Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology (CP-ICU)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Intensive Care Unit; Chronic Periodontitis

Treatments: Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02672384

CP-ICU STUDY (RB 15.108)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

patients in ICU

Experimental group

Description:

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.

Treatment:

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