Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology (CP-ICU)
Primary Purpose
Chronic Periodontitis, Intensive Care Unit
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Periodontitis focused on measuring Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test
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
Sites / Locations
- Brest, University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients in ICU
Arm 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.
Outcomes
Primary Outcome Measures
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
P. gingivalis test in saliva and P. gingivalis antibodies in sera
Secondary Outcome Measures
Ratio of enrolled patients/eligible patients
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
measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined
Mortality at 90 days after intubation
Mortality
Incidence of CP (Chronic periodontitis) in mechanically ventilated patients
CP (Chronic periodontitis) measure
Incidence of VAP(Ventilator-Associated Pneumonia)
VAP(Ventilator-Associated Pneumonia)
Recruitment rate
Recruitment rate
Full Information
NCT ID
NCT02672384
First Posted
September 18, 2015
Last Updated
December 6, 2018
Sponsor
University Hospital, Brest
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT02672384
Brief Title
Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
Acronym
CP-ICU
Official Title
Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
October 14, 2018 (Actual)
Study Completion Date
October 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Intensive Care Unit
Keywords
Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients in ICU
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )
Intervention Description
Dental examination Study exams (oral and blood sample collection)
Primary Outcome Measure Information:
Title
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
Description
P. gingivalis test in saliva and P. gingivalis antibodies in sera
Time Frame
one day
Secondary Outcome Measure Information:
Title
Ratio of enrolled patients/eligible patients
Description
compare listing of enrolled patients and eligible patients
Time Frame
one year
Title
Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined
Description
measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined
Time Frame
90 days
Title
Mortality at 90 days after intubation
Description
Mortality
Time Frame
90 days
Title
Incidence of CP (Chronic periodontitis) in mechanically ventilated patients
Description
CP (Chronic periodontitis) measure
Time Frame
90 days
Title
Incidence of VAP(Ventilator-Associated Pneumonia)
Description
VAP(Ventilator-Associated Pneumonia)
Time Frame
90 days
Title
Recruitment rate
Description
Recruitment rate
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Brest, University Hospital
City
Brest
ZIP/Postal Code
29200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
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