Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial

Area of Science:

• Regenerative Medicine
• Oral and Maxillofacial Surgery
• Biomaterials Science

Background:

• Maxillary sinus floor augmentation is crucial for dental implant placement.
• Bone morphogenetic proteins (BMPs) show potential for bone regeneration.
• Evaluating novel biomaterials for enhanced bone formation is essential.

Purpose of the Study:

• To compare the early efficacy of low-dose Escherichia coli-derived recombinant human bone morphogenetic protein 2 (rhBMP-2) with hydroxyapatite (BMP-2/H) against an inorganic bovine bone xenograft (ABX).
• To assess bone formation and safety in maxillary sinus augmentation.
• To determine noninferiority of BMP-2/H to ABX.

Main Methods:

• A randomized, single-blinded, active-controlled clinical study involving 127 subjects.
• Maxillary sinus floors were augmented with either BMP-2/H or ABX.
• Core biopsies analyzed histomorphometrically at 3 months post-surgery.

Main Results:

• Mean new bone formation was significantly higher in the BMP-2/H group (16.10%) compared to the ABX group (8.25%) (P < 0.0001).
• BMP-2/H demonstrated noninferiority to ABX, with a lower confidence interval limit of 4.33% exceeding the -3.75% margin.
• No significant differences in soft tissue, residual graft areas, or adverse events were observed between groups.

Conclusions:

• Low-dose Escherichia coli-derived rhBMP-2 with hydroxyapatite is effective for early bone formation in maxillary sinus augmentation.
• The BMP-2/H treatment is safe and comparable to traditional xenografts.
• This rhBMP-2 formulation offers a promising alternative for sinus lift procedures.