A feasibility study evaluating rhBMP-2/absorbable collagen sponge device for local alveolar ridge preservation or...

Area of Science:

• Regenerative Medicine
• Oral and Maxillofacial Surgery
• Biomaterials

Background:

• Alveolar ridge preservation and augmentation are critical for successful dental implantology.
• Recombinant human bone morphogenetic protein-2 delivered in an absorbable collagen sponge (rhBMP-2/ACS) is a potential biomaterial for bone regeneration.

Purpose of the Study:

• To evaluate the short-term safety and technical feasibility of rhBMP-2/ACS implantation.
• To assess bone induction and osseointegration potential in alveolar ridge preservation and osseous defect augmentation.

Main Methods:

• A two-center human clinical trial involving 12 patients (6 preservation, 6 augmentation).
• rhBMP-2/ACS device implantation followed by safety monitoring (oral exams, radiographs, blood samples) and technical feasibility assessment.
• Evaluation of bone induction using direct measurements and imaging techniques over a 4-month period.

Main Results:

• rhBMP-2/ACS was well-tolerated systemically and locally, with no serious adverse events.
• The device exhibited good handling properties and was easily adapted to surgical sites.
• Bone fill was observed in all alveolar sockets treated for preservation; however, significant augmentation was not consistently observed in defect sites.

Conclusions:

• rhBMP-2/ACS implantation is safe and technically feasible for alveolar ridge preservation and osseous defect augmentation.
• The material shows promise for promoting bone fill in extraction sockets.
• Further investigation is warranted to optimize outcomes for osseous defect augmentation.