- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
- 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
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Suez, Egipto
- Suez Canal University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retention rate of two types of pit and fissure sealants
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
marginal integrity assessments
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 376/2021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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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