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Inion GTR™ Biodegradable Membrane System

The concept of GTR/GBR

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, and/or bone graft

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.

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 maximising 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 bony

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

and peri-implant surgery, bony defects and extraction sockets.

Intended use

The Inion GTR™ Biodegradable Membrane System is intended

to be used as a barrier membrane in dental guided tissue

regeneration (GTR) and guided bone regeneration (GBR)

procedures.

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 membrane provides a barrier over 8-12 weeks in vivo, and

resorbs thereafter. The plasticiser provided temporarily softens

the membrane and is used to facilitate the handling and shaping

of membranes.

Inion GTR™ Biodegradable Membrane System implants are

supplied sterile and are non-collagenous.

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.

Post-operative X-ray

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The Inion® Biomaterial Advantage

The need for removal surgery is eliminated by using

Inion GTR™ membranes. Biodegradable materials are safe

and synthetic, eliminating the risk of disease transmission from

materials of human or animal origin. The polymers used in the

Inion® membranes and tacks degrade in vivo by hydrolysis into

alphahydroxy 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.

Tack

D, L-Lactide

DLPLATrimethylene Carbonate

TMC

Membrane

Polyglycolide

PGALPLAL-LactideTrimethylene Carbonate

TMC

Space maintenance*

• Improved space maintenance and membrane geometry due to unique

material characteristics

• The Inion GTR™ membrane is the first GTR membrane that is soft when applied,

but becomes rigid in-situ

Cell exclusion*

• The 3 layer (porous/dense/porous) structure of the Inion GTR™ membrane

is designed to prevent the gingival cells from penetrating the membrane

Biocompatibility*

• Biodegradable: no removal surgery needed

• Safe and synthetic biomaterials (eliminates the risk of disease transmission

from materials of human or animal origin)

Tissue integration*

• Preclinical histological analysis of defects treated with Inion GTR™ membrane

shows in-growth of cells into the membrane surface

The Benefits of Inion GTR™

Biodegradable Membrane System

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Spacemakingmaterial

Non-spacemakingmaterial

Cross-sectional cut showing 3 layer structure of the membrane

Preclinical histological analysis of defect treated with Inion GTR™membrane shows in-growth of cells into the membrane surface

High magnification showing surface morphology of the membrane

Bone

Inion GTR™ membrane

In-growth of cells

*Design criteria according to Tatakis et al. Periodontology 2000, vol.19, 1999 59-73.

Ease of use*

• For easy handling and reduced inventory, the Inion GTR™ membrane is supplied

in one standard size (30 x 40 mm) together with three different shaping templates

• The membrane is easy to cut to the desired shape

• The membrane is easily adapted for optimal placement

• Membranes can be quickly attached with the tacks - no suturing is necessary,

but sutures can be used in combination with Inion GTR™ membranes, if needed

• It is possible to drill directly through the membrane, for immediate tack placement

• Fully reversible 3 layer structure

Biological activity*

• In vivo results with 6 mm diameter cranial defects did show a significant acceleration

of bone healing in defects treated with Inion GTR™ membrane (A) when compared to

untreated control defects (B). Shown on the right are representative middle sections

of defects harvested after 4 weeks. In the histosections, bone is shown in green and

osteoid in red due to the Goldner-Trichrome staining. Further preclinical studies are

ongoing to confirm this observation.

The Benefits of Inion GTR™

Biodegradable Membrane System

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A

Defect

Defect

B

*Design criteria according to Tatakis et al. Periodontology 2000, vol.19, 1999 59-73.

Preparation and fastening of the Inion GTR™ membrane

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Start the preparation of the membrane when starting the surgicalprocedure. The membrane is supplied in one standard size (30 x 40 mm) together with three different shaping templates anda bottle of plasticiser. The membrane and templates are packedin a plastic blister. After opening the blister, remove the templatesfrom the blister before starting the membrane preparation.

1. Pour all the plasticiser from the bottleonto the membrane (which is already incompartment A of the blister pack).

2. Leave the membrane to soak in theplasticiser for 20-30 seconds.(NOTE: Longer immersion time maycompromise mechanical properties.)

3. Lift the membrane out with non-toothedforceps, letting excess plasticiser drip away.

4. Place the membrane in compartment Bto cure for at least 10 minutes, duringwhich it becomes very flexible.

5. Trim the membrane to the desired shape using sterile surgicalscissors. The preshaped templates are provided as an aid toshaping. Discard the templates after use – do NOT implant.Take care to round any sharp edges or corners of the trimmedmembrane before implantation to prevent irritation of the soft tissues.

6. Secure the membrane in position with Inion® biodegradable Tacks or suture it in place.

At normal room temperature and humidity, the membrane staysmalleable for several hours. When exposed to water, as in themouth, the membrane starts to stiffen. The stiffness lasts as long as the membrane remains intact and will reach maximumstiffness after 30 minutes. The stiffening of the membrane can be accelerated by copious flushing with sterile water prior toimplantation or once the membrane has been secured intoposition. If stiffened prior to implantation take care to ensure themembrane is adequately adapted to prevent soft tissue irritation.

Fastening a membrane with tacks

The Tacks are supplied in a plastic dispenser. Open thedispenser carefully to avoid dislodging any Tacks.

1. Take the Tack Applicator and press it firmly onto the Tackhead to fasten the Tack to the Applicator.

2. Hold the membrane securely in the desired position and drilldirectly through it into the bone.

3. While keeping the membrane immobile, take the loaded TackApplicator and press the tack firmly into the hole. When usingthe angled end, apply finger pressure to the head of theApplicator and not to the shaft.

4. Angle the Tack Applicator slightly to release it from the tack.

Preparation of the membrane