Publication: Comportamiento clínico de los implantes dentales con una superficie SLActive vs. SLA. Estudio clínico aleatorizado. Resultados preliminares.
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2021
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Abstract
Objetivo: El objetivo principal de este estudio fue confirmar la seguridad y evaluar el comportamiento clínico de los implantes SLActive® mediante el seguimiento de los efectos adversos del dispositivo, estabilidad de los implantes y parámetros clínicos en comparación con los implantes SLA®.Materiales y Métodos: Se llevó a cabo un estudio clínico prospectivo, multicéntrico, aleatorizado, a simple ciego y con un diseño de boca partida. La muestra estudiada estuvo formada por 18 pacientes (34 implantes) quienes recibieron un implante SLA® (n=17) siendo estos los implantes del grupo control y uno SLActive® (n=17) pertenecientes al grupo test. Se evaluaron los efectos adversos, la estabilidad de los implantes mediante análisis de frecuencia de resonancia (ARF), la cicatrización de los tejidos blandos (índice de cicatrización de Landry), parámetros clínicos: mucosa queratinisada (MQ), profundidad al sondaje (PS), sangrado al sondaje (SaS), supervivencia del implante, éxito y supervivencia protésica, y satisfacción del paciente (OHIP-14) por un periodo de seguimiento de 12 meses.Resultados: 12 meses después de la colocación de los implantes no se encontraron diferencias estadísticamente significativas entre la estabilidad de los implantes de ambos grupos a las 8 semanas (cociente de estabilidad del implante [ISQ] Paralelo test: 77,5±9.3, paralelo control: 75,7± 12.1; p= 0,638; Perpendicular test: 74,7 ±10.4 , perpendicular control: 78,8±11.3; p= 0,290); los parámetros clínicos ([QM: test(T): 2,7±1,3; control(C):2,5±1,1; p: 0,666. SaS: (T): 13,6±20,5;(C):6,8±11,6 ; p:0,349. PS: (T): 2,2±0,7 ; (C):1,8±0,5; p:0,144] y la cicatrización de los tejidos blandos periimplantarios. La supervivencia de los implantes fue de un 100% en el grupo SLA®(grupo control) , y un 88.2% en el grupo SLActive®(grupo test). No se evidenciaron fracasos ni complicaciones protésicas.Conclusiones: Los implantes SLActive® muestran una seguridad, estabilidad y un rendimiento clínico similar a los SLA® según lo probado a partir del los eventos adversos reportados, el ARF y los parámetros clínicos (MQ, PS, SaS).
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