Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

Completed

• Conditions: Inflammation Gum; Cytokines; Polycystic Ovary Syndrome
• Interventions: Diagnostic Test: Collection of Serum and Saliva Samples

• Registration Number: NCT03264846
• Lead Sponsor: Ebru Saglam

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Primary Completion: 2017-11-29
• Study Completion: 2017-11-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Collection of Serum and Saliva Samples	PCOS participants with periodontitis
Group 3	Collection of Serum and Saliva Samples	systemically healthy participants with periodontitis
Group 2	Collection of Serum and Saliva Samples	PCOS participants with periodontally healthy
Group 4	Collection of Serum and Saliva Samples	systemically and periodontally healthy participants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical attachment level (CAL)	one year	Periodontal measurement
Probing pocket depth (PD)	one year	Periodontal measurement
Gingival Index	One year	Periodontal measurement

Trial Locations

Locations (1)

Ebru Sağlam; 🇹🇷 İstanbul, Eyalet/Yerleşke, Turkey