Biological performance of a novel bovine hydroxyapatite in a guided bone regeneration model: A preclinical study in a mandibular defect in dogs

Abstract

Objectives: This preclinical model study aims to evaluate the performance and safety of a novel hydroxyapatite biomaterial (Wishbone Hydroxyapatite, WHA) on guided bone regeneration compared to a commercially available deproteinized bovine bone mineral (Bio-Oss, BO). Material and Methods: Twenty-four beagle dogs were allocated to three timepoint cohorts (4, 12, and 26 weeks) of eight animals each. In all animals, four critical-sized, independent wall mandibular defects were created (32 defects/cohort). Each animal received all four treatments, allocated randomly to separated defects: WHA + collagen membrane (M), BO + M, no treatment (Sham, Sh), and Sh + M. At each timepoint, the specimens were harvested for histologic and histomorphometric analyses to determine the newly formed bone and osteoconductivity. Results: At 4 weeks, bone regeneration was significantly higher for WHA + M (46.8%) when compared to BO + M (21.4%), Sh (15.1%), and Sh + M (23.1%) (p < 0.05); at 12 and 26 weeks, regeneration was similar for WHA and BO. Bone-to-material contact increased over time similarly for WHA + M and BO + M. From a safety point of view, inflammation attributed to WHA + M or BO + M was minimal; necrosis or fatty infiltrate was absent. Conclusions: WHA + M resulted in higher bone regeneration rate than BO + M at 4 weeks. Both BO + M and WHA + M were more efficient than both Sh groups at all timepoints. Safety and biocompatibility of WHA was favorable and comparable to that of BO.