15% HYDROXYAPATITE85% BETA-TRICALCIUM PHOSPHATE

MASTERGRAFT® GranulesMASTERGRAFT® Mini GranulesMASTERGRAFT® Putty

MASTERGRAFT ® Family of Products

MASTERGRAFT ® | Family oF Products1

Calcium phosphate

Calcium carbonate

Magnesium

Fluoride

Sodium

Introduction

The MASTERGRAFT® Family of Products are biphasic, resorbable ceramics composed of hydroxyapatite (HA) and beta-tricalcium phosphate (β-TCP), either in granule form or distributed evenly throughout a Type I collagen in putty form. The biphasic blend of HA/β-TCP throughout the products provides a purely osteoconductive graft made of materials similar to the mineral found inherently in bone.1,2 The uniform mixture of hydroxyapatite and beta-tricalcium phosphate provides the surgeon with characteristics that balance long-term stability with a natural cell-mediated (osteoclastic) resorption process.2

Bone is composed of organic and inorganic, or mineral, elements. The weight of dry bone is made up of an inorganic calcium phosphate and an organic matrix of fibrous protein and collagen. The inorganic portion of bone can be further broken into minerals including calcium phosphate, calcium carbonate, and small quantities of magnesium, fluoride, and sodium.1,2

30% Organic (collagen, non-collagenous proteins)

70% Inorganic (mineral)

Composition of BoneBone

Composition of Inorganic, Mineral Portion of Bone

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Resorption Mechanism

The MASTERGRAFT® Family of Products has demonstrated no inflammatory or pathologic response. The use of MASTERGRAFT® Products eliminates the risk associated with products that contain tissues of human origin.

MASTERGRAFT® Granules and MASTERGRAFT® Mini Granules are tested using:

» Preclinical studies » Sterility tests » Biocompatibility tests » In vitro biodegradation testing

MASTERGRAFT® Putty is tested using:

» Preclinical studies » Biocompatibility tests » Sterility tests

Biocompatibility and Sterilization

The 15% hydroxyapatite, 85% beta-tricalcium phosphate blend which makes up the MASTERGRAFT® Products results in a unique material which balances long-term stability with resorption. Hydroxyapatite alone remains without remodeling for long periods of time allowing bone to encapsulate the graft and preventing resorption. Pure tricalcium phosphate tends to remodel

too quickly eliminating the scaffolding and allowing for soft tissue to collapse into the defect.2 The biphasic blend of the MASTERGRAFT® Products provides the surgeon with a space maintaining product that resorbs through natural, cell-mediated creeping substitution, replacing the scaffold with new host bone.2

Immediately Postoperative 6 Months Postoperative

MASTERGRAFT® Family15% HA/85% β-TCP

(Long term stability and resorption)

Chemical Composition2

Mat

eria

l Res

orpt

ion

Time (Months)

Pure HA

Calcium Carbonate/HA

15% HA/85% β-TCP(MASTERGRAFT® Family)

Pure β-TCP

Calcium Sulfate100%

0%

MASTERGRAFT ® | Family oF Products3

MASTERGRAFT® Granules and MASTERGRAFT® Mini Granules

Composition, Structure, and Handling

MASTERGRAFT® Granules and MASTERGRAFT® Mini Granules are biphasic, resorbable, ceramic granules composed of 15% hydroxyapatite (HA) and 85% beta-tricalcium phosphate (β-TCP). The granules have a natural, interconnected, porous structure which mimics the natural structure of bone and allows for rapid, homogenous bone ingrowth throughout each granule.2 Each granule is 80% porous with an average pore size of 500 microns and 125 microns interconnected diameter. MASTERGRAFT® Granules have an average diameter of 1.6mm – 3.2mm. MASTERGRAFT® Mini Granules have an average diameter of 0.5mm – 1.6mm.

