Chronic Periodontitis in Critically Ill Patients: Diagnosis and Epidemiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Edentulous
- •Known to be pregnant
- •ICU stay<48 hours
- •High risk of infectious endocarditis
- •Patient under guardianship
研究组 & 干预措施
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.
干预措施: Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) ) (Procedure)
结局指标
主要结局
Result (positive/negative) of the point-of-care P. gingivalis test in saliva and P. gingivalis antibodies in sera
时间窗: one day
P. gingivalis test in saliva and P. gingivalis antibodies in sera
次要结局
- Recruitment rate(one year)
- Incidence of CP (Chronic periodontitis) in mechanically ventilated patients(90 days)
- Incidence of VAP(Ventilator-Associated Pneumonia)(90 days)
- 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)
- Ratio of enrolled patients/eligible patients(one year)