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NCT Number: NCT07575347

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

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.

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Key information

Conditions

Periodontal Disease Alport Syndrome Autoimmune Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn CKD Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Chronic Disease Chronic Kidney Disease Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Disease Attributes Fabry Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genetic Diseases, X-Linked Hamartoma Heredodegenerative Disorders, Nervous System Immune System Diseases Kidney Diseases Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lupus Erythematosus, Systemic Lupus or SLE Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Male Urogenital Diseases Malformations of Cortical Development Malformations of Cortical Development, Group I Metabolic Diseases Metabolism, Inborn Errors Mouth Diseases Neoplasms Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nephritis Nephritis, Hereditary Nervous System Diseases Nervous System Malformations Neurocutaneous Syndromes Neurodegenerative Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Renal Insufficiency Renal Insufficiency, Chronic Skin and Connective Tissue Diseases Sphingolipidoses Stomatognathic Diseases Systemic Lupus Erythematosus (SLE) Tuberous Sclerosis Tuberous Sclerosis Complex (TSC) Urogenital Abnormalities Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location status: Recruiting

Location contact

Bahtiar Ismail, MD, PhD

PRINCIPAL_INVESTIGATOR

Stefan N Lujinschi, MD, PhD candidate

CONTACT

[email protected]

+40728102643

Stefan N Lujinschi, MD, PhD candidate

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Assessment

Other

Non-interventional observational assessment including periodontal examination and clinical data collection.

Primary outcomes

  1. Prevalence of Periodontitis

    Time frame: At the single study visit (baseline)

    Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.

Secondary outcomes

  1. Mean Probing Pocket Depth (PPD)

    Time frame: At the single study visit (baseline)

    Mean probing pocket depth (in millimeters) measured across all examined sites during full-mouth periodontal examination.

  2. Mean Clinical Attachment Level (CAL)

    Time frame: At the single study visit (baseline)

    Mean clinical attachment level (in millimeters) measured across all examined sites during full-mouth periodontal examination.

  3. Percentage of Sites with Probing Pocket Depth ≥6 mm

    Time frame: At the single study visit (baseline)

    Percentage of periodontal sites with probing pocket depth of 6 mm or greater, reflecting severe periodontal involvement.

  4. Percentage of Sites with Bleeding on Probing (BOP)

    Time frame: At the single study visit (baseline)

    Percentage of periodontal sites exhibiting bleeding on probing during full-mouth periodontal examination, as a marker of gingival inflammation.

  5. Prevalence of Gingivitis

    Time frame: At the single study visit (baseline)

    Proportion of participants with clinical signs of gingival inflammation without attachment loss, consistent with gingivitis.

  6. Prevalence of Xerostomia

    Time frame: At the single study visit (baseline)

    Proportion of participants reporting subjective dry mouth symptoms or presenting clinical evidence of reduced salivary flow.

  7. Presence of Disease-Specific Oral Findings

    Time frame: At the single study visit (baseline)

    Presence of oral manifestations associated with underlying systemic disease, such as gingival fibromas, mucosal lesions, or enamel defects.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan N Lujinschi, MD, PhD candidate

CONTACT

[email protected]

+40728102643

Sponsors and collaborators

Lead sponsor

Stefan Lujinschi

Other

Collaborators

  • Institutul Clinic Fundeni

Registry information

Official study title

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

Acronym: PERIO-RA-RE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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