Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hepcidin Levels in Periodontal Health and Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789565
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
ÇİĞDEM COŞKUN TÜRER, 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.

Condition or disease Intervention/treatment
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Days
Official Title: Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : February 15, 2018

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




Primary Outcome Measures :
  1. Hepcidin levels [ Time Frame: 1 year ]
    Change in inflammatory phases


Secondary Outcome Measures :
  1. IL-6 levels [ Time Frame: 1 year ]
    Change in inflammatory phases

  2. IL-10 levels [ Time Frame: 1 year ]
    Change in inflammatory phases


Biospecimen Retention:   Samples Without DNA
Gingival crevicular fluid and Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   32 Years to 52 Years   (Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789565


Locations
Layout table for location information
Turkey
Çiğdem Coşkun Türer
Zonguldak, Turkey, 67600
Sponsors and Collaborators
Bulent Ecevit University

Additional Information:

Layout table for additonal information
Responsible Party: ÇİĞDEM COŞKUN TÜRER, clinical associate professor, DDS, PhD, Bulent Ecevit University
ClinicalTrials.gov Identifier: NCT03789565     History of Changes
Other Study ID Numbers: hepcidin
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ÇİĞDEM COŞKUN TÜRER, Bulent Ecevit University:
periodontal diseases
hepcidin
elisa
interleukin 6
interleukin 10
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hepcidins
Anti-Infective Agents