An observational study in Periodontal Disease, Periodontitis and CKD, sponsored by Stefan Lujinschi. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Stefan Lujinschi · Observational
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 372 observational studies indexed under Periodontitis.
Browse Periodontitis studies →Stefan Lujinschi is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Belonging to one of the predefined study groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Alport syndrome confirmed by genetic testing or kidney biopsy
Other: Observational assessment
Patients with enzymatic or genetically confirmed Fabry disease
Other: Observational assessment
Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria
Other: Observational assessment
Systemic lupus erythematosus defined according to EULAR/ACR 2019 classification criteria, with renal involvement defined by at least one of the following: * Biopsy-proven lupus nephritis * Persistent proteinuria (\>0.5 g/day or equivalent) * Active urinary sediment (hematuria and/or cellular casts) consistent with lupus nephritis
Other: Observational assessment
Patients with chronic kidney disease of non-rare etiology
Other: Observational assessment
Individuals without known chronic kidney disease
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Prevalence of Periodontitis
Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.
Time frame: At the single study visit (baseline)
Mean Probing Pocket Depth (PPD)
Mean probing pocket depth (in millimeters) measured across all examined sites during full-mouth periodontal examination.
Time frame: At the single study visit (baseline)
Mean Clinical Attachment Level (CAL)
Mean clinical attachment level (in millimeters) measured across all examined sites during full-mouth periodontal examination.
Time frame: At the single study visit (baseline)
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.
Time frame: At the single study visit (baseline)
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.
Time frame: At the single study visit (baseline)
Prevalence of Gingivitis
Proportion of participants with clinical signs of gingival inflammation without attachment loss, consistent with gingivitis.
Time frame: At the single study visit (baseline)
Prevalence of Xerostomia
Proportion of participants reporting subjective dry mouth symptoms or presenting clinical evidence of reduced salivary flow.
Time frame: At the single study visit (baseline)
Presence of Disease-Specific Oral Findings
Presence of oral manifestations associated with underlying systemic disease, such as gingival fibromas, mucosal lesions, or enamel defects.
Time frame: At the single study visit (baseline)
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
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Stefan Lujinschi