NCT02280122|CompletedResults
Activated MMP-8 as Diagnostic Test for Periodontitis
MMP-8
Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study
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MMP-8
Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study
Sponsor study identifier
observational
60
0 countries
N/A
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Actual (reported)February 2014
Actual (reported)October 29, 2014
Actual (reported)October 31, 2014
Actual (reported)June 4, 2015
Actual (reported)Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)
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.
5 minutes
* Sites with probing pocket depths (PPD) ≥ 3.5 mm * Attachment loss (PAL-V) ≥ 3 mm \> 30% of sites * no Intervention provided
* PPD ≤ 3 mm * PAL-V ≤ 2 mm at \< 30% of sites * BOP \< 20% * No radiographically detectable bone loss: distance cemento-enamel junction to provided * no Intervention but aMMP-8 test
No Intervention was rendered but the aMMP-8 test was made
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Periodontally healthy individuals and patients with untreated generalized moderate and generalized severe ChP from a German dental Office in Frankfurt/Main
Izadi Borujeni S, Mayer M, Eickholz P. Activated matrix metalloproteinase-8 in saliva as diagnostic test for periodontal disease? A case-control study. Med Microbiol Immunol. 2015 Dec;204(6):665-72. doi: 10.1007/s00430-015-0413-2. Epub 2015 Apr 5.
The aMMP-8 test is sensitive to distinguish untreated periodontally diseased from healthy individuals. However, this study does not provide information how clearly the test may distinguish between gingivitis and untreated chronic periodontitis.
Peter Eickholz, Dr.
Johann Wolfgang Goethe-Universität
60 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Contact the study team to confirm eligibility.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)Last Updated
July 13, 2015
Results First Posted
June 4, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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