Clinical trial NCT05568290: Interleukin-38 Levels in Individuals With Periodontitis
Official title: Evaluation of Interleukin-38 Levels in Individuals With Healthy and Periodontal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Gingivitis
Healthy
Keywords: periodontal disease
IL-38
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals will be divided into three different groups, about 20-25 people in each group.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: IL-38 levels
timeFrame: initial examination, baseline
measure: IL-1β levels
timeFrame: initial examination, baseline
measure: IL-10 levels
timeFrame: initial examination, baseline
Secondary outcomes:
measure: Plaque Index
timeFrame: initial examination, baseline
measure: Probing Depth
timeFrame: initial examination, baseline
measure: Bleeding on Probe
timeFrame: initial examination, baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Ayşe Toraman, Dr
role: PRINCIPAL_INVESTIGATOR
References: