Meteorin-like Levels in Individuals With Periodontitis

Sponsor
Istanbul Saglik Bilimleri University (Other)
Overall Status
Completed
CT.gov ID
NCT04402996
Collaborator
(none)
53
1
17.3
3.1

Study Details

Study Description

Brief 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.

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. 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

Study Design

Study Type:
Observational
Actual Enrollment :
53 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease
Actual Study Start Date :
Sep 23, 2019
Actual Primary Completion Date :
Mar 3, 2021
Actual Study Completion Date :
Mar 3, 2021

Arms and Interventions

Arm Intervention/Treatment
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
  • 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
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. TNF-α [through study completion, an average of 6 months]

      saliva and serum levels

    2. IL-1β [through study completion, an average of 6 months]

      saliva and serum levels

    3. Metrnl [through study completion, an average of 6 months]

      saliva and serum levels

    4. IL-10 levels [through study completion, an average of 6 months]

      saliva and serum levels

    5. saliva VEGF [through study completion, an average of 6 months]

      saliva and serum levels

    6. TGF-β [through study completion, an average of 6 months]

      saliva and serum levels

    Secondary Outcome Measures

    1. Plaque Index [up to 20 weeks]

      Silness-Löe

    2. Probing Depth [up to 20 weeks]

      millimeter

    3. Bleeding on Probe [up to 20 weeks]

      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

    • menopausal or menstrual period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ebru Sağlam İstanbul Eyalet/Yerleşke Turkey 34668

    Sponsors and Collaborators

    • Istanbul Saglik Bilimleri University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebru SAĞLAM, Principal Investigator,Health Sciences University, Dentistry Faculty, Istanbul Saglik Bilimleri University
    ClinicalTrials.gov Identifier:
    NCT04402996
    Other Study ID Numbers:
    • Sağlık Bilimleri Üniversitesi
    First Posted:
    May 27, 2020
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    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 Ebru SAĞLAM, Principal Investigator,Health Sciences University, Dentistry Faculty, Istanbul Saglik Bilimleri University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2021