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PsoriasisNCT07158125

Pathogenesis of Periodontal Disease in Individuals With Psoriasis

An observational study of Psoriasis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate the levels of Th17 cell-associated cytokines (IL-17, IL-21, IL-23) and the salivary stress biomarkers cortisol, dehydroepiandrosterone, and Chromogranin A in the pathogenesis of periodontal disease in individuals with psoriasis, thereby revealing immunological and neuroendocrine… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2025to 6 Apr 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with psoriasis who came to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment

Who may be able to join

  • Being between the ages of 18 and 65
  • Being diagnosed with psoriasis by a dermatologist
  • Having at least 20 teeth
  • Not having received periodontal treatment in the last 6 months
  • Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks
  • Not having any autoimmune disease, osteoporosis, or cancer
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  • Not using immunosuppressive drugs, oral contraceptives, or bisphosphonates
  • Not being pregnant
  • Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)
  • Not using chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)
  • Not having taken antioxidant supplements in the last 6 months

Who cannot join

  • <20 teeth
  • Any significant oral infection (i.e., herpes or candidiasis)
  • Oral injuries or bleeding unrelated to periodontitis
  • Periodontal therapy and antibiotic therapy within the past 3 months
  • Salivary gland dysfunction
  • Acute illness (fever, sore throat)
Show all 9Show fewer
  • Systemic illness, mental illness, immunosuppressive drugs or immunodeficiency
  • Pregnancy or breastfeeding
  • Use of antidepressants

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oguz KOSE, Professor Dr. contact

+90 541 348 64 65

oguz.kose@erdogan.edu.tr

Turkey (Türkiye)1 site
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University

    Rize, Rize Province, 53200

    RTEU Faculty of Dentistry, Department of Periodontology, +90 464 222 00 00, dis@erdogan.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Role of Th17 and Stress-related Neuroendocrine Markers in the Pathogenesis of Periodontal Disease in Individuals With Psoriasis

The aim of this study is to evaluate the levels of Th17 cell-associated cytokines (IL-17, IL-21, IL-23) and the salivary stress biomarkers cortisol, dehydroepiandrosterone, and Chromogranin A in the pathogenesis of periodontal disease in individuals with psoriasis, thereby revealing immunological and neuroendocrine interactions.

The fundamental question it aims to answer is:

Read more

What are the biological mechanisms that may increase the risk of periodontal disease in individuals with psoriasis?

In this context, the periodontal status of individuals with psoriasis will be clinically assessed, followed by analysis of the levels of Th17-associated cytokines and stress biomarkers in gingival crevicular fluid and saliva samples. Additionally, patients will be asked questions from the Social Appearance Anxiety Scale. The periodontal status of individuals with psoriasis will be determined cross-sectionally, and the resulting biomarker levels will be examined. In addition, the data obtained will be evaluated with statistical analysis in relation to disease severity and clinical parameters.

Read the detailed description

Psoriasis and periodontitis are chronic inflammatory diseases, and Th17 cells and their secreted cytokines, such as IL-17, IL-21, and IL-23, have been shown to play a significant role in the pathogenesis of both. Recent studies suggest a possible immunological link between these two diseases. Furthermore, in a stress-induced disease like psoriasis, the effects of chronic stress on the immune system are attracting increasing attention. The interaction of neuroendocrine markers, such as cortisol, dehydroepiandrosterone (DHEA), and chromogranin A (CgA), released via the hypothalamic-pituitary-adrenal axis, with immune responses and inflammatory processes may play a significant role in the development of periodontal disease.

This project will jointly examine the immunological and neuroendocrine basis of periodontal disease in individuals with psoriasis. Cortisol, DHEA, and CgA levels will be measured in saliva samples, and the relationship between these biomarkers and periodontal parameters will be analyzed. Cytokine levels related to the Th17 pathways will be examined in gingival crevicular fluid to reveal the impact of psoriasis on periodontal tissue. The Social Appearance Anxiety Scale will also be administered. All data obtained will be statistically analyzed.

In this context, this study aims to investigate the role of these two chronic and inflammatory diseases (periodontitis and psoriasis) in the Th17 axis based on stress biomarkers (IL-17, IL-21, and IL-23). Thus, we plan to evaluate the relationship between periodontitis and psoriasis biochemically using salivary stress markers (cortisol, DHEA, and CgA) and to evaluate the immunopathogenesis of Th17.

The findings of this study may significantly contribute to clinical practice regarding the early diagnosis and management of periodontal disease in individuals with psoriasis. It also aims to encourage multidisciplinary approaches by providing a holistic understanding of the effects of stress on the immune system and periodontal health.

Conditions
Psoriasis
Keywords
psoriasis, periodontitis, Th17, cortisol, dehydroepiandrosterone, chromogranin A
Medical subject headings
Psoriasis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07158125
Study groupRoleWhat they receive
No psoriasis severityPatients with a PASI (Psoriasis Area and Severity Index) score of 0
Mild psoriasis severityPatients with a PASI (Psoriasis Area and Severity Index) score of 1-10
Moderate psoriasis severityPatients with a PASI (Psoriasis Area and Severity Index) score of 10-20
Severe psoriasisPatients with a PASI (Psoriasis Area and Severity Index) score of >20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gingival Crevicular Fluid (GCF) Collection

    Specimens will be collected from four different teeth from each participant, each with the deepest pocket. Before collection, supragingival plaque will be gently removed with sterile curettes, the surfaces will be dried, and the tissue will be isolated with cotton rolls. Filter paper strips will be carefully inserted into the sulcus until slight resistance is felt, or no deeper than 1 mm to prevent mechanical trauma in patients with periodontitis. The strips will be left in the sulcus/pocket for 30 seconds. The GCF volume of each strip will be measured using a pre-calibrated electronic device (Peritron 8000). Four strips from each participant will be placed in coded sterile Eppendorf tubes and stored at -80°C until analysis.

    Measured: Day 1

  2. Saliva sampling

    Prior to saliva collection, participants will be instructed to abstain from caffeine and/or nicotine for at least 4 hours and alcohol for at least 24 hours. Participants will be asked to rinse their mouth with water and wait 5 minutes to prevent contamination. After waiting, they will be asked to collect saliva in the bottom of their mouth and then spit into a sterile metal cup for another 5 minutes. Unstimulated saliva samples will be transferred to sterile Eppendorf tubes. Saliva flow rate will be calculated by dividing the total saliva volume by the collection time for each participant. Samples will be stored at -80°C until the day of laboratory analysis.

    Measured: Day 1

  3. Clinical Periodontal Parameters (Plaque Index)

    Plaque Index (PI) (Silness and Löe, 1964) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth.

    Score Description 0 No plaque.

    1. No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.
    2. Visible plaque along the gingival margin, forming a continuous band.
    3. Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.

    Measured: Day 1

  4. Clinical Periodontal Parameters (Gingival Index)

    The Gingival Index is used to assess the presence and severity of gingival inflammation (gingivitis).

    Four surfaces of each tooth (buccal, lingual, mesial, distal) are examined visually and with a periodontal probe. The evaluation considers color changes, edema (swelling), tissue consistency, and bleeding on probing. Each surface is scored from 0 to 3.

    The average score per tooth is calculated, and then the overall average is used to determine the individual's GI score.

    Score Description 0 Healthy gingiva: normal color and texture, no bleeding

    1. Mild inflammation: slight color change and swelling, no bleeding on probing
    2. Moderate inflammation: redness, edema, soft tissue, bleeding on probing
    3. Severe inflammation: marked redness and swelling, ulceration, possible spontaneous bleeding

    Measured: Day 1

  5. Periodontal Clinical Parametres (Bleeding on Probing Index)

    This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation.

    Score Description:

    0 No bleeding

    1 Bleeding present (mild or severe)

    Measured: Day 1

  6. Periodontal Clinical Parametres (Probing Pocket Depth)

    Using a Williams periodontal probe, the distance between the gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.

    Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket

    ≥6 mm Deep periodontal pocket (advanced disease)

    Measured: Day 1

  7. Periodontal Clinical Parametres (Clinical Attachment Loss)

    Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.

    CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss

    ≥6 mm Severe attachment loss

    Measured: Day 1

  8. Application of the Social Appearance Anxiety Scale

    This 16-item scale concerns how patients feel about their appearance. Each item is scored from 1 to 5 as follows: 1, strongly disagree; 2, somewhat disagree; 3, unsure; 4, somewhat agree; and 5, strongly agree. Scores range from 16 to 80, with higher scores representing greater social appearance anxiety.

    Measured: Day 1

Secondary outcomes (1)
  1. Analysis of cortisol, dehidroepiandrosteron (DHEA) and chromogranin A

    Salivary cortisol, DHEA, and chromogranin A will be obtained from unstimulated whole saliva samples. Human salivary cortisol will be measured using a commercial enzyme-linked immunosorbent assay (ELISA) radioenzyme immunoassay kit according to the manufacturer's instructions. An ELISA kit will be used to measure DHEA, and the Human Chromogranin A ELISA Kit will be used to measure chromogranin A levels. Saliva samples will be kept on ice and stored at -20°C until analyzed. On the day of analysis, saliva samples will be centrifuged at 2000×g for 10 minutes to remove particulate material. All samples will be processed in triplicate during the same assay. Statistical analyses will be performed using the average of three replicate measurements.

    Measured: 5th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion2 Feb 2026 (estimated)
  4. Study completion6 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158125
Sponsor's protocol ID
periopsoriasis06/2025
Status last verified
Aug 2025
First submitted
28 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oguz KOSE, Professor Dr. (+90 541 348 64 65, oguz.kose@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival Crevicular Fluid (GCF) Collection (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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