Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)

Sponsor
Stefan Lujinschi
Study ID
NCT07575347
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational assessment — OTHER
    Non-interventional observational assessment including periodontal examination and clinical data collection.

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Alport Syndrome
    Patients with Alport syndrome confirmed by genetic testing or kidney biopsy
  • Arm: Fabry Disease
    Patients with enzymatic or genetically confirmed Fabry disease
  • Arm: Tuberous Sclerosis Complex
    Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria
  • Arm: Systemic Lupus Erythematosus
    Systemic lupus erythematosus defined according to EULAR/ACR 2019 classification criteria, with renal involvement defined by at least one of the following: * Biopsy-proven lupus nephritis * Persistent proteinuria (\>0.5 g/day or equivalent) * Active urinary sediment (hematuria and/or cellular casts) consistent with lupus nephritis
  • Arm: CKD Controls
    Patients with chronic kidney disease of non-rare etiology
  • Arm: Population Controls
    Individuals without known chronic kidney disease

Primary Outcome Measure

Prevalence of Periodontitis [ Time Frame: At the single study visit (baseline) ]

Central Contacts

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