Periodontal DiseasePERIO-RA-RENCT07575347
Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
An observational study of Periodontal Disease and Periodontitis, run by Stefan Lujinschi at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease, Periodontitis, CKD
- What is being tested?
- Observational assessment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 4 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Fundeni Clinical Institute
Bucharest, 022328
Stefan N Lujinschi, MD, PhD candidate, +40728102643, stefanlujinschi@gmail.com
Stefan N Lujinschi, MD, PhD candidate
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Periodontal Disease, Periodontitis, CKD, Chronic Kidney Disease, Alport Syndrome, Fabry Disease
- Being tested
- Observational assessment
- Keywords
- Periodontal Disease, Periodontitis, CKD, Rare Kidney Diseases, Alport syndrome, Systemic Lupus Erythematosus, Tuberous Sclerosis Complex (TSC), Chronic Kidney Disease
- Medical subject headings
- Periodontal Diseases, Periodontitis, Renal Insufficiency, Chronic, Nephritis, Hereditary, Fabry Disease, Lupus Erythematosus, Systemic, Tuberous Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
Non-interventional observational assessment including periodontal examination and clinical data collection.
| Study group | Role | What they receive |
|---|---|---|
| Alport Syndrome | Patients with Alport syndrome confirmed by genetic testing or kidney biopsy Receives: Other: Observational assessment | |
| Fabry Disease | Patients with enzymatic or genetically confirmed Fabry disease Receives: Other: Observational assessment | |
| Tuberous Sclerosis Complex | Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria Receives: Other: Observational assessment | |
| 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 Receives: Other: Observational assessment | |
| CKD Controls | Patients with chronic kidney disease of non-rare etiology Receives: Other: Observational assessment | |
| Population Controls | Individuals without known chronic kidney disease Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Periodontitis
Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.
Measured: At the single study visit (baseline)
Secondary outcomes (7)
Mean Probing Pocket Depth (PPD)
Mean probing pocket depth (in millimeters) measured across all examined sites during full-mouth periodontal examination.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the single study visit (baseline)
Prevalence of Gingivitis
Proportion of participants with clinical signs of gingival inflammation without attachment loss, consistent with gingivitis.
Measured: 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.
Measured: 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.
Measured: At the single study visit (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start4 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Lujinschi
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Clinic Fundeni
- Responsible party
- Sponsor-investigator, Stefan Lujinschi, Institutul Clinic Fundeni
- Investigators
- Gener Ismail, Professor, MD, PhD, Study chair, Fundeni Clinical InstituteBahtiar Ismail, MD, PhD, Principal investigator, Emergency University Hospital Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575347
- Sponsor's protocol ID
- 12796
- Other IDs
- 12796, PERIO-RA-RE_1
- Acronym
- PERIO-RA-RE
- Status last verified
- Jun 2026
- First submitted
- 3 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease
- ClinicalTrials.gov ID
- NCT07575347
- Acronym / sponsor ID
- PERIO-RA-RE / 12796
- Conditions
- Periodontal Disease, Periodontitis, CKD, Chronic Kidney Disease, Alport Syndrome, Fabry Disease
- Keywords
- Periodontal Disease, Periodontitis, CKD, Rare Kidney Diseases, Alport syndrome, Systemic Lupus Erythematosus, Tuberous Sclerosis Complex (TSC), Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stefan LujinschiUniversity, hospital or other
- Collaborators
- Institutul Clinic Fundeni
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Alport Syndrome | – | Other: Observational assessmentPatients with Alport syndrome confirmed by genetic testing or kidney biopsy |
| Fabry Disease | – | Other: Observational assessmentPatients with enzymatic or genetically confirmed Fabry disease |
| Tuberous Sclerosis Complex | – | Other: Observational assessmentPatients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria |
| Systemic Lupus Erythematosus | – | Other: Observational assessmentSystemic 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 |
| CKD Controls | – | Other: Observational assessmentPatients with chronic kidney disease of non-rare etiology |
| Population Controls | – | Other: Observational assessmentIndividuals without known chronic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age ≥18 years
- Ability to provide written informed consent
- At least 10 natural teeth present
- Belonging to one of the predefined study groups:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentNon-interventional observational assessment including periodontal examination and clinical data collection. | Other | Alport Syndrome, CKD Controls, Fabry Disease, Population Controls, Systemic Lupus Erythematosus, Tuberous Sclerosis Complex |
Primary outcome
Prevalence of Periodontitis
Time frame: At the single study visit (baseline)
Prevalence of periodontitis defined according to the 2018 classification of periodontal diseases.
7 secondary outcomes
Mean Probing Pocket Depth (PPD)
Time frame: At the single study visit (baseline)
Mean Clinical Attachment Level (CAL)
Time frame: 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 Sites with Bleeding on Probing (BOP)
Time frame: At the single study visit (baseline)
Prevalence of Gingivitis
Time frame: At the single study visit (baseline)
Prevalence of Xerostomia
Time frame: At the single study visit (baseline)
Presence of Disease-Specific Oral Findings
Time frame: At the single study visit (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gener Ismail, Professor, MD, PhD study chair
Fundeni Clinical Institute
Bahtiar Ismail, MD, PhD principal investigator
Emergency University Hospital Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease and Periodontitis, run by Stefan Lujinschi at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan N Lujinschi, MD, PhD candidate (+40728102643, stefanlujinschi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Periodontitis (time frame: At the single study visit (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.