Brest, University Hospital
Brest, 29200, France
NCT Number: NCT02672384
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)
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Brest, 29200, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dental examination Study exams (oral and blood sample collection)
Time frame: one day
P. gingivalis test in saliva and P. gingivalis antibodies in sera
Time frame: one year
compare listing of enrolled patients and eligible patients
Time frame: 90 days
measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined
Time frame: 90 days
Mortality
Time frame: 90 days
CP (Chronic periodontitis) measure
Time frame: 90 days
VAP(Ventilator-Associated Pneumonia)
Time frame: one year
Recruitment rate
University Hospital, Brest
Other
Acronym: CP-ICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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