Straumann MembraGel® –
The next generation
membrane
Advanced technology for your GBR cases
Straumann® ­MembraGel® is an advanced technology membrane that sets new standards in the
surgical use for guided bone regeneration (GBR).
Straumann ­M embraGel
Precise, simple, and quick application
pp Stabilizes the bone graft
pp Barrier properties lasting 4-6 months1
pp Degradable material2
pp Synthetic origin
pp
The liquid applicable membrane is designed for precise, simple, and quick procedures. When
solidified, ­Straumann ­MembraGel stabilizes the bone graft material confining it to the site of bone
augmentation. Straumann ­­MembraGel is designed for optimal barrier properties ­effective for
4–6 months before it is b
­ iodegraded.1
The synthetic material has demonstrated soft tissue compatibility, which is a prerequisite for achieving
undisturbed bone ­formation.2
Precise application in situ.
No extension of the membrane over the
bone crest necessary for stabilization.
The esthetic outcome. Three years
postoperatively. (Courtesy of PD Dr.
R. Jung)
Straumann ­MembraGel is intended for use in guided bone regeneration procedures including the
surgical treatment of:
peri-implant defects
pp bone defects
pp deficient alveolar ridges
pp extraction sockets
pp
1
Wechsler S et al., J Biomed Mater Res A. 2008 May;85(2):285-92.
2
Herten M et al., Clin Oral Implants Res. 2009 Feb;20(2):116-25.
1
The ideal combination of membrane properties
Stability for optimal bone healing
Once the liquid material has solidified in situ, Straumann® ­MembraGel® stabilizes the underlying bone
graft. In this way, Straumann ­MembraGel aims at undisturbed bone regeneration, a ­prerequisite
for the optimal clinical ­outcome.
Precise, simple, and quick application
pp Due to its gel-like consistency and its formation in situ, Straumann ® ­­MembraGel ® is adaptable
to various types and sizes of bone defects. It can be precisely applied to the surgical site.
pp For the stabilization of the membrane it is sufficient to extend the membrane area 1–2 mm
beyond the margins of the defect walls.
pp In case of buccal bone defects, it is not necessary to position the membrane over the alveolar
crest for further stabilization.
pp The preparation does not require any laborious pre-shaping prior to application.
pp As a result of the easy application of Straumann ­­MembraGel, the time of the application can
be r­educed s­ ignificantly.
In a randomized, controlled clinical trial the time of ­application was significantly reduced when
­compared to a conventional collagen membrane.3
Stabilization of the grafted site after
solidification (Courtesy of PD Dr.
R. Jung)
Optimized barrier function for peace of mind
In order to achieve good bone quality with a regenerative procedure, Straumann ­MembraGel
is designed to function as a barrier to prevent ingrowth of soft tissue into the defect region.
­Straumann ­MembraGel has been shown to ­effectively prevent gingival soft tissue from entering
the protected area over a period of 4–6 months in an animal model.1
Straumann ­MembraGel is designed for prolonged integrity of the membrane in order to enhance
the protection of the regenerating bone. In vivo data demonstrate that Straumann ­MembraGel is
degraded significantly slower than a standard collagen membrane. Due to the biodegradation
of Straumann ­MembraGel no surgical removal of the membrane is necessary.
140
8
7
6
5
4
3
2
1
2
3,1
4,3
4,6
6
7
Months after implantation
Straumann ­M embraGel implanted subcutaneously in rats. Only after
4.3 months a significant change in the number of cells that have
passed the barrier was ­d etectable1
2
100
80
60
40
20
1
0
195 seconds: Time for application of a
­standard collagen membrane
(n=18, SD=123 sec)
Collagen membrane
Straumann ­M embraGel
120
9
Residual membrane
thickness (%)
Cell infiltration (in % of positive
control without membrane)
10
61 seconds: Average time for application
of Straumann ­M embraGel
(n=19, SD=26 sec)
1
Wechsler S et al., J Biomed Mater Res A. 2008 May;85(2):285-92.
2
Herten M et al., Clin Oral Implants Res. 2009 Feb;20(2):116-25.
0
1
2
4
8
16
24
Weeks after implantation
Straumann M
­ embraGel biodegrades s­ ignificantly slower than a standard
collagen membrane2
3
Jung R et al., Clin Oral Implants Res. 2009 Feb;20(2):162-8
3
The clinical benefits
Horizontal dimensions of the bone
defect prior to augmentation
Bone graft in situ
Improvement of bone quality
A significantly larger proportion of new bone is formed with Straumann® ­MembraGel® when
compared to a bone augmentation procedure without using a membrane.2 The use of Straumann
­MembraGel leads to a similar amount of newly formed bone as with a non-degradable ePTFE
membrane.2
Proportion of newly formed bone
(% area fraction)
Effective bone augmentation
The effectiveness of Straumann® ­MembraGel® in supporting bone formation has been
­demonstrated in a v­ ariety of pre-clinical and clinical studies.1–4
35
20.3
18.9
Straumann
MembraGel
(n=12)
ePTFE
(n=10)
30
25
20
15
7.3
10
5
0
No membrane
(n=10)
Histological bone area fraction from a study in rats. ­D ifferences between
the two membranes were statistically not significant.2
Straumann ­M embraGel solidified on
top of the graft material
Horizontal bone gain 6 months
postoperatively (Courtesy of PD Dr.
