- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264846
Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation
The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation
Periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. Endocan is a proteoglycan secreted mainly by endothelial cells under the control of inflammatory cytokines.
Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).
Several lines of evidence established the association between periodontal and systemic diseases, including metabolic syndrome, diabetes, and cardiovascular disease.
Because of the fact that both periodontal disease and PCOS are associated with systemic inflammation and insulin resistance, these two disorders may be linked through a common pathophysiologic pathway.
A number of studies have indicated a possible relationship between PCOS and periodontal inflammation. Despite common risk factors, including oxidative stress, the relationship between chronic periodontitis (CP) and PCOS remains unclear.
The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to evaluate the correlation between these two biomarker in women with periodontal disease and PCOS.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Eyalet/Yerleşke
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İstanbul, Eyalet/Yerleşke, Turkey, 34668
- Ebru Sağlam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Exclusion Criteria:
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
- Using antibiotics and antiinflammatory within the past 6 months
- Periodontal treatment within the past 6 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
PCOS participants with periodontitis
|
Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
|
|
Group 2
PCOS participants with periodontally healthy
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Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
|
|
Group 3
systemically healthy participants with periodontitis
|
Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
|
|
Group 4
systemically and periodontally healthy participants
|
Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum and salivary Endocan levels
Time Frame: one year
|
Enzyme-Linked Immunosorbent Assay (ELISA)
|
one year
|
|
Serum and salivary interleukin-6 levels
Time Frame: one year
|
Enzyme-Linked Immunosorbent Assay (ELISA)
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical attachment level (CAL)
Time Frame: one year
|
Periodontal measurement
|
one year
|
|
Probing pocket depth (PD)
Time Frame: one year
|
Periodontal measurement
|
one year
|
|
Gingival Index
Time Frame: One year
|
Periodontal measurement
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ebru Sağlam, PhD, Bezmialem Vakif University
- Principal Investigator: Ayşe Toraman, Ataturk University
- Principal Investigator: Engin Şebin, Erzurum Regional Training and Research Hospital
- Study Chair: Cenk Fatih Çanakçı, Professor, Ataturk University
- Principal Investigator: Hümeyra Çanakçı, Dr, Private Practice
- Study Director: Metin İngeç, Professor, Ataturk University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EbSAGLAM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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