Interleukin-38 Levels in Individuals With Periodontitis

Healthy Clinical Trial

Official title:

Evaluation of Interleukin-38 Levels in Individuals With Healthy and Periodontal Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05568290
• Other study ID #: IstanbulSBU
• Status: Not yet recruiting
• Start date: September 30, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: September 2022
• Source: Saglik Bilimleri Universitesi
• Contact: Ayse Toraman, Dr
• Phone: 05385025422
• Email: draysetoraman[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Interleukin (IL)-38 is the newest member of the IL-1 family. It can bind to receptors through various pathways and regulate the formation and function of inflammatory cytokines. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The aim of this study is to compare the IL-38, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Description:

Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. More than any other cytokine family, the interleukin (IL)-1 family (IL-1α, IL-1β, IL-18, IL-33, IL-36α, IL-36β, IL-36γ, IL-1Ra, IL-36Ra, IL-37, IL-38) includes key signaling molecules that trigger and perpetuate periodontal inflammation.

Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has been reported to decrease periodontal disease progression rate.

Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.

In recent studies, IL-38 expression has been reported to be abnormal (abnormal) in chronic inflammatory diseases, especially in rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Therefore, this relationship of this inflammatory cytokine with chronic inflammatory diseases draws attention to the regulatory effect of IL-38 in these diseases. The aim of this study is to compare the IL-38, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• systemically healthy individuals who does not have a disease under treatment,

• individuals without regular systemic medication

Exclusion Criteria:

• smoking

• receiving periodontal treatment in the last 6 months

• pregnancy

• lactation

Related Conditions & MeSH terms

• Gingivitis
• Healthy
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Saliva
individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.
• gingival crevicular fluid
GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.Until biochemical analysis is carried out will be stored in -80ºC.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-38 levels	saliva and DOS levels	initial examination, baseline
Primary	IL-1ß levels	saliva and DOS levels	initial examination, baseline
Primary	IL-10 levels	saliva and DOS levels	initial examination, baseline
Secondary	Plaque Index	Silness-Löe	initial examination, baseline
Secondary	Probing Depth	millimeter	initial examination, baseline
Secondary	Bleeding on Probe	Ainamo&Bay	initial examination, baseline