Introduction of a novel guided bone regeneration memory shape based device.

Abstract

Bone regeneration by periosteal distraction has been reported in numerous animal studies; however, the main disadvantages of this technique are poor bone quality and soft tissue invasion in the distracted space. The purpose of this study was to evaluate a novel shape memory-based device to promote bone regeneration in a large, secluded growth space in a rabbit model. Twenty rabbits were divided into two groups. In the first group (n = 10), a device composed of silicone sheets and nitinol strips was inserted subperiosteally in the calvarial area. In the second group (n = 10), only silicone sheets were inserted in the calvarial area. Each group was further divided in half: five animals were sacrificed at 8 weeks postoperatively, and the other five were sacrificed at 16 weeks postoperatively. In the study group, the new device vertically expanded the overlying soft tissue 4 mm above the original bone and created a secluded space; the newly generated bone maximum height median ranged between 2.7 mm in 8 weeks group and 2.6 mm in 16 weeks group. In the control group, a very thin rim of bone was generated below the flat silicone sheets on top of the original bone. Maximum bone heights median ranged from 0.37 mm in 8 weeks group to 0.32 mm in 16 weeks group. The device was proven to be effective at vertically augmenting bone by applying the guided bone regeneration and soft tissue expansion procedures simultaneously. This device may pave the way for a new generation of smart guided bone regeneration membranes that can remember the original dimensions of resorbed bone areas.