Chronic Periodontitis, Intensive Care Unit
Conditions
Keywords
Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test
Brief summary
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
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.
Interventions
PROCEDUREDental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )
Dental examination Study exams (oral and blood sample collection)
Sponsors
Bayer
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera | one day | P. gingivalis test in saliva and P. gingivalis antibodies in sera |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined | 90 days | measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined |
| Mortality at 90 days after intubation | 90 days | Mortality |
| Ratio of enrolled patients/eligible patients | one year | compare listing of enrolled patients and eligible patients |
| Incidence of VAP(Ventilator-Associated Pneumonia) | 90 days | VAP(Ventilator-Associated Pneumonia) |
| Recruitment rate | one year | Recruitment rate |
| Incidence of CP (Chronic periodontitis) in mechanically ventilated patients | 90 days | CP (Chronic periodontitis) measure |
Countries
France
Outcome results
None listed