Inflammatory Stress and Periodontal Tissue Destruction

NCT06092853 | Completed

• 2 other identifiers: Recep Tayyip ErdoganUniversityRecepTayyipErdoganUniversity
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Inflammation

Keywords

Metabolic syndrome; periodontitis; interleukin-20

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• value of periodontal clinical parameters

  1 year

• value of patients' clinical metabolic syndrome parameters

  1 year

Study Arms (4)

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

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

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

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

Interventions

Gingival crevicular fluid (GCF) and serum samples OTHER

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

Metabolic syndrome and periodontally healthy (MG); Metabolic syndrome and periodontitis (MPG); systemically and periodontally healthy (CG); systemically healthy and periodontitis (PG)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead
• Recep Tayyip Erdogan University: collaborator

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Location

Related Publications (1)

• Senkal R, Yemenoglu H, Kose O, Karakas SM, Yilmaz A, Akyildiz K, Beder M, Bostan SA. The role of interleukin-20 on inflammatory stress and periodontal tissue destruction in patients with metabolic syndrome and periodontitis. BMC Oral Health. 2024 Nov 22;24(1):1423. doi: 10.1186/s12903-024-05224-3.

  PMID: 39578819 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma and gingival crevicular fluid

MeSH Terms

Conditions

Inflammation; Metabolic Syndrome; Periodontitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: June 6, 2022
• Primary Completion: March 6, 2023
• Study Completion: June 6, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)