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Activated MMP-8 as Diagnostic Test for Periodontitis

Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02280122
Acronym
MMP-8
Enrollment
60
Registered
2014-10-31
Start date
2012-09-30
Completion date
2014-02-28
Last updated
2015-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Chronic Periodontitis

Keywords

activated matrix metalloproteinase 8, untreated moderate/severe chronic periodontitis, saliva, sensitivity/specificity

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.

Detailed description

.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). The companies had provided 70 tests for use. During use the idea arose to retrospectively correlate test results and clinical diagnoses. Thus, a study protocol was submitted to the ethics committee of the Medical Faculty of the Johann Wolfgang Goethe-University Frankfurt/Main. All patients that were examined prior to the vote of the ethics committee were evaluated retrospectively. All following patients were recruited prospectively. All patients were asked about current smoking (yes/no) and education level (basic school, high school, university). The study complied with the rules of the Declaration of Helsinki and was approved by the Institutional Review Board for Human Studies of the Medical Faculty of the Goethe-University Frankfurt/Main (Application# 144/13). Chair side test For all periodontitis patients the activated matrix metalloproteinase-8 test was performed at least 24 hours after clinical examination. For periodontally healthy controls the test was done within a week after clinical examination. First of 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 taken up 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 activated matrix metalloproteinase-8 per ml). All test results were photographed with 2fold magnification. Statistical analysis The patient was looked upon as statistical unit. The sensitivity and specificity of the aMMP-8 test was defined as the main outcome variables. All other parameters were control variables. For all individuals, cigarette pack years were calculated. Group frequencies were expressed for sex, current smoking, education, and activated matrix metalloproteinase-8 (positive/negative). Group means and standard deviations were calculated for age and bleeding on probing. Further, for each individual the following variables were calculated to describe the periodontal status. Comparisons between groups for dichotomous parameters were made by χ² or Fisher's exact test and for all other parameters by Kruskal-Wallis and Mann-Whitney-U test. Using backward stepwise logistic regression analysis, factors should be identified that were associated with positive activated matrix metalloproteinase-8 tests.

Interventions

No Intervention was rendered but the aMMP-8 test was made

Sponsors

Goethe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)5 minutesFirst 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.

Participant flow

Participants by arm

ArmCount
Generalised Moderate to Severe Chronic Periodontitis
* Sites with probing pocket depths (PPD) ≥ 3.5 mm * Attachment loss (PAL-V) ≥ 3 mm \> 30% of sites * no Intervention provided no intervention provided: No Intervention was rendered but the aMMP-8 test was made
30
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 no intervention provided: No Intervention was rendered but the aMMP-8 test was made
30
Total60

Baseline characteristics

CharacteristicGeneralised Moderate to Severe Chronic PeriodontitisPeriodontally HealthyTotal
Age, Continuous53.9 years
STANDARD_DEVIATION 10.7
28.4 years
STANDARD_DEVIATION 7.9
41.2 years
STANDARD_DEVIATION 15.9
Region of Enrollment
Germany
30 participants30 participants60 participants
Sex: Female, Male
Female
14 Participants20 Participants34 Participants
Sex: Female, Male
Male
16 Participants10 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

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.

Time frame: 5 minutes

ArmMeasureValue (NUMBER)
Sensitivity: Generalised Moderate/Severe Chronic PeriodontitisPercentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)87 percentage of true cases (sens./spec.)
Specificity: Periodontally HealthyPercentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)60 percentage of true cases (sens./spec.)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026