Generalized Chronic PeriodontitisMMP-8NCT02280122
Activated MMP-8 as Diagnostic Test for Periodontitis
An observational study of Generalized Chronic Periodontitis, run by Goethe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Chronic Periodontitis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Periodontally healthy individuals and patients with untreated generalized moderate and generalized severe ChP from a German dental Office in Frankfurt/Main
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study
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.
Read the 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.
- Conditions
- Generalized Chronic Periodontitis
- Being tested
- no intervention provided
- Keywords
- activated matrix metalloproteinase 8, untreated moderate/severe chronic periodontitis, saliva, sensitivity/specificity
- Medical subject headings
- Chronic Periodontitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention providedOther
No Intervention was rendered but the aMMP-8 test was made
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: no intervention provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Eickholz, Goethe University
- Investigators
- Peter Eickholz, Dr., Study chair, Johann Wolfgang Goethe-Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280122
- Sponsor's protocol ID
- 144/13
- Acronym
- MMP-8
- Status last verified
- Jul 2015
- First submitted
- 29 Oct 2014
- Last updated
- 13 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25841875
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activated Matrix Metalloproteinase 8 (aMMP-8) in Saliva as Diagnostic Test for Periodontal Disease? A Case-control Study
- ClinicalTrials.gov ID
- NCT02280122
- Acronym / sponsor ID
- MMP-8 / 144/13
- Conditions
- Generalized Chronic Periodontitis
- Keywords
- activated matrix metalloproteinase 8, untreated moderate/severe chronic periodontitis, saliva, sensitivity/specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 4 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontally healthy individuals and patients with untreated generalized moderate and generalized severe ChP from a German dental Office in Frankfurt/Main
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention providedNo Intervention was rendered but the aMMP-8 test was made | Other | periodontally healthy |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25841875Izadi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Eickholz, Dr. study chair
Johann Wolfgang Goethe-Universität
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Chronic Periodontitis, run by Goethe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.