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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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University Hospital, Brest

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)

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Ratio of enrolled patients/eligible patients [ Time Frame: one year ]
    compare listing of enrolled patients and eligible patients

  2. 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

  3. Mortality at 90 days after intubation [ Time Frame: 90 days ]
    Mortality

  4. Incidence of CP (Chronic periodontitis) in mechanically ventilated patients [ Time Frame: 90 days ]
    CP (Chronic periodontitis) measure

  5. Incidence of VAP(Ventilator-Associated Pneumonia) [ Time Frame: 90 days ]
    VAP(Ventilator-Associated Pneumonia)

  6. Recruitment rate [ Time Frame: one year ]
    Recruitment rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
Brest, University Hospital
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
Bayer

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02672384     History of Changes
Other Study ID Numbers: CP-ICU STUDY (RB 15.108)
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
Intensive care unit
Invasive mechanical ventilation
Chronic periodontitis
Point of Care P. gingivalis test

Additional relevant MeSH terms:
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Critical Illness
Periodontitis
Chronic Periodontitis
Disease Attributes
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases