Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-18 @ 2:19 AM
Study NCT ID:
NCT07154420
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Health and Quality of Life in Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of oral health-related quality of life in psoriasis patients', 'timeFrame': 'Baseline', 'description': 'The Turkish version of the OHIP-14 questionnaire was administered through face-to-face interviews by a single investigator (G.U.), who was blinded to the periodontal status of the participants. The OHIP-14 consists of seven subscales, each including two items: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants rated the frequency of negative experiences on a five-point Likert scale (0 = never, 1 = rarely, 2 = occasionally, 3 = quite often, 4 = very often). The total score ranges from 0 to 56, with higher scores reflecting a greater negative impact on oral health-related quality of life'}], 'secondaryOutcomes': [{'measure': 'Evaluation of dermatology-specific quality of life in psoriasis patients', 'timeFrame': 'Baseline', 'description': 'Psoriasis Quality of Life Questionnaire (PQLQ) measures functional limitation, physical discomfort, psychological distress, social maladjustment, and disability. Each item was scored on a Likert-type scale, with higher scores reflecting a greater impact on daily life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis,periodontitis'], 'conditions': ['Psoriasis', 'Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the relationship between psoriasis, a chronic inflammatory skin disease, and oral health. We will assess the periodontal (gum) condition of patients with psoriasis and examine how it affects their quality of life. A group of psoriasis patients and a control group without psoriasis will undergo oral examinations and complete a short questionnaire. The goal is to better understand whether psoriasis has an impact on gum health and daily well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants aged 18 to 65 years, clinically diagnosed with active psoriasis, and applying to the Dermatology and Venereal Diseases Department outpatient clinic of the Gulhane Faculty of Medicine were recruited into the test group (n=113). The control group consisted of healthy individuals without any dermatological or systemic diseases (n=113).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 18 to 65 years\n* Clinically diagnosed with active psoriasis\n* The presence of at least 12 teeth (excluding third molars)\n* Absence of contraindications for periodontal clinical examination\n\nExclusion Criteria:\n\n* Other dermatological conditions\n* Pregnancy or lactation\n* Antibiotic use within the last 3 months\n* Chemotherapy or radiotherapy within the last year\n* Periodontal treatment within the last 6 months'}, 'identificationModule': {'nctId': 'NCT07154420', 'briefTitle': 'Periodontal Health and Quality of Life in Psoriasis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Periodontal Status and Quality of Life in Patients With Psoriasis: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'GUSTAOGLU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'psoriasis patient group', 'interventionNames': ['Diagnostic Test: Diagnostic Test: Periodontal Examination']}, {'label': 'healthy control group', 'interventionNames': ['Diagnostic Test: Diagnostic Test: Periodontal Examination']}], 'interventions': [{'name': 'Diagnostic Test: Periodontal Examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic Test: Periodontal Examination', 'armGroupLabels': ['healthy control group', 'psoriasis patient group']}, {'name': 'Diagnostic Test: Periodontal Examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Periodontal Examination', 'armGroupLabels': ['healthy control group', 'psoriasis patient group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Sağlık Bilimleri Üniversitesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Gülbahar Ustaoğlu', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}