Straumann MembraGel The next generation membrane

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1 Straumann MembraGel The next generation membrane

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3 Advanced technology for your GBR cases Straumann membragel is an advanced technology membrane which sets new standards in the surgical use for guided bone regeneration (GBR). Straumann MembraGel Precise, simple, and quick alication Stabilizes the bone graft Barrier properties lasting 4-6 months 1 Degradable material 2 Synthetic origin The liquid alicable 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 biodegraded. 1 The synthetic material shows excellent tissue compatibility which is a prerequisite for achieving undisturbed bone formation. 2 Precise alication in situ. No extension of the membrane over the bone crest necessary for stabilization. The esthetic outcome. Three years postoperatively. (By courtesy of PD Dr. R. Jung) Straumann MembraGel is intended for the use in guided bone regeneration procedures including: peri-implant defects bone defects deficient alveolar ridges extraction sockets 1 Wechsler S et al., J Biomed Mater Res A May;85(2): Herten M et al., Clin Oral Implants Res Feb;20(2):

4 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. Stabilization of the grafted site after solidification (By 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. 1 Straumann membragel has been designed for prolonged integrity of the membrane in order to enhance the protection of the regenerating bone. Pre-clinical data demonstrate that Straumann membragel is degraded significantly slower than a standard collagen membrane. 2 Due to the biodegradation of Straumann membragel no surgical removal of the membrane is necessary. Cell infiltration (in % of positive control without membrane) Residual membrane thickness (%) Collagen membrane Straumann MembraGel ,1 4,3 4, Months after implantation Weeks after implantation Straumann MembraGel implanted subcutaneously in rats. Only after 4.3 months a significant change in the number of cells that have passed the barrier was detectable 1 Straumann MembraGel biodegrades significantly slower than a standard collagen membrane Wechsler S et al., J Biomed Mater Res A May;85(2): Herten M et al., Clin Oral Implants Res Feb;20(2):

5 Precise, simple, and quick alication 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 alied to the surgical site. For the stabilisation of the membrane it is sufficient to extend the membrane area 1 2 mm beyond the margins of the defect walls. In case of buccal bone defects is not necessary to position the membrane over the alveolar crest for further stabilization. The preparation does not require any laborious pre-shaping prior to alication. As a result of the easy alication of Straumann MembraGel the time of the intraoral alication can be reduced significantly. In a randomized, controlled clinical trial the time of intraoral alication could be significantly reduced when compared to a conventional collagen membrane seconds: Average time for intraoral alication of Straumann MembraGel (n=19, SD=26 sec) 195 seconds: Time for intraoral alication of a standard collagen membrane (n=18, SD=123 sec) 3 Jung R et al., Clin Oral Implants Res Feb;20(2):

6 The clinical benefits Effective bone augmentation The effectiveness of Straumann membragel in suorting bone formation has been demonstrated in a variety of pre-clinical and clinical studies. 1 4 Horizontal dimensions of the bone defect prior to augmentation Bone graft in situ Straumann MembraGel solidified on top of the graft material Horizontal bone gain 6 months postoperatively (By courtesy of PD Dr. R. Jung) Excellent defect resolution Clinical data indicate that Straumann membragel effectively suorts the defect fill when used with a bone graft material 1 thereby providing the basis for the esthetic result of the GBR procedure. 8 Defect in mm Initial defect 5.6 mm bone gain = 95 % defect fill Residual defect Straumann membragel (n=19) Initial defect 4.3 mm bone gain = 96 % defect fill 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 Jung R et al., Clin Oral Implants Res Feb;20(2):162-8

7 Effective suort for new bone formation 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) No membrane (n=10) Straumann MembraGel (n=12) eptfe (n=10) Histological bone area fraction from a study in rats. Differences between the two membranes were statistically not significant. 2 Good soft tissue healing The observed progress of wound healing with straumann membragel makes the material wellsuited for GBR procedures. Even in case of soft tissue dehiscences, gingival tissue usually heals without incidents. In this way straumann membragel is designed to facilitate the successful clinical outcome of the GBR procedure. Small soft tissue dehiscence at the time of suture removal Soft tissue healing