An open randomized controlled clinical trial to evaluate ridge preservation and repair using SocketKAP(™) and SocketKAGE(™) : part 1-three-dimensional volumetric soft tissue analysis of study casts.

Abstract

The aims of this study were to evaluate (i) the efficacy of ridge preservation and repair involving SocketKAP(™) and SocketKAGE(™) devices following tooth removal; and (ii) ridge contour changes at 6months post-extraction in intact sockets and sockets with dehiscence defects. Thirty-six patients required a total of 61 teeth to be extracted. Five cohorts were established with groups A-C involving intact sockets and groups D and E involving facial dehiscence: (A) Negative Control; (B) SocketKAP(™) alone; (C) Anorganic Bovine Bone Mineral (ABBM)+SocketKAP(™) ; (D) Negative Control; and (E) ABBM+SocketKAP(™) +SocketKAGE(™) . Preoperative CBCT and laser-scanned casts were obtained. Teeth segmented from preoperative CBCT were merged with study cast images to allow for digital removal of teeth from the casts. Volumetric measurements of ridge contour were performed. Images of preoperative and 6months post-operative casts were superimposed to measure ridge contour changes. Post-extraction contour loss occurred in all sockets primarily in the crestal 3mm but was also detected up to 6mm from alveolar crest. For intact sockets, SocketKAP(™) or SocketKAP(™) +ABBM interventions led to greater percentages of remaining ridge contour when compared to controls. A significant difference favoring SocketKAP(™) +SocketKAGE(™) +ABBM treatment was observed for sockets with facial dehiscence when compared to controls. SocketKAP(™) , with or without ABBM, significantly limited post-extraction ridge contour loss in intact sockets. In the absence of a group treated with only the SocketKAGE(™) , it is not possible to determine its efficacy, although the combination of SocketKAGE(™) +SocketKAP(™) +ABBM was effective in limiting post-extraction ridge contour loss in sockets with dehiscence defects.