Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

NCT ID: NCT02672384

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2018-10-14

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.

Conditions

Chronic Periodontitis; Intensive Care Unit

Keywords

Intensive care unit; Invasive mechanical ventilation; Chronic periodontitis; Point of Care P. gingivalis test

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Dental examination Study exams (oral and blood sample collection)

Interventions

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

Dental examination Study exams (oral and blood sample collection)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brest, University Hospital

Brest, , France

Countries

France

Other Identifiers

CP-ICU STUDY (RB 15.108)

Identifier Type: -

Identifier Source: org_study_id