Inion GTR™ Biodegradable

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 GTR™ Biodegradable Membrane System
For Dental Regenerative Surgery
1. The Concept of GTR/GBR
1.1 Guided tissue regeneration (GTR)
1.2 Guided bone regeneration (GBR)
The aim of modern treatment for periodontal disease is to
Because bone tissue heals more slowly than mucoperiosteal
regenerate lost periodontal and supporting bone tissues.
tissue in the mouth, the faster healing soft tissue would prevent
Selected cell populations residing in the periodontal tissues
the bone from maximizing its full healing potential following a
can produce new periodontal soft tissue, cementum and
surgical procedure. The concept of guided bone regeneration
alveolar bone tissue, provided that these populations are given
(GBR) treatment suggests that if a biocompatible membrane is
the opportunity to occupy a fresh periodontal wound.
placed between the soft tissue and bone, the membrane acts
Treatment includes the use of bone grafts, bone substitutes
as a barrier. This barrier prevents the down-growth of the soft
with GTR-membranes or of membranes alone. With guided
tissue, connective and epithelial cells into the underlying bone
tissue regeneration (GTR, membrane therapy), the faster
during its healing period. GBR is used in pre- and peri-implant
growing connective tissue and epithelial cells are prevented
surgery, bony defects and extraction sockets.
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.
2. Inion GTR™ Biodegradable Membrane System
|PLA/PDLA/PGA/TMC-based guided tissue regeneration system|
2.1 Intended use
membranes. The membrane provides a barrier over 8-12 weeks
The Inion GTR Biodegradable Membrane is intended to be
in vivo, and resorbed thereafter. The plasticizer provided
used as a barrier membrane in dental guided tissue
temporarily softens the membrane and is used to facilitate the
regeneration (GTR) and guided bone regeneration (GBR)
handling and shaping of membranes.
procedures.
Inion GTR Biodegradable Membrane System implants are
sterile, non-collagenous and non-pyrogenic.
2.2 System description
Inion GTR Biodegradable Membrane System consists of
2.3 Indications
composed of L-lactic, D-lactic, glycolic acid and trimethylene
for the surgical treatment of periodontal defects (e.g. class II
carbonate. These polymers degrade in vivo by hydrolysis into
furcation defects, intrabony defects and recession type defects),
alpha-hydroxy acids that are metabolised by the body.
for pre-implant and peri-implant surgery and for covering bone
Inionco-polymers
Dental otsikointia
The Inion GTR Biodegradable Membrane System is indicated
membranes and tacks made of biodegradable
The biodegradable Inion GTR tacks are used to fasten the
2
defects and empty sockets.
3 Inion’s Biomaterial Advantage
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-
Membrane
TMC
LPLA
PGA
Trimethylene
L-lactide
Polyglycolide
Carbonate
hydroxy acids that are metabolised by the body into CO2 and
Tack
water. Since the 1970s, the excellent biocompatibility of PLA
TMC
DLPLA
has been documented in hundreds of publications. The
Trimethylene
D,L-lactide
biocompatibility of co-polymers of polylactic and polyglycolic
Carbonate
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.
LEIKKAUSKUVA 1
LEIKKAUSKUVA 2
LEIKKAUSKUVA 3
3
The Benefits of Inion GTR™
Biodegradable Membrane System
Design criteria*
1
Inion Benefit
1
Space maintenance
• Improved space maintenance and membrane geo
characteristics.
• The Inion GTR-membrane is the first GTR-memb
but becomes rigid in-situ.
Space maintenance
2
2
Cell exclusion
Cell exclusion
3
• The 3 layer (porous/dense/porous) structure of t
designed to prevent the gingival cells from penetr
3
Inion Biomaterial benefit
• Biodegradable: no removal surgery needed
• Safe and synthetic biomaterials (eliminates the ris
from materials of human or animal origin).
Biocompatibility
4
4
Tissue integration
Tissue integration
5
Preclinical histological analysis of defects treated
in-growth of cells into the membrane surface.
5
Ease of use
6
Ease of use
• For easy handling and reduced inventory, the Inio
standard 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.
6
Biological activity
Biological activity
4
* Tatakis et al. Periodontology 2000, vol. 19, 1999 59-73.
In vivo results with 6 mm diameter cranial defects
bone healing in defects treated with Inion GTR-m
control defects (B). Shown on the right are repres
harvested after 4 weeks. In the histosections, bon
to the Goldner-Trichrome staining. Further prec
observation.
1
ane geometry due to unique material
R-membrane that is soft when applied,
Non-Spacemaking
material
Spacemaking
material
2
ture of the Inion GTR-membrane is
m penetrating the membrane.
Cross-sectional cut showing
3 layer structure of the
membrane
High magnification showing
surface morphology of the
membrane
ed
es the risk of disease transmission
).
4
s treated with Inion GTR-membrane shows
face.
Ingrowth of cells
Inion GTR-membrane
Bone
5
the Inion GTR-membrane is supplied in one
three different shaping templates.
ed shape.
mal placement.
the tacks – no suturing is necessary, but
nion GTR-membranes, if needed.
membrane, for immediate tack placement.
6
A
B
al defects did show a significant acceleration of
GTR-membrane (A) when compared to untreated
re representative middle sections of defects
ons, bone is shown in green and osteoid in red due
her preclinical studies are ongoing to confirm this
5
5. Preparation and fastening of the Inion GTR-membrane
5.1 Preparation of the membrane
5.2 Fastening a membrane with tacks
1. Start the preparation of the membrane when starting the
1. The tacks are placed in a plastic dispenser. Place the
surgical procedure.
dispenser to the table and open the dispenser carefully to
The membrane and templates are packed in a plastic
avoid dislodging any of the tacks. Take the tack applicator,
blister. After opening the blister, remove the template from
press it firmly on to the tack head to fasten the tack to the
the packaging and pour all the plasticizer from bottle onto
applicator.
the membrane (cavity A). The membrane must be fully
immersed in the plasticizer for 20-30 seconds (longer
2. Place the shaped membrane in the desired position.
immersion time may reduce mechanical properties).
3. Drill a hole through the membrane into the bone.
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
4. While keeping the membrane in position, take the loaded
tack applicator and press the tack firmly into the hole.
membrane. Thereafter place the membrane in cavity B of
the blister.
5. Angle the tack applicator slightly to one side to release it
from the tack.
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.
6
7
2/2004
3654
30000053
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 company
The core competence of Inion lies in its knowledge of
surgical biodegradable polymer applications and production 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.
“Our mission is to create safe, innovative and efficient
surgical solutions that ensure excellent surgical care.“
Inion Ltd • Lääkärinkatu 2
Inion Inc.
FIN-33520 Tampere, FINLAND
Americas Corporate Office
Toll-free telephone (866-Inion-US)
tel +358-3-2306 600 • fax +358-3-2306 601
800 Research Parkway, Suite 380
Toll-free fax (866-Inion-BIO)
email: [email protected] • internet: www.inion.com
Oklahoma City, OK 73104
tel (405) 236-0017 • fax (405) 236-0634
/ Kirjapaino Örhling
The products