Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis
Condition: Periodontitis; Gingivitis; Infertility
MeSH terms: Gingivitis; Periodontitis; Infertility
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): salivary MMP8 test; periodontal examination; blood tests
Intervention type(s): Diagnostic Test; Other; Other
Intervention description(s): All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response; Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.; All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will comprise a total of 100 women, of which 25 fertile women without
        periodontitis; 25 fertile women, with periodontitis; 25 infertile women, with unknown cause
        of infertility and with periodontitis and 25 infertile women with unknown cause of
        infertility and without periodontitis.
      
Biospecimen description: 
      salivary samples for salivary MMP8 test