Inflammatory Stress and Periodontal Tissue Destruction

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06092853
• Collaborator: Recep Tayyip Erdogan University (Other)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress; Inflammation	Other: Gingival crevicular fluid (GCF) and serum samples

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Inflammatory Stress and Periodontal Tissue Destruction in Patients With Metabolic Syndrome and Periodontitis
• Actual Study Start Date: Jun 6, 2022
• Actual Primary Completion Date: Mar 6, 2023
• Actual Study Completion Date: Jun 6, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. concentration of gingival crevicular fluid (GCF) parameters [1 year]

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

2. concentration of serum parameters [1 year]

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

Secondary Outcome Measures

1. value of periodontal clinical parameters [1 year]

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

2. value of patients' clinical metabolic syndrome parameters [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Recep Tayyip Erdogan University	Rize		Turkey

Sponsors and Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital
• Recep Tayyip Erdogan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hatice Yemenoğlu, assistant professor, Recep Tayyip Erdogan University Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06092853
• Other Study ID Numbers: Recep Tayyip ErdoganUniversity; RecepTayyipErdoganUniversity
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hatice Yemenoğlu, assistant professor, Recep Tayyip Erdogan University Training and Research Hospital: Metabolic syndrome; periodontitis; interleukin-20
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Oct 23, 2023