Activated MMP-8 as Diagnostic Test for Periodontitis (MMP-8)
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|ClinicalTrials.gov Identifier: NCT02280122|
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : June 4, 2015
Last Update Posted : July 13, 2015
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.
|Condition or disease||Intervention/treatment|
|Generalized Chronic Periodontitis||Other: no intervention provided|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
gen. mod. to sev. chronic periodontitis
Other: no intervention provided
No Intervention was rendered but the aMMP-8 test was made
- Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity) [ Time Frame: 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 . 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280122
|Study Chair:||Peter Eickholz, Dr.||Johann Wolfgang Goethe-Universität|