Interleukin- 17 (IL-17), Bcl-3, and NF-kappa-B Inhibitor Zeta (IκBζ) Expression Levels in the Psoriasis Patients

Psoriasis Clinical Trial

Official title:

Determination of IL-17, Bcl-3, AND IκBζ Expression Levels in the Gingival Crevicular Fluid of Psoriasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06408454
• Other study ID #: KSU-ONERTALMAC-01
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: May 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 15, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Psoriasis

Intervention

Diagnostic Test:
• Gingival crevicular fluid 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.
• periodontal test
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.

Locations

Country	Name	City	State
Turkey	Ayse Gül Öner Talmaç	Kahramanmaras	Onikisubat

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Gene expression	In the real-time polymerase chain reaction (PCR) results of the ß-actin gene, which was used as a housekeeping gene in the study, the automatic threshold value was determined by the device as 0.02. It was observed that all samples were above the threshold value and gave a ct value. According to the housekeeping gene, IL-17, I?B?, and Bcl-3gene expression values were determined.	Sample collection during examination, approximately 2 months
Secondary	Plaque index	To determine the plaque index of the patients, their dental plaque thickness was evaluated by probing surfaces of selected teeth using a periodontal probe. Scores range from 0 to 3.	Baseline, week 2
Secondary	Gingival index	To determine the gingival index of the patients, gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of selected teeth was evaluated. Scores range from 0 to 3.	Baseline, week 2
Secondary	Clinical attachment level	This parameter represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance from the cemento-enamel junction (CEJ) to the base of the pocket (in mm)	Baseline, week 2
Secondary	Tooth Mobility	The amount of tooth mobility can be displayed by a value called periotest value (PTV) ranging from -8 to +50	Baseline, week 2