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Completed

NCT Number: NCT03542630

Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis

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.

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Key information

Age range

25 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

salivary MMP8 test

Diagnostic Test

All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response

periodontal examination

Other

Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.

Blood tests

Other

All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.

Primary outcomes

  1. Salivary MMP8 test for diagnostics of periodontitis

    Time frame: 2018-2019

    Evaluation of salivary MMP8 test for diagnostics of periodontitis

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 31, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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