Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Observational assessment (Other)
Population Controls
Individuals without known chronic kidney disease
干预措施: Observational assessment (Other)
Fabry Disease
Patients with enzymatic or genetically confirmed Fabry disease
干预措施: Observational assessment (Other)
Tuberous Sclerosis Complex
Patients diagnosed with Tuberous Sclerosis Complex according to established clinical or genetic criteria
干预措施: Observational assessment (Other)
Alport Syndrome
Patients with Alport syndrome confirmed by genetic testing or kidney biopsy
干预措施: Observational assessment (Other)
CKD Controls
Patients with chronic kidney disease of non-rare etiology
干预措施: Observational assessment (Other)
研究者
Stefan Lujinschi
MD, PhD candidate
Institutul Clinic Fundeni