Publication: Ensayo clínico aleatorizado, ciego y placebo controlado sobre el uso de profilaxis antibiótica en la prevención de la infección postoperatoria de terceros molares mandibulares impactados. Un estudio piloto
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2011
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Objetivo: Determinar la utilidad de la administración de profilaxis antibiótica (PA) para la prevención de complicaciones infecciosas e inflamatorias en la cirugía de terceros molares mandibulares impactados y mesioangulados (TMMim) y verificar la factibilidad de llevar a cabo un protocolo de investigación bajo condiciones ideales, aportando información para un posterior estudio. Diseño del Estudio: Ensayo clínico aleatorizado piloto, ciego y placebo controlado. Materiales y Métodos: 34 pacientes fueron aleatorizados en 2 grupos de 17 pacientes. Al grupo experimental se le administró 2 gramos de amoxicilina 1 hora antes de la intervención, mientras que al grupo control se le administró 2 comprimidos placebo en las mismas condiciones. Los pacientes fueron controlados a los 3, 7 y 30 días. Resultados: Del grupo placebo 1 paciente presentó una complicación infecciosa (alveolitis), mientras que en el grupo experimental ningún paciente presentó infección. (p>0.05) Sin embargo, hubo diferencias significativas en la necesidad de analgesia de rescate en el grupo placebo. (p<0.05) Conclusiones: Los resultados obtenidos en este ensayo clínico piloto determinaron que el uso de amoxicilina 2 gramos una hora antes de la cirugía no es efectiva en la prevención de complicaciones infecciosas postquirúrgicas de TMMim, pero sí disminuyen la necesidad de analgesia de rescate. El presente estudio demostró tener un protocolo factible de realizar en un ensayo clínico definitivo, cuyo tamaño muestral debería alcanzar 362 pacientes sanos con TMMim, para lograr una potencia estadística satisfactoria.
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