Product Information

MIS Corporation. All Rights Reserved.

MISs Quality System complies with international

quality standards: ISO 13485: 2003 - Quality
Management System for Medical Devices, ISO
9001: 2008 - Quality Management System and
CE Directive for Medical Devices 93/42/EEC.
BONDBONE is cleared for marketing in the
USA and is CE approved.

MIS Warranty: MIS exercises great care and effort in maintaining the
superior quality of its products. All MIS products are guaranteed to
be free from defects in material and workmanship. However, should
a customer find fault with any MIS product after using it according
to the directions, the defective product will be replaced.

3.

Introduction.
Technological advances over the
past decade have led to a new era
in bone repair and growth. Today,
augmentation procedures are a
part of routine dental surgical care.
Current augmentation methods use
materials from different sources
such as autografts, allografts,
xenografts, and alloplasts, which are
in a granulated form. BONDBONE
has been developed to facilitate
handling and reduce time in dental
augmentation procedures.

4.

Overview.
BONDBONE is a novel synthetic bone graft material and is
considered to be a breakthrough in the field of dental bone
grafting. It is composed of biphasic calcium sulfate, which has
well-established and documented biocompatible, osteoconductive,
and bioresorbable properties. The biphasic calcium sulfate is
fast setting, and its physical properties are not affected by the
presence of blood or saliva.

Fast setting and prevents

particle migration

5.

Indications.
BONDBONE can be mixed with other granular bone-filling
agents to prevent particle migration in an osseous defect,
creating an outstanding composite graft. It can be used
alone in bone regenerative techniques. It can also be used
as a resorbable barrier over other bone graft materials.

6.

Advantages.
BONDBONE is available in a granulated powder form that is packaged
in 1cc and 0.5cc drivers and marketed in units of three. With its unique
driver and implantation method, BONDBONE provides a new
approach to bone defect reconstruction. It has several advantages:

Kg

10

Kg

MM

Kg
Kg

Kg

10

Kg

100

10
MM

MM

Kg

100
%

Kg

Kg

Kg

Kg

Kg

100
%

Kg

Kg

10

Kg

10

10
MM

MM

Kg

100
%

Kg

Kg

Kg

Kg

100
%

Kg

Kg

MM

100
%

Kg

Kg

100

Kg

10
MM

Kg

Kg

7.

Excellent binder
The material is excellent for bonding other granular augmentation
materials, allowing easy handling, and preventing particle migration
thus obtaining predictable outcomes.

Versatile
In most cases BONDBONE does not require membrane
coverage, when used as a composite graft for different kinds
of defects or by itself. When used alone, it is ideal for obtaining
a complete regeneration in defects that are less than 10mm
with at least three-wall bony support. It also can be used as a
membrane over other augmentation materials.

Easy handling
BONDBONE allows significant reduction in procedure time.
The initial pliable paste hardens in two to five minutes, allowing
excellent handling time.

Adaptivity
Its setting is not affected by the presence of blood or saliva.

100
%

Pure and safe

BONDBONE does not contain any components other than
calcium sulfate.

Osteoconductive
Its unique porous structure allows infiltration of growth factors
through its micropores and angiogenesis, as well as cell proliferation
through its macropores.

Completely resorbs
It is completely resorbed, leaving behind natural bone.

8.

Properties (During Setting)

The setting time allows the practitioner a reasonable working time
of approximately three minutes. The heat released after mixing
reaches an average reaction temperature of 30C (85F) after
about three minutes, while the pH of the surrounding tissue remains
neutral. The inherent dihydrate phase of BONDBONE reduces the
exothermic reaction found in products that use accelerators during
setting. This results in reduced patient discomfort.

30

T max = 29.5 c (03: 35)

Temperature {c}

28

26

T setting
T setting
= 25.20=c25.20
(01: 10)c (01: 10)
24

22

T ambient = 20.9 c
20
00:00

02:00

04:00

06:00

Time {mm:ss}

08:00

10:00

12:00

9.

Material Characteristics (Post-setting)

The morphology of the resulting structure is characterized by a
porosity of about 46 percent. The microstructure contains macropores
ranging from 300m to 800m - allowing angiogenesis formation
and cell proliferation to induce bone tissue regeneration - and
the micropores range from 1m to 50m - allowing infiltration
of growth factors. The needlelike particles increase the strength
of the cement.
The composition is characterized by an average bioresorption
rate that corresponds to the established bone generation rate of
approximately four to ten weeks.

1.

2.

3.

10.

Mechanism of Action.
Once BONDBONE encounters saline, the granulated powder goes through
an efficient setting process. This setting allows the in situ formation of a rigid
structure that is highly crystalline despite the intervening harsh environment
of blood, proteins, and saliva. In order to shorten the setting time (cement
reaction), the reaction is started in the manufacturing plant so that the
preset and post-set components of calcium sulfate are combined within the
material. The unique particle-size distribution controls the reaction rate and
thus controls both the setting time and the microstructure being built. Finally,
the resulting microstructure determines the strength and the resorption rate,
which is comparable to that of bone growth.
In summary, the composition of
BONDBONE, characterized
by a controlled, predetermined
setting time, strength, and
resorption rate, can be utilized
beneficially in a variety of
case types during repair of
bone defects.

1.
Seed crystals

2.
Rapid growth and
crystallization

3.
A crystal net being
rapidly built in spite of the
harsh environment

11.

The Concept of
Biphasic Calcium Sulfate.

Biphasic
Calcium
Sulfate

Moldable

Cementable

Hemihydrate
CaSO40.5H2O

Dihydrate
CaSO42H2O

Highly rigid

Resorption rate equivalent

to that of bone growth

Not affected by
blood and saliva

12.

Clinical Cases.
Case 1 shows BONDBONE being used as a composite graft,
combined with granular bone graft material. Case 2 shows
BONDBONE being used on its own.

Case 1.

1.
Large defect in a narrow ridge
following implant failure

2.
Using BONDBONE as
a composite graft

3.
Same area after three
months of healing

Case 2.

1.
Bone defect
before treatment

2.
BONDBONE in place

3.
Healing after three months

13.

Histology.
Histological sections show a dense lamellar bone is
formed without remnants of the bone graft.

Socket preservation

Regenerated bone after healing

Sources & Credits:

Page 8.
Page 9.
Page 12.
Page 13.

Source: RMS Foundation

SEM images: RMS Foundation
Photos: Dr. Amos Yahav
Photos: Dr. Robert A. Horowitz

All rights reserved. No part of this publication may be reproduced, transcribed, stored in an electronic
retrieval system, translated into any language or computer language, or be transmitted in any form
whatsoever, without the prior written consent of the publisher. Warning: Only a licensed dentist should
use these products.

MC-BBOLF Rev.4

BONDBONE tutorial:
www.mis-implants.com/bondbone-guide

MIS Implants Technologies Ltd.

www.mis-implants.com

BONDBONE forum:
http://www.mis-implants.com/bb-forum

MISs Quality System complies with international quality standards:

ISO 13485:2003 - Quality Management System for Medical
Devices, ISO 9001: 2008 Quality Management System and
CE Directive for Medical Devices 93/42/EEC. MISs products are
cleared for marketing in the USA and CE approved.