Meteorin-like Levels in Individuals With Periodontitis

NCT04402996 | Completed

• 1 other identifier: Sağlık Bilimleri Üniversitesi
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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, IL-1β, and IL-10 levels of healthy and periodontitis individuals.

Conditions

Periodontitis; Gingivitis; Healthy

Keywords

Meteorin-like

Outcome Measures

Primary Outcomes (3)

• IL-1β

  saliva and serum levels

  through study completion, an average of 6 months

• Metrnl

  saliva and serum levels

  through study completion, an average of 6 months

• IL-10 levels

  saliva and serum levels

  through study completion, an average of 6 months

Secondary Outcomes (3)

• Plaque Index

  up to 20 weeks

• Probing Depth

  up to 20 weeks

• Bleeding on Probe

  up to 20 weeks

Study Arms (3)

Healthy

Individuals with Periodontally Healthy

Other: Saliva; Other: gingival crevicular fluid

Gingivitis

Individuals with Gingival Inflammation

Other: Saliva; Other: gingival crevicular fluid

Periodontitis

Individuals with Periodontitis

Other: Saliva; Other: gingival crevicular fluid

Interventions

Saliva OTHER

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

Also known as: sampling

Gingivitis; Healthy; Periodontitis

gingival crevicular fluid OTHER

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.

Also known as: sampling

Gingivitis; Healthy; Periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• systemically healthy
• individuals who does not have a disease under treatment,
• individuals without regular systemic medication

You may not qualify if:

• smoking
• receiving periodontal treatment in the last 6 months
• pregnancy
• menopausal or menstrual period

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Ebru Sağlam

Istanbul, Eyalet/Yerleşke, 34668, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival Crevicular Fluid and Saliva

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• 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

  STUDY CHAIR

• Ebru Sağlam, Dr

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Health Sciences University, Dentistry Faculty

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 27, 2020
• Study Start: September 23, 2020
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)