- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408454
Interleukin- 17 (IL-17), Bcl-3, and NF-kappa-B Inhibitor Zeta (IκBζ) Expression Levels in the Psoriasis Patients
Determination of IL-17, Bcl-3, AND IκBζ Expression Levels in the Gingival Crevicular Fluid of Psoriasis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Onikişubat
-
Kahramanmaraş, Onikişubat, Turkey, 46000
- Ayşe Gül Öner Talmaç
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Ayşe Gül Öner Talmaç, PhD, Faculty of Dentistry, Kahraman Maraş Sütçü İmam University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU-ONERTALMAC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Periodontal Diseases
-
Tel Aviv UniversityRecruitingPeriodontal Disease | Periodontal Attachment Loss | Periodontal PocketsIsrael
-
Riga Stradins UniversityUniversity of TurkuRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Periodontal Disease | Periodontal Regeneration | Periodontal Healing | Periodontal Granulation Tissue | Vertical Periodontal Bone DefectsLatvia
-
Ohio State UniversityNot yet recruitingPeriodontal Disease | Periodontal SurgeryUnited States
-
G. d'Annunzio UniversityRecruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, PeriodontalAlbania
-
Saglik Bilimleri UniversitesiRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Intrabony Periodontal Defect | Periodontal DefectTurkey (Türkiye)
-
University of Roma La SapienzaActive, not recruitingPeriodontal Disease | Periodontal Disease, AVDC Stage 3 | Periodontal Disease Stage 2Italy
-
Siddharth ShanbhagUniversidad Complutense de MadridNot yet recruitingPeriodontal Disease | Intrabony Periodontal DefectsNorway, Spain
-
Kafrelsheikh UniversityActive, not recruitingPeriodontal Diseases | Periodontal Attachment LossEgypt
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontitis | Periodontal Attachment Loss | Periodontal Inflammation | Pocket, PeriodontalIndia
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
Clinical Trials on Gingival crevicular fluid collection
-
Hacer Sahin AydinyurtCompletedPeriodontal Diseases | Preeclampsia
-
Abant Izzet Baysal UniversityRecruiting
-
Ondokuz Mayıs UniversityCompletedPeriodontal Diseases | Oral Hygiene | OrthodonticsTurkey
-
University of MichiganCompleted
-
Cumhuriyet UniversityKırıkkale UniversityCompletedPeriodontal Diseases | Alveolar Bone Loss | Periodontal InflammationTurkey (Türkiye)
-
Baskent UniversityCompletedChronic Periodontitis
-
Uşak UniversityCompleted
-
Ondokuz Mayıs UniversityCompletedPeriodontal Diseases | Neurogenic Inflammation | Periimplant Diseases | Gingival Crevicular Fluid | Periimplant Sulcular Fluid
-
Bezmialem Vakif UniversitySelcuk UniversityCompletedPeriodontal Diseases
-
University of MessinaCompleted