Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

Sponsor

Ebru Saglam (Other)

Overall Status

Completed

CT.gov ID

NCT03264846

Collaborator

Ataturk University (Other)

Enrollment

Location

7.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Inflammation Gum Cytokines	Diagnostic Test: Collection of Serum and Saliva Samples

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

87 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 3, 2017

Actual Primary Completion Date :

Nov 29, 2017

Actual Study Completion Date :

Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Group 1 PCOS participants with periodontitis	Diagnostic Test: 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.
Group 2 PCOS participants with periodontally healthy	Diagnostic Test: 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.
Group 3 systemically healthy participants with periodontitis	Diagnostic Test: 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.
Group 4 systemically and periodontally healthy participants	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

Serum and salivary Endocan levels [one year]
Enzyme-Linked Immunosorbent Assay (ELISA)
Serum and salivary interleukin-6 levels [one year]
Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary Outcome Measures

Clinical attachment level (CAL) [one year]
Periodontal measurement
Probing pocket depth (PD) [one year]
Periodontal measurement
Gingival Index [One year]
Periodontal measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ebru Sağlam	İstanbul	Eyalet/Yerleşke	Turkey	34668

Sponsors and Collaborators

Ebru Saglam
Ataturk University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ebru Saglam, Principal Investigator, Bezmialem Universitesi, Dentistry Faculty, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT03264846

Other Study ID Numbers:

EbSAGLAM1

First Posted:

Aug 29, 2017

Last Update Posted:

Feb 10, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Polycystic Ovary Syndrome

Syndrome

Inflammation

Study Results

No Results Posted as of Feb 10, 2020