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- Ensaio Clínico NCT07732127
Early Detection of Initial Caries Using Fluorescent Starch Nano-particles Compared With Salivary Biomarkers
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Conventional diagnostic methods, including visual-tactile examination, radiographic assessment, and caries detection systems such as the International Caries Detection and Assessment System (ICDAS), are routinely used to diagnose caries. However, these methods have several limitations. Visual examination depends greatly on the clinician's experience and often detects lesions only after visible changes in enamel have occurred.
Similarly, bitewing radiographs have limited sensitivity for detecting early enamel lesions because radiographic changes become evident only after considerable mineral loss. Consequently, many early carious lesions remain undetected until the disease has progressed.
In addition, saliva liquid sample had gained increasing attention as a valuable diagnostic method. Saliva contains numerous biological molecules that reflect the metabolic activity of the oral environment. Changes in salivary biomarkers associated with demineralization, inflammation, microbial activity, and host immune response may occur before obvious clinical manifestations become visible. Therefore, salivary biomarker analysis provides a non-invasive approach for detecting biological changes related to the initiation and progression of dental caries.
These limitations have encouraged the development of more sensitive, non-invasive diagnostic techniques capable of identifying carious lesions before irreversible structural damage becomes clinically apparent using fluorescent starch nano-particles. One of these emerging technologies is LumiCare mouth rinse, a fluorescence-based diagnostic aid that enhances the visualization of early enamel demineralization by highlighting areas of altered mineral content. This technique has the potential to improve the detection of initial carious lesions that may not be recognized using conventional clinical examination alone.
Recent research suggests that combining structural detection methods with biological indicators may significantly improve the diagnostic accuracy of early caries detection.
While LumiCare mouth rinse identifies early mineral changes within enamel, salivary biomarkers provide information regarding the biological activity of the disease.
The integration of both diagnostic approaches may overcome many of the limitations associated with conventional diagnostic methods and enable clinicians to identify initial carious lesions at a much earlier stage.
However, limited evidence is available regarding the combined use of LumiCare mouth rinse and salivary biomarkers for the diagnosis of initial enamel caries.Therefore, further clinical investigation is required to evaluate whether this combined approach offers superior diagnostic performance compared with conventional methods.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Walaa Mohamed Hassan, M.D
- Número de telefone: +201098246330
- E-mail: walaamohammed700@dent.menofia.edu.eg
Locais de estudo
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Menoufia
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Shibīn al Kawm, Menoufia, Egito
- Recrutamento
- Menoufia Dental Hospital
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Contato:
- Walaa Mohamed Hassan, M.D
- Número de telefone: +201098246330
- E-mail: walaamohammed700@dent.menofia.edu.eg
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Contato:
- Mahmoud Ahmed Abdo Saeed, M.D
- Número de telefone: +201226567748
- E-mail: dr.mahmoudsaeed2014@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Presence of at least one suspected initial enamel carious lesion.
Exclusion Criteria:
- Cavitated carious lesions
- Previous restorative treatment on the examined tooth
- Antibiotic therapy during the previous month,
- Systemic diseases affecting salivary secretion
- Xerostomia or salivary gland disorders
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Group A: Caries Group
About 30 participants will subject to Fluorescent Starch Nano-particles Compared with Salivary Biomarkers to detect the initial caries .
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The evaluation of the diagnostic accuracy of LumiCare mouth rinse combined with salivary biomarkers for the early detection of initial enamel caries and to compare its diagnostic performance with conventional clinical diagnostic methods.
Outros nomes:
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Comparador de Placebo: Group B: Control Group
About 30 healthy participants
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The evaluation of the diagnostic accuracy of LumiCare mouth rinse combined with salivary biomarkers for the early detection of initial enamel caries and to compare its diagnostic performance with conventional clinical diagnostic methods.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Diagnosis of Initial Caries
Prazo: immediately after the intervention
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Evaluation of the participants by Using Fluorescent Starch Nano-particles and Salivary Biomarkers in early detection of initial caries
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immediately after the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Walaa Mohamed Hassan, Lecturer, conservative department, Faculty of Dentistry, Menofia University
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
Outros números de identificação do estudo
- Initial Caries Early Detection
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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