Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis

Completed

• Conditions: Gingivitis; Infertility; Periodontitis
• Interventions: Diagnostic Test: salivary MMP8 test; Other: periodontal examination; Other: blood tests

• Registration Number: NCT03542630
• Lead Sponsor: University of Zagreb

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fertile, without periodontitis	periodontal examination	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
infertile, with periodontitis	salivary MMP8 test	Women who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests
infertile, with periodontitis	periodontal examination	Women who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests
fertile, with periodontitis	salivary MMP8 test	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
fertile, with periodontitis	blood tests	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
infertile, without periodontitis	salivary MMP8 test	Women who are diagnosed with infertility of unknown cause, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination;blood tests
infertile, without periodontitis	periodontal examination	Women who are diagnosed with infertility of unknown cause, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination;blood tests
infertile, without periodontitis	blood tests	Women who are diagnosed with infertility of unknown cause, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination;blood tests
fertile, without periodontitis	salivary MMP8 test	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
fertile, without periodontitis	blood tests	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
fertile, with periodontitis	periodontal examination	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
infertile, with periodontitis	blood tests	Women who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests

Primary Outcome Measures

Name	Time	Method
Salivary MMP8 test for diagnostics of periodontitis	2018-2019	Evaluation of salivary MMP8 test for diagnostics of periodontitis

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia