Inflammatory Stress and Periodontal Tissue Destruction

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress
• Intervention / Treatment: Other: Gingival crevicular fluid (GCF) and serum samples

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey
    • Recep Tayyip Erdogan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The sample size of the study was calculated using the G*Power program with an effect size of 0.4, 80% power, and a margin of error of 0.05.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
systemically and periodontally healthy (CG); Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.	Other: Gingival crevicular fluid (GCF) and serum samples; Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
systemically healthy and periodontitis (PG); Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses	Other: Gingival crevicular fluid (GCF) and serum samples; Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
Metabolic syndrome and periodontally healthy (MG); Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses	Other: Gingival crevicular fluid (GCF) and serum samples; Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
Metabolic syndrome and periodontitis (MPG); Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses	Other: Gingival crevicular fluid (GCF) and serum samples; Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of gingival crevicular fluid (GCF) parameters	interleukin-20, RANKL, OPG values evaluated in GCF.	1 year
concentration of serum parameters	interleukin-20, RANKL, OPG, MMP-8, TOS, TAS values evaluated in serum	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
value of periodontal clinical parameters	plaque index, gingival index, bleeding on probing, Clinical attachment loss, probing pocket depth	1 year
value of patients' clinical metabolic syndrome parameters	Body mass index (BMI), abdominal circumference, and HbA1c	1 year

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Collaborators: Recep Tayyip Erdogan University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic syndrome; periodontitis; interleukin-20
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Recep Tayyip ErdoganUniversity (Recep Tayyip Erdogan University); RecepTayyipErdoganUniversity (Recepteutrh)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No