Interleukin-38 Levels in Individuals With Periodontitis

September 30, 2022 updated by: Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Saglik Bilimleri Universitesi
        • Contact:
        • Principal Investigator:
          • Ayşe Toraman, Dr
        • Sub-Investigator:
          • Ebru Sağlam, assoc prof
        • Sub-Investigator:
          • Serhat Köseoğlu, Prof
        • Sub-Investigator:
          • Mehmet Sağlam, Prof
        • Sub-Investigator:
          • Levent Savran, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals will be divided into three different groups, about 20-25 people in each group.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-38 levels
Time Frame: initial examination, baseline
saliva and DOS levels
initial examination, baseline
IL-1β levels
Time Frame: initial examination, baseline
saliva and DOS levels
initial examination, baseline
IL-10 levels
Time Frame: initial examination, baseline
saliva and DOS levels
initial examination, baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: initial examination, baseline
Silness-Löe
initial examination, baseline
Probing Depth
Time Frame: initial examination, baseline
millimeter
initial examination, baseline
Bleeding on Probe
Time Frame: initial examination, baseline
Ainamo&Bay
initial examination, baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2022

Primary Completion (Anticipated)

November 10, 2022

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

September 10, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulSBU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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