Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07294456
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periodontal Findings in HS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D004368', 'term': 'Dry Socket'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association Between Periodontal Status and Hidradenitis Suppurativa Severity', 'timeFrame': 'Baseline (single assessment)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HİDRADENİTİS SUPPURATİVA', 'PERİODONTAL DİSEASE', 'PERİODONTİTİS', 'GİNGİVAL İNFLAMMATİON'], 'conditions': ['HİDRADENİTİS SUPPURATİVA']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aims to evaluate the periodontal status of individuals diagnosed with hidradenitis suppurativa (HS) and to compare them with systemically healthy controls. HS is a chronic inflammatory skin disease characterized by recurrent lesions and systemic inflammation, which may influence periodontal health. In this study, periodontal parameters-including probing depth, clinical attachment loss, gingival index, plaque index, and bleeding on probing-will be assessed using standard clinical methods. Dermatological examination will include disease duration, lesion characteristics, and Hurley staging. The study will investigate the prevalence of periodontitis in HS patients and explore potential associations between periodontal findings and HS severity. Findings from this research may provide insight into shared inflammatory pathways and contribute to understanding the possible link between HS and periodontal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult individuals with a confirmed diagnosis of hidradenitis suppurativa and age-matched healthy controls, each having at least 12 teeth (excluding third molars), and no recent periodontal or systemic treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aving a diagnosis of hidradenitis suppurativa.\n\nAge greater than 18 years.\n\nPresence of at least 12 teeth in the mouth, excluding third molars.\n\nExclusion Criteria:\n\n* Age under 18 years.\n\nPregnancy.\n\nBreastfeeding.\n\nReceiving treatment for periodontitis or hidradenitis suppurativa within the past 3 months.\n\nUse of antibiotics, anti-inflammatory drugs, or immunomodulatory medications within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT07294456', 'briefTitle': 'Periodontal Findings in HS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Evaluation of Periodontal Status in Individuals With Hidradenitis Suppurativa: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'SUDE1824'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hidradenitis Suppurativa Group', 'description': 'Participants diagnosed with hidradenitis suppurativa undergoing periodontal examination.', 'interventionNames': ['Other: No intervention (observational study)']}, {'label': 'Healthy Control Group', 'description': 'Systemically healthy individuals without hidradenitis suppurativa undergoing periodontal examination.', 'interventionNames': ['Other: No intervention (observational study)']}], 'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'Observational study with no treatment or intervention applied.', 'armGroupLabels': ['Healthy Control Group', 'Hidradenitis Suppurativa Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6220', 'city': 'Ankara', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Gülhane Faculty of Dentistry', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSİSTANT PROFESSOR', 'investigatorFullName': 'Şeyma Çardakçı', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}