Bone Regeneration from PLGA Micro-Nanoparticles

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.