Last reviewed · How we verify
bone substitute
A bone substitute material that replaces or augments lost or damaged bone tissue by providing a scaffold for new bone formation and integration.
A bone substitute material that replaces or augments lost or damaged bone tissue by providing a scaffold for new bone formation and integration. Used for Bone defects and fractures requiring augmentation, Spinal fusion procedures, Periodontal bone loss.
At a glance
| Generic name | bone substitute |
|---|---|
| Sponsor | Al-Azhar University |
| Drug class | Bone graft substitute / Biomaterial |
| Modality | Biologic |
| Therapeutic area | Orthopedics / Bone Regeneration |
| Phase | FDA-approved |
Mechanism of action
Bone substitutes are biocompatible materials designed to fill bone defects and promote osteogenesis (new bone formation). They work by serving as a structural scaffold that allows host bone cells to migrate, proliferate, and differentiate, while gradually being resorbed and replaced by native bone tissue. The material may be derived from natural sources (allograft, xenograft) or synthetic (ceramics, polymers, composites).
Approved indications
- Bone defects and fractures requiring augmentation
- Spinal fusion procedures
- Periodontal bone loss
- Maxillofacial reconstruction
Common side effects
- Infection at surgical site
- Inadequate bone integration
- Inflammatory response
- Material resorption failure
Key clinical trials
- Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults (NA)
- Collagenic vs Collagen-enriched Graft in Sinus Elevation: RCT (NA)
- Bone Augmentation Techniques in the Mandible Posterior Region (NA)
- Free Mucogingival Graft for Isolated Root Coverage (NA)
- Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane (NA)
- MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery (NA)
- FIBERGRAFT Aeridyan Posterolateral Fusion Study (NA)
- Vallomix Socket Preservation Study (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- bone substitute CI brief — competitive landscape report
- bone substitute updates RSS · CI watch RSS
- Al-Azhar University portfolio CI