Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology (CP-ICU)

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)

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Intensive Care Unit
• Intervention / Treatment: Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Brest, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of enrolled patients/eligible patients	compare listing of enrolled patients and eligible patients	one year
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	90 days
Mortality at 90 days after intubation	Mortality	90 days
Incidence of CP (Chronic periodontitis) in mechanically ventilated patients	CP (Chronic periodontitis) measure	90 days
Incidence of VAP(Ventilator-Associated Pneumonia)	VAP(Ventilator-Associated Pneumonia)	90 days
Recruitment rate	Recruitment rate	one year

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2017
• Primary Completion (ACTUAL): October 14, 2018
• Study Completion (ACTUAL): October 14, 2018

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (ESTIMATE): February 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Intensive care unit; Chronic periodontitis; Invasive mechanical ventilation; Point of Care P. gingivalis test
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: CP-ICU STUDY (RB 15.108)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No