Inflammatory Stress and Periodontal Tissue Destruction

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06092853
• Other study ID #: Recep Tayyip ErdoganUniversity
• Secondary ID: RecepTayyipErdog
• Status: Completed
• Start date: June 6, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: October 2023
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University	Rize

Sponsors (2)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital	Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of gingival crevicular fluid (GCF) parameters	interleukin-20, RANKL, OPG values evaluated in GCF.	1 year
Primary	concentration of serum parameters	interleukin-20, RANKL, OPG, MMP-8, TOS, TAS values evaluated in serum	1 year
Secondary	value of periodontal clinical parameters	plaque index, gingival index, bleeding on probing, Clinical attachment loss, probing pocket depth	1 year
Secondary	value of patients' clinical metabolic syndrome parameters	Body mass index (BMI), abdominal circumference, and HbA1c	1 year