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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04402996
Other study ID # Saglik Bilimleri Üniversitesi
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2019
Est. completion date March 3, 2021

Study information

Verified date March 2024
Source Istanbul Saglik Bilimleri University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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, TNF-α, IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis individuals.


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. Tumor Necrosis Factor-α (TNF-α), Interleukine -1β ( IL-1β )and Interleukine-6 (IL-6), Prostaglandin E2 (PGE2) and Interferon gamma (IFN- γ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Vascular endothelial growth factor (VEGF) are important features of inflammation, wound healing and bone healing. 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, TNF-α, IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis individuals


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 3, 2021
Est. primary completion date March 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Ebru Saglam Istanbul Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary TNF-a saliva and serum levels through study completion, an average of 6 months
Primary IL-1ß saliva and serum levels through study completion, an average of 6 months
Primary Metrnl saliva and serum levels through study completion, an average of 6 months
Primary IL-10 levels saliva and serum levels through study completion, an average of 6 months
Primary saliva VEGF saliva and serum levels through study completion, an average of 6 months
Primary TGF-ß saliva and serum levels through study completion, an average of 6 months
Secondary Plaque Index Silness-Löe up to 20 weeks
Secondary Probing Depth millimeter up to 20 weeks
Secondary Bleeding on Probe Ainamo&Bay up to 20 weeks
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