Clinical trial NCT03264846: Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation
Official title: The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Inflammation Gum
Cytokines
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2017-08-29
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.


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

Primary outcomes:
measure: Serum and salivary Endocan levels
timeFrame: one year
measure: Serum and salivary interleukin-6 levels
timeFrame: one year
Secondary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: one year
measure: Probing pocket depth (PD)
timeFrame: one year
measure: Gingival Index
timeFrame: One year
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Ebru Sağlam
state: Eyalet/Yerleşke
Study officials:
affiliation: Bezmialem Vakif University
name: Ebru Sağlam, PhD
role: STUDY_DIRECTOR
affiliation: Ataturk University
name: Ayşe Toraman
role: PRINCIPAL_INVESTIGATOR
affiliation: Erzurum Regional Training and Research Hospital
name: Engin Şebin
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Cenk Fatih Çanakçı, Professor
role: STUDY_CHAIR
affiliation: Private Practice
name: Hümeyra Çanakçı, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Metin İngeç, Professor
role: STUDY_DIRECTOR
References: