Inion GTR™

Biodegradable

Membrane

System

• Improved space maintenance

• Easily adaptable due to plasticizer

• Preclinical studies suggested accelerated bone healing

• 3 layer structure providing stabilization and cell occlusion

• Safe, synthetic & biodegradable

Inion Dental otsikointia

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1.1 Guided tissue regeneration (GTR)

The aim of modern treatment for periodontal disease is to

regenerate lost periodontal and supporting bone tissues.

Selected cell populations residing in the periodontal tissues

can produce new periodontal soft tissue, cementum and

alveolar bone tissue, provided that these populations are given

the opportunity to occupy a fresh periodontal wound.

Treatment includes the use of bone grafts, bone substitutes

with GTR-membranes or of membranes alone. With guided

tissue regeneration (GTR, membrane therapy), the faster

growing connective tissue and epithelial cells are prevented

from migrating into the wound and space is maintained

between the membrane and bone, allowing time for periodontal

ligament, cementum and bone to repopulate and mature in the

defect area.

1.2 Guided bone regeneration (GBR)

Because bone tissue heals more slowly than mucoperiosteal

tissue in the mouth, the faster healing soft tissue would prevent

the bone from maximizing its full healing potential following a

surgical procedure. The concept of guided bone regeneration

(GBR) treatment suggests that if a biocompatible membrane is

placed between the soft tissue and bone, the membrane acts

as a barrier. This barrier prevents the down-growth of the soft

tissue, connective and epithelial cells into the underlying bone

during its healing period. GBR is used in pre- and peri-implant

surgery, bony defects and extraction sockets.

1. The Concept of GTR/GBR

Inion GTR™ Biodegradable Membrane SystemFor Dental Regenerative Surgery

2. Inion GTR™ Biodegradable Membrane System|PLA/PDLA/PGA/TMC-based guided tissue regeneration system|

2.1 Intended use

The Inion GTR Biodegradable Membrane is intended to be

used as a barrier membrane in dental guided tissue

regeneration (GTR) and guided bone regeneration (GBR)

procedures.

2.2 System description

Inion GTR Biodegradable Membrane System consists of

membranes and tacks made of biodegradable co-polymers

composed of L-lactic, D-lactic, glycolic acid and trimethylene

carbonate. These polymers degrade in vivo by hydrolysis into

alpha-hydroxy acids that are metabolised by the body.

The biodegradable Inion GTR tacks are used to fasten the

membranes. The membrane provides a barrier over 8-12 weeks

in vivo, and resorbed thereafter. The plasticizer provided

temporarily softens the membrane and is used to facilitate the

handling and shaping of membranes.

Inion GTR Biodegradable Membrane System implants are

sterile, non-collagenous and non-pyrogenic.

2.3 Indications

The Inion GTR Biodegradable Membrane System is indicated

for the surgical treatment of periodontal defects (e.g. class II

furcation defects, intrabony defects and recession type defects),

for pre-implant and peri-implant surgery and for covering bone

defects and empty sockets.

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LEIKKAUSKUVA 1 LEIKKAUSKUVA 2 LEIKKAUSKUVA 3

The need for removal surgery is eliminated by using Inion

GTR-membranes. Biodegradable materials are safe and

synthetic, without any of the potential problems associated

with collagen membranes. The polymers used in the Inion

membranes and tacks degrade in vivo by hydrolysis into alpha-

hydroxy acids that are metabolised by the body into CO2 and

water. Since the 1970s, the excellent biocompatibility of PLA

has been documented in hundreds of publications. The

biocompatibility of co-polymers of polylactic and polyglycolic

acids (PLGA) has been shown to be comparable to that of

PLA. These same polymers have been clinically used for more

than 30 years in biodegradable sutures and osteosynthesis

devices.

3 Inion’s Biomaterial Advantage

TMC DLPLA

Trimethylene D,L-lactide

Carbonate

Membrane

Tack

TMC LPLA PGA

Trimethylene L-lactide Polyglycolide

Carbonate

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Space maintenance

The Benefits of Inion GTR™Biodegradable Membrane System

Space maintenance

• Improved space maintenance and membrane geo

characteristics.

• The Inion GTR-membrane is the first GTR-memb

but becomes rigid in-situ.

Tissue integrationTissue integration

Preclinical histological analysis of defects treated

in-growth of cells into the membrane surface.

Ease of use

Ease of use

• For easy handling and reduced inventory, the Iniostandard size (30 x 40 mm) together with three d

• The membrane is easy to cut to the desired shape• The membrane is easily adapted for optimal plac• Membranes can be quickly attached with the tack

sutures can be used in combination with Inion GT• It is possible to drill directly through the membran• Fully reversible 3 layer structure.

