Table 1.
Summary of clinical and animal studies using BMP-2 for sinus floor elevation (adapted from [38]). The included studies overall concluded that rhBMP-2 induces new bone formation with comparable bone quality and quantity of newly formed bone to that induced by autogenous bone graft.
| Reference | Study design | Follow-up (months) | Species (subjects) | Core biopsy harvesting (months) | Graft material | % Newly formed bone | Bone height gain (mm) | Bone width gain (mm) | Bone density (mg/mL) | Immune response | Histology |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Boyne et al. 2005 [37] | RCT | 52 | Human (48) | 6–11 | 0.75 mg/mL rhBMP-2/ACS | NA | 11.29 | Crest: 2.02 Midpoint: 8.54 Apical: 11.86 |
84 | None | NA |
| 1.50 mg/mL rhBMP-2/ACS | 0.47 | Crest: 1.98 Midpoint: 7.80 Apical: 10.78 |
134 | ||||||||
| Autogenous bone graft; autogenous bone graft + allogeneic bone graft | 10.16 | Crest: 4.66 Midpoint: 10.17 Apical: 10.56 |
350 | ||||||||
|
| |||||||||||
| Triplett et al. 2009 [40] | RCT | 58 | Human (160) | 6 | 1.50 mg/mL rhBMP-2/ACS | NA | 7.83 ± 3.52 | NA | 200 | None | Rich vascular marrow space high in cellular content |
| Autogenous bone graft (iliac crest, tibia or oral cavity); autogenous bone graft + allogeneic bone graft | 9.46 ± 4.11 | 283 | Osteoclasts still present; higher fibrous tissue | ||||||||
|
| |||||||||||
| Kao et al. 2012 [41] | Prospective | 6–9 | Human (22) | 6–9 | rhBMP-2/ACS + ABB | 16.04 ± 7.45 | NA | NA | NA | None | Fewer ABB particles; less newly formed bone (woven and mature bone structure) |
| ABB | 24.85 ± 5.82 | More ABB particles remaining; higher newly formed bone (woven and matured bone structure) | |||||||||
|
| |||||||||||
| Nevins et al. 1996 [36] | Prospective | 12 | Goat (6) | 12 | rhBMP-2/ACS | NA | NA | NA | NA | None | Dense isolated trabeculae and bone marrow; osteoblast and osteoclasts; no cortical bone |
| ACS/Buffer | Collagenous connective tissue; no evidence of inflammation; no neo-osteogenesis | ||||||||||
|
| |||||||||||
| Hanisch et al. 1997 [42] | RCT | 24 | Nonhuman primate (12) | 24 | rhBMP-2/ACS | NA | 6.0 ± 0.3 | NA | 14.4 ± 2.9 | NA | Newly formed bone indistinguishable from residual bone |
| ACS | 2.6 ± 0.3 | 13.9 ± 4.6 | |||||||||
|
| |||||||||||
| Wada et al. 2001 [43] | Prospective | 8 | Rabbit (10) | 8 | rhBMP-2/ACS | 22.4 ± 4.4 | NA | NA | NA | NA | Cortical bone formation in both groups; trabeculae with clear lamellar structure were embedded in fatty marrow |
| Autogenous bone graft (iliac crest) | 21.9 ± 4.5 | ||||||||||
|
| |||||||||||
| Lee et al. 2013 [39] | Prospective | 8 | Mini-pig (8) | 8 | rhBMP-2/ACS | NA | 9.3 ± 0.5 | NA | 51.9 ± 3 | NA | Newly formed cancellous bone; new bone continuous with resident bone; woven bone in fibrovascular and fatty marrow |
| Autogenous bone graft (iliac crest) | 8.6 ± 0.7 | 32.9 ± 2.5 | Irregular and variable bone among different subjects | ||||||||
NA: not available; RCT: randomized clinical trial; ACS: absorbable collagen sponge; ABB: anorganic bovine bone.