Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis

Study Overview
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Brief Summary
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Despite the great progress in understanding the causes of infertility, the reason for the failure of pregnancy has not been discovered among 25% of infertile couples. Some studies have shown the negative impact of periodontal disease on the reproductive potential of women. It is known that there is an elevated level of matrix metalloproteinase 8 (MMP8) in the gingival fluid of patients with periodontitis. It is possible to establish a fast diagnosis of periodontitis by using a non-invasive assay based on monoclonal antibodies to two epitopes of MMP-8. The goal of the research is to use the above described assay in order to compare the level of MMP8 in the gingival fluid of infertile patients with the control group of fertile women, depending on the existence of periodontal disease. It is expected to find significantly higher values of MMP8 in infertile patients in relation to the fertile patient with/without periodontitis. The prompt treatment of periodontitis in preconception care of this group of women could have a significant impact on the improvement of fertility and ability to achieve pregnancy.

Detailed Description
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Periodontal disease or periodontitis is a common chronic infection and inflammatory gingival disease and its supportive tissue associated with several unwanted effects, including serious obstetric consequences. Periodontitis is commonly diagnosed in clinical practice based on clinical findings and radiological examinations, but also with the help of microbiological or periodontal bacterial specimens. Several salivary markers have been investigated and it appears that the determination of matrix metalloproteinases provides clear information on the difference between gingivitis, periodontitis, and healthy periodontitis. Especially in this respect, matrix metalloproteinase 8 (MMP 8) was investigated, which proved to be a fairly good marker. Little is known about the effect of periodontitis on reproductive potential of women. Some studies have assumed that periodontitis could be one of the possible risk factors of infertility of an unknown cause. One of the possible mechanisms responsible for the negative influence of periodontitis is the conception of the mediator of inflammation at the level of the endometrium and the place of implantation of the embryo.The aim of the study was to compare the level of MMP8 in salivary fluid in infertile patients in relation to the control group of fertile women, depending on the existence of periodontitis.

Official Title
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Evaluation of Matrix Metalloproteinase 8 Salivary Test for Periodontal Diagnosis in Infertile Women

Conditions
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Periodontitis, Gingivitis, Infertility

Intervention / Treatment
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* Diagnostic Test: salivary MMP8 test
* Other: periodontal examination
* Other: blood tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fertile women- women who gave birth to at least one child, without previous fertility treatments, with or without periodontitis infertile women- women who are diagnosed with infertility of unknown cause, with or without periodontitis Exclusion Criteria: female with known cause of infertility

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fertile, without periodontitis<br>Women who gave birth to at least one child, without preovious fertility treatments, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests | Diagnostic Test: salivary MMP8 test<br>* All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response<br>Other: periodontal examination<br>* Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.<br>Other: blood tests<br>* All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.<br>|
| fertile, with periodontitis<br>Women who gave birth to at least one child, without preovious fertility treatments, and who do have periodontitis. Interventions: salivary MMP8 test;periodontal examination;blood tests | Diagnostic Test: salivary MMP8 test<br>* All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response<br>Other: periodontal examination<br>* Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.<br>Other: blood tests<br>* All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.<br>|
| infertile, without periodontitis<br>Women who are diagnosed with infertility of unknown cause, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination;blood tests | Diagnostic Test: salivary MMP8 test<br>* All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response<br>Other: periodontal examination<br>* Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.<br>Other: blood tests<br>* All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.<br>|
| infertile, with periodontitis<br>Women who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests | Diagnostic Test: salivary MMP8 test<br>* All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response<br>Other: periodontal examination<br>* Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.<br>Other: blood tests<br>* All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary MMP8 test for diagnostics of periodontitis | Evaluation of salivary MMP8 test for diagnostics of periodontitis | 2018-2019 |