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OpenTrials
Completed

NCT Number: NCT06092853

Inflammatory Stress and Periodontal Tissue Destruction

Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. The aim of this study was to evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with metabolic syndrome while considering the relationship between metabolic syndrome and periodontitis.

This study included a total of 80 individuals who were systemically and periodontally healthy (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.

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Key information

Conditions

Oxidative Stress Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study groups were created based on the guidelines of the 2017 Classification of Periodontal Diseases and the 2005 Metabolic Syndrome Diagnostic Criteria of the Endocrinology and Metabolic Society of Turkey

Inclusion criteria

  • all participants were required to have at least 20 teeth and be between the ages of 20 and 65 years

Exclusion criteria

  • Smokers, patients who had used antibiotics or anti-inflammatory and antioxidant drugs in the last 6 months, patients who were pregnant or lactating, those who had cancer or autoimmune diseases, and those who had undergone any periodontal treatment in the last 6 months

Treatment and study plan

Gingival crevicular fluid (GCF) and serum samples

Other

Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses

Primary outcomes

  1. concentration of gingival crevicular fluid (GCF) parameters

    Time frame: 1 year

    interleukin-20, RANKL, OPG values evaluated in GCF.

  2. concentration of serum parameters

    Time frame: 1 year

    interleukin-20, RANKL, OPG, MMP-8, TOS, TAS values evaluated in serum

Secondary outcomes

  1. value of periodontal clinical parameters

    Time frame: 1 year

    plaque index, gingival index, bleeding on probing, Clinical attachment loss, probing pocket depth

  2. value of patients' clinical metabolic syndrome parameters

    Time frame: 1 year

    Body mass index (BMI), abdominal circumference, and HbA1c

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Collaborators

  • Recep Tayyip Erdogan University

Registry information

Official study title

Inflammatory Stress and Periodontal Tissue Destruction in Patients With Metabolic Syndrome and Periodontitis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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