Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
NCT07575347 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-05-08
Summary
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.
This 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.
The 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.
Exploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.
Conditions
- Periodontal Disease
- Periodontitis
- CKD
- Chronic Kidney Disease
- Alport Syndrome
- Fabry Disease
- Lupus or SLE
- Tuberous Sclerosis Complex (TSC)
- Systemic Lupus Erythematosus (SLE)
Interventions
- OTHER
-
Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Sponsors & Collaborators
-
Institutul Clinic Fundeni
collaborator OTHER -
Stefan Lujinschi
lead OTHER
Principal Investigators
-
Gener Ismail, Professor, MD, PhD · Fundeni Clinical Institute
-
Bahtiar Ismail, MD, PhD · Emergency University Hospital Bucharest
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-04
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Romania
Study Locations
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