Design criteria* Inion Benefit

Biological activity

Biological activity

In vivo results with 6 mm diameter cranial defectsbone healing in defects treated with Inion GTR-mcontrol defects (B). Shown on the right are represharvested after 4 weeks. In the histosections, bonto the Goldner-Trichrome staining. Further precobservation.

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5

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Inion Biomaterial benefit

• Biodegradable: no removal surgery needed

• Safe and synthetic biomaterials (eliminates the ris

from materials of human or animal origin).

Biocompatibility

Cell exclusionCell exclusion

• The 3 layer (porous/dense/porous) structure of t

designed to prevent the gingival cells from penetr

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* Tatakis et al. Periodontology 2000, vol. 19, 1999 59-73.

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ane geometry due to unique material

R-membrane that is soft when applied,

Spacemakingmaterial

Non-Spacemakingmaterial

s treated with Inion GTR-membrane shows

face.

the Inion GTR-membrane is supplied in onethree different shaping templates.

ed shape.mal placement.

the tacks – no suturing is necessary, butnion GTR-membranes, if needed.

membrane, for immediate tack placement.

al defects did show a significant acceleration ofGTR-membrane (A) when compared to untreated

re representative middle sections of defectsons, bone is shown in green and osteoid in red dueher preclinical studies are ongoing to confirm this

ed

es the risk of disease transmission

).

ture of the Inion GTR-membrane is

m penetrating the membrane.

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1

4

5

6

Ingrowth of cells BoneInion GTR-membrane

A B

Cross-sectional cut showing3 layer structure of themembrane

High magnification showingsurface morphology of themembrane

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5. Preparation and fastening of the Inion GTR-membrane

5.1 Preparation of the membrane

1. Start the preparation of the membrane when starting the

surgical procedure.

The membrane and templates are packed in a plastic

blister. After opening the blister, remove the template from

the packaging and pour all the plasticizer from bottle onto

the membrane (cavity A). The membrane must be fully

immersed in the plasticizer for 20-30 seconds (longer

immersion time may reduce mechanical properties).

2. Pick-up the membrane using forceps and hold vertically to

allow the excess plasticizer to drain away. Wipe any

remaining drops of plasticizer from the lower edge of the

membrane. Thereafter place the membrane in cavity B of

the blister.

3. Let the membrane dry for 5-10 minutes. Then rinse the

membrane shortly with sterile water. Now the membrane is

ready for immediate use.

4. Trim the membrane to the desired shape using sterile

surgical scissors. The templates are provided as an aid to

shaping. Discard the templates after use. When exposed to

moisture, as in the oral cavity, the membrane starts to stiffen

and will reach maximum stiffness after 30 minutes. The

stiffness lasts as long as the membrane remains intact.

1. The tacks are placed in a plastic dispenser. Place the

dispenser to the table and open the dispenser carefully to

avoid dislodging any of the tacks. Take the tack applicator,

press it firmly on to the tack head to fasten the tack to the

applicator.

2. Place the shaped membrane in the desired position.

3. Drill a hole through the membrane into the bone.

4. While keeping the membrane in position, take the loaded

tack applicator and press the tack firmly into the hole.

5. Angle the tack applicator slightly to one side to release it

from the tack.

5.2 Fastening a membrane with tacks

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“Our mission is to create safe, innovative and efficient

surgical solutions that ensure excellent surgical care.“

The company

The products

MBR-2000 1 membrane (30x40 mm), 3 single-use templates, 1 bottle of plasticizer

TCK-2001 6 tacks, 1 drill, 1 tack applicator, single-use

TCK-2003 6 tacks

INS-9051 Drill for tacks

INS-9052 Tack applicator, reusable

The core competence of Inion lies in its knowledge of

surgical biodegradable polymer applications and pro-

duction processes.

Inion’s product concept is to provide comprehensive,

high-quality solutions for surgeons. Inion products are

characterized by safety, efficiency, speed and ease of use

and competitive pricing.

Inion Ltd • Lääkärinkatu 2

FIN-33520 Tampere, FINLAND

tel +358-3-2306 600 • fax +358-3-2306 601

email: info@inion.com • internet: www.inion.com

Toll-free telephone (866-Inion-US)

Toll-free fax (866-Inion-BIO)

tel (405) 236-0017 • fax (405) 236-0634

Inion Inc.

Americas Corporate Office

800 Research Parkway, Suite 380

Oklahoma City, OK 73104

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