Allograft Bone Graft

Product Overview

Swiss-Graft® Allograft Bone Graft is a demineralized human bone matrix (DBM) derived from carefully screened human donors. Unlike synthetic alternatives, allograft bone preserves the native organic architecture of human bone tissue, including naturally present bone morphogenetic proteins (BMPs), collagen type I, proteoglycans, and other osteoinductive growth factors essential for bone regeneration.

The demineralization process selectively removes the mineral phase while preserving the organic matrix—a critical distinction that maintains the three-dimensional collagen scaffold structure identical to human bone. This preservation of the native ECM (extracellular matrix) with its intrinsic osteogenic proteins provides superior biological activity compared to processed xenografts or purely synthetic materials.

Clinical evidence demonstrates that allograft bone exhibits both osteoinductive properties (promoting new bone cell formation through growth factor signaling) and osteoconductive properties (providing physical scaffolding for bone cells). The naturally preserved BMP-2, BMP-7, and other growth factors trigger the cascade of mesenchymal stem cell differentiation, leading to superior osseointegration rates and predictable bone formation kinetics.

Clinical Indications & Evidence-Based Applications

Swiss-Graft® Allograft Bone Graft is indicated for use in horizontal and vertical bone reconstruction where osteoinductive and osteoconductive properties are therapeutically required:

• Implant Site Development: Alveolar bone deficiencies requiring regeneration prior to implant placement (horizontal ridge augmentation, vertical ridge elevation)
• Socket Preservation: Extraction socket preservation to minimize alveolar bone resorption and maintain ridge morphology for future prosthetics
• Ridge Augmentation: Severe ridge resorption cases requiring significant volume restoration (anterior esthetics, posterior molar sites)
• Sinus Floor Elevation: Internal and external sinus augmentation procedures for posterior maxillary implant placement
• Periodontal Regeneration: Advanced intrabony periodontal defects (Glickman classification III-IV) with combined regenerative therapy
• Maxillofacial Reconstruction: Trauma, tumor resection, or congenital defect reconstruction requiring reliable bone regeneration
• Orthognathic Defects: Segmental gaps and irregularities post-orthognathic surgery
• Maxillary-Mandibular Augmentation: Complex three-dimensional defects requiring predictable regeneration kinetics

Biological Processing & Preservation Methodology

Swiss-Graft® allograft undergoes a proprietary multi-stage processing protocol:

• 1. Donor Screening: Comprehensive serology (HIV Antigen/Antibody, Hepatitis B/C, syphilis, HTLV-I/II) + health history evaluation following FDA and AATB guidelines
• 2. Procurement & Cleaning: Aseptic tissue recovery within 12 hours of death; removal of soft tissue and blood elements
• 3. Demineralization: Controlled hydrochloric acid treatment selectively removes mineral (hydroxyapatite, calcium phosphate) while preserving organic matrix protein composition and three-dimensional architecture
• 4. Sterilization: Ethylene oxide gas sterilization per ISO 11135 (no gamma irradiation to preserve growth factor bioactivity)
• 5. Lyophilization: Freeze-drying to create shelf-stable product with enhanced shelf-life (5 years) while maintaining biological activity upon rehydration
• 6. Quality Control: Histological analysis, endotoxin testing (LAL assay, USP <85> limits), biocompatibility validation (ISO 10993), sterility assurance level (SAL) verification

Clinical Evidence & Outcome Data

Peer-reviewed literature demonstrates superior clinical outcomes with demineralized human bone allograft:

• Osseointegration Rate: 85-95% within 6 months (CBCT/histological confirmation) vs. 75-80% for xenograft, 65-75% for synthetic materials
• Bone Regeneration Volume: Average 78-82% of original defect volume restored vs. 65-70% for processed grafts
• Resorption Pattern: Linear predictable resorption (8-14 months) with concurrent new bone formation—maintained mechanical support during critical healing phases
• Implant Success Rate: 96-98% implant survival in grafted sites (10-year follow-up data) comparable to native bone sites
• Infection Rate: <0.5% with rigorous donor screening and sterilization protocols

Product Forms & Clinical Packaging

Swiss-Graft® Allograft is available in customized demineralization levels and particle morphologies to optimize clinical outcomes for specific applications:

• Cancellous Chips (Particulate): 250-1000 µm particles for moldability and intimate bone contact—optimal for socket preservation and ridge augmentation
• Cortical-Cancellous Blend: Mixed morphology providing structural support combined with enhanced bioactivity for complex three-dimensional defects
• Demineralization Levels: Light, moderate, and extensive demineralization options calibrating osteoinductive potency to clinical indication

Available Sizes: 0.5cc, 1cc, 2cc, 5cc, 10cc — All individually packaged in sterile triple-barrier systems with complete donor information documentation and clinical guidelines. Shelf-life: 5 years at 2-8°C (refrigerated storage).