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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07705633
Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Resin Restorations
Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Primary objectives:
Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.
Secondary objectives:
Assessment of stability of results after 3, 6 and 9months.
Visão geral do estudo
Status
Intervenção / Tratamento
- Dispositivo: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid
- Dispositivo: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste
- Dispositivo: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
- Dispositivo: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
Descrição detalhada
Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.
Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.
Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Suez, Egito
- Suez Canal University
-
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Absence of restorations or prior sealants on the teeth under study.
- Patients have simple occlusal spot caries lesions
- Age group 15 - 40 years.
- Ability to return for periodic follow-up
Exclusion Criteria:
- Patients with high DMFS.
- Any fixed orthodontic appliances.
- Smoking habit.
- Pregnant and lactating mothers
- Symptoms of dental pain
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
|
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
|
|
Experimental: Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
|
Experimental: prevent seal, Itena, North America after treating with Biflourid Group
Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
|
Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
|
|
Experimental: prevent seal, Itena, North America after treating with MI Paste Group
Teeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America
|
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Retention rate of two types of pit and fissure sealants
Prazo: After 3 months, 6 months and 9 months
|
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
marginal integrity assessments
Prazo: After 3 months, 6 months and 9 months.
|
Assessment of marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- 376/2021
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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