Periodontal DiseasesNCT03789565
Hepcidin Levels in Periodontal Health and Disease
An observational study of Periodontal Diseases, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 52 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Biomarker test
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 15 Feb 2018
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 52 years
- All sexes
- Adult
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
Who may be able to join
- Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months
Who cannot join
- Individuals who smoked and women who were pregnant and/or lactating were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- Biomarker test
- Keywords
- periodontal diseases, hepcidin, elisa, interleukin 6, interleukin 10
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker testOther
Diagnostic biomarker study
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Healthy individuals from periodontal perspective: | GI < 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography. Receives: Other: Biomarker test | |
| Group 2. Individuals diagnosed with Gingivitis | GI > 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography. Receives: Other: Biomarker test | |
| Group 3. Individuals diagnosed with CP | GI > 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography. Receives: Other: Biomarker test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepcidin levels
Change in inflammatory phases
Measured: 1 year
Secondary outcomes (2)
IL-6 levels
Change in inflammatory phases
Measured: 1 year
IL-10 levels
Change in inflammatory phases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start15 Mar 2017
- Primary completion20 Jan 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇİĞDEM COŞKUN TÜRER, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789565
- Sponsor's protocol ID
- hepcidin
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease
- ClinicalTrials.gov ID
- NCT03789565
- Acronym / sponsor ID
- hepcidin
- Conditions
- Periodontal Diseases
- Keywords
- periodontal diseases, hepcidin, elisa, interleukin 6, interleukin 10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1. Healthy individuals from periodontal perspective: | – | Other: Biomarker testGI < 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography. |
| Group 2. Individuals diagnosed with Gingivitis | – | Other: Biomarker testGI > 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography. |
| Group 3. Individuals diagnosed with CP | – | Other: Biomarker testGI > 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography. |
Who may qualify
- Ages
- 32 to 52 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Systematically healthy patients. Patients who did not receive any medication or periodontal treatment within the previous 6 months
Key exclusion criteria (1 listed)
- Individuals who smoked and women who were pregnant and/or lactating were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker testDiagnostic biomarker study | Other | Group 1. Healthy individuals from periodontal perspective:, Group 2. Individuals diagnosed with Gingivitis, Group 3. Individuals diagnosed with CP |
Primary outcome
Hepcidin levels
Time frame: 1 year
Change in inflammatory phases
2 secondary outcomes
IL-6 levels
Time frame: 1 year
IL-10 levels
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepcidin levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.