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Completed

NCT Number: NCT02672384

Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest, University Hospital

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Dental examination Study exams (oral and blood sample collection)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Bayer

Registry information

Acronym: CP-ICU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2016
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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