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
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedFirst Submitted
Initial submission to the registry
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
December 28, 2018
CompletedOctober 4, 2019
October 1, 2019
10 months
December 27, 2018
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepcidin levels
Change in inflammatory phases
1 year
Secondary Outcomes (2)
IL-6 levels
1 year
IL-10 levels
1 year
Study Arms (3)
Group 1. Healthy individuals from periodontal perspective:
GI \< 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.
Group 2. Individuals diagnosed with Gingivitis
GI \> 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.
Group 3. Individuals diagnosed with CP
GI \> 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.
Interventions
Diagnostic biomarker study
Eligibility Criteria
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
You may qualify if:
- Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months
You may not qualify if:
- Individuals who smoked and women who were pregnant and/or lactating were excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Çiğdem Coşkun Türer
Zonguldak, 67600, Turkey (Türkiye)
Biospecimen
Gingival crevicular fluid and Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical associate professor, DDS, PhD
Study Record Dates
First Submitted
December 27, 2018
First Posted
December 28, 2018
Study Start
March 15, 2017
Primary Completion
January 20, 2018
Study Completion
February 15, 2018
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share