Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis
September 28, 2021 updated by: Božana Lončar Brzak, University of Zagreb
Evaluation of Matrix Metalloproteinase 8 Salivary Test for Periodontal Diagnosis in Infertile Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zagreb, Croatia, 10000
- School of Dental Medicine, University of Zagreb
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
fertile, without periodontitis
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 |
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.
|
|
fertile, with periodontitis
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 |
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.
|
|
infertile, without periodontitis
Women who are diagnosed with infertility of unknown cause, and who do not have periodontitis. Interventions: salivary MMP8 test; periodontal examination;blood tests |
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.
|
|
infertile, with periodontitis
Women who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary MMP8 test for diagnostics of periodontitis
Time Frame: 2018-2019
|
Evaluation of salivary MMP8 test for diagnostics of periodontitis
|
2018-2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Božana Lončar Brzak, Assist.Prof., University of Zagreb School of Dental Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mantyla P, Stenman M, Kinane DF, Tikanoja S, Luoto H, Salo T, Sorsa T. Gingival crevicular fluid collagenase-2 (MMP-8) test stick for chair-side monitoring of periodontitis. J Periodontal Res. 2003 Aug;38(4):436-9. doi: 10.1034/j.1600-0765.2003.00677.x.
- Hart R, Doherty DA, Pennell CE, Newnham IA, Newnham JP. Periodontal disease: a potential modifiable risk factor limiting conception. Hum Reprod. 2012 May;27(5):1332-42. doi: 10.1093/humrep/des034. Epub 2012 Feb 22.
- Kraft-Neumarker M, Lorenz K, Koch R, Hoffmann T, Mantyla P, Sorsa T, Netuschil L. Full-mouth profile of active MMP-8 in periodontitis patients. J Periodontal Res. 2012 Feb;47(1):121-8. doi: 10.1111/j.1600-0765.2011.01416.x. Epub 2011 Sep 30.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Zagreb
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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