Publication: Ensayo clínico aleatorizado comparando una nueva membrana de colágeno reabsorbible no "cross-linked" para regeneración ósea guiada de dehiscencias en implantes. Resultados parciales
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2016
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Abstract
Objetivo: comparar el resultado clínica de una nueva membrana de colágeno reabsorbible nativo sin entrecruzamiento, creos xenoprotect (CXP), con una membrana de referencia, bio-gide (BG), para regeneración ósea guiada de implantes con dehiscencias.
Material y métodos: este ensayo clínico aleatorizado incluyó pacientes en los que se esperaba que existieran dehiscencias óseas en el momento de la colocación del implante. Se incluyeron brechas edéntulas unitarias en las zonas de incisivos y premolares tanto en maxilar superior como en mandíbula. Los implantes fueron colocados usando un protocolo de dos fases con carga diferida. El biomaterial empleado para el aumento óseo se inmovilizó con las membranas CXP o BG. La salud del tejido blando fue evaluada durante el periodo de cicatrización y el tamaño de la dehiscencia residual, en los casos en que existía, fue medida en la cirugía de re-entrada a los 6 meses.
Resultados: de los 12 pacientes incluidos en el ensayo, 6 fueron tratados con CXP y 6 con BG. Las características de los pacientes no difirieron entre los dos grupos. En el grupo CXP, la altura del defecto en el momento de la inserción del implante fue 5,3mm±2,1mm. Este defecto se redujo en un 94% hasta 0,5mm±0,8mm. En el grupo BG, la altura del defecto en el momento de la inserción del implante fue 6,5mm±0,9mm. Este defecto se redujo en un 70% hasta 1,9mm±1,9mm. Asumiendo un margen de no inferioridad de 1mm, CXP no tuvo resultados inferiores a BG. No se produjo ninguna exposición de membrana durante el periodo de cicatrización y únicamente una dehiscencia de tejidos blandos en el grupo BG.
Conclusiones: la nueva membrana de colágeno no entrecruzada permite la ganancia de hueso en dehiscencias previstas. Es necesario hacer otros estudios con esta nueva membrana para investigar las diferencias observadas en cuanto a mayor ganancia ósea y menor tasa de exposición de CXP frente a BG.
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