Through a highly porous granular structure and the 15% HA/85% β-TCP chemical composition, MASTERGRAFT® Granules and MASTERGRAFT® Mini Granules facilitates rapid, homogenous osseointegration, which supports the bone healing process by acting as a scaffold over which bone can grow. The porosity of the material provides an excellent basis for vascularization and penetration of associated cells, which support integration of the substitute materials required for healing while preserving the bony architecture and attached gingiva.4

MASTERGRAFT® Granule 25 × Magnification

125 microns

500 microns

Average Pore Size:

Summary of Indications

MASTERGRAFT® Granules can be used alone or in combination with autogenous bone in oral/maxillofacial augmentation or reconstruction and other larger bony defects. MASTERGRAFT® Mini Granules are ideal for smaller defects such as extraction site preservation and periodontal defects, or in combination with autogenous bone in larger defects such as sinus augmentation and cystic defects.

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Composition, Structure, and Handling

MASTERGRAFT® Putty is composed of resorbable ceramic granules uniformly distributed through a highly purified resorbable Type I bovine collagen. The resorbable ceramic granules of 15% HA, 85% β-TCP balance long-term stability with complete resorption.2 The granules range in size from 0.5mm-1.6mm in diameter and are 80% porous. The Type I bovine collagen used is composed of two formulations of collagen: 70% insoluble fibrous collagen and 30% soluble collagen. The collagen allows the graft materials to be malleable and resistant to water solubility while still maintaining the graft's integrity. MASTERGRAFT® Putty is an osteoconductive scaffold that

resorbs by cell-mediated creeping substitution, and is gradually replaced with new, homogenous bone growth throughout the site. MASTERGRAFT® Putty also enables the user to perform radiographic assessment of the graft after implantation.

MASTERGRAFT® Putty was designed for easy hydration using sterile water or blood. Once hydrated, it can be mixed with autogenous bone to increase the volume of graft material while providing a small level of osteogenic potential due to the presence of autograft.3 The putty structure allows for retention of biological factors at the site of implantation.

MASTERGRAFT® Putty

MASTERGRAFT ® | Family oF Products5

MASTERGRAFT® Granules placed in extraction socket

Final restoration at 6 months post implant placement

Implant placement at 4 months post-extraction

Nonrestorable tooth #9

Proven Bone Formation

Using MASTERGRAFT® Granules, a seven-patient study was conducted to evaluate the implant survival and changes in alveolar bone histology and morphology following post-extraction socket augmentation.

In seven patients, between the ages of 35 and 82, MASTERGRAFT® Granules were used to graft an extraction socket defect to preserve ridge form after tooth extraction. Bone core samples were taken from the grafted sites for histologic and radiographic evaluation. Intraoperative and postoperative images using MASTERGRAFT® Granules can be seen below.4

H & E histological analysis of core samples taken from MASTERGRAFT® Granules augmented extraction site bone.

New bone formation is seen around MASTERGRAFT® Granules.

MASTERGRAFT® Granules Bone Formation and Mechanism of Action

Trephine core biopsy taken at time of implant placement

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8 weeks post-op MASTERGRAFT® Putty + Autograft (50:50)

MASTERGRAFT® Putty Bone Formation and Mechanism of Action

Proven Bone Formation in Pre-clinical Studies

Animal studies are not necessarily predictive of human clinical outcomes.

MASTERGRAFT® Putty/Autograft 50%/50%

MASTERGRAFT® Putty has been evaluated for osteoconductivity and bone forming potential when combined with autograft in a challenging preclinical model. Results from this model can be seen below.

Autograft alone and MASTERGRAFT® Putty plus autograft (in either a 50:50 or 25:75 percent composition) were used in a single level, bilateral, posterolateral intertransverse process fusion in 30 rabbits. Results shown below were determined at 8 weeks post surgery.

Results show that MASTERGRAFT® Putty can be effectively combined with autograft as an extender to produce new bone bridging the space between the bony segment.

Histological evaluation indicated that bone formed directly on the putty’s ceramic particles, that remodeling was ongoing, and that there was no evidence of inflammatory reactions.

