Table 1.
Randomized Controlled Trials on the Use of rhBMP-2 in Maxillary Sinus, Alveolar Ridge, and Alveolar Cleft Reconstruction
| Clinical Application | References | Methodology | LOE | n | Age (y) | FU (mo) | Comparison | Efficacy (Bone Formation) | Adverse Events (rhBMP-2- related) |
|---|---|---|---|---|---|---|---|---|---|
| Maxillary sinus augmentation | Boyne et al19 | PB-RCT (multicenter) | Ib | 48 | ≥18 | 36 | rhBMP-2 (0.75 mg/mL) + ACS versus rhBMP-2 (1.50 mg/mL) + ACS versus bone graft (auto ± allograft) | Favors control | Edema (dose dependent) |
| Triplett et al20 | P-RCT (multicenter) | IIb | 160 | ≥18 | 24 | rhBMP-2 (1.5 mg/mL) + ACS versus bone graft (auto ± allograft) | Favors control | Edema | |
| Kao et al21 | P-RCT (number of centers NR) | IIb | 22 | ≥18 | 9 | rhBMP-2 (1.5 mg/mL) +ACS + Bio-Oss versus Bio-Oss alone | Favors control | None | |
| Kim et al22 | PB-RCT (multicenter) | Ib | 46 | >18 | 6 | rhBMP-2 (1.5 mg/mL) + BCP versus Bio-Oss | No difference | None | |
| Kim et al23 | PB-RCT (multicenter) | Ib | 147 | >18 | 3 | rhBMP-2 (1 mg/mL) + hydroxyapatite vs Bio-Oss |
Favors rhBMP-2 | Edema (2–5 weeks) | |
| Alveolar ridge augmentation | Jung et al24 | PB-RCT (single center) | Ib | 11 | 27–75 | 6 | rhBMP-2 (0.5 mg/mL) + Bio-Oss versus Bio-Oss | Favors rhBMP-2 | None |
| Fiorellini et al25 | PB-RCT (multicenter) | Ib | 80 | 47.4 (mean) | 4 | rhBMP-2 (0.75 mg/mL) + ACS versus rhBMP-2 (1.50 mg/mL) + ACS versus ACS alone versus no treatment | Favors rhBMP-2 (dose dependent) | Edema, erythema | |
| Huh et al26 | PB-RCT (multicenter) | Ib | 72 | 35–65 | 3 | rhBMP-2 (1.5 mg/mL) + β-TCP/HA versus β-TCP/HA | Favors rhBMP-2 | None | |
| De Freitas et al27 | P-RCT (single center) | IIb | 24 | ≥18 | 6 | rhBMP-2 (1.5mg/mL) + ACS versus mandibular autogenous bone graft | No difference | Edema (2 weeks) | |
| Coomes et al28 | P-RCT (single center) | IIb | 39 | ≥18 | 5 | rhBMP-2 (1.5 mg/mL) + ACS versus ACS | Favors rhBMP-2 | Edema, erythema (10 d) | |
| Kim et al29 | PB-RCT (multicenter) | IIb | 69 | 20–70 | 3 | rhBMP-2 (0.05 mg/mL) + DBM gel versus DBM | No difference | None | |
| Nam et al30 | PB-RCT (single center) | IIb | 17 | 20–68 | 4 | rhBMP-2 (1mg/mL) + hydroxyapatite versus Bio-Oss | No difference | Edema | |
| Alveolar cleft | Dickinson et al31 | PB-RCT (single center) | IIb | 21 | 16 (mean) | 12 | rhBMP-2 (1.5 mg/ml) + ACS versus ICBG | Favors rhBMP-2 | None |
| Alonso et al32 | PB-RCT (single center) | IIb | 16 | 8–12 | 12 | rhBMP-2 (1.5 mg/mL) + ACS versus ICBG | Favors control | Edema (in 37% of rhBMP-2 group) | |
| Canan et al33 | P-RCT (single center) | IIb | 18 | 8–15 | 12 | rhBMP-2 (1.5 mg/mL) + ACS versus ICBG versus periosteoplasty | No difference between rhBMP-2 and ICBG; both superior to periosteoplasty | None | |
| Neovius et al34 | P-RCT (single center) | IIb | 7 | 9.9 (mean) | 6 | rhBMP-2 (0.05 mg/mL + hydrogel versus 0.25 mg/mL + hydrogel versus ICBG | No difference; dose-dependent response noted | Edema (2 weeks) in higher dose group with associated wound dehiscence |
β-TCP/HA, β-Tricalcium phosphate and hydroxyapatite; B, blinded; BCP, biphasic calcium phosphate; DMB, demineralized bone matrix; FU: follow-up; NR, not reported; P, prospective.