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Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum

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ClinicalTrials.gov Identifier: NCT03516565
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Veli Özgen Öztürk, Aydin Adnan Menderes University

Study Description
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Brief 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

Condition or disease Intervention/treatment
Pregnancy Other: Saliva collection Other: GCF collection

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
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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Modulation of Matrix Metalloproteinases-8, -9 and Endogenous Tissue Inhibitor-1 in Oral Biofluids During Pregnancy and Postpartum
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : October 15, 2014
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnancy group
Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)
 Other: Saliva collection
Other: GCF collection
Postpartum group
Postpartum group included women, who were evaluated 6 months after giving birth
 Other: Saliva collection
Other: GCF collection
Non-pregnant group
Women who were systemically healthy and non-pregnant.
 Other: Saliva collection
Other: GCF collection


Outcome Measures
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Primary Outcome Measures :
  1. Changing MMP-8 levels [ Time Frame: 6 months ]
    Salivary and GCF level measured by IFMA

  2. Changing MMP-9 levels [ Time Frame: 6 months ]
    Salivary and GCF level measured by ELISA

  3. Changing TIMP-1 levels [ Time Frame: 6 months ]
    Salivary and GCF level measured by ELISA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All women were systemically healthy
Criteria

Inclusion Criteria:

  • Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)

Exclusion Criteria:

  • (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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Veli Özgen Öztürk, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03516565    
Other Study ID Numbers: BAP-18
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veli Özgen Öztürk, Aydin Adnan Menderes University:
gingivitis
saliva
gingival crevicular fluid