Salud Bucal y Enfermedad de Wilson: SOMAWI (SOMAWI)
Patients with Wilson disease have poorer dental and periodontal health and a have lower oral quality of life than control patients. Patients with a neurological form would also more frequently present limitations in the function of the masticatory apparatus. Systemic treatments for Wilson disease are associated with lesions of the oral mucosa. Analysis of copper level in saliva could testify to the effectiveness of copper depletion in treated patients The main objective is to compare the state of dental health between: patients with Wilson disease in the hepatic form and patients with the neurological form, and a population of controls.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The comparaison between the three groups is based on evaluation criteria wich is CAOD index of caries severity (developed by Klein and Palmer in 1940) counting the number of permanent teeth with caries (evolving to include non-cavitary caries) (C), absent due to caries (A) and filled (O) in an individual. The maximum score is 28 (third molars are not taken into account). The index is obtained from clinical examination and panoramic dental imaging.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amélie YAVCHITZ
- Número de teléfono: 01 48 03 64 54
- Correo electrónico: ayavhitz@for.paris
Copia de seguridad de contactos de estudio
- Nombre: Aurélia POUJOIS
- Número de teléfono: 01 48 30 66 56
- Correo electrónico: apoujois@for.paris
Ubicaciones de estudio
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Ivry-sur-Seine, Francia, 94200
- Reclutamiento
- Hopital Charles Foix
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Contacto:
- Marjolaine GOSSET
- Número de teléfono: 01 49 59 48 03
- Correo electrónico: marjolaine.gosset@aphp.fr
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Paris, Francia, 75019
- Reclutamiento
- Fondation Adolphe de Rothschild
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Contacto:
- Aurélia Poujois
- Número de teléfono: 0148036656
- Correo electrónico: apoujois@for.paris
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The recruitment of Wilson patients will be done in the coordinating center of the CRMR Wilson at the Fondation A de Rothschild Hospital. Control patients matched in age and sex will be identified among patients consulting in the oral medicine department of Charles Foix Hospital. Posters will be placed in the waiting room to inform patients of the existence of the study and promote recruitment.
Descripción
Inclusion Criteria:
- Express consent to participate in the study
- Member of or beneficiary of a social security scheme
- For cases: Affected by Wilson's disease
- For controls: Benefiting from a first routine dental consultation with dental panoramic imaging, outside of an emergency context or treatment follow-up/maintenance
Exclusion Criteria:
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Patient benefiting from a legal protection measure
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Pregnant or breastfeeding women
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Severe psychiatric disorders with behavioral disorders
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For cases:
- hepatic or neurological decompensation
- liver transplant patient
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For witnesses:
- Patient with hepatic or neurological disease
- Patient taking dietary supplements enriched with copper or zinc or zinc supplementation
- Patient wearing removable prostheses with zinc-enriched prosthetic adhesives (Fixodent ProPlus®)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cases
patients with hepatic form of Wilson disease and those with neurological form |
A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire. A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire. A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire. |
|
controls
control population consulting in routine dental with panoramic dental imaging, outside of an emergency context |
A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire. A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
CAOD index of the severity of the caries impairment counting the number of permanent teeth decayed in an individual. The maximum score is 28 (third molars are not taken into account)
Periodo de tiempo: inclusion visit
|
The index is obtained from clinical examination and panoramic dental imaging |
inclusion visit
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Marjolaine GOSSET, Hopital Charles Foix
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Metabolismo, errores congénitos
- Enfermedades Genéticas Congénitas
- Enfermedades metabólicas
- Enfermedades del Sistema Digestivo
- Enfermedades neurodegenerativas
- Enfermedades del HIGADO
- Trastornos del movimiento
- Trastornos Heredodegenerativos, Sistema Nervioso
- Enfermedades de los ganglios basales
- Enfermedades Cerebrales Metabólicas Congénitas
- Enfermedades Cerebrales Metabólicas
- Metabolismo de metales, errores congénitos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades Nutricionales y Metabólicas
- Degeneración hepatolenticular
Otros números de identificación del estudio
- APS_2022_5
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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