The Clinical Performance of Inlay Zirconia Bridges
9 de septiembre de 2018 actualizado por: Damascus University
The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs
When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. The development use of zirconia technology and all-ceramic systems has opened the potential for fabrication inlays zirconia bridges with durability and good aesthetics.
The purpose of this study is to clinically evaluate the placement of inlay bridge made of a Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive approach in the replacement of a single missing tooth.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with three designs in the replacement process of one single tooth (i.e. a missing premolar or molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press.
The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with glaze layer to improve the adhesion.
The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with a layer of e-max ceramic press to improve the adhesion.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Damascus, República Árabe Siria, DM20AM18
- Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
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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
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Good oral hygiene
- Low susceptibility to caries
- Parallel alignment of abutment teeth
- Immobility of the abutment teeth
- Minimum height of abutment teeth ≥ 5 mm (connector thickness)
- Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or 12 mm (width of molar)
Exclusion Criteria:
- Severe para-functional habits.
- Short clinical crowns (<5 mm)
- Extensive defects of the clinical crown,
- Loosening of teeth because of factors related to the periodontal tissues.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Zirconia and E-max Press
The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
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Experimental: Zirconia and E-max Press and Glaze
The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with a glaze layer to improve adhesion.
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A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
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Experimental: Zirconia and E-max Press twice
The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press and the internal surface coated with an E-max Press layer to improve adhesion.
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A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in marginal fit
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Material Integrity
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in the Retention Status
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The resistance of a prosthesis to displacement will be measured.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Marginal Color Matching
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sensitivity
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The presence of any spontaneous or stimulated pain will be assumed.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Patients' Satisfaction
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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A questionnaire will be used to detect the level of satisfaction regarding function and shade
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Change in Shade
Periodo de tiempo: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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The shade is going to be determined using Vita(R) shade guide.
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Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mansour Abo Alkasab, DDS MSc, PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
- Director de estudio: Jihad Abo Nassar, DDS MSc PhD, Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Coelho PG, Bonfante EA, Silva NR, Rekow ED, Thompson VP. Laboratory simulation of Y-TZP all-ceramic crown clinical failures. J Dent Res. 2009 Apr;88(4):382-6. doi: 10.1177/0022034509333968.
- Cura C, Ozcan M, Isik G, Saracoglu A. Comparison of alternative adhesive cementation concepts for zirconia ceramic: glaze layer vs zirconia primer. J Adhes Dent. 2012 Feb;14(1):75-82. doi: 10.3290/j.jad.a21493.
- Monaco C, Ferrari M, Caldari M, Baldissara P, Scotti R. Comparison of 2 bonding systems and survival of fiber-reinforced composite inlay fixed partial dentures. Int J Prosthodont. 2006 Nov-Dec;19(6):577-85.
- Raigrodski AJ, Chiche GJ, Potiket N, Hochstedler JL, Mohamed SE, Billiot S, Mercante DE. The efficacy of posterior three-unit zirconium-oxide-based ceramic fixed partial dental prostheses: a prospective clinical pilot study. J Prosthet Dent. 2006 Oct;96(4):237-44. doi: 10.1016/j.prosdent.2006.08.010.
- Sanli S, Comlekoglu MD, Comlekoglu E, Sonugelen M, Pamir T, Darvell BW. Influence of surface treatment on the resin-bonding of zirconia. Dent Mater. 2015 Jun;31(6):657-68. doi: 10.1016/j.dental.2015.03.004. Epub 2015 Apr 7.
- Valentino TA, Borges GA, Borges LH, Platt JA, Correr-Sobrinho L. Influence of glazed zirconia on dual-cure luting agent bond strength. Oper Dent. 2012 Mar-Apr;37(2):181-7. doi: 10.2341/10-220-L. Epub 2011 Dec 14.
- Chaar MS, Kern M. Five-year clinical outcome of posterior zirconia ceramic inlay-retained FDPs with a modified design. J Dent. 2015 Dec;43(12):1411-5. doi: 10.1016/j.jdent.2015.11.001. Epub 2015 Nov 10.
- Monaco C, Cardelli P, Ozcan M. Inlay-retained zirconia fixed dental prostheses: modified designs for a completely adhesive approach. J Can Dent Assoc. 2011;77:b86.
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 junio de 2016
Finalización primaria (Actual)
15 de enero de 2018
Finalización del estudio (Actual)
15 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
14 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
14 de diciembre de 2016
Publicado por primera vez (Estimar)
19 de diciembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- UDDS-FixPro-02-2016
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .