Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems

9 de octubre de 2020 actualizado por: Nazire Nurdan Çakır, Nuh Naci Yazgan University

Erciyes University Clinical Research Ethics Committee

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch & rinse (ER) and self-etch (SE) systems have been used for many years. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch & rinse (ER) and self-etch (SE) systems have been used for many years. Compared to SE systems, which are simplified and very easy to use, requiring less technical precision, traditional ER systems are still very popular and preferred by dentists. However, current researchers indicate that ER systems are more effective on enamel than dentin and that this effect is better than SE systems. SE systems are approaches in which the acid application and washing step are eliminated clinically and the possibility of making mistakes during the application and manipulation is reduced. An important advantage of these systems is that demineralization and resin infiltration occurs at the same time. Clinically, the application times are shorter than traditional systems. Two-steps SE systems have been used for a long time. In this system, the need for a separate acidic primer application has needed clinicians reason to search for single-steps bonding agents. And, in recent years, single-step SE systems also called "all in one", have been developed that include all steps of pickling, primer application, and adhesive agent application. However, there are studies showing that these systems do not perform as well as two-step SE systems. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Tipo de estudio

Intervencionista

Inscripción (Actual)

78

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años a 18 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • At least 3 Class-I caries lesions
  • Good health
  • Acceptable level of oral hygiene

Exclusion Criteria:

  • Did not have four caries lesions at least
  • Did not have Class-II caries lesions
  • Deep caries reaching the pulp
  • The patients are not 18-22 years old
  • Bruxism
  • Periodontal disease
  • Refused to participate

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Single Bond 2
Single Bond 2 is a traditional etch and rinse adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.
It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.
Comparador activo: Clearfil SE Bond
Clearfil SE bond is traditional two step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.
It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.
Comparador activo: Tri-S Bond
Tri-S bond is traditional one step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions.
It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
Periodo de tiempo: One years
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
One years
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
Periodo de tiempo: Two years
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Two years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nazire Nurdan Çakır, Nuh Naci Yazgan University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2016

Finalización primaria (Actual)

1 de febrero de 2018

Finalización del estudio (Actual)

1 de abril de 2018

Fechas de registro del estudio

Enviado por primera vez

3 de octubre de 2020

Primero enviado que cumplió con los criterios de control de calidad

9 de octubre de 2020

Publicado por primera vez (Actual)

19 de octubre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de octubre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

9 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 5930

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Materiales Adhesivos Dentales

Ensayos clínicos sobre Dental adhesive materials.

Suscribir