Inflammatory Stress and Periodontal Tissue Destruction

Completed

• Conditions: Inflammation; Oxidative Stress
• Interventions: Other: Gingival crevicular fluid (GCF) and serum samples

• Registration Number: NCT06092853
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-06
• Primary Completion: 2023-03-06
• Study Completion: 2023-06-06
• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metabolic syndrome and periodontitis (MPG)	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	Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses
systemically and periodontally healthy (CG)	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	Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Recep Tayyip Erdogan University; 🇹🇷 Rize, Turkey