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

May 6, 2024 updated by: AYŞE GÜL ÖNER TALMAÇ, Kahramanmaras Sutcu Imam University

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey, 46000
        • Ayşe Gül Öner Talmaç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The patients living in Eastern region of Turkey and visiting our clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriasis patients
IL-17, Bcl-3, IκBζ gene expression levels were examined
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.
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.
Control group
IL-17, Bcl-3, IκBζ gene expression levels were examined
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Gene expression
Time Frame: Sample collection during examination, approximately 2 months
In the real-time polymerase chain reaction (PCR) results of the β-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, IκBζ, and Bcl-3gene expression values were determined.
Sample collection during examination, approximately 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: Baseline, week 2
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
Gingival index
Time Frame: Baseline, week 2
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
Clinical attachment level
Time Frame: Baseline, week 2
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
Tooth Mobility
Time Frame: Baseline, week 2
The amount of tooth mobility can be displayed by a value called periotest value (PTV) ranging from -8 to +50
Baseline, week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayşe Gül Öner Talmaç, PhD, Faculty of Dentistry, Kahraman Maraş Sütçü İmam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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