Histological and Histomorphometric Response to SocketKAP™ and SocketKAGE™ Used for Ridge Preservation and Repair: Results From a Randomized Controlled Clinical Trial.
This study investigated the histologic tissue response to SocketKAP and SocketKAGE as novel devices designed for ridge preservation. This randomized controlled clinical trial recruited participants among patients who presented to a university dental clinic. The study protocol entailed randomization into 5 intervention groups after tooth extraction: unassisted healing of intact sockets (group A), SocketKAP (group B), anorganic bovine bone minerals (ABBM) plus SocketKAP (group C), unassisted healing of sockets with dehiscence (group D), and SocketKAGE plus ABBM plus SocketKAP (group E). The primary outcome variable was bone volume fraction of total volume (BV/TV). Secondary outcome variables were percentages of residual graft material (RG) and void volume (VV). One-way analysis of variance was run on BV/TV, RG, and VV based on the independent variable (treatment groups). Bone core samples were harvested from participants (N = 22) who presented for implant installation at 6 months after extraction. Sockets without biomaterial filler (groups A and B) showed more mature bone compared with grafted sockets. In groups in which sockets were filled with biomaterial (groups C and E), vital bone was observed in direct apposition to the graft particles. In group E, remnants of SocketKAGE were not readily discernable at 6 months. No substantial inflammatory infiltrate or other adverse histologic patterns were detected. Quantitative analysis showed a statistically significant difference in BV/TV between groups A and C (P = .028) and between groups A and E (P = .019). Histologic and histomorphometric results showed that the application of SocketKAP and SocketKAGE did not interfere with wound healing of extraction sockets. In agreement with previous reports, the percentage of BV/TV within sites with ABBM was smaller than within sites without biomaterial. The favorable histologic response to SocketKAP and SocketKAGE observed in the present study provided additional insights to the authors' previous studies showing the benefits of these devices in decreasing postextraction dimensional alterations of alveolar bone and tissue contour.