Clinical trial NCT02672384: Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
Official title: Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Intensive Care Unit
Keywords: Intensive care unit
Invasive mechanical ventilation
Chronic periodontitis
Point of Care P. gingivalis test
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
timeFrame: one day
Secondary outcomes:
measure: Ratio of enrolled patients/eligible patients
timeFrame: one year
measure: Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined
timeFrame: 90 days
measure: Mortality at 90 days after intubation
timeFrame: 90 days
measure: Incidence of CP (Chronic periodontitis) in mechanically ventilated patients
timeFrame: 90 days
measure: Incidence of VAP(Ventilator-Associated Pneumonia)
timeFrame: 90 days
measure: Recruitment rate
timeFrame: one year
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest, University Hospital
Study officials:
References: