NCT06408454

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

April 15, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

psoriasisgene expressionperiodontal health

Outcome Measures

Primary Outcomes (1)

  • Level of Gene expression

    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 Outcomes (4)

  • Plaque index

    Baseline, week 2

  • Gingival index

    Baseline, week 2

  • Clinical attachment level

    Baseline, week 2

  • Tooth Mobility

    Baseline, week 2

Study Arms (2)

Psoriasis patients

IL-17, Bcl-3, IκBζ gene expression levels were examined

Diagnostic Test: Gingival crevicular fluid collectionDiagnostic Test: periodontal test

Control group

IL-17, Bcl-3, IκBζ gene expression levels were examined

Diagnostic Test: Gingival crevicular fluid collectionDiagnostic Test: periodontal test

Interventions

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.

Control groupPsoriasis patients
periodontal testDIAGNOSTIC_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.

Control groupPsoriasis patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Gül Öner Talmaç

Kahramanmaraş, Onikişubat, 46000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid

MeSH Terms

Conditions

PsoriasisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Ayşe Gül Öner Talmaç, PhD

    Faculty of Dentistry, Kahraman Maraş Sütçü İmam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 15, 2024

First Posted

May 10, 2024

Study Start

February 1, 2023

Primary Completion

April 10, 2023

Study Completion

August 15, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations