Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology (CP-ICU)
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|ClinicalTrials.gov Identifier: NCT02672384|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis Intensive Care Unit||Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology|
|Actual Study Start Date :||January 20, 2017|
|Actual Primary Completion Date :||October 14, 2018|
|Actual Study Completion Date :||October 14, 2018|
Experimental: patients in ICU
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) )
Dental examination Study exams (oral and blood sample collection)
- Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera [ Time Frame: one day ]P. gingivalis test in saliva and P. gingivalis antibodies in sera
- Ratio of enrolled patients/eligible patients [ Time Frame: one year ]compare listing of enrolled patients and eligible patients
- Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined [ Time Frame: 90 days ]measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined
- Mortality at 90 days after intubation [ Time Frame: 90 days ]Mortality
- Incidence of CP (Chronic periodontitis) in mechanically ventilated patients [ Time Frame: 90 days ]CP (Chronic periodontitis) measure
- Incidence of VAP(Ventilator-Associated Pneumonia) [ Time Frame: 90 days ]VAP(Ventilator-Associated Pneumonia)
- Recruitment rate [ Time Frame: one year ]Recruitment rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672384
|Brest, University Hospital|
|Brest, France, 29200|