N/A
Completed N=60
Activated MMP-8 as Diagnostic Test for Periodontitis
Generalized Chronic Periodontitis
Source: ClinicalTrials.gov NCT02280122 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity) — 87; 60 percentage of true cases (sens./spec.)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity) |
87; 60 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02280122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.