NCT07575347Recruiting
Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 3 May 2026
- Start date
- 4 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Stefan Lujinschi
- Diseases
- Chronic kidney disease, Lupus (SLE), Fabry disease
- NCT number
- NCT07575347
What you commit to
- Study type: Observational
- Planned participants: 100
- From 4 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic therapy within the last 4 weeks
Other illness
- Conditions precluding periodontal examination
Other
- Periodontal treatment within the last 6 months
- Pregnancy
- Inability to comply with study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.