Chronic PeriodontitisCP-ICUNCT02672384
Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
A study testing Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) in people with Chronic Periodontitis and Intensive Care Unit, run by University Hospital, Brest at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis, Intensive Care Unit
- What is being tested?
- Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2017to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Edentulous
- Known to be pregnant
- ICU stay<48 hours
- High risk of infectious endocarditis
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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
- Being tested
- Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )
- Keywords
- Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )Procedure or surgery
Dental examination Study exams (oral and blood sample collection)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
- gingivalis test in saliva and P. gingivalis antibodies in sera
Measured: one day
Secondary outcomes (6)
Ratio of enrolled patients/eligible patients
compare listing of enrolled patients and eligible patients
Measured: 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
Measured: 90 days
Mortality at 90 days after intubation
Mortality
Measured: 90 days
Incidence of CP (Chronic periodontitis) in mechanically ventilated patients
CP (Chronic periodontitis) measure
Measured: 90 days
Incidence of VAP(Ventilator-Associated Pneumonia)
VAP(Ventilator-Associated Pneumonia)
Measured: 90 days
Recruitment rate
Recruitment rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start20 Jan 2017
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672384
- Sponsor's protocol ID
- CP-ICU STUDY (RB 15.108)
- Acronym
- CP-ICU
- Status last verified
- Dec 2018
- First submitted
- 18 Sep 2015
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
- ClinicalTrials.gov ID
- NCT02672384
- Acronym / sponsor ID
- CP-ICU / CP-ICU STUDY (RB 15.108)
- Conditions
- Chronic Periodontitis, Intensive Care Unit
- Keywords
- Intensive care unit, Invasive mechanical ventilation, Chronic periodontitis, Point of Care P. gingivalis test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients in ICU | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Edentulous
- Known to be pregnant
- ICU stay<48 hours
- High risk of infectious endocarditis
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )Dental examination Study exams (oral and blood sample collection) | Procedure or surgery | patients in ICU |
Primary outcome
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
Time frame: one day
P. gingivalis test in saliva and P. gingivalis antibodies in sera
6 secondary outcomes
Ratio of enrolled patients/eligible patients
Time frame: one year
Number of patient with discrepancies in findings of dental exam and point of care P. gingivalis test combined
Time frame: 90 days
Mortality at 90 days after intubation
Time frame: 90 days
Incidence of CP (Chronic periodontitis) in mechanically ventilated patients
Time frame: 90 days
Incidence of VAP(Ventilator-Associated Pneumonia)
Time frame: 90 days
Recruitment rate
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) in people with Chronic Periodontitis and Intensive Care Unit, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.