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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStefan Lujinschi

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years

Ability to provide written informed consent

At least 10 natural teeth present

Alport syndrome (genetically or clinically confirmed)

Disqualifiers

Periodontal treatment within the last 6 months

Antibiotic therapy within the last 4 weeks

Pregnancy

Conditions precluding periodontal examination

Trial design

Treatments tested in this trial

  • Observational assessment

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Stefan Lujinschi

Lead sponsor

Institutul Clinic Fundeni

Sponsor institution

Institutul Clinic Fundeni

Collaborator