Bond Bone Brosura Engleza

8/10/2019 Bond Bone Brosura Engleza

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MIS Corporation. All Rights Reserved.

ProductInformation


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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 thesuperior quality of its products . All MIS products are guaranteed tobe free from defects in material and workmanship. However, shoulda customer nd fault with any MIS product after using i t accordingto the directions, the defective product will be replaced.


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3.

Technological advances over the

past decade have led to a new erain 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.

Introduction.


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4.

BONDBONEis a novel synthetic bone graft material and isconsidered to be a breakthrough in the eld of dental bonegrafting. It is composed of biphasic calcium sulfate, which haswell-established and documented biocompatible, osteoconductive,and bioresorbable properties. The biphasic calcium sulfate isfast setting, and its physical properties are not affected by the

presence of blood or saliva.

Overview.

Fast setting and preventsparticle migration


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5.

BONDBONEcan be mixed with other granular bone-llingagents to prevent particle migration in an osseous defect,creating an outstanding composite graft. It can be usedalone in bone regenerative techniques. It can also be usedas a resorbable barrier over other bone graft materials.

Indications.


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10

1MM

MM

100%

100%

100%

00

6.

BONDBONEis available in a granulated powder form that is packagedin 1cc and 0.5cc drivers and marketed in units of three. With its uniquedriver and implantation method, BONDBONEprovides a newapproach to bone defect reconstruction. It has several advantages:

Advantages.


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7.

Excellent binderThe material is excellent for bonding other granular augmentationmaterials, allowing easy handling, and preventing particle migrationthus obtaining predictable outcomes.

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

OsteoconductiveIts unique porous structure allows inltration of growth factorsthrough its micropores and angiogenesis, as well as cell proliferationthrough its macropores.

Pure and safeBONDBONEdoes not contain any components other than

calcium sulfate.

Completely resorbsIt is completely resorbed, leaving behind natural bone.

Easy handlingBONDBONEallows signicant reduction in procedure time.The initial pliable paste hardens in two to ve minutes, allowing

excellent handling time.

Versatile

In most cases BONDBONE

does not require membranecoverage, when used as a composite graft for different kindsof defects or by itself. When used alone, it is ideal for obtaininga complete regeneration in defects that are less than 10mmwith at least three-wall bony support. It also can be used as amembrane over other augmentation materials.

100%

100%


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20

00:00 02:00 04:00 06:00 08:00 10:00 12:00

22

24

26

28

30

= 25.20 c (01: 10)

= 20.9 cTambient

Tsetting

= 29.5 c (03: 35)Tmax

= 25.20 c (01: 10)Tsetting

8.

The setting time allows the practitioner a reasonable working timeof approximately three minutes. The heat released after mixingreaches an average reaction temperature of 30C (85F) afterabout three minutes, while the pH of the surrounding tissue remainsneutral. The inherent dihydrate phase of BONDBONEreduces theexothermic reaction found in products that use accelerators during

setting. This results in reduced patient discomfort.

Properties (During Setting)

Temp

erature{c}

Time{mm:ss}


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1. 2. 3.

9.

The morphology of the resulting structure is characterized by aporosity of about 46 percent. The microstructure contains macroporesranging from 300m to 800m - allowing angiogenesis formationand cell proliferation to induce bone tissue regeneration - andthe micropores range from 1m to 50m - allowing inltrationof growth factors. The needlelike particles increase the strength

of the cement.

The composition is characterized by an average bioresorptionrate that corresponds to the established bone generation rate ofapproximately four to ten weeks.

Material Characteristics (Post-setting)


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10.

Once BONDBONEencounters saline, the granulated powder goes throughan efcient setting process. This setting allows the in situ formation of a rigidstructure that is highly crystalline despite the intervening harsh environmentof blood, proteins, and saliva. In order to shorten the setting time (cementreaction), the reaction is started in the manufacturing plant so that thepreset and post-set components of calcium sulfate are combined within the

material. The unique particle-size distribution controls the reaction rate andthus 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 ofBONDBONE, characterizedby a controlled, predeterminedsetting time, strength, andresorption rate, can be utilizedbenecially in a variety of

case types during repair ofbone defects.

Mechanism of Action.

Seed crystals

Rapid growth andcrystallization

A crystal net beingrapidly built in spite of the

harsh environment

1.

2.

3.


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11.

Highly rigid

Not affected byblood and saliva

Resorption rate equivalentto that of bone growth

Biphasic Calcium Sulfate.The Concept of

Moldable HemihydrateCaSO

4

0.5H2

O

DihydrateCaSO

4

2H2

O

BiphasicCalciumSulfate

Cementable


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12.

Clinical Cases.

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

1.

2.

3.

Bone defectbefore treatment

BONDBONEin place

Healing after three months

Case2.

1.

2.

3.

Large defect in a narrow ridgefollowing implant failure

Using BONDBONEasa composite graft

Same area after threemonths of healing

Case1.


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13.

Histology.

Histological sections show a dense lamellar bone isformed without remnants of the bone graft.

Socket preservation

Regenerated bone after healing


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Sources & Credits:

Source: RMS Foundation

SEM images: RMS Foundation

Photos: Dr. Amos Yahav

Photos: Dr. Robert A. Horowitz

Page 8.

Page 9.

Page 12.

Page 13.


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All rights reserved. No part of this publication may be reproduced, transcribed, stored in an electronicretrieval system, translated into any language or computer language, or be transmitted in any formwhatsoever, without the prior wri tten consent of the publisher. Warning: Only a licensed dentist shoulduse these products.

MC-BBOLF Rev.4


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MISs Quality System complies with international quality standards:

ISO 13485:2003 - Quality Management System for Medical

Devices, ISO 9001: 2008 Quality Management System andCE Directive for Medical Devices 93/42/EEC. MISs products are

cleared for marketing in the USA and CE approved.

C O e

MIS Implants Technologies Ltd.www.mis-implants.com

BONDBONEtutorial:

www.mis-implants.com/bondbone-guide

BONDBONEforum:

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

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Bond Bone Brosura Engleza