Features and Benefits

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Inert Biological Carrier Matrix

• Thermoplastic. Formable into any shape at 45°C

• A resilient solid at body temperature

• Insoluble in aqueous fluids at 39°C

• Inert biological carrier used in surgery since 1952 (1)
  

Demineralized Bone Matrix (DBM)

• Also known as demineralized freeze-dried bone allograft (DFDBA)

• Optimal concentration of DBM for osteoinductivity (1)

• Donor osteoinductivity verified 100% (*)

• Osteogenic property of demineralized bone matrix was first demonstrated in 1965 (2)

• Room Temperature Regenafil contains 60% DBM by weight

Critical Components

By optimizing the concentration of osteoinductive (*) demineralized bone matrix (DBM), Regenaform and Regenafil provide the foundation for bone regeneration.3 The inert biological carrier matrix allows revascularization to occur, making it an ideal carrier for DBM. (4)

Clinical Use

These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created for traumatic injury to the bone, including:
Periodontal defects;
Alveolar ridge augmentation;
Extraction sockets (ridge preservation, implant preparation/placement);
Maxillary sinus floor elevation;
Craniofacial augmentation;
Root resection, apicoectomy and cystectomy;
Tumor resection
One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect.

References:
1. Wironen J.F. et al., Effect of bone protein and carrier matrices on BMPstimulated osteogenesis. Transactions of the 44th Annual Meeting. Orthopaedic Research Society, 23:2, p. 603, 1998.
2. Urist M.R., Bone: Formation by Autoinduction. Science, 1965. 150(3698): pp. 893-899.
3. Goldberg V., et al., Biology of autografts and allografts. In Bone and Cartilage Allografts: Biology and Clinical Applications. Edited by V. Goldberg and G. Friedlaender. Park Ridge, IL, American Academy of Orthopaedic Surgeons, 1989, p. 3.
4. Gellad FE, Sadato N, Numaguchi Y, Levine AM. Vascular metastatic lesions of the spine: pre-operative embolization. Radiology. 176: 683-6, 1990.

Additional Reading
King C., et al., Effectiveness of Regenafil in Treating Intrabony Pockets–6 Month Results. IADR, March 2002.

*These products were evaluated in a human clinical study and were shown to induce bone formation.  Each lot of product is tested using the athymic nude rat assay to verify osteoinductive potential.
Products processed by RTI Biologics, Inc and distributed by Exactech, Inc.