Hepcidin Levels in Periodontal Health and Disease

October 2, 2019 updated by: ÇİĞDEM COŞKUN TÜRER, Bulent Ecevit University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 year
Change in inflammatory phases
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bulent Ecevit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

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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