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±0.13g/cm(3)) and 16 weeks (0.97±0.08g/cm(3)) in the graft compared to native (control) bone (0.04±0.02g/cm(3)). 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±0.53mm. It is concluded that PepGen P-15 Putty is capable of conducting and accelerating new bone formation and can successfully support dental implants.