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OpenTrials
Completed

NCT Number: NCT03264846

Endocan Levels at 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of Serum and Saliva Samples

Diagnostic Test

Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.

Primary outcomes

  1. Serum and salivary Endocan levels

    Time frame: one year

    Enzyme-Linked Immunosorbent Assay (ELISA)

  2. Serum and salivary interleukin-6 levels

    Time frame: one year

    Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary outcomes

  1. Clinical attachment level (CAL)

    Time frame: one year

    Periodontal measurement

  2. Probing pocket depth (PD)

    Time frame: one year

    Periodontal measurement

  3. Gingival Index

    Time frame: One year

    Periodontal measurement

Sponsors and collaborators

Lead sponsor

Ebru Saglam

Other

Collaborators

  • Ataturk University

Registry information

Official study title

The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2017
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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