Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)
研究概览
简要总结
Background: Untreated periodontal disease may influence general health. However, how may a physician who is not trained in periodontal probing detect untreated periodontitis? Activated matrix metalloproteinase-8 (aMMP-8) in saliva correlates with periodontal probing parameters. Thus, sensitivity and specificity of a chair-side test for activated matrix metalloproteinase-8 to detect periodontitis was evaluated.
Methods: Thirty cases (untreated chronic periodontitis; 15 generalized moderate and 15 generalized severe) and 30 controls (probing pocket depths ≤ 3 mm, vertical probing attachment level ≤ 2 mm at < 30% of sites) were examined periodontally. Further, the activated matrix metalloproteinase-8 test was performed. The test kit becomes positive with ≥ 25 ng/ml activated matrix metalloproteinase-8 in the sample.
详细描述
.The hypotheses behind this study were:
- The aMMP-8 test discriminates between individuals with and without untreated generalized chronic periodontitis
Thus, sensitivity and specificity of a chair-side test for activated matrix metalloproteinase-8 to distinguish between individuals with and without untreated chronic periodontitis as well as between patients with generalized moderate and generalized severe ChP was evaluated.
Patients
A commercially available chair side test to detect increased levels of activated matrix metalloproteinase-8 was used at Dr. Matthias Mayer's dental office (Arndtstr. 14, 60325 Frankfurt am Main) in periodontally healthy individuals and patients with untreated generalized moderate chronic periodontitis (mChP) and generalized severe chronic Periodontitis (sChP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least18 years of age
- •Clinical diagnosis of generalized moderate or generalized severe ChP
- •At least 5 teeth present per quadrant
- •After application to the ethics committee: written informed consent
排除标准
- •Requirement of systemic antibiotics for measures that may cause transitory bacteraemia (e.g. pocket probing)
- •Nonsurgical or surgical periodontal treatment within the last 12 months prior to PerioMarker® test
- •Systemic or topical subgingival antibiotics within the last 6 months prior to PerioMarker® test
- •Anti-inflammatory medication (e.g. non-steroidal anti-inflammatory drugs) during the last 3 months prior to PerioMarker® test
结局指标
主要结局
Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)
时间窗: 5 minutes
First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit \[21\]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.
次要结局
未报告次要终点
研究者
Peter Eickholz
Prof. Dr. med. dent.
Goethe University