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Relationship Between NLRP3 Inflammasome Activation and Stages of Periodontitis: An Association With Inflammaging

10 de mayo de 2026 actualizado por: RANDA SHEABAN SHINKADA, Misr University for Science and Technology

Relationship Between NLRP3 Inflammasome Activation and Different Stages of Periodontitis and Its Association With Inflammaging

This study aims to investigate the relationship between NLRP3 inflammasome activation and different stages of periodontitis, with a focus on its association with inflammaging. Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth, and aging-related inflammation may influence its progression.

The study will include participants with different stages of periodontitis as well as healthy individuals. Clinical periodontal parameters will be recorded, and biological samples such as saliva or gingival crevicular fluid will be collected to measure levels of NLRP3 inflammasome components and inflammatory markers.

The results of this study may help improve understanding of the role of inflammation and aging in periodontal disease and could contribute to better diagnosis and treatment strategies.

Descripción general del estudio

Descripción detallada

Periodontitis is a chronic inflammatory disease characterized by progressive destruction of the supporting structures of the teeth. Recent evidence suggests that the NLRP3 inflammasome plays a significant role in the pathogenesis of periodontal disease by regulating the production of pro-inflammatory cytokines such as interleukin-1β.

In addition, inflammaging, defined as low-grade chronic inflammation associated with aging, may contribute to increased susceptibility and severity of periodontal disease. However, the relationship between NLRP3 inflammasome activation and different stages of periodontitis, particularly in the context of inflammaging, is not fully understood.

This observational study aims to evaluate the expression levels of NLRP3 inflammasome components in subjects with varying stages of periodontitis compared to healthy controls. Clinical periodontal parameters, including probing depth, clinical attachment level, and bleeding on probing, will be recorded. Biological samples such as saliva and/or gingival crevicular fluid will be collected for laboratory analysis.

The primary objective is to assess the association between NLRP3 activation and disease severity. Secondary objectives include evaluating the correlation between inflammasome markers and aging-related inflammatory changes.

The findings of this study may provide insight into the molecular mechanisms underlying periodontitis progression and highlight potential biomarkers for early diagnosis and therapeutic targets.

Tipo de estudio

De observación

Inscripción (Actual)

80

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Cairo, Egipto
        • Department of Periodontology, Faculty of Dentistry, [MUST University]

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

he study population will include adult participants aged 18 years and above attending the dental clinic. Participants will be categorized into healthy controls and patients with different stages of periodontitis based on clinical periodontal examination. Individuals will be systemically healthy and not under medications affecting periodontal status. Both males and females will be included. Clinical parameters such as probing depth, clinical attachment level, and bleeding on probing will be recorded, and biological samples (saliva and/or gingival crevicular fluid) will be collected for analysis of NLRP3 inflammasome-related biomarkers.

Descripción

Inclusion Criteria:

  • 1. Male and Female 2. Aged from18 years and above 50. 3. Have at least 15 natural teeth excluding wisdoms. 4. Provide informed consent and willingness to cooperate with study protocol. 5. Stage I periodontitis and Grade A

    • CAL of 1-2 mm
    • Probing depths typically ≤ 3 6. Periodontitis stage II or stage III and Grads B or C patients:
    • CAL from 3-4 mm.
    • Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

  • 1- History of antibiotic in previous three months. 2- Pregnant or lactating female. 3- Treatment with any systemic drug. 4- History of systemic disease. 5- Patients who received periodontal treatment in last 6 months

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Group 1
20 Patients with chronic periodontitis (stage I) and Grade) (A )18 to 40years.
Group 2
20 Patients with chronic periodontitis (stage II /III) and Grade (B/ C) aged between 18 to 40 years.
Group 3
20 Patients with chronic periodontitis (stage I) and Grade) (A) aged 50 and above years.
Group 4
20 Patients with chronic periodontitis (stage II /III) and (Grade B/ C) aged 50 years and above.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of NLRP3 Inflammasome in Gingival Crevicular Fluid Among Different Stages of Periodontitis
Periodo de tiempo: 6 months
NLRP3 inflammasome concentration will be measured in gingival crevicular fluid (GCF) samples collected from participants with different stages of periodontitis using enzyme-linked immunosorbent assay (ELISA). Results will be reported in pg/mL.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
RELATCorrelation Between NLRP3 Inflammasome Concentration and Clinical Periodontal ParametersIONSHIP BETWEEN NLRP3 INFLAMMASOME ACTIVATION AND STAGES OF PERIODONTITIS: AN ASSOCIATION WITH INFLAMMAGING
Periodo de tiempo: 6 months
The correlation between GCF NLRP3 inflammasome concentration measured by ELISA (pg/mL) and clinical periodontal parameters including probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI) will be assessed.
6 months
Correlation Between Age and NLRP3 Inflammasome Concentration in Gingival Crevicular Fluid
Periodo de tiempo: 6 months
The correlation between participant age (years) and GCF NLRP3 inflammasome concentration measured by ELISA (pg/mL) will be evaluated to assess the association with inflammaging.
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: RANDA SHAEBAN SHINKADA, MASTER, RANDA SHAEBAN SHINKADA. MUST
  • Director de estudio: RADWA Mohamed, PHD, RADWA MOHAMED

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • Marchesan JT, et al. NLRP3 inflammasome in periodontitis: pathogenesis and therapeutic implications. Journal of Periodontal Research. 2020. Mitra R, et al. Salivary NLRP3 inflammasome levels in chronic periodontitis. Journal of Clinical Periodontology. 2022.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2025

Finalización primaria (Actual)

31 de diciembre de 2025

Finalización del estudio (Actual)

20 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NLRP3-PD-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared due to ethical considerations and to protect participant confidentiality, as this is an academic observational study without a formal data-sharing framework.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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