- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06091800
Interleukin 20 and Periodontal Tisuue Destruction
Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals
Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.
In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Rize, Turkey
- Recep Tayyip Erdogan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth
Exclusion Criteria:
- smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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control group (periodontally healthy)
no attachment loss, probing pocket depth ≤ 3 mm, minimal bleeding on probing ≤ 10%, and no radiographic bone loss
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GCF and serum samples were collected from the participants for biochemical analysis.
|
|
periodontitis group
interdental clinical attachment level ≥ 5 mm, probing pocket depth ≥ 6 mm, radiographic bone loss extending to the middle or apical thirds of the root, mid-crest defect, and a history of ≤4 teeth loss of periodontal origin
|
GCF and serum samples were collected from the participants for biochemical analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concentration of biochemical findings in gingival crevicular fluid (GCF)
Time Frame: june 2022-june 2023
|
IL-20, RANKL, OPG and RANKL/OPG values eveluated in GCF
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june 2022-june 2023
|
|
concentration of biochemical findings in serum
Time Frame: 1 year
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IL-20, RANKL, OPG, RANKL/OPG, MMP-8, TNF-α, IL-1β, IL-10 and IL-1β/IL-10
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
value of periodontal clinical parameters
Time Frame: 1 year
|
plaque index (PI) (Silness & Löe), gingival index (GI) (Silness & Löe) and bleeding on probing index (BOP) of all natural teeth of the patients
|
1 year
|
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value of periodontal clinical parameters were measured in mm
Time Frame: 1 year
|
probing pocket depth (PPD), clinical attachment loss (CAL) of all natural teeth of the patients
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yemenoglu, Recep Tayyip Erdogan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RecepTayyip ErdoganUniversity
- Recep Tayyip ErdoganUniversity (Recep Tayyip Erdogan University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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