- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402996
Meteorin-like Levels in Individuals With Periodontitis
Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease
Study Overview
Status
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. 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Eyalet/Yerleşke
-
İstanbul, Eyalet/Yerleşke, Turkey, 34668
- Ebru Sağlam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
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:
|
|
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:
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:
|
|
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:
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:
|
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sağlık Bilimleri Üniversitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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