Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133335
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Brief Title:
Cystic Fibrosis and Periodontal Diseases
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Prevalence of Periodontal Disease in Adult Patients Suffering From Cystic Fibrosis in the University Hospital of Reims a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MucoParo
Brief Summary:
The number of CF adults is increasing year after year 617 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 andor 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
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 andor 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
Detailed Description:
The main objective of this study is to determine the prevalence of periodontal disease in adult CF subjects followed at CRCM of the CHU of Reims Periodontal diseases periodontitis and gingivitis will be diagnosed according to the international classification of periodontal diseases Chicago 2017 Periodontal examination will be performed with periodontal probe PCP UNC15 The diagnosis of periodontal disease is defined from the decision algorithm including measurement of interdental attachment loss CAL measurement of gingival recession REC and depth of vestibular or lingual pocket PPD Tonetti and Sanz 2019The clinical indices noted will therefore include pocket depth on probing gingival recession Ramfjord 1959 periodontal attachment loss CALPPDREC and bleeding index BOP Ainamo and Bay 1975
The secondary objectives are
1 To Investigate an association between the presence of periodontal disease and
the CFTR expression genotype type of mutation
the ventilatory capacity FEV1
the treatments administered and their mode of administration
the value of glycated hemoglobin Hba1c
2 To assess the prevalence of carious lesions in adult cystic fibrosis patients
3 To assess the impact of cystic fibrosis and its treatments on oral health-related quality of life
4 To look for an association between periodontal clinical indices and the level of expression of genes encoding antimicrobial peptides
The secondary objectives are
1 To Investigate an association between the presence of periodontal disease and
the CFTR expression genotype type of mutation
the ventilatory capacity FEV1
the treatments administered and their mode of administration
the value of glycated hemoglobin Hba1c
2 To assess the prevalence of carious lesions in adult cystic fibrosis patients
3 To assess the impact of cystic fibrosis and its treatments on oral health-related quality of life
4 To look for an association between periodontal clinical indices and the level of expression of genes encoding antimicrobial peptides
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None