Meteorin-like Levels in Individuals With Periodontitis

April 25, 2024 updated by: Ebru SAĞLAM, Istanbul Saglik Bilimleri University

Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease

Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. 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 authors think that Metrnl may play a role in the periodontitis. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals.

Study Overview

Status

Completed

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. Cytokines play an important role in inflammation that occurs in periodontal disease.

Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Cytokines such as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have 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.

Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an effective marker in preventing the progression of destruction. We think that Metrnl plays an important role in periodontitis, an inflammatory disease. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

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

Study Locations

    • Eyalet/Yerleşke
      • İstanbul, Eyalet/Yerleşke, Turkey, 34668
        • Ebru Sağlam

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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
  • menopausal or menstrual period

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis
Individuals with Periodontitis

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

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

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

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

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

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-1β
Time Frame: through study completion, an average of 6 months
saliva and serum levels
through study completion, an average of 6 months
Metrnl
Time Frame: through study completion, an average of 6 months
saliva and serum levels
through study completion, an average of 6 months
IL-10 levels
Time Frame: through study completion, an average of 6 months
saliva and serum levels
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: up to 20 weeks
Silness-Löe
up to 20 weeks
Probing Depth
Time Frame: up to 20 weeks
millimeter
up to 20 weeks
Bleeding on Probe
Time Frame: up to 20 weeks
Ainamo&Bay
up to 20 weeks

Collaborators and Investigators

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

Investigators

  • Study Chair: Ayşe Toraman, Dr., Saglik Bilimleri Universitesi
  • Principal Investigator: Ebru Sağlam, Dr, Saglik Bilimleri Universitesi
  • Study Chair: Serhat Köseoğlu, assoc prof, Saglik Bilimleri Universitesi
  • Study Chair: Mehmet Sağlam, assoc prof, İzmir Katip Çelebi University
  • Study Chair: Levent Savran, PhD, İzmir Katip Çelebi University

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 (Actual)

September 23, 2020

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sağlık Bilimleri Üniversitesi

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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