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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
Sponsor:
Information provided by (Responsible Party):
Peter Eickholz, Goethe University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
gen. mod. to sev. chronic periodontitis
  • Sites with probing pocket depths (PPD) ≥ 3.5 mm
  • Attachment loss (PAL-V) ≥ 3 mm > 30% of sites
  • no Intervention provided
periodontally healthy
  • 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
Other: no intervention provided
No Intervention was rendered but the aMMP-8 test was made




Primary Outcome Measures :
  1. 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 [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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Periodontally healthy individuals and patients with untreated generalized moderate and generalized severe ChP from a German dental Office in Frankfurt/Main
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280122


Sponsors and Collaborators
Goethe University
Investigators
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Study Chair: Peter Eickholz, Dr. Johann Wolfgang Goethe-Universität
Publications of Results:
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Responsible Party: Peter Eickholz, Prof. Dr. med. dent., Goethe University
ClinicalTrials.gov Identifier: NCT02280122    
Other Study ID Numbers: 144/13
First Posted: October 31, 2014    Key Record Dates
Results First Posted: June 4, 2015
Last Update Posted: July 13, 2015
Last Verified: July 2015
Keywords provided by Peter Eickholz, Goethe University:
activated matrix metalloproteinase 8
untreated moderate/severe chronic periodontitis
saliva
sensitivity/specificity
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases