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| ID | Type | Description | Link |
|---|---|---|---|
| 12796 | Other Identifier | Fundeni Clinical Institute Ethical Committee | |
| PERIO-RA-RE_1 | Other Identifier | Fundeni Clinical Institute - Adult Nephrology Department |
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| Name | Class |
|---|---|
| Institutul Clinic Fundeni | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alport Syndrome | Patients with Alport syndrome confirmed by genetic testing or kidney biopsy |
| |
| Fabry Disease | Patients with enzymatic or genetically confirmed Fabry disease |
| |
| Tuberous Sclerosis Complex | Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria |
| |
| Systemic Lupus Erythematosus | Systemic lupus erythematosus defined according to EULAR/ACR 2019 classification criteria, with renal involvement defined by at least one of the following:
|
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| CKD Controls | Patients with chronic kidney disease of non-rare etiology |
| |
| Population Controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational assessment | Other | Non-interventional observational assessment including periodontal examination and clinical data collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Periodontitis | Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases. | At the single study visit (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Probing Pocket Depth (PPD) | Mean probing pocket depth (in millimeters) measured across all examined sites during full-mouth periodontal examination. | At the single study visit (baseline) |
| Mean Clinical Attachment Level (CAL) |
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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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan N Lujinschi, MD, PhD candidate | Contact | +40728102643 | stefanlujinschi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gener Ismail, Professor, MD, PhD | Fundeni Clinical Institute | Study Chair |
| Bahtiar Ismail, MD, PhD | Emergency University Hospital Bucharest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundeni Clinical Institute | Recruiting | Bucharest | 022328 | Romania |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| D051436 | Renal Insufficiency, Chronic |
| D009394 | Nephritis, Hereditary |
| D000795 | Fabry Disease |
| D008180 | Lupus Erythematosus, Systemic |
| D014402 | Tuberous Sclerosis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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Individuals without known chronic kidney disease |
|
Mean clinical attachment level (in millimeters) measured across all examined sites during full-mouth periodontal examination.
| 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. | 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. | At the single study visit (baseline) |
| Prevalence of Gingivitis | Proportion of participants with clinical signs of gingival inflammation without attachment loss, consistent with gingivitis. | 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. | 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. | At the single study visit (baseline) |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014564 | Urogenital Abnormalities |
| D009393 | Nephritis |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D008661 | Metabolism, Inborn Errors |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |