Saúde Oral e Doença 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Amélie YAVCHITZ
- Número de telefone: 01 48 03 64 54
- E-mail: ayavhitz@for.paris
Estude backup de contato
- Nome: Aurélia POUJOIS
- Número de telefone: 01 48 30 66 56
- E-mail: apoujois@for.paris
Locais de estudo
-
-
-
Ivry-sur-Seine, França, 94200
- Recrutamento
- Hopital Charles Foix
-
Contato:
- Marjolaine GOSSET
- Número de telefone: 01 49 59 48 03
- E-mail: marjolaine.gosset@aphp.fr
-
Paris, França, 75019
- Recrutamento
- Fondation Adolphe de Rothschild
-
Contato:
- Aurélia Poujois
- Número de telefone: 0148036656
- E-mail: apoujois@for.paris
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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:
-
Patient benefiting from a legal protection measure
-
Pregnant or breastfeeding women
-
Severe psychiatric disorders with behavioral disorders
-
For cases:
- hepatic or neurological decompensation
- liver transplant patient
-
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®)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_CONTROL
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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)
Prazo: inclusion visit
|
The index is obtained from clinical examination and panoramic dental imaging |
inclusion visit
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Marjolaine GOSSET, Hopital Charles Foix
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Metabolismo, Erros Inatos
- Doenças Genéticas, Congênitas
- Doenças Metabólicas
- Doenças do aparelho digestivo
- Doenças Neurodegenerativas
- Doenças do Fígado
- Distúrbios do Movimento
- Distúrbios Heredodegenerativos, Sistema Nervoso
- Doenças dos Gânglios da Base
- Doenças Cerebrais Metabólicas Inatas
- Doenças Cerebrais Metabólicas
- Metabolismo de metais, erros inatos
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Doenças Nutricionais e Metabólicas
- Degeneração Hepatolenticular
Outros números de identificação do estudo
- APS_2022_5
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .