NCT07480291

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

CytokinesGingival crevicular fluidserumsalivaPeriodontal statusnon-infectious uveitis

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (20)

  • TNF-α concentration in gingival crevicular fluid (ng/sec)

    Baseline

  • TNF-α concentration in saliva (ng/min)

    Baseline

  • TNF-α concentration in serum (ng/L)

    Baseline

  • IL-1β concentration in gingival crevicular fluid (pg/sec)

    Baseline

  • IL-1β concentration in saliva (pg/min)

    Baseline

  • +15 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Faculty of Dentistry

Konya, Konya, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, gingival crevicular fluid, and serum samples were collected from participants for cytokine analysis.

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Duygu durmaz, DDS,MSc

    Pendik Oral and Dental Health Hospital, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MSc, Periodontist

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 18, 2026

Study Start

October 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations