Fast Degradable Calcium Phosphate Cement for Maxillofacial Bone Regeneration

Area of Science:

• Biomaterials Science
• Regenerative Medicine
• Oral and Maxillofacial Surgery

Background:

• Guided bone regeneration (GBR) is crucial for alveolar ridge augmentation, but membrane stabilization and graft containment pose challenges.
• Existing bone graft materials require additional membranes, complicating procedures and potentially hindering predictable bone regeneration.
• There is a clinical need for advanced bone substitute materials that simplify GBR procedures and enhance bone formation.

Purpose of the Study:

• To evaluate the efficacy of a novel calcium phosphate cement-poly(lactic-co-glycolic acid)-carboxymethylcellulose (CPC-PLGA-CMC) composite as a bone substitute.
• To compare the bone regeneration potential and material degradation of CPC-PLGA-CMC against a predicate device (BioOss) in a minipig mandibular defect model.
• To assess the feasibility of using CPC-PLGA-CMC in GBR procedures without a separate GBR membrane.

Main Methods:

• Creation of critical-sized mandibular defects in minipigs.
• Defects were filled with either CPC-PLGA-CMC (without membrane) or BioOss (with membrane).
• Bone formation and material degradation were assessed at 4 and 12 weeks post-implantation.

Main Results:

• Both CPC-PLGA-CMC and BioOss demonstrated significant increases in bone formation over time.
• No significant differences in bone formation were observed between CPC-PLGA-CMC and BioOss at 4 or 12 weeks.
• CPC-PLGA-CMC exhibited significantly higher degradation (~85%) compared to BioOss (~12%) at 12 weeks.

Conclusions:

• CPC-PLGA-CMC effectively stimulates bone regeneration comparable to BioOss in a preclinical mandibular defect model.
• CPC-PLGA-CMC offers advantages including faster degradation, easier application, and eliminates the need for a GBR membrane.
• The findings support further clinical investigation of CPC-PLGA-CMC for guided bone regeneration applications.