NCT02672384

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

January 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

September 18, 2015

Last Update Submit

December 6, 2018

Conditions

Chronic PeriodontitisIntensive Care Unit

Keywords

Intensive care unitInvasive mechanical ventilationChronic periodontitisPoint of Care P. gingivalis test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Ratio of enrolled patients/eligible patients

    one year

  • Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined

    90 days

  • Mortality at 90 days after intubation

    90 days

  • Incidence of CP (Chronic periodontitis) in mechanically ventilated patients

    90 days

  • Incidence of VAP(Ventilator-Associated Pneumonia)

    90 days

  • +1 more secondary outcomes

Study Arms (1)

patients in ICU

EXPERIMENTAL

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) )

Interventions

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

Dental examination Study exams (oral and blood sample collection)

patients in ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Edentulous
  • Known to be pregnant
  • ICU stay\<48 hours
  • High risk of infectious endocarditis
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brest, University Hospital

Brest, 29200, France

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

February 3, 2016

Study Start

January 20, 2017

Primary Completion

October 14, 2018

Study Completion

October 14, 2018

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations

FR(1)