Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

NCT02672384 — Not applicable, Completed, 100 participants, University Hospital, Brest

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RegistryNCT02672384, acronym CP-ICU
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment100 (Actual)
SponsorUniversity Hospital, Brest (Other); collaborators: Bayer
ConditionsChronic Periodontitis, Intensive Care Unit
InterventionsDental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) (Procedure)
Datesstart 2017-01-20, primary completion 2018-10-14, completion 2018-10-14, first posted 2016-02-03, last updated 2018-12-07
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Periodontitis All trials for Intensive Care Unit All trials of Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )

-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)

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
patients in ICUExperimentalProcedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )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.
  • Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) (Procedure): Dental examination Study exams (oral and blood sample collection)

+Outcome measures

Primary outcomes

  • Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera [one day]: P. gingivalis test in saliva and P. gingivalis antibodies in sera

Secondary outcomes

  • Ratio of enrolled patients/eligible patients [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 [90 days]: measure of discrepancies in findings of dental exam and point of care P. gingivalis test combined
  • Mortality at 90 days after intubation [90 days]: Mortality
  • Incidence of CP (Chronic periodontitis) in mechanically ventilated patients [90 days]: CP (Chronic periodontitis) measure
  • Incidence of VAP(Ventilator-Associated Pneumonia) [90 days]: VAP(Ventilator-Associated Pneumonia)
  • Recruitment rate [one year]: Recruitment rate

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Brest, University HospitalBrestFrance