The efficacy of a tissue-engineered xenograft in conjunction with sodium hyaluronate carrier in maxillary sinus augmentation: a clinical study

PepGen P-15 Putty comprises anorganic bovine bone matrix (ABM) coupled with a synthetic cell-binding peptide, suspended in a sodium hyaluronate carrier. The P-15 portion exhibits a similar structure and properties to the cell-binding region of type I collagen. This study was performed to evaluate ABM/P-15 putty as the sole graft in sinus augmentation. Ten patients for whom both a sinus augmentation and two implants were indicated in the posterior maxilla were enrolled. Bone cores were harvested at 8 and 16 weeks, followed by placement of one implant at 8 weeks and the second at 16 weeks. Twenty collected bone cores were evaluated histologically and by micro-computed tomography. Results showed a significant increase (P < 0.05) in bone mineral density at 8 weeks (0.70 ± 0.13 g/cm3) and 16 weeks (0.97 ± 0.08 g/cm3) in the graft compared to native (control) bone (0.04 ± 0.02 g/cm3). There was no significant difference (P > 0.05) in the percentage bone volume at the two time intervals (PBV 21.14 ± 4.56 at 8 weeks and 26.33 ± 5.60 at 16 weeks). The average increase in bone height at 16 weeks was 10.55 ± 0.53 mm. It is concluded that PepGen P-15 Putty is capable of conducting and accelerating new bone formation and can successfully support dental implants.