[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638972":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":39,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":76,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":10,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":101,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Institutul Clinic Fundeni","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Alport Syndrome",null,"Patients with Alport syndrome confirmed by genetic testing or kidney biopsy",[13],"Other: Observational assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Fabry Disease","Patients with enzymatic or genetically confirmed Fabry disease",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Tuberous Sclerosis Complex","Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Systemic Lupus Erythematosus","Systemic lupus erythematosus defined according to EULAR\u002FACR 2019 classification criteria, with renal involvement defined by at least one of the following:\n\n* Biopsy-proven lupus nephritis\n* Persistent proteinuria (\\>0.5 g\u002Fday or equivalent)\n* Active urinary sediment (hematuria and\u002For cellular casts) consistent with lupus nephritis",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"CKD Controls","Patients with chronic kidney disease of non-rare etiology",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Population Controls","Individuals without known chronic kidney disease",[13],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Observational assessment","Non-interventional observational assessment including periodontal examination and clinical data collection.",[9,27,15,31,23,19],[40,44],{"name":41,"affiliation":42,"role":43},"Gener Ismail, Professor, MD, PhD","Fundeni Clinical Institute","STUDY_CHAIR",{"name":45,"affiliation":46,"role":47},"Bahtiar Ismail, MD, PhD","Emergency University Hospital Bucharest","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":10,"email":53},"Stefan N Lujinschi, MD, PhD candidate","CONTACT","+40728102643","stefanlujinschi@gmail.com",[55],{"facility":42,"status":56,"city":57,"state":10,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Bucharest","022328","Romania","RO",{"type":62,"coordinates":63},"Point",[64,65],26.10626,44.43225,{"lat":65,"lon":64},[68,69,71],{"name":50,"role":51,"phone":52,"phoneExt":10,"email":53},{"name":50,"role":70,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":45,"role":47,"phone":10,"phoneExt":10,"email":10},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Stefan Lujinschi","MD, PhD candidate",[77],{"name":5,"class":6},"100638972","periodontal-disease-in-rare-renal-disorders-perio-ra-re-100638972",false,"NCT07575347","Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)","Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease","PERIO-RA-RE","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* At least 10 natural teeth present\n* Belonging to one of the predefined study groups:\n\n  1. Alport syndrome (genetically or clinically confirmed)\n  2. Fabry disease (enzymatically or genetically confirmed)\n  3. Tuberous sclerosis complex (according to established clinical or genetic criteria)\n  4. Systemic lupus erythematosus defined according to the 2019 EULAR\u002FACR or SLICC 2012 classification criteria, with renal involvement defined by at least one of the following: \\[1\\] Biopsy-proven lupus nephritis, \\[2\\] Persistent proteinuria (\\>0.5 g\u002Fday or equivalent), \\[3\\] Active urinary sediment (hematuria and\u002For cellular casts) consistent with lupus nephritis\n  5. Chronic kidney disease (CKD) of non-rare etiology: defined according to KDIGO criteria (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m² and\u002For markers of kidney damage)\n  6. Individuals without CKD, recruited from clinical or dental care settings as non-CKD controls\n\nExclusion Criteria:\n\n* Periodontal treatment within the last 6 months\n* Antibiotic therapy within the last 4 weeks\n* Pregnancy\n* Conditions precluding periodontal examination\n* Inability to comply with study procedures","ALL","18 Years",{"count":89,"type":90},100,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls.\n\nThis is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data.\n\nThe primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes.\n\nExploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.",[94,95,96,97,9,15,98,99,100],"Periodontal Disease","Periodontitis","CKD","Chronic Kidney Disease","Lupus or SLE","Tuberous Sclerosis Complex (TSC)","Systemic Lupus Erythematosus (SLE)",[94,95,96,102,103,23,99,97],"Rare Kidney Diseases","Alport syndrome","2026-06-24",{"date":106,"type":107},"2026-06-26","ACTUAL",{"date":109,"type":107},"2026-05-04",{"date":111,"type":90},"2027-12-31",{"name":74,"class":6},1]