Clinical Study on Zirconia Bridges
zirconia bridge restoration
Anomalías Congénitas+3
+ Enfermedades Estomatognáticas
+ Enfermedades y Anomalías Congénitas, Hereditarias y Neonatales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2010
Fecha en la que se inscribió al primer participante.To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 9 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion. The subject is healthy and compliant with good oral hygiene The subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible. The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition. Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation. No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth. Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed. The subject should be available for the 5-year term of the investigation. Exclusion Criteria: The subject is not able to give her/his informed consent to participate. Alcohol or drug abuse as noted in patient records or in patient history. Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history. An existing condition where acceptable retention of the restoration is impossible to attain Mobility of the tooth to be restored. Pathologic pocket formation of 4 mm or greater around the tooth to be restored Severe bruxism or other destructive habits Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth). Health conditions, which do not permit the restorative procedure
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios