Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

February 7, 2020 updated by: Ebru Saglam

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

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Eyalet/Yerleşke
      • İstanbul, Eyalet/Yerleşke, Turkey, 34668
        • Ebru Sağlam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All participants were included among women at the Department of Obstetrics and Gynecology, School of Medicine and Department of Periodontology, Faculty of Dentistry , Ataturk University

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
one year

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2017

Primary Completion (ACTUAL)

November 29, 2017

Study Completion (ACTUAL)

November 29, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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