Interleukin-38 Levels in Individuals With Periodontitis

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05568290
Collaborator
(none)
75
1
2.3
32.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Saliva
  • Other: gingival crevicular fluid

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Interleukin-38 Levels in Individuals With Healthy and Periodontal Disease
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Nov 10, 2022
Anticipated Study Completion Date :
Dec 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Periodontitis

Individuals with Periodontitis

Other: Saliva
individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.
Other Names:
  • sampling
  • Other: 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.
    Other Names:
  • sampling
  • Gingivitis

    Individuals with Gingival Inflammation

    Other: Saliva
    individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.
    Other Names:
  • sampling
  • Other: 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.
    Other Names:
  • sampling
  • Healthy

    Individuals with Periodontally Healthy

    Other: Saliva
    individuals' saliva samples will be collected and transferred to eppendorf tubes. Until biochemical analysis is carried out will be stored in -80ºC.
    Other Names:
  • sampling
  • Other: 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.
    Other Names:
  • sampling
  • Outcome Measures

    Primary Outcome Measures

    1. IL-38 levels [initial examination, baseline]

      saliva and DOS levels

    2. IL-1β levels [initial examination, baseline]

      saliva and DOS levels

    3. IL-10 levels [initial examination, baseline]

      saliva and DOS levels

    Secondary Outcome Measures

    1. Plaque Index [initial examination, baseline]

      Silness-Löe

    2. Probing Depth [initial examination, baseline]

      millimeter

    3. Bleeding on Probe [initial examination, baseline]

      Ainamo&Bay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saglik Bilimleri Universitesi İstanbul Turkey

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi

    Investigators

    • Principal Investigator: Ayşe Toraman, Dr, Saglik Bilimleri Universitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05568290
    Other Study ID Numbers:
    • IstanbulSBU
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Oct 5, 2022
    Last Verified:
    Sep 1, 2022
    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 Saglik Bilimleri Universitesi
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2022