Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

Chronic Periodontitis Clinical Trial

— CP-ICU  

Official title:

Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672384
• Other study ID #: CP-ICU STUDY (RB 15.108)
• Status: Completed
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: October 14, 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 14, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Critical Illness
• Intensive Care Unit
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
France	Brest, University Hospital	Brest

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Bayer

Country where clinical trial is conducted

France, 

Outcome

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