Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational assessment.
- Who it may be relevant to
- Registry conditions: Periodontal Disease, Periodontitis, CKD, Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease
Overview
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.
Detailed description
Periodontal disease is a chronic inflammatory condition associated with systemic inflammation and has been linked to chronic kidney disease (CKD) severity and outcomes. However, data regarding periodontal disease in rare kidney disorders remain limited.
Rare renal diseases such as Alport syndrome, Fabry disease, and tuberous sclerosis complex, as well as systemic lupus erythematosus (SLE), may present unique biological and treatment-related factors influencing periodontal health.
This study is a cross-sectional, controlled observational study designed to evaluate the prevalence and severity of periodontal disease in these populations.
Participants will be recruited from Fundeni Clinical Institute Adult Nephrology Department and general population sources. Each participant will undergo a single study visit including a standardized full-mouth periodontal examination performed by a calibrated dentist, a structured questionnaire, and extraction of clinical data from medical records.
The primary outcome is the prevalence of periodontitis, defined according to the 2018 classification of periodontal diseases. Secondary outcomes include measures of periodontal disease severity and associated oral conditions.
Statistical analyses will include descriptive statistics, group comparisons, and multivariable regression models adjusted for relevant confounders.
Interventions
- Other Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Primary outcome measures
- Prevalence of Periodontitis [Time frame: At the single study visit (baseline)]
Secondary outcome measures (7)
- Mean Probing Pocket Depth (PPD) [Time frame: At the single study visit (baseline)]
- Mean Clinical Attachment Level (CAL) [Time frame: At the single study visit (baseline)]
- Percentage of Sites with Probing Pocket Depth ≥6 mm [Time frame: At the single study visit (baseline)]
- Percentage of Sites with Bleeding on Probing (BOP) [Time frame: At the single study visit (baseline)]
- Prevalence of Gingivitis [Time frame: At the single study visit (baseline)]
- Prevalence of Xerostomia [Time frame: At the single study visit (baseline)]
- Presence of Disease-Specific Oral Findings [Time frame: At the single study visit (baseline)]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Ability to provide written informed consent
- At least 10 natural teeth present
- Belonging to one of the predefined study groups:
- Alport syndrome (genetically or clinically confirmed)
- Fabry disease (enzymatically or genetically confirmed)
- Tuberous sclerosis complex (according to established clinical or genetic criteria)
- Systemic lupus erythematosus defined according to the 2019 EULAR/ACR 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/day or equivalent), \[3\] Active urinary sediment (hematuria and/or cellular casts) consistent with lupus nephritis
- Chronic kidney disease (CKD) of non-rare etiology: defined according to KDIGO criteria (eGFR <60 ml/min/1.73 m² and/or markers of kidney damage)
- Individuals without CKD, recruited from clinical or dental care settings as non-CKD controls
Exclusion criteria
- Periodontal treatment within the last 6 months
- Antibiotic therapy within the last 4 weeks
- Pregnancy
- Conditions precluding periodontal examination
- Inability to comply with study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Romania · 1 center
- Fundeni Clinical Institute — Bucharest
Identifiers
NCT: NCT07575347 · 12796 · 12796 · PERIO-RA-RE_1