- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07666126
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss and Oxidative Stress
Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism.
A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hatice Yemenoglu
- Número de teléfono: +905052977517
- Correo electrónico: htcymnglu@hotmail.com
Ubicaciones de estudio
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Rize, Turquía (Türkiye), 53020
- Reclutamiento
- Recep Tayyip Erdogan University
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Contacto:
- Hatice Yemenoglu
- Número de teléfono: +904642220000
- Correo electrónico: htcymnglu@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Being between 18 and 65 years of age
- Being systemically healthy or diagnosed with hyperuricemia
- Having at least 20 natural teeth
- Being periodontally healthy or diagnosed with periodontitis
Exclusion Criteria:
- Diabetes, cardiovascular disease, osteoporosis, chronic kidney disease, metabolic syndrome, and obesity are systemic diseases that may affect purine metabolism.
- Smoking
- Pregnancy or lactation
- Having received periodontal treatment within the last 3-6 months
- Use of antibiotics, anti-inflammatory drugs, or uric acid-lowering drugs
- Presence of systemic diseases that may affect purine metabolism
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Group 1: Individuals with periodontitis and hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 2: Periodontally healthy individuals with hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 3: Individuals with periodontitis but without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 4: Periodontally healthy individuals without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Periodontal pocket depth
Periodo de tiempo: at baseline
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The distance between the gingival margin and the base of the pocket will be measured in millimeters.
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at baseline
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clinical attachment loss
Periodo de tiempo: at baseline
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The distance between the enamel-cementum junction and the base of the pocket will be measured in millimeters.
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at baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Level of interleukin-1 beta
Periodo de tiempo: at baseline
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Interleukin-1 beta levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-10
Periodo de tiempo: at baseline
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Interleukin-10 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-18
Periodo de tiempo: at baseline
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Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/302
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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