OsteoGen^® Synthetic Bioactive Resorbable Graft (SBRG)

Impladent Ltd. is the sole manufacturer of this synthetic bioactive resorbable graft (SBRG) used for sinus elevations, filling tooth extractions and cyst defects, as well as repair of periodontal bone defects

OsteoGen^® is an osteoconductive, resorbable, synthetically-derived non-ceramic form of hydroxylapatite (HA), the major mineral component of bone and dental enamel. OsteoGen^® implant material is used for the augmentation and repair of bone defects. OsteoGen® is a highly crystalline material, comparable to natural bone, with NO alpha/beta tricalcium phosphates, amorphous phases, or bone-inhibiting pyrophosphates found in ceramic HA. Critically-controlled manufacturing produces a bone grafting particulate of nearly perfectly-formed clusters of relatively hexagonal-shaped crystals bound to a single nucleus. These clusters intertwine for greater porosity to form a 360E lattice mechanism for the host bone. OsteoGen^® is an osteoconductive material in that the highly porous crystalline clusters act as a slowly-resorbing matrix permitting the infiltration of bone-forming cells and the subsequent deposition of host bone. OsteoGen^® non-ceramic crystal clusters are highly hydrophilic, allowing the material to readily absorb liquid; potential for migration or material loss is greatly reduced by controlling excessive bleeding. Preparation is simple and delivery is easily accomplished with conventional instrumentation or syringe in a sandy consistency.

OsteoGen^® Indications and Usage

OsteoGen^® is indicated as an aid in sinus augmentation (sinus lift) procedures; for augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects; and, for the treatment of periapical and periodontal defects. Because the crystal clusters are non-ceramic, OsteoGen^® is extremely hydrophilic. A "sandy" consistency is readily achieved by the addition of sterile saline or patient's blood; the coagulum is easily transferred by conventional tools to the osseous defect. Control of excessive bleeding should be managed for better bone fill-in.

FOR DOCTOR’S IMMEDIATE ATTENTION
PRIOR TO USE and PRODUCT APPLICATION of  OSTEOGEN^®

TOOTH EXTRACTION PROTOCOL:

PRODUCT INSERT:

After anesthesia, a small sharp periodontal elevator or surgical curette is placed around the tooth root to separate the periodontal fibers.  The tooth is extruded without a periosteal flap.  Debridment and enucleation of the PDL and all pathosis from the socket is achieved by using a Number 4 or Number 5 round bur.  Amoxicillin powder may be applied topically; wash and aspirate site.  Number 1 or Number 2 round bur is used to decorticate, making holes through the lamina dura (lamina propria) at sites where anatomical structure permits (Figure1).  These openings into the trabecular structure will permit cells to enter the socket from the endosteum and be stimulated by OsteoGen® Synthetic Bioactive Resorbable Graft (SBRG).  Delivery of the product is accomplished with a periodontal elevator to the site, or a pre-filled OsteoGen®  syringe.  Excessive bleeding should be controlled.*   Blood and/or antibiotic powder could be mixed with OsteoGen® graft and directly delivered to socket.  Pack extremely well until you have reached crestal bone height and then overfill by 13% above the ridge creating a convexity.  Place a membrane on top to saddle the graft (fold the membrane in half).**   Passively suture, in a cris-cross method, over the membrane to maintain the products in place.

*     Avitene® hemostatic agent. 
        Use Epinephrin for patients with no heart complications

**  Wound dressing (such as CollaTape^® or CollaCote^® )