Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

NCT03264846 | Completed

• 1 other identifier: EbSAGLAM1
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Inflammation Gum; Cytokines

Outcome Measures

Primary Outcomes (2)

• Serum and salivary Endocan levels

  Enzyme-Linked Immunosorbent Assay (ELISA)

  one year

• Serum and salivary interleukin-6 levels

  Enzyme-Linked Immunosorbent Assay (ELISA)

  one year

Secondary Outcomes (3)

• Clinical attachment level (CAL)

  one year

• Probing pocket depth (PD)

  one year

• Gingival Index

  One year

Study Arms (4)

Group 1

PCOS participants with periodontitis

Diagnostic Test: Collection of Serum and Saliva Samples

Group 2

PCOS participants with periodontally healthy

Diagnostic Test: Collection of Serum and Saliva Samples

Group 3

systemically healthy participants with periodontitis

Diagnostic Test: Collection of Serum and Saliva Samples

Group 4

systemically and periodontally healthy participants

Diagnostic Test: Collection of Serum and Saliva Samples

Interventions

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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women were included to study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Newly diagnosed PCOS patients
• Never smokers
• Had no history of systemic disease
• BMI\<25 kg/m2
• Participants had ≥20 teeth present.

You may not qualify if:

• Pregnancy
• Lactation
• Hemoglobin A1c (HbA1c) ≥ 6.5%
• 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

Sponsors & Collaborators

• Ebru Saglam: lead
• Ataturk University: collaborator

Study Sites (1)

Ebru Sağlam

Istanbul, Eyalet/Yerleşke, 34668, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and Saliva

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Gingivitis

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ebru Sağlam, PhD

  Bezmialem Vakif University

  STUDY DIRECTOR

• Ayşe Toraman

  Ataturk University

  PRINCIPAL INVESTIGATOR

• Engin Şebin

  Erzurum Regional Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Cenk Fatih Çanakçı, Professor

  Ataturk University

  STUDY CHAIR

• Hümeyra Çanakçı, Dr

  Private Practice

  PRINCIPAL INVESTIGATOR

• Metin İngeç, Professor

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Bezmialem Universitesi, Dentistry Faculty

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: April 3, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

TU (1)