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
This trial does not accept healthy volunteersQualifiers
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 population
Adult participants will be recruited from the Adult Nephrology Department of the Fundeni Clinical Institute, as well as from associated rare disease follow-up programs and dental or clinical care settings. The study population will include patients with Alport syndrome, Fabry disease, tuberous sclerosis complex, and systemic lupus erythematosus with renal involvement, as well as CKD controls with non-rare etiologies and non-CKD controls recruited from clinical or dental care settings. Participants will be enrolled consecutively based on eligibility criteria.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Observational assessment
Other interventionNon-interventional observational assessment including periodontal examination and clinical data collection.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Prevalence of Periodontitis
Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.
Secondary outcomes
Mean Probing Pocket Depth (PPD)
Mean probing pocket depth (in millimeters) measured across all examined sites during full-mouth periodontal examination.
Mean Clinical Attachment Level (CAL)
Mean clinical attachment level (in millimeters) measured across all examined sites during full-mouth periodontal examination.
Percentage of Sites with Probing Pocket Depth ≥6 mm
Percentage of periodontal sites with probing pocket depth of 6 mm or greater, reflecting severe periodontal involvement.
Percentage of Sites with Bleeding on Probing (BOP)
Percentage of periodontal sites exhibiting bleeding on probing during full-mouth periodontal examination, as a marker of gingival inflammation.
Sponsors and contacts
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Stefan Lujinschi
Lead sponsor
Institutul Clinic Fundeni
Sponsor institution
Institutul Clinic Fundeni
Collaborator