Interleukin 20 and Periodontal Tisuue Destruction

Periodontitis Clinical Trial

Official title:

Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06091800
• Other study ID #: RecepTayyip ErdoganUniversity
• Secondary ID: Recep Tayyip Erd
• Status: Completed
• Start date: June 6, 2022
• Est. completion date: June 6, 2023

Study information

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

Clinical Trial Summary

Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction. In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth

Exclusion Criteria:

• smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• biochemical analysis
GCF and serum samples were collected from the participants for biochemical analysis.

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of biochemical findings in gingival crevicular fluid (GCF)	IL-20, RANKL, OPG and RANKL/OPG values eveluated in GCF	june 2022-june 2023
Primary	concentration of biochemical findings in serum	IL-20, RANKL, OPG, RANKL/OPG, MMP-8, TNF-a, IL-1ß, IL-10 and IL-1ß/IL-10	1 year
Secondary	value of periodontal clinical parameters	plaque index (PI) (Silness & Löe), gingival index (GI) (Silness & Löe) and bleeding on probing index (BOP) of all natural teeth of the patients	1 year
Secondary	value of periodontal clinical parameters were measured in mm	probing pocket depth (PPD), clinical attachment loss (CAL) of all natural teeth of the patients	1 year