Hepcidin Levels in Periodontal Health and Disease

• Sponsor: Bulent Ecevit University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03789565
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease
• Actual Study Start Date: Mar 15, 2017
• Actual Primary Completion Date: Jan 20, 2018
• Actual Study Completion Date: Feb 15, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Hepcidin levels [1 year]

   Change in inflammatory phases

Secondary Outcome Measures

1. IL-6 levels [1 year]

   Change in inflammatory phases

2. IL-10 levels [1 year]

   Change in inflammatory phases

Eligibility Criteria

Criteria

• Ages Eligible for Study: 32 Years to 52 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Çiğdem Coşkun Türer	Zonguldak		Turkey	67600

Sponsors and Collaborators

• Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ÇİĞDEM COŞKUN TÜRER, clinical associate professor, DDS, PhD, Bulent Ecevit University
• ClinicalTrials.gov Identifier: NCT03789565
• Other Study ID Numbers: hepcidin
• First Posted: Dec 28, 2018
• Last Update Posted: Oct 4, 2019
• Last Verified: Oct 1, 2019

• 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 ÇİĞDEM COŞKUN TÜRER, clinical associate professor, DDS, PhD, Bulent Ecevit University: periodontal diseases; hepcidin; elisa; interleukin 6; interleukin 10
• Additional relevant MeSH terms: Periodontal Diseases

Study Results

No Results Posted as of Oct 4, 2019