NCT07575347 Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
| NCT ID | NCT07575347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stefan Lujinschi |
| Condition | Periodontal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-05-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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: 1. Alport syndrome (genetically or clinically confirmed) 2. Fabry disease (enzymatically or genetically confirmed) 3. Tuberous sclerosis complex (according to established clinical or genetic criteria) 4. 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 5. 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) 6. 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
Contact & Investigator
Gener Ismail, Professor, MD, PhD
STUDY CHAIR
Fundeni Clinical Institute
Frequently Asked Questions
Who can join the NCT07575347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07575347 currently recruiting?
Yes, NCT07575347 is actively recruiting participants. Contact the research team at stefanlujinschi@gmail.com for enrollment information.
Where is the NCT07575347 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT07575347 clinical trial?
NCT07575347 is sponsored by Stefan Lujinschi. The principal investigator is Gener Ismail, Professor, MD, PhD at Fundeni Clinical Institute. The trial plans to enroll 100 participants.