4.

Using Abutments

8.

®

4BONE&RCM

Step-by-Step

© MIS Corporation. All rights Reserved.

Published by MIS, which reserves the right to ameliorate the products described in this manual as well as to revise this publication at any time and without informing any person of such revision or change. All rights reserved. No part of this publication may be reproduced, transcribed, stored in an electronic retrieval system translated to any language or computer language, or be transmitted in any form whatsoever without the written consent of the publisher.

Note: This guide is for educational use only.

MIS is offering 4BONE & RCM forming a complete solution for bone augmentation and

regeneration procedures. 4BONE is a fully synthetic bone grafting material made of HA (60%) and TCP (40%). Its 70% interconnected macro and micro porosity promotes colonization of osteogenic cells and allows biological fluid diffusion. 4BONE incorporates optimized morphology and resorption properties that enable a predictable healing process and outcome. RCM is a complementary resorbable collagen membrane intended for guided bone regeneration (GBR) and guided tissue regeneration (GTR).

For any queries regarding 4BONE, please contact MIS’ specialists directly at: service@mis-implants.com. For comprehensive updated information regarding MIS products and innovations, visit our website: www.mis-implants.com.

Forming a complete Augmentation:

RCMResorbable Collagen Membrane

4BONESynthetic Bone Graft

Overview

4BONE and RCM products are packaged in various weights and volumes, providing practitioners with the freedom to choose the precise amount required for each specific procedure.

4BONE Syringe

Quantity: 0.5cc(0.36g)Granule size: 0.5-1mm

4BONE Tubes

Available in three quantities: 1cc (0.6gr), granules size: 1-2mm2cc (1.2gr), granules size: 1-2mm6cc (3.6gr), granules size: 1-2mm

RCM

Available in three sizes:15x25x0.3mm 20x30x0.3mm 30x40x0.3mm

4BONE Synthetic Bone Graft & RCM Resorbable Collagen Membrane

Uniquely advantageous4BONE’s microporosity is a key factor in terms of new bone formation. Its exclusively controlled micropore size and disribution, allowed by its advanced production process, facilitates the development of high osteogenic scaffold for bone ingrowth.

4BONE - Functional properties

4BONE is an efficient, 100% synthetic, safe and cost-effective bone graft. Unlike organic materials, 4BONE is bacteriostatic and conveys no risk of disease transmission. 4BONE is composed of real chemical synthesis of 60% HA and 40% ß-TCP which guarantees homogenous distribution and a diffusion of the two phases. 4BONE functions as a 3D interconnected scaffold that mimics the trabecular architecture as well as the thin crystalline structure of natural bone. Incorporating calibration of its micro & macroporous structure, the unique production process of 4BONE allows permeability for cells spreading and angiogenesis. 4BONE completely transforms into cortical or cancellous bone resulting in the creation of new bone that possess mechanical strength similar to that of a natural bone. 4BONE permeability is obtained through interconnected micropores allowing fast vascularization of the biological fluids into the granule, resulting in a strong interface compared to bio inert materials. The formation of this dynamic interface between the bio active 4BONE and the host bone, is the result of a sequence of events involving interactions with cells and the formation of a carbonate Hydroxyapatite, which is similar to the mineral bone in terms of dissolution and precipitation process.

With a 30 year clinical experience and evident qualities, 4BONE offers an optimal therapeutic solution and a proficient alternative for bone regeneration. Supported by vast research, 4BONE avoids risk of contamination by non-identified prions coming from natural grafts. Among the available materials used for bone reconstruction, autologous bone is biologically ideal, though relatively complex and hurtfull for the patient. Supplied by local tissue banks, allograft materials availability has always been limited, and xenograft materials have always been the most popular non-autograft materials due to their extensive use in dental schools.

Types of bone grafting materialsComparison

Biphasic Calcium phosphate HA/TCP

- 100% Synthetic

- Biocompatible Osteogenic

- 30 years of experience in orthopedic, spine and maxillo facial procedures

- Over 600 publications regarding the mateiral

- Complete resorption

- Limited initial mechanical properties

- Must not be compacted

Synthetic Bone Graft HydroxyapatiteTCP

Calcium phosphate

- Granules/blocks- Unlimited

- 100% Synthetic - Biocompatible

- Osteoconductive- 30 years of

experience in orthopedic and spine surgery

- HA - Very slow resorption

- Not completely resorbed

Allograft Xenograft

- Granules- Unlimited

- Granules- Unlimited

- Available in large quantities (for xenograft)

Human originAnimal origin

- Good mechanical properties

- Fast turnover

Autograft

Self bone

- Biological tissue- Limited

- Best & fastest results (takes 4 to 6 months to mature in the sinus)

- Fastest turnover - Bio-active

Unperedictable/ slow resorption Potential contamination risksPsychological reservations

-

-

-

Limited availabilty

Secondary surgical site may be needed

Very fast turnover rate

Might be painful for the patient and non esthetic.

--

-

-

Type of bone graft

Benefits

Disadvantages

Origin

Type & availability of material

Osteogenic Properties

By its nature, 4BONE supports the regeneration of new vital bone tissue. The hydroxyapatite comprising 4BONE is a specific form of calcium phosphate, composed to mimic the mineral which embodies the natural bone. Thanks to its small crystals dimensions (HA crystal at nano level), obtained by a low temperature sintering process, the hydroxyapatite comprising 4BONE is completely resorbable.

