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MASTERGRAFT BONE GRAFT CLINICAL EVIDENCE Bone Grafting (Oral Maxillofacial and Dental)

MASTERGRAFT GRANULES STUDY

Human Extraction Socket Preservation – Proven Bone Formation Study

Wakimoto M, Ueno T, Hirata A, Iida S, Aghaloo T, & Moy PK.  Histologic Evaluation of Human Alveolar Sockets Treated With an Artificial Bone Substitute Material.  J of Cranio Surg. 2011;22(2):490-493.

Study Design

  • Seven patients (ages 35 – 82 years)
  • Teeth extracted and immediately grafted using Mastergraft Granules
  • No primary closure
  • Implants placed at 4 – 5 months post-grafting

Procedure Process

  1. Mastergraft Granules placed into the extracted socket as a graft material.  
  2. Mastergraft Granules were covered with a cellulose sponge.  
  3. Bone core samples were taken from the grafted sites at 4 months after grafting.
  4. Installed implant into the grafted site at 4 months after grafting.

Conclusion

Mastergraft Granules in human extraction sockets demonstrated:

  • Osteoconductive scaffold for new bone formation
  • Maintenance of space within the defect
  • Support of new blood vessel formation
  • Support of osteoclasts and osteoblasts for bone remodeling
  • Effective for repairing bone defects
Bone Grafting Oral Maxillofacial Mastergraft Granules Dental Study

CONTRAINDICATIONS

This product is not intended to provide structural support during the healing process, therefore, Mastergraft Granules is contraindicated where the device is intended as structural support in the skeletal system.

Conditions representing relative contraindications include:

  • Severe neurological or vascular disease
  • Uncontrolled diabetes
  • Hypercalcemia
  • Pregnancy
  • Where stabilization of fracture is not possible
  • Segmental defects
  • Where there is significant vascular impairment proximal to the graft site
  • When there are systemic and/or metabolic disorders that affect the bone or wound healing
  • Any patient unwilling to follow postoperative instructions
  • Any case not described in the indications

POTENTIAL ADVERSE EVENTS

A listing of potential adverse events includes, but is not limited to:

  • Deformity of the bone at the surgical site
  • Fracture or extrusion of the Mastergraft Granules, with or without generation of particulate debris
  • Wound complications including hematoma, site damage, infection, bone fracture, and other complications common to any surgical procedure
  • Incomplete or lack of osseous ingrowth into bone void, as possible with any bone filler

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results and other important medical information