Treatment Group Graft Type

Manual Palpation Fusion Rate

Radiographic Fusion Rate

Autograft Autograft alone (3.0cc) 63% 63%

Putty + Autograft 50:50

Putty 50% (1.5cc) + Autograft 50% (1.5cc)

73% 91%

Putty + Autograft 25:75

Putty 25% (0.75cc) + Autograft 75% (2.25cc)

64% 73%

1 week postoperative 8 weeks postoperative

8 weeks post-op autograft alone bridging new bone in the central region

of the grafted area.

8 weeks post-op autograft alone bridging new bone in the central region

of the grafted area with residual bone graft in the center of the image.

8 weeks post-opMASTERGRAFT® Putty surrounded by new, woven bone in the central

portion of the grafted site.

MASTERGRAFT ® | Family oF Products7

MASTERGRAFT® Granules and MASTERGRAFT® Mini Granules Applications

MASTERGRAFT® Mini Granules with sterile water for extraction site preservation

MASTERGRAFT® Mini Granules with blood for extraction site preservation

MASTERGRAFT® Mini Granules with sterile water for sinus augmentation

MASTERGRAFT® Mini Granules with blood for sinus augmentation

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MASTERGRAFT® Putty Applications

MASTERGRAFT® Putty hydrated with sterile water for extraction site preservation

MASTERGRAFT® Putty hydrated with blood for extraction site preservation

MASTERGRAFT® Putty with autograft for sinus augmentation

MASTERGRAFT® Putty with autograft for sinus augmentation

Mandibular ridge deficiency

Mandibular ridge augmentation using MASTERGRAFT® Putty with autograft and a titanium mesh for space maintenance

MASTERGRAFT ® | Family oF Products9

MASTERGRAFT® Family of Products Summary

Proven Bone Formation via osteoconduction

» 15% HA, 85% β-TCP, biphasic blend » Balances long-term stability with resorption » Cell-mediated resorption process » 80% interconnected porosity » Resorbable

Handling

» Moldable putty form » Packable putty form » Radiopaque in putty and granular form » Space maintaining in granular form » Can be mixed with autograft in putty or granular form » Resists migration in putty form » Granules are hydrophilic in nature

Biocompatibility

» No inflammatory or pathologic response » Sterile

References

1. Kalfas IH. Principles of bone healing. Neurosurg Focus. 2001 Apr 15;10(4):E1.

2. LeGeros RZ. Properties of osteoconductive biomaerials: calcium phosphates. Clin Orthop Relat Res. 2002 Feb;(395):81-98.

3. Smucker JD, Peterson E, et al. Assessment of Mastergraft putty as an autograft extender in a rabbit posterolateral fusion model. Unpublished manuscript, The University of Iowa Department of Orthopaedics, The Iowa Spine Research Center and the Bone Healing Research Laboratory, Iowa City, IA, 2008.

4. Wakimoto M, Sawaki M, et al. Implant survival and changes in alveolar bone following post-extraction socket augmentation using Mastergraft Granules. Poster session, Academy of Osseointegration. Boston, MA, February, 2008.

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Product Ordering Information

MASTERGRAFT® Putty

MASTERGRAFT® Mini Granules

MASTERGRAFT® Granules

Item Number Number

7600701 MASTERGRAFT® Putty 0.75cc

7600702 MASTERGRAFT® Putty 1.5cc

7600703 MASTERGRAFT® Putty 3.0cc

7600706 MASTERGRAFT® Putty 6.0cc

7600709 MASTERGRAFT® Putty 9.0cc

Item Number Number

8600100 MASTERGRAFT® Mini Granules 0.5cc

8600101 MASTERGRAFT® Mini Granules 1.0cc

8600103 MASTERGRAFT® Mini Granules 3.0cc

8600105 MASTERGRAFT® Mini Granules 5.0cc

Item Number Number

7600105 MASTERGRAFT® Granules 5cc

7600110 MASTERGRAFT® Granules 10cc

7600115 MASTERGRAFT® Granules 15cc

7600130 MASTERGRAFT® Granules 30cc

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