Macroporosity - 70%

Comprised of 300 - 600 μm pores, similar to that of the bone, macroporosity promotes a deep invasion of osteogenic cells by osteoconduction.

Microporosity - 30%

With pores smaller than 10μm, similar to that of the bone, the micropores are interconnected, allowing the diffusion of biological fluids.

Porosity: 4BONE is a fully synthetic bone graft. Its optimized morphology, forms an ideal habitat for new vital bone to proliferate. Unlike other ceramics featuring micro-pores only, 4BONE incorporates both micro and macro pores, maximizing its compatibility with the size of regenerated bone cells. Permeability is obtained through interconnected micropores allowing biological fluids diffusion into the granules. Once biological fluids flow through the granules, microporosity acts as a sieve, attracting bone generating cells and allowing the formation of new bone from the inside of the granule (osteogenic). 4BONE is gradually replaced by newly architectured bone, similar to the hosting one.

4BONE Synthetic Bone GraftProduct description

Micropores <10μm, 20-30% microporosity

Macropores 400μm, 70-80% macroporosity

RCM is a resorbable dental membrane made from porcine skin-sourced collagen, aimed for guided bone and tissue regeneration (GBR and GTR). Thanks to a unique cross-linkage production technique, 4BONE RCM functions as an efficient barrier for a 4-6 months period. Due to its substantially proven biocompetability and low immunogenicity, porcine collagen has been successfully used in a variety of medical and dental procedures for many years.

Purified collagenPurified skin-sourced collagen ■ Collagen types I and III ■ Conservation of the fibrous structure (supporting mechanical strength)

Cross-linkage

A bath in the cross-linking reagent ■ Prolonged resorption time ■ Neutralization: elimination of the residual cross-linker ■ Chemical analysis of residual reagent

RCM Resorbable Collagen MembraneProduct description

RCM natural collagen fibers

Magnification 500K X

Step 1.

Components:

4BONE

Extraction Forceps

Flap is retracted.

Post extraction augmentation.

Gain access to the bony defect: expose the bony defect and carefully remove all granulation tissue, if necessary.

A.A.

Ste

p 1

A. B.

For defects less than 2 cc, 4BONE smallgranules 0,5-1mm are recommended.

Sterile packaging opening: open the two blisters and remove the syringe.

Hydrate the content of the syringe by sucking up sterile physiological saline through the filter until liquid level is slightly above level of granules.

It is recommend to humidify 4BONE particles with saline solution to avoid osmotic choc with living cells. Hydrated, the particles are more easy to handle to the defect site.

Expulsion of excess liquid.

4BONE preperation.Step 2.

Expel excess liquid by depressing the syringe plunger slightly. Do not compact the granules in the syringe.

The composite blend.

Components:

If vascularization in the defect is not sufficient, after hydrating the grains with sterile physiological saline, impregnate 4BONE granules with blood to stimulate bone healing.

Note:

Saline (or blood)

4BONE

Material preparation.

Ste

p 2

Step 3.

Components:

Remove the filter from the tip of the syringe.

Apply the hydrated 4BONE to the vascularized bone defect using the syringe. The defect site should always be vascularized with blood. Fill the defect without any pressure; In order to preserve the delicate structure of the material, do not press, jam or compact the granules. Do not overfill.

Please note: Keeping a free space between the grains is imperative to allow bone colonization and to avoid inconvenience.

Applying 4BONE using the syringe. Filling the defect with 4BONE.

Applying 4BONE. The defect is filled.

Make sure to maximize contact between 4BONE and the vascularized recipient bone.

Once the defect is filled, remove redundant grains. Excess grains that would not be in contact with bone or in mucosa will not be replaced by bone and will be slowly degrade by the body.

B.A.

4BONE

Ste

p 3

For defects with at least three intact walls, an elastic resorbable membrane can beused to preserve the defect site during bone regeneration period.

Due to its unique properties and sustainability for a 3 months period, RCM membrane would ideal l y complement your 4BONE procedure.

Apply RCM membrane on the defect. The membrane should overlap the walls of the defect by at least 2 mm. The size of the membrane can be adapted to the bone defect using sterile scissors, before the membrane is hydrated.

The wet membrane will immediately adhere to the bone defect. A dry membrane has to be held in place with moderate pressure until perfect adherence to the bone surface is achieved. The adherence to the bone surface is achieved by gel formation as collagen fibers come in touch with blood.

Applying the membrane onto the defect site. The membrane applied overlapping the defect walls.

Applying the membrane.Step 4. RCM is applied.

Components:

A. B.

RCM

Ste

p 4

Achieve complete and tension free surgical incision closure, by suturing the mucoperiosteal flaps. The healing time to be respected with regards to the described procedure is 6 months minimum. Healing can be expedited if autologous bone is incorporated, accelerating kinetic bone regeneration.

Wound closure.Step 5.

Suturing the surgical incision for complete closure.

Components:

A.

Suture Needle

Ste

p 5

FIN. END. FINAL. FINE. SON. ..

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.

www.mis-implants.com

®

© MIS Corporation. All Right Reserved

MIS’s Quality System complies with international

quality standards: ISO 13485:2003 - Quality Man-

agement System for Medical Devices, ISO 9001:

2008 – Quality Management System and CE

Directive for Medical Devices 93/42/EEC. MIS’s

products are cleared for marketing in the USA

and CE approved.

MC-PMU08 Rev. 1