R. Jung)
Excellent defect resolution
Clinical data indicate that Straumann ­MembraGel ­effectively supports the defect fill when used
with a bone graft material1, thereby providing the basis for the esthetic result of the GBR p
­ rocedure.
Good soft tissue healing
The observed progress of wound healing with ­Straumann ­MembraGel makes the material
well-suited for GBR procedures. Even in the case of soft tissue dehiscences, gingival tissue usually
heals without incidents. In this way, ­Straumann ­MembraGel is designed to facilitate the s­ uccessful
clinical outcome of the GBR procedure.
8
7
5.6 mm bone gain
= 95 % defect fill
Defect in
mm
6
4.3 mm bone gain
= 96 % defect fill
5
4
3
2
Small soft tissue dehiscence at the time
of suture removal
1
0
Initial
defect
Residual
defect
Straumann ­MembraGel
(n=19)
Initial
defect
Soft tissue healing after 30 days
Soft tissue healing after 3 months
(By courtesy of PD Dr. R. Jung)
Residual
defect
Collagen Membrane
(n=18)
Effective bone augmentation in a randomized, controlled clinical
trial. Defect resolution of bone dehiscence defects 6 months
postoperatively. The differences in % defect fill were not significant.1
1
4
Jung R et al., Clin Oral Implants Res. 2009 Feb;20(2):162-8
2
Jung R et al., Clin Oral Implants Res. 2006 Aug;17(4):426-33 4
Thoma D et al., Clin Oral Implants Res. 2009 Jan;20(1):7-16 3
5
Jung R et al., Clin Oral Implants Res. 2009 Feb;20(2):151-61 Jung R et al., Clin Oral Implants Res. 2009 Feb;20(2):162-8
5
The PEG Technology
Formation of Straumann® ­MembraGel® is triggered by combining PEG A, PEG B, and Activators
A and B. Components of PEG A and B form a ­molecular network of polyethylene glycol (PEG) that
is designed to form a barrier to prevent tissue ingrowth, and, at the same time, remain permeable for
nutrients. This process is visible by in situ solidification.
Straumann® MembraGel® –
handling
Formation of a molecular network
Straumann ­MembraGel is continuously degraded by water (hydrolysis). The degradation of
Straumann ­MembraGel does not involve any acidification of the surrounding tissue.
Biodegradation by water without acidification
6
7
The Handling
Preparation prior to application
Bring to room temperature.
Mixing of Activators and PEG components
The PEG components and the corresponding Activators
are mixed by fully expelling the content of one syringe
into the other. This should be done at least 15 times to
ensure thorough and homogeneous mixing (Fig. 4).
It is advantageous for easy handling and faster gelation
to let all components warm to room temperature before
commencing the mixing procedure. This may take up to
30 minutes after removing from refrigeration.
Removal of closure caps
Remove the closure caps from the tips of the four syringes.
Unscrew the screw caps from the activator syringes and
remove the rubber caps from the PEG syringes (Fig. 1).
Fig. 4 First mixing procedure. 15 times back and forth.
In order to reduce the amount of air bubbles, expel
air that may be present in the syringes by holding the
­syringes upright while pressing each plunger slightly.
Fig. 1 Remove the closure caps from all 4 syringes
After mixing, the diluted PEGs must be transferred into
the PEG components device. Press the red button and
disengage the PEG components containing the two
solutions (Fig. 5). The red button cannot be pressed until
all material is in the glass syringes. Discard the empty
plastic syringes.
Connection of syringe holders
It is beneficial to place both syringe holders on a rigid
surface before connecting them.
Fig. 5 Disconnection
Connect the glass syringes labelled “PEG” to the plastic
syringes labelled “Activator” in such a way that the
symbols (triangles/circles) printed on the syringe labels
match (Fig. 2).
Attach the applicator tip to the PEG components (Fig. 6).
Make sure both parts are connected firmly.
Fig. 2 Connection of syringes
Push both parts with sufficient force to ensure that the
­syringes click together and are firmly joined (Fig. 3). Before
­starting the mixing procedure, make sure that the connection
of the syringes is flush in order to avoid any material loss.
Use the syringe holders to click both parts together.
Fig. 6 Connection of the applicator tip
The device is now ready to use (Fig. 7). The material should
be applied within 45 minutes after the mixing procedure.
Fig. 3 Syringes and syringe holders must be firmly joined
Fig. 7 Ready to use
8
9
Application in situ
For the purpose of accessibility to the surgical site and
in preparation for optimal closure of the mucoperiosteal
flap, vertical releasing incisions are placed at a 4–5 mm
distance from the defect region. Upon beginning the
application of the liquid through the applicator device
continuous pushing of the plungers, without interruptions
if possible, is recommended. Interruptions of more than
30 seconds should be avoided to prevent clogging of
the applicator.
Prevent saliva from entering the treatment site during
application. Remove excess blood. This will allow optimal
adhesion of the membrane to bone walls; however, blood
or saliva will not prevent formation of the membrane and
will not dilute the PEG material during the gelation process.
Apply the first two to three free falling drops outside the
mouth/treatment site to avoid large air bubbles.
Straumann® ­MembraGel® must be used in combination
with a bone graft material in order to maintain space under
the membrane. In order to stabilize Straumann MembraGel
and to prevent non-osteogenic soft tissue cells from
entering the defect, it is sufficient to apply Straumann
­MembraGel by extending at least 1–2 mm beyond the
margins of the defect walls. It is advantageous to apply
the membrane by the first outlining the outer margin of the
site (Fig. 8). At this point, apply the membrane in parallel
lines from the bottom to the top of the application area
(Fig. 9).
10
Try to keep the membrane as thin as possible (Fig. 10)
and avoid applying the liquid in several layers on top
of each other. If the solidified membrane is too thick,
a sharp scalpel may be used to reduce the thickness if
necessary, taking care not to detach the membrane (Fig. 11).
Before wound closure, wait at least 90 seconds until a
firm, but elastic consistency has been established. Do not
attempt to reposition Straumann® ­MembraGel® after it
has been placed and formed.
Fig. 8 Outline the outer margin of the site (Courtesy of Dr. Ronald
Jung).
Fig. 10 Freshly applied Straumann M
­ embraGel
Wherever possible, make sure that the mucoperiosteal
flap is completely closed over Straumann ­­MembraGel.
As with all GBR procedures, it is recommended to apply
a two-layer wound closure with ­Straumann ­MembraGel.
Fig. 11 If necessary, the outer borders and the thickness of the
membrane may be trimmed using a sharp scalpel.
Fig. 9 A
pply membrane in parallel lines. (Courtesy of Dr. Ronald
Jung)
11
Literature on Straumann ® ­M embraGel®
Pre-clinical studies with Straumann ­M embraGel
Jung RE, Zwahlen R, Weber FE, Molenberg A, van Lenthe GH, Hämmerle CH. Evaluation of an
in situ formed synthetic hydrogel as a biodegradable membrane for guided bone regeneration.
Clin Oral Implants Res. 2006 Aug;17(4):426-33
Herten M, Jung RE, Ferrari D, Rothamel D, Golubovic V, Molenberg A, Hämmerle CH, Becker J,
Schwarz F. Biodegradation of different synthetic hydrogels made of polyethylene glycol
hydrogel/RGD-peptide modifications: an immunohistochemical study in rats. Clin Oral Implants Res.
2009 Feb;20(2):116-25.
Wechsler S, Fehr D, Molenberg A, Raeber G, Schense JC, Weber FE. A novel, tissue occlusive
poly (ethylene glycol) hydrogel material. J Biomed Mater Res A. 2008 May;85(2):285-92.
Jung RE, Lecloux G, Rompen E, Ramel CF, Buser D, Hämmerle CH. A feasibility study evaluating
an in situ formed synthetic biodegradable membrane for guided bone regeneration in dogs. Clin
Oral Implants Res. 2009 Feb;20(2):151-61
Thoma DS, Hälg GA, Dard MM, Seibl R, Hämmerle CH, Jung RE. Evaluation of a new biodegradable
membrane to prevent gingival ingrowth into mandibular bone defects in minipigs. Clin Oral Implants
Res. 2009 Jan;20(1):7-16
Randomized, controlled clinical trial with Straumann ­M embraGel
Jung RE, Hälg GA, Thoma DS, Hämmerle CH. A randomized, controlled clinical trial to evaluate
a new membrane for guided bone regeneration. Clin Oral Implants Res. 2009 Feb;20(2):162-8.
12
Straumann USA
Straumann USA, LLC
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Andover, MA 01810
Phone
800/448 8168
978/747 2500
Fax
978/747 2490
www.straumannusa.com
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Straumann Canada Limited
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Burlington, ON L7L 6A3
Phone
800/363 4024
905/319 2900
Fax
905/319 2911
www.straumann.ca
© Straumann USA, LLC 2010. Straumann® and MembraGel® are registered trademarks of Straumann Holding AG, or its affiliates. All rights reserved.
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