Non-infectious UveitisNIU-PERIONCT07480291
Periodontal Status and Cytokine Levels in Patients With Non-Infectious Uveitis
An observational study of Non-infectious Uveitis and Periodontal Disease, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-infectious Uveitis, Periodontal Disease
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 31 Aug 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional study included adult individuals diagnosed with non-infectious uveitis (NIU) and systemically healthy controls. Participants were recruited from the outpatient clinic of the Department of Ophthalmology at Selcuk University. All participants underwent comprehensive periodontal examination and biofluid sampling, including gingival crevicular fluid, saliva, and serum, for cytokine analysis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry
Konya, Konya
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-infectious Uveitis, Periodontal Disease
- Keywords
- Cytokines, Gingival crevicular fluid, serum, saliva, Periodontal status, non-infectious uveitis
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Healthy Control Group | Systemically healthy individuals without ocular inflammatory disease who underwent periodontal examination and biological sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-10 concentration in serum (pg/L)
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).
Measured: Baseline
Secondary outcomes (20)
TNF-α concentration in gingival crevicular fluid (ng/sec)
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).
Measured: Baseline
TNF-α concentration in saliva (ng/min)
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).
Measured: Baseline
TNF-α concentration in serum (ng/L)
TNF-α concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
Measured: Baseline
IL-1β concentration in gingival crevicular fluid (pg/sec)
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).
Measured: Baseline
IL-1β concentration in saliva (pg/min)
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).
Measured: Baseline
IL-1β concentration in serum (pg/L)
IL-1β concentration was measured in serum samples using ELISA and expressed as picograms per liter (pg/L).
Measured: Baseline
IL-2 concentration in gingival crevicular fluid (ng/sec)
IL-2 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
Measured: Baseline
IL-2 concentration in saliva (ng/min)
IL-2 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
Measured: Baseline
IL-2 concentration in serum (ng/L)
IL-2 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
Measured: Baseline
IL-6 concentration in gingival crevicular fluid (ng/sec)
IL-6 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
Measured: Baseline
IL-6 concentration in saliva (ng/min)
IL-6 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
Measured: Baseline
IL-6 concentration in serum (ng/L)
IL-6 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
Measured: Baseline
IL-8 concentration in gingival crevicular fluid (ng/sec)
IL-8 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
Measured: Baseline
IL-8 concentration in saliva (ng/min)
IL-8 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
Measured: Baseline
IL-8 concentration in serum (ng/L)
IL-8 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
Measured: Baseline
IL-10 concentration in gingival crevicular fluid (pg/sec)
IL-10 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as picograms per second (pg/sec).
Measured: Baseline
IL-10 concentration in saliva (pg/min)
IL-10 concentration was measured in saliva samples using ELISA and expressed as picograms per minute (pg/min).
Measured: Baseline
IL-17 concentration in gingival crevicular fluid (ng/sec)
IL-17 concentration was measured in gingival crevicular fluid samples using ELISA and expressed as nanograms per second (ng/sec).
Measured: Baseline
IL-17 concentration in saliva (ng/min)
IL-17 concentration was measured in saliva samples using ELISA and expressed as nanograms per minute (ng/min).
Measured: Baseline
IL-17 concentration in serum (ng/L)
IL-17 concentration was measured in serum samples using ELISA and expressed as nanograms per liter (ng/L).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious UveitisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Durmaz, Selcuk University
- Investigators
- Duygu durmaz, DDS,MSc, Principal investigator, Pendik Oral and Dental Health Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480291
- Sponsor's protocol ID
- NIU-Perio-2020
- Acronym
- NIU-PERIO
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Status and Cytokines in Individuals With Non-Infectious Uveitis
- ClinicalTrials.gov ID
- NCT07480291
- Acronym / sponsor ID
- NIU-PERIO / NIU-Perio-2020
- Conditions
- Non-infectious Uveitis, Periodontal Disease
- Keywords
- Cytokines, Gingival crevicular fluid, serum, saliva, Periodontal status, non-infectious uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Mar 2026 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Healthy Control Group | – | –Systemically healthy individuals without ocular inflammatory disease who underwent periodontal examination and biological sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study included adult individuals diagnosed with non-infectious uveitis (NIU) and systemically healthy controls. Participants were recruited from the outpatient clinic of the Department of Ophthalmology at Selcuk University. All participants underwent comprehensive periodontal examination and biofluid sampling, including gingival crevicular fluid, saliva, and serum, for cytokine analysis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
20 secondary outcomes
TNF-α concentration in gingival crevicular fluid (ng/sec)
Time frame: Baseline
TNF-α concentration in saliva (ng/min)
Time frame: Baseline
TNF-α concentration in serum (ng/L)
Time frame: Baseline
IL-1β concentration in gingival crevicular fluid (pg/sec)
Time frame: Baseline
IL-1β concentration in saliva (pg/min)
Time frame: Baseline
IL-1β concentration in serum (pg/L)
Time frame: Baseline
IL-2 concentration in gingival crevicular fluid (ng/sec)
Time frame: Baseline
IL-2 concentration in saliva (ng/min)
Time frame: Baseline
IL-2 concentration in serum (ng/L)
Time frame: Baseline
IL-6 concentration in gingival crevicular fluid (ng/sec)
Time frame: Baseline
IL-6 concentration in saliva (ng/min)
Time frame: Baseline
IL-6 concentration in serum (ng/L)
Time frame: Baseline
IL-8 concentration in gingival crevicular fluid (ng/sec)
Time frame: Baseline
IL-8 concentration in saliva (ng/min)
Time frame: Baseline
IL-8 concentration in serum (ng/L)
Time frame: Baseline
IL-10 concentration in gingival crevicular fluid (pg/sec)
Time frame: Baseline
IL-10 concentration in saliva (pg/min)
Time frame: Baseline
IL-17 concentration in gingival crevicular fluid (ng/sec)
Time frame: Baseline
IL-17 concentration in saliva (ng/min)
Time frame: Baseline
IL-17 concentration in serum (ng/L)
Time frame: Baseline
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 18 Mar 2026.
- 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.
Duygu durmaz, DDS,MSc principal investigator
Pendik Oral and Dental Health Hospital, Istanbul, Turkey
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 Non-infectious Uveitis and Periodontal Disease, run by Selcuk 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 5 inclusion and 6 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 18 Mar 2026. 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?
IL-10 concentration in serum (pg/L) (time frame: Baseline). 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 18 Mar 2026.