Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

NCT ID: NCT03264846

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2017-11-29

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1

PCOS participants with periodontitis

Collection of Serum and Saliva Samples

Intervention Type: 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 2

PCOS participants with periodontally healthy

Collection of Serum and Saliva Samples

Intervention Type: 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 3

systemically healthy participants with periodontitis

Collection of Serum and Saliva Samples

Intervention Type: 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 4

systemically and periodontally healthy participants

Collection of Serum and Saliva Samples

Intervention Type: 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.

Interventions

Collection of Serum and Saliva Samples

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Ebru Saglam

OTHER

Sponsor Role: lead

Responsible Party

Ebru Saglam

Principal Investigator, Bezmialem Universitesi, Dentistry Faculty

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ebru Sağlam, PhD

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Ayşe Toraman

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Engin Şebin

Role: PRINCIPAL_INVESTIGATOR

Erzurum Regional Training and Research Hospital

Cenk Fatih Çanakçı, Professor

Role: STUDY_CHAIR

Ataturk University

Hümeyra Çanakçı, Dr

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Metin İngeç, Professor

Role: STUDY_DIRECTOR

Ataturk University

Locations

Ebru Sağlam

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EbSAGLAM1

Identifier Type: -

Identifier Source: org_study_id