MASTERGRAFT ®
Family of Products
MASTERGRAFT® Granules
MASTERGRAFT® Mini Granules
MASTERGRAFT® Putty
15% HYDROXYAPATITE
85% BETA-TRICALCIUM PHOSPHATE
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MASTERGRAFT ® | Family of Products
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)
Calcium phosphate
Calcium carbonate
70% Inorganic
(mineral)
Magnesium
Fluoride
Bone
Composition of Bone
Sodium
Composition of Inorganic,
Mineral Portion of Bone
MASTERGRAFT ® | Family of Products
Resorption Mechanism
The 15% hydroxyapatite, 85% beta-tricalcium phosphate
blend which makes up the MASTERGRAFT® Products
results in a unique material which balances longterm 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
MASTERGRAFT® Family
15% HA/85% β-TCP
(Long term stability and resorption)
Chemical Composition2
100%
Calcium Sulfate
Material Resorption
Pure β-TCP
15% HA/85% β-TCP
(MASTERGRAFT® Family)
Calcium Carbonate/HA
Pure HA
0%
Time (Months)
Immediately Postoperative
6 Months Postoperative
Biocompatibility and Sterilization
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:
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Preclinical studies
Sterility tests
Biocompatibility tests
In vitro biodegradation testing
MASTERGRAFT® Putty is tested using:
»» Preclinical studies
»» Biocompatibility tests
»» Sterility tests
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MASTERGRAFT ® | Family of Products
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% betatricalcium 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
Average Pore Size:
125 microns
MASTERGRAFT® Granule
25 × Magnification
500 microns
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.
MASTERGRAFT ® | Family of Products
MASTERGRAFT® Putty
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.
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MASTERGRAFT ® | Family of Products
Proven Bone Formation
MASTERGRAFT® Granules Bone Formation and Mechanism of Action
Using MASTERGRAFT® Granules, a
seven-patient study was conducted
to evaluate the implant survival and
changes in alveolar bone histology
and morphology following postextraction 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
Nonrestorable tooth #9
MASTERGRAFT® Granules placed in
extraction socket
Implant placement at 4 months
post-extraction
Final restoration at 6 months post
implant placement
Trephine core biopsy taken at
time of implant placement
H & E histological analysis of core samples taken from
MASTERGRAFT® Granules augmented extraction site bone.
New bone formation is seen around
MASTERGRAFT® Granules.
MASTERGRAFT ® | Family of Products
Proven Bone Formation in Pre-clinical Studies
MASTERGRAFT® Putty Bone Formation and Mechanism of Action
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.
8 weeks post-op MASTERGRAFT®
Putty + Autograft (50:50)
Treatment Group
Graft Type
Manual
Palpation
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%
Radiographic
Fusion Rate
MASTERGRAFT® Putty/Autograft 50%/50%
8 weeks post-op
MASTERGRAFT® Putty surrounded
by new, woven bone in the central
portion of the grafted site.
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.
1 week postoperative
8 weeks postoperative
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.
Animal studies are not necessarily predictive of human clinical outcomes.
8 weeks post-op autograft alone
bridging new bone in the central region
of the grafted area.
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MASTERGRAFT ® | Family of Products
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
MASTERGRAFT ® | Family of Products
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
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MASTERGRAFT ® | Family of Products
MASTERGRAFT® Family of Products Summary
Proven Bone Formation via osteoconduction
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15% HA, 85% β-TCP, biphasic blend
Balances long-term stability with resorption
Cell-mediated resorption process
80% interconnected porosity
Resorbable
Handling
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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.
MASTERGRAFT ® | Family of Products
Product Ordering Information
MASTERGRAFT® Mini Granules
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
MASTERGRAFT® Granules
Item Number
Number
7600105
MASTERGRAFT® Granules 5cc
7600110
MASTERGRAFT® Granules 10cc
7600115
MASTERGRAFT® Granules 15cc
7600130
MASTERGRAFT® Granules 30cc
MASTERGRAFT® Putty
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
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