis

Keywords

Cystic fibrosis; Periodontitis; gingivitis

Outcome Measures

Primary Outcomes (1)

• Prevalence of periodontal disease

  Periodontal Disease will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Diagnosis will be based on Buccal or lingual Clinical attachment level (CAL), Recession (REC) and Periodontal Pocket Depths (PPD) measurement.

  Day 0

Secondary Outcomes (3)

• Oral Health Quality of Life

  Day 0

• Prevalence of carious lesions

  Day 0

• Level of expression of antimicrobial peptides genes

  Day 0

Study Arms (1)

cystic fibrosis subjects

OTHER

Adult patients with cystic fibrosis consulting the Resource and Competence Center for Cystic Fibrosis at the C.H.U. from Reims

Other: Periodontal examination

Interventions

Periodontal examination OTHER

Periodontal examination is performed using PCP UNC15 periodontal probe (common diagnostic method not added by research). Gingival smear from various points in the oral cavity. This intervention consists in a smear of gingival area with an absorbent paper point into the space between the gum and the tooth (Jourdain et al. 2018). The objective of this technique is to remove the various elements of the periodontal pocket and in particular the desquamated cells.

cystic fibrosis subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients affected by cystic fibrosis consulting the Resource and Competence Center for Cystic Fibrosis of the C.H.U. from Reims
• Patient who signed the consent
• Patient affiliated to the French social security system

You may not qualify if:

• A medical history that could compromise the protocol (psychiatric, medical disorders)
• Cancer
• Pregnancy
• Patients protected by law, minors, adults under guardianship and curatorship, people hospitalized without their consent and not protected by law, or people deprived of their liberty

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Periodontitis; Gingivitis

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; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Central Study Contacts

Anne QUINQUENEL

CONTACT

03 26 78 74 76; aquinquenel@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: July 20, 2023
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

FR (1)