Hepcidin Levels in Periodontal Health and Disease

Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease

Periodontal disease refers to inflammatory disease of the periodontium caused by the host and/or pathogenic microorganisms. Anti-inflammatory and pro-inflammatory cytokines play a role in the periodontal inflammation process. The aim of this study was to evaluate the levels of hepcidin, interleukin (IL)-6, and IL-10 levels in gingival crevicular fluid (GCF) and in serum samples obtained from individuals with periodontal inflammation.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: Biomarker test

Detailed Description

The study included 90 individuals, who were divided into three groups: periodontally healthy (PH) (n=30); gingivitis (G) (n=30); and chronic periodontitis (CP) (n=30). GCF and serum samples were obtained from each individual, and samples were evaluated using ELISA. Statistical evaluation of the data was performed using the SPSS packet data program.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey, 67600
    • Çiğdem Coşkun Türer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 32 years to 52 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study included a total of 60 individuals between 32 and 52 years of age, with a total number of teeth > 20, who underwent consultation for periodontal treatment

Description

Inclusion Criteria:

• Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months

Exclusion Criteria:

• Individuals who smoked and women who were pregnant and/or lactating were excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1. Healthy individuals from periodontal perspective: GI < 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.	Other: Biomarker test; Diagnostic biomarker study
Group 2. Individuals diagnosed with Gingivitis; GI > 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.	Other: Biomarker test; Diagnostic biomarker study
Group 3. Individuals diagnosed with CP; GI > 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.	Other: Biomarker test; Diagnostic biomarker study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepcidin levels	Change in inflammatory phases	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6 levels	Change in inflammatory phases	1 year
IL-10 levels	Change in inflammatory phases	1 year

Collaborators and Investigators

• Sponsor: Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ACTUAL): January 20, 2018
• Study Completion (ACTUAL): February 15, 2018

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (ACTUAL): December 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: hepcidin; periodontal diseases; interleukin 6; elisa; interleukin 10
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: hepcidin

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