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Completed

NCT Number: NCT06408454

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ayşe Gül Öner Talmaç

Kahramanmaraş, Onikişubat, 46000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gingival crevicular fluid collection

Diagnostic Test

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

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 10, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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