Clinical trial NCT06408454: Interleukin- 17 (IL-17), Bcl-3, and NF-kappa-B Inhibitor Zeta (IκBζ) Expression Levels in the Psoriasis Patients
Official title: Determination of IL-17, Bcl-3, AND IκBζ Expression Levels in the Gingival Crevicular Fluid of Psoriasis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Periodontal Diseases
Keywords: psoriasis
gene expression
periodontal health
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients living in Eastern region of Turkey and visiting our clinic

Brief summary: This study aimed to compare the levels of IL-17 (interleukin- 17), Bcl-3 (B-cell lymphoma 3-encoded protein), and IκBζ (NF-kappa-B inhibitor zeta) in the gingival crevicular fluid of psoriatic and healthy individuals and the clinical parameters such as periodontal health, gingival index, plaque index and mobility (using periotest device)in the patient and control groups.

Detailed description: Patient selection

Ten patients previously diagnosed with psoriasis who visited the Van 100. Yıl University Faculty of Dentistry Oral and Maxillofacial Radiology dental clinic were included in the study. Non-psoriasis individuals were selected from volunteer patients attending the same dental clinic.

Clinical measurements

A periodontist conducted the periodontal evaluation, which included a comprehensive assessment of clinical periodontal status, a full mouth manual periodontal charting, measurement of probing depth, clinical attachment level, bleeding on probing, and evaluation of mobility using a periotest device. Additionally, information regarding the patient's smoking status, frequency of smoking, and oral hygiene habits was obtained.

Gingival crevicular fluid (GCF) collection

Samples were taken from two mandibular molar teeth. Before sampling, the sites were isolated with cotton rolls and then carefully dried with an air syringe to avoid saliva contamination. GCF was collected using sterile periodontal strips by gently inserting them into the gingival sulcus or pocket until slight resistance was noticed. After 30 s, the strips were collected into sterile tubes and immediately transported to the laboratory for storage (-40 °C) and posterior analysis.

Eligibility criteria: Inclusion Criteria:

* Patients previously diagnosed with psoriasis
* Adults who are 18 years of age or older
* Patients having at least 11 teeth

Exclusion Criteria:

* Patients with any known systemic disease other than psoriasis
* Patients who had received antibiotic, nonsteroidal anti-inflammatory, and/or immunomodulatory therapy within the last three months
* Patients who had received radiotherapy and/or chemotherapy within the last years

Primary outcomes:
measure: Level of Gene expression
timeFrame: Sample collection during examination, approximately 2 months
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline, week 2
measure: Gingival index
timeFrame: Baseline, week 2
measure: Clinical attachment level
timeFrame: Baseline, week 2
measure: Tooth Mobility
timeFrame: Baseline, week 2
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Ayşe Gül Öner Talmaç
state: Onikişubat
Study officials:
affiliation: Faculty of Dentistry, Kahraman Maraş Sütçü İmam University
name: Ayşe Gül Öner Talmaç, PhD
role: PRINCIPAL_INVESTIGATOR
References: