Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

Study Overview
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Brief Summary
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This study evaluates the diagnostic performances of Point of Care P. gingivalis test in saliva with serum IgG P. gingivalis, in reference to dental examination as a gold standard in patients hospitalised in intensive care unit (ICU)

Detailed Description
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Chronic Periodontitis (CP) is a common but under diagnosed chronic infection and inflammation of the periodontal tissue. Porphyromonas gingivalis is one of the most common pathogens associated with CP. In patients hospitalised in Intensive Care Unit (ICU), P. gingivalis has been reported to be associated with Ventilator-Associated Pneumonia (VAP). This pilot study evaluate an easily accessible method the Point of care P. gingivalis tests on saliva and detection of antibodies against P. gingivalis in sera (already validated to diagnose CP in the general population) to dental examination as a gold standard, in ICU patients. A biobank from critically ill patients will be establish for future oral health research in this patient population: for about 50 patients with both samples available, at enrolment and at day 5 +/-2 days after enrolment. Oral pathogens of different sites (tongue, saliva, dental plaque, internal jaw) at enrolment and at day 5 +/- 2 days after enrolment. Samples of periodontal pocket will be collected only for patients diagnosed with CP. When patients will have a pulmonary sample performed in routine, pulmonary sample will also be stored. Plasma and sera will also be taken at enrolment and stored for further research on P. gingivalis and inflammation in ICU patients Patients will be enrolled and will be contacted after 3 months.

Official Title
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Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

Conditions
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Chronic Periodontitis, Intensive Care Unit

Intervention / Treatment
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* Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years or older Admitted to medical or surgical intensive care unit Invasive mechanical ventilation for an anticipated duration of at least 48 hours Exclusion Criteria: Edentulous Known to be pregnant ICU stay<48 hours High risk of infectious endocarditis Patient under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients in ICU<br>Dental examination will be performed to diagnose CP based on the Centre for Diseases Control definition. A point of care P. gingivalis test (Denka Seiken Co (Japan) ) on saliva and detection of antibodies against P. gingivalis in sera will be performed. In case of discrepancies between both diagnoses methods, RT-PCR for identification of P. gingivalis and other pathogens will be performed on samples of periodontal pocket performed in routine. | Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )<br>* Dental examination Study exams (oral and blood sample collection)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera | P. gingivalis test in saliva and P. gingivalis antibodies in sera | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of enrolled patients/eligible patients | compare listing of enrolled patients and eligible patients | one year | 
| Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined | measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined | 90 days | 
| Mortality at 90 days after intubation | Mortality | 90 days | 
| Incidence of CP (Chronic periodontitis) in mechanically ventilated patients | CP (Chronic periodontitis) measure | 90 days | 
| Incidence of VAP(Ventilator-Associated Pneumonia) | VAP(Ventilator-Associated Pneumonia) | 90 days | 
| Recruitment rate | Recruitment rate | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test