Hepcidin Levels in Periodontal Health and Disease

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Biomarker test

• Registration Number: NCT03789565
• Lead Sponsor: Bulent Ecevit University

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.

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 Timeline

• Study Start: 2017-03-15
• Primary Completion: 2018-01-20
• Study Completion: 2018-02-15
• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3. Individuals diagnosed with CP	Biomarker test	GI \> 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.
Group 2. Individuals diagnosed with Gingivitis	Biomarker test	GI \> 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.
Group 1. Healthy individuals from periodontal perspective:	Biomarker test	GI \< 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.

Primary Outcome Measures

Name	Time	Method
Hepcidin levels	1 year	Change in inflammatory phases

Secondary Outcome Measures

Name	Time	Method
IL-10 levels	1 year	Change in inflammatory phases
IL-6 levels	1 year	Change in inflammatory phases

Trial Locations

Locations (1)

Çiğdem Coşkun Türer; 🇹🇷 Zonguldak, Turkey