Clinical evaluations of OSTEON® as a new alloplastic material in sinus bone grafting and its effect on bone healing

Purpose: The objective of this study was to clinically evaluate the use of OSTEON® as a sinus graft material and to measure the effect of healing at 4 and 6 months after surgery. Materials and Methods: After sinus graft using OSTEON® in 17 patients, bone specimens were collected from lateral sinus using 2.0‐mm trephine bur at the time of 4 or 6 months after surgery. Histology of the bone specimens was prepared and the percentage of newly formed bone fraction, lamellar bone/woven bone ratio (LB/WB), and newly formed bone/graft material ratio (NB/GM) were measured to indicate the suitability of the materials and the successful healing of the graft. Results: The morphology of OSTEON® was observed to be interconnected, with 77% porosity and a pore size of 300–500 μm. After implantation, the mean percentage of newly formed bone fraction after 4 months and 6 months surgery was 40.6 and 51.9%, respectively. Statistical analysis indicated no significant difference ( p = 0.135) in the newly formed bone fraction between the two postoperative periods. The mean LB/WB ratio after 4 months and 6 months surgery was 0.14 and 0.45, respectively, with significant difference observed between the two postoperative periods ( p = 0.027). Additionally, the mean NB/GM ratio after 4 months and 6 months surgery was 1.95 and 7.72, respectively, with significant difference observed between the two postoperative periods ( p = 0.046). Conclusion: It was concluded that OSTEON® is suitable for use in sinus graft application since desirable time‐dependent healing was demonstrated. © 2007 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2008