Pivotal, randomized, parallel evaluation of recombinant human bone morphogenetic protein-2/absorbable collagen sponge and autogenous bone graft for maxillary sinus floor augmentation.
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PURPOSE: The purpose of this prospective study was to evaluate the safety and effectiveness of recombinant human morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) compared with an autogenous bone graft when used for 2-stage maxillary sinus floor augmentation. The study assessed new bone formation, placement integration, and functional loading after 6 months and long term for 2 years. MATERIALS AND METHODS: A total of 160 subjects were randomized, enrolled, and followed from January 1999 to February 2004 at 21 centers in the United States. The subjects with less than 6 mm of native bone height were treated with 1.50 mg/mL rhBMP-2/ACS or with an autograft. The height and density measurements were quantified by computed tomography scans. Core biopsies were obtained at dental implant placement and used for histological analysis. Safety was evaluated by oral examinations, radiographs, serum chemistries, and hematology. RESULTS: A significant amount of new bone was formed by 6 months postoperatively in each group. The mean change in bone height in the rhBMP-2/ACS subjects was 7.83 +/- 3.52 mm versus 9.46 +/- 4.11 mm for the bone graft subjects. At 6 months after dental restoration, the induced bone in the rhBMP-2/ACS group was significantly denser than that in the bone graft group. No marked differences were found in the histologic parameters evaluated between the 2 groups. The new bone was comparable to the native bone in density and structure in both groups. The success rate for the rhBMP-2/ACS group was 79% (64 of 81 subjects), and 201 of 251 implants placed in the bone graft group and 199 of 241 implants placed in the rhBMP-2/ACS group were integrated, retained, and functional at 6 months after loading. No adverse events were deemed related to the rhBMP-2/ACS treatment. The autograft group was noted to have a 17% rate of long-term parasthesia, pain, or gait disturbance related to the bone graft harvest. CONCLUSIONS: The results of our multicenter, randomized, prospective, clinical trial have shown the effectiveness and safety of rhBMP-2/ACS compared with bone graft for sinus floor augmentation. The study's primary endpoint was exceeded, and the implants placed in rhBMP-2/ACS and bone graft groups performed similarly after functional loading.
