- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480291
Periodontal Status and Cytokine Levels in Patients With Non-Infectious Uveitis (NIU-PERIO)
Periodontal Status and Cytokines in Individuals With Non-Infectious Uveitis
This cross-sectional observational study aimed to evaluate periodontal clinical parameters and inflammatory cytokine levels in gingival crevicular fluid (GCF), saliva, and serum in patients with non-infectious uveitis (NIU) compared with systemically healthy individuals.
Twenty-five patients diagnosed with non-infectious uveitis and twenty-seven age- and sex-matched healthy controls were included. Clinical periodontal parameters including probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing were recorded. Biological samples including saliva, gingival crevicular fluid, and serum were collected.
Levels of TNF-α, IL-1β, IL-2, IL-6, IL-8, IL-10, and IL-17 were measured using ELISA. The study aimed to investigate whether periodontal inflammatory status and systemic cytokine profiles are associated with non-infectious uveitis.
Study Overview
Status
Conditions
Detailed Description
Non-infectious uveitis (NIU) is an immune-mediated inflammatory condition affecting the uveal tract of the eye and may be associated with systemic immune dysregulation. Periodontal disease is a chronic inflammatory disease characterized by destruction of the supporting tissues of the teeth and is known to contribute to systemic inflammatory burden through the release of cytokines and other inflammatory mediators.
Both NIU and periodontal disease involve complex immune responses and cytokine networks. However, the potential relationship between periodontal inflammation and NIU remains unclear. The present cross-sectional study was designed to investigate possible associations between periodontal clinical status and systemic and local inflammatory cytokine profiles in patients with NIU.
Participants included patients diagnosed with non-infectious uveitis and systemically healthy control individuals. Periodontal examinations were performed and biological samples including gingival crevicular fluid, saliva, and serum were collected. Levels of TNF-α, IL-1β, IL-2, IL-6, IL-8, IL-10, and IL-17 were measured using enzyme-linked immunosorbent assay (ELISA).
The objective of this study was to compare periodontal parameters and cytokine levels between NIU patients and healthy controls in order to evaluate whether periodontal inflammatory burden is associated with systemic immune alterations in individuals with non-infectious uveitis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Konya
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Konya, Konya, Turkey (Türkiye)
- Selcuk University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants aged 18 years or older.
- Patients diagnosed with non-infectious uveitis according to the
- Standardization of Uveitis Nomenclature (SUN) criteria.
- Presence of at least 20 natural teeth.
- Individuals who agreed to participate in the study and provided informed consent.
Exclusion Criteria:
- Presence of infectious uveitis.
- Pregnancy or lactation.
- Use of antibiotics, anti-inflammatory drugs, or immunosuppressive therapy within the previous 6 months.
- History of periodontal treatment within the previous 6 months.
- Presence of systemic diseases known to affect periodontal status.
- Current smokers.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Non-infectious Uveitis Group
Participants diagnosed with non-infectious uveitis who underwent periodontal examination and provided saliva, gingival crevicular fluid, and serum samples for cytokine analysis.
|
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Healthy Control Group
Systemically healthy individuals without ocular inflammatory disease who underwent periodontal examination and biological sample collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-10 concentration in serum (pg/L)
Time Frame: Baseline
|
IL-10 concentration was measured in serum samples using enzyme-linked immunosorbent assay (ELISA).
Cytokine concentrations were calculated based on standard curves and expressed as picograms per liter (pg/L).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TNF-α concentration in gingival crevicular fluid (ng/sec)
Time Frame: Baseline
|
TNF-α concentration was measured in gingival crevicular fluid samples using ELISA.
Total cytokine amount was calculated by multiplying concentration by sample volume and expressed as nanograms per second (ng/sec).
|
Baseline
|
|
TNF-α concentration in saliva (ng/min)
Time Frame: Baseline
|
TNF-α concentration was measured in saliva samples using ELISA.
Salivary cytokine amounts were adjusted for salivary flow rate and expressed as nanograms per minute (ng/min).
|
Baseline
|
|
TNF-α concentration in serum (ng/L)
Time Frame: Baseline
|
TNF-α concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
|
Baseline
|
|
IL-1β concentration in gingival crevicular fluid (pg/sec)
Time Frame: Baseline
|
IL-1β concentration was measured in gingival crevicular fluid samples using ELISA.
Total cytokine amount was calculated by multiplying concentration by sample volume and expressed as picograms per second (pg/sec).
|
Baseline
|
|
IL-1β concentration in saliva (pg/min)
Time Frame: Baseline
|
IL-1β concentration was measured in saliva samples using ELISA.
Salivary cytokine amounts were adjusted for salivary flow rate and expressed as picograms per minute (pg/min).
|
Baseline
|
|
IL-1β concentration in serum (pg/L)
Time Frame: Baseline
|
IL-1β concentration was measured in serum samples using ELISA and expressed as picograms per liter (pg/L).
|
Baseline
|
|
IL-2 concentration in gingival crevicular fluid (ng/sec)
Time Frame: Baseline
|
IL-2 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
|
Baseline
|
|
IL-2 concentration in saliva (ng/min)
Time Frame: Baseline
|
IL-2 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
|
Baseline
|
|
IL-2 concentration in serum (ng/L)
Time Frame: Baseline
|
IL-2 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
|
Baseline
|
|
IL-6 concentration in gingival crevicular fluid (ng/sec)
Time Frame: Baseline
|
IL-6 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
|
Baseline
|
|
IL-6 concentration in saliva (ng/min)
Time Frame: Baseline
|
IL-6 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
|
Baseline
|
|
IL-6 concentration in serum (ng/L)
Time Frame: Baseline
|
IL-6 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
|
Baseline
|
|
IL-8 concentration in gingival crevicular fluid (ng/sec)
Time Frame: Baseline
|
IL-8 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
|
Baseline
|
|
IL-8 concentration in saliva (ng/min)
Time Frame: Baseline
|
IL-8 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
|
Baseline
|
|
IL-8 concentration in serum (ng/L)
Time Frame: Baseline
|
IL-8 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
|
Baseline
|
|
IL-10 concentration in gingival crevicular fluid (pg/sec)
Time Frame: Baseline
|
IL-10 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as picograms per second (pg/sec).
|
Baseline
|
|
IL-10 concentration in saliva (pg/min)
Time Frame: Baseline
|
IL-10 concentration was measured in saliva samples using ELISA and expressed as picograms per minute (pg/min).
|
Baseline
|
|
IL-17 concentration in gingival crevicular fluid (ng/sec)
Time Frame: Baseline
|
IL-17 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
|
Baseline
|
|
IL-17 concentration in saliva (ng/min)
Time Frame: Baseline
|
IL-17 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
|
Baseline
|
|
IL-17 concentration in serum (ng/L)
Time Frame: Baseline
|
IL-17 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Duygu durmaz, DDS,MSc, Pendik Oral and Dental Health Hospital, Istanbul, Turkey
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
- NIU-Perio-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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