Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedSeptember 29, 2021
September 1, 2021
3.3 years
May 18, 2018
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Salivary MMP8 test for diagnostics of periodontitis
Evaluation of salivary MMP8 test for diagnostics of periodontitis
2018-2019
Study Arms (4)
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
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
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
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- female with known cause of infertility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dental Medicine, University of Zagreb
Zagreb, 10000, Croatia
Related Publications (3)
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.
PMID: 12828663BACKGROUNDHart 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.
PMID: 22362927BACKGROUNDKraft-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.
PMID: 21958332BACKGROUND
Related Links
Biospecimen
salivary samples for salivary MMP8 test
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Božana Lončar Brzak, Assist.Prof.
University of Zagreb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asisstant Professor
Study Record Dates
First Submitted
May 18, 2018
First Posted
May 31, 2018
Study Start
January 1, 2018
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share