Table 5.
Parameter | Aspect | Property/Specification |
---|---|---|
Raw material |
Source | Health- and feed-controlled isolated pig colony |
Tissue | Porcine teeth | |
Material properties | Physical form | Irregular shaped particles, retaining dentin microstructure |
Particle size | 300–900 μm | |
Composition | ca. 70% hydroxyapatite and ca. 30% organic ECM (89% type I collagen, 1% proteoglycans, 10% others—non-collagenous proteins), partially degraded |
|
Vickers hardness | 73 HV ± 14 HV | |
Ca/P | 1.59–1.67 | |
Microstructure | Porosity: 80% 0.7–1.5 μm tubules; 20% coarse pores 2–15 μm | |
Implant properties | Clinical bone growth |
Superior new bone formation, bone-graft integration, and higher radiodensity than a porcine bone graft material with retained ECM at 4 months after mandibular premolar or molar tooth extraction in patients |
Preclinical bone growth |
Superior to both deproteinated bone and sham treatment, in terms of bone regeneration and tolerability, in a canine mandibular two-wall defect model at 4, 12, and 26 weeks follow-up Good bone repair in extraction sockets and sub-periosteum pouches in a clinically relevant porcine mandibular defect model at 2.5 months after grafting |
|
Biocompatibility | In clinical use for socket preservation, local site reactions and adverse events following extraction socket grafting and implant placement were similar to that of a standard clinically established bone graft material In a rabbit femoral condyle defect model, no intrinsically local adverse reactions, no local draining lymph node reaction, and no signs of systemic toxicity In a canine mandibular two-wall defect model, tolerability and initial inflammatory reaction was similar to the control deproteinized bone material In a porcine extraction socket and sub-periosteum pouch model, only moderate inflammation consistent with normal healing was seen No in vitro cytotoxicity of extracts |
|
Resorption | In a canine two wall defect model, resorption up to 6.5 months was more rapid than for a deproteinated bovine bone material. In a rabbit condyle bone defect model, resorption assessed at 3 months was much slower than for a porcine bone material with retained organic ECM. Therefore, resorption is prolonged but not as long as for deproteinized xenograft bone graft material |
Ca = calcium; ECM = extracellular matrix; HV = Vickers hardness; P = phosphate.