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

May 3, 2026 updated by: Stefan Lujinschi

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute
        • Contact:
        • Sub-Investigator:
          • Stefan N Lujinschi, MD, PhD candidate
        • Principal Investigator:
          • Bahtiar Ismail, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alport Syndrome
Patients with Alport syndrome confirmed by genetic testing or kidney biopsy
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Fabry Disease
Patients with enzymatic or genetically confirmed Fabry disease
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Tuberous Sclerosis Complex
Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
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:

  • 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
Non-interventional observational assessment including periodontal examination and clinical data collection.
CKD Controls
Patients with chronic kidney disease of non-rare etiology
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.
Population Controls
Individuals without known chronic kidney disease
Other: Observational assessment
Non-interventional observational assessment including periodontal examination and clinical data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Periodontitis
Time Frame: At the single study visit (baseline)
Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.
At the single study visit (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)
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.
At the single study visit (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefan Lujinschi

Collaborators

Institutul Clinic Fundeni

Investigators

  • Study Chair: Gener Ismail, Professor, MD, PhD, Fundeni Clinical Institute
  • Principal Investigator: Bahtiar Ismail, MD, PhD, Emergency University Hospital Bucharest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 4, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 3, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12796 (Other Identifier: Fundeni Clinical Institute Ethical Committee)
  • PERIO-RA-RE_1 (Other Identifier: Fundeni Clinical Institute - Adult Nephrology Department)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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