ClinicalTrials.gov record NCT07575347

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationRomania
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a cross-sectional, case-control observational study that compares periodontal disease across adults with selected rare kidney disorders (Alport syndrome, Fabry disease, tuberous sclerosis complex), people with SLE and renal involvement, people with CKD of non-rare causes, and people without CKD. Each participant has a single study visit with a full-mouth periodontal exam, a structured questionnaire, and clinical/nephrology data collection from medical records. The main aim is to compare the prevalence of periodontitis; secondary aims include measuring disease severity and other oral findings.

What it is studying. Whether and how the frequency and characteristics of periodontal disease differ between people with selected rare renal disorders, SLE with renal involvement, CKD controls, and people without CKD, and how periodontal findings relate to kidney-related clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.

What the researchers hope to learn. Compare prevalence of periodontitis across study groups; characterize periodontal severity (pocket depth, attachment loss, bleeding on probing), prevalence of gingivitis and xerostomia, and presence of disease-specific oral signs; explore associations between periodontal findings and kidney function, proteinuria, and immunosuppressive exposure.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Observational assessment

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in one single study visit that includes a standardized full‑mouth periodontal examination performed by a calibrated dentist and a structured questionnaire about oral health and symptoms (for example dry mouth). Study staff will review your medical and nephrology records to collect relevant clinical data. This is an observational assessment only—no study treatments are given. You will be asked about recent dental treatments and antibiotic use because recent periodontal therapy or antibiotics are exclusion criteria.

How the study is structured. A cross-sectional, case-control observational study. Participants attend one standardized visit for a calibrated dentist to perform a full-mouth periodontal examination, complete a questionnaire, and permit extraction of relevant clinical and nephrology data from their records. No treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Romania. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Fabry disease

This trial is also listed on this site under tuberous sclerosis complex.

Clinical trials47 trials listed for Fabry diseaseEvery trial the registry lists for Fabry disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Fabry disease researchLatest monthly update: September 2026. Includes: SGLT2 outcome link. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 4, 2026
Primary completion
Dec 31, 2027 (estimated)
Study completion
Dec 31, 2027 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Jun 26, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Stefan Lujinschi
Collaborators
  • Institutul Clinic Fundeni

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Fundeni Clinical InstituteRecruiting

    Bucharest, 022328 · Romania

Terms used on this page · explanations by MedicalUpdates.ai

primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Biopsy-proven
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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