Cystic FibrosisMucoParoNCT06133335
Cystic Fibrosis and Periodontal Diseases
A study testing Periodontal examination in people with Cystic Fibrosis and Periodontitis, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Periodontitis, Gingivitis
- What is being tested?
- Periodontal examination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2023to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Anne QUINQUENEL, 03 26 78 74 76 ext. 0033, aquinquenel@chu-reims.fr
About this study
Official title: Prevalence of Periodontal Disease in Adult Patients Suffering From Cystic Fibrosis in the University Hospital of Reims: a Pilot Study
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.
Read more
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.
Read the 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 2019).The clinical indices noted will therefore include: pocket depth on probing, gingival recession (Ramfjord 1959), periodontal attachment loss (CAL=PPD+REC) and bleeding index (BOP) (Ainamo and Bay 1975).
The secondary objectives are:
- 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%)
- To assess the prevalence of carious lesions in adult cystic fibrosis patients
- To assess the impact of cystic fibrosis and its treatments on oral health-related quality of life.
- To look for an association between periodontal clinical indices and the level of expression of genes encoding antimicrobial peptides
- Conditions
- Cystic Fibrosis, Periodontitis, Gingivitis
- Being tested
- Periodontal examination
- Keywords
- Cystic fibrosis, Periodontitis, gingivitis
- Medical subject headings
- Cystic Fibrosis, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (3)
Oral Health Quality of Life
GOHAI validated in French for general population -Tubert-Jeanin et al., 2003)
Measured: Day 0
Prevalence of carious lesions
Evaluated by ICDAS (International Caries Detection and Assessment Score) (Ismaïl et al., 2007)
Measured: Day 0
Level of expression of antimicrobial peptides genes
Evaluated by ΔΔCt compared to a classically used reference gene
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start20 Jul 2023
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133335
- Sponsor's protocol ID
- PO23074
- Acronym
- MucoParo
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Periodontal Disease in Adult Patients Suffering From Cystic Fibrosis in the University Hospital of Reims: a Pilot Study
- ClinicalTrials.gov ID
- NCT06133335
- Acronym / sponsor ID
- MucoParo / PO23074
- Conditions
- Cystic Fibrosis, Periodontitis, Gingivitis
- Keywords
- Cystic fibrosis, Periodontitis, gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 2019).The clinical indices noted will therefore include: pocket depth on probing, gingival recession (Ramfjord 1959), periodontal attachment loss (CAL=PPD+REC) and bleeding index (BOP) (Ainamo and Bay 1975).
The secondary objectives are:
- 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%)
- To assess the prevalence of carious lesions in adult cystic fibrosis patients
- To assess the impact of cystic fibrosis and its treatments on oral health-related quality of life.
- To look for an association between periodontal clinical indices and the level of expression of genes encoding antimicrobial peptides
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis subjects | Other | Other: Periodontal examinationAdult patients with cystic fibrosis consulting the Resource and Competence Center for Cystic Fibrosis at the C.H.U. from Reims |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal examinationPeriodontal 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. | Other | cystic fibrosis subjects |
Primary outcome
Prevalence of periodontal disease
Time frame: Day 0
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.
3 secondary outcomes
Oral Health Quality of Life
Time frame: Day 0
Prevalence of carious lesions
Time frame: Day 0
Level of expression of antimicrobial peptides genes
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal examination in people with Cystic Fibrosis and Periodontitis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne QUINQUENEL (03 26 78 74 76 ext. 0033, aquinquenel@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of periodontal disease (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.