PeriodontitisNCT03542630
Evaluation of Matrix Metalloproteinase 8 Salivary Test for Diagnosis of Periodontitis
An observational study of Periodontitis and Gingivitis, run by University of Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Infertility
- What is being tested?
- salivary MMP8 test, periodontal examination and blood tests
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2018to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- female with known cause of infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Gingivitis, Infertility
- Being tested
- salivary MMP8 test, periodontal examination, blood tests
- Medical subject headings
- Periodontitis, Gingivitis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary MMP8 testDiagnostic test
All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response
periodontal examinationOther
Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.
blood testsOther
All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: salivary MMP8 test; Other: periodontal examination; Other: 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 Receives: Diagnostic Test: salivary MMP8 test; Other: periodontal examination; Other: 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 Receives: Diagnostic Test: salivary MMP8 test; Other: periodontal examination; Other: 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 Receives: Diagnostic Test: salivary MMP8 test; Other: periodontal examination; Other: blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary MMP8 test for diagnostics of periodontitis
Evaluation of salivary MMP8 test for diagnostics of periodontitis
Measured: 2018-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jan 2018
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
- Investigators
- Božana Lončar Brzak, Assist.Prof., Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542630
- Sponsor's protocol ID
- University of Zagreb
- Status last verified
- Sep 2021
- First submitted
- 18 May 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12828663Hart 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.
PubMed 22362927Kraft-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.
PubMed 21958332
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Matrix Metalloproteinase 8 Salivary Test for Periodontal Diagnosis in Infertile Women
- ClinicalTrials.gov ID
- NCT03542630
- Acronym / sponsor ID
- University of Zagreb
- Conditions
- Periodontitis, Gingivitis, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fertile, without periodontitis | – | Diagnostic Test: salivary MMP8 test, Other: periodontal examination, Other: blood testsWomen 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 | – | Diagnostic Test: salivary MMP8 test, Other: periodontal examination, Other: blood testsWomen 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 | – | Diagnostic Test: salivary MMP8 test, Other: periodontal examination, Other: blood testsWomen 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 | – | Diagnostic Test: salivary MMP8 test, Other: periodontal examination, Other: blood testsWomen who are diagnosed with infertility of unknown cause, and who do have periodontitis. Interventions: salivary MMP8 test; periodontal examination; blood tests |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- female with known cause of infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary MMP8 testAll female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response | Diagnostic test | fertile, with periodontitis, fertile, without periodontitis, infertile, with periodontitis, infertile, without periodontitis |
| periodontal examinationPeriodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror. | Other | fertile, with periodontitis, fertile, without periodontitis, infertile, with periodontitis, infertile, without periodontitis |
| blood testsAll female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters. | Other | fertile, with periodontitis, fertile, without periodontitis, infertile, with periodontitis, infertile, without periodontitis |
Primary outcome
Salivary MMP8 test for diagnostics of periodontitis
Time frame: 2018-2019
Evaluation of salivary MMP8 test for diagnostics of periodontitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 12828663Mantyla 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.
- Background: PubMed 22362927Hart 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.
- Background: PubMed 21958332Kraft-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.
- related informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Božana Lončar Brzak, Assist.Prof. principal investigator
University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Gingivitis, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary MMP8 test for diagnostics of periodontitis (time frame: 2018-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542630, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.