PregnancyNCT03516565
Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum
An observational study of Pregnancy, run by Aydin Adnan Menderes University.
Trial summary
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Saliva collection and GCF collection
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 1 Sep 2015
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women were systemically healthy
Who may be able to join
- Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)
Who cannot join
- (a) any known systemic disease, (b) periodontal treatment within the last six months, (c) patients having less than 10 teeth, (d) smokers and (e) individuals with BMI > 30 kg/m2
About this study
Official title: Modulation of Matrix Metalloproteinases-8, -9 and Endogenous Tissue Inhibitor-1 in Oral Biofluids During Pregnancy and Postpartum
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery
Read the detailed description
MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. The balance between tissue inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the integrity of healthy periodontium.
- Conditions
- Pregnancy
- Being tested
- Saliva collection, GCF collection
- Keywords
- gingivitis, saliva, gingival crevicular fluid
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
GCF collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy group | Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34) Receives: Other: Saliva collection; Other: GCF collection | |
| Postpartum group | Postpartum group included women, who were evaluated 6 months after giving birth Receives: Other: Saliva collection; Other: GCF collection | |
| Non-pregnant group | Women who were systemically healthy and non-pregnant. Receives: Other: Saliva collection; Other: GCF collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing MMP-8 levels
Salivary and GCF level measured by IFMA
Measured: 6 months
Changing MMP-9 levels
Salivary and GCF level measured by ELISA
Measured: 6 months
Changing TIMP-1 levels
Salivary and GCF level measured by ELISA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Apr 2013
- Primary completion15 Oct 2014
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Özgen Öztürk, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516565
- Sponsor's protocol ID
- BAP-18
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Matrix Metalloproteinases-8, -9 and Endogenous Tissue Inhibitor-1 in Oral Biofluids During Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT03516565
- Acronym / sponsor ID
- BAP-18
- Conditions
- Pregnancy
- Keywords
- gingivitis, saliva, gingival crevicular fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 15 Oct 2014 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 4 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.
The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery
Detailed description
MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. The balance between tissue inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the integrity of healthy periodontium.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnancy group | – | Other: Saliva collection, Other: GCF collectionPregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34) |
| Postpartum group | – | Other: Saliva collection, Other: GCF collectionPostpartum group included women, who were evaluated 6 months after giving birth |
| Non-pregnant group | – | Other: Saliva collection, Other: GCF collectionWomen who were systemically healthy and non-pregnant. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women were systemically healthy
Key inclusion criteria (1 listed)
- Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)
Key exclusion criteria (1 listed)
- (a) any known systemic disease, (b) periodontal treatment within the last six months, (c) patients having less than 10 teeth, (d) smokers and (e) individuals with BMI > 30 kg/m2
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 |
|---|---|---|
| Saliva collection | Other | Non-pregnant group, Postpartum group, Pregnancy group |
| GCF collection | Other | Non-pregnant group, Postpartum group, Pregnancy group |
Primary outcome
Changing MMP-8 levels
Time frame: 6 months
Salivary and GCF level measured by IFMA
Changing MMP-9 levels
Time frame: 6 months
Salivary and GCF level measured by ELISA
Changing TIMP-1 levels
Time frame: 6 months
Salivary and GCF level measured by ELISA
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 4 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Aydin Adnan Menderes University.
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 1 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Changing MMP-8 levels (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2018.