Идёт набор NCT07575347

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

— Наблюдательное Periodontal Disease Periodontitis CKD Chronic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Observational assessment.
Кому может быть актуально: Состояния в реестре: Periodontal Disease, Periodontitis, CKD, Chronic Kidney Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Румыния
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Prevalence of Periodontitis [Срок оценки: At the single study visit (baseline)]

Вторичные конечные точки (7)

Mean Probing Pocket Depth (PPD) [Срок оценки: At the single study visit (baseline)]
Mean Clinical Attachment Level (CAL) [Срок оценки: At the single study visit (baseline)]
Percentage of Sites with Probing Pocket Depth ≥6 mm [Срок оценки: At the single study visit (baseline)]
Percentage of Sites with Bleeding on Probing (BOP) [Срок оценки: At the single study visit (baseline)]
Prevalence of Gingivitis [Срок оценки: At the single study visit (baseline)]
Prevalence of Xerostomia [Срок оценки: At the single study visit (baseline)]
Presence of Disease-Specific Oral Findings [Срок оценки: At the single study visit (baseline)]

Критерии участия

Критерии включения

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