Activated MMP-8 as Diagnostic Test for Periodontitis

NCT02280122 | Completed Results

• 1 other identifier: 144/13
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Chronic Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

no intervention provided OTHER

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

periodontally healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Related Publications (1)

• 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.

  PMID: 25841875 RESULT

MeSH Terms

Conditions

Chronic Periodontitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof. Dr. Peter Eickholz
• Organization: JWGUniversity

eickholz@med.uni-frankfurt.de

+49696301

Study Officials

• Peter Eickholz, Dr.

  Johann Wolfgang Goethe-Universität

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. dent.

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: September 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 13, 2015
• Results First Posted: June 4, 2015

Record last verified: 2015-07