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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStefan Lujinschi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Ability to provide written informed consent

At least 10 natural teeth present

Alport syndrome (genetically or clinically confirmed)

Disqualifiers

Periodontal treatment within the last 6 months

Antibiotic therapy within the last 4 weeks

Pregnancy

Conditions precluding periodontal examination

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational assessment

    Other intervention

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

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Alport Syndrome1 intervention
Group B: Fabry Disease1 intervention
Group C: Tuberous Sclerosis Complex1 intervention
Group D: Systemic Lupus Erythematosus1 intervention
Group E: CKD Controls1 intervention
Group F: Population Controls1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of Periodontitis

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

Time frame
At the single study visit (baseline)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stefan Lujinschi

Lead sponsor

Institutul Clinic Fundeni

Sponsor institution

Institutul Clinic Fundeni

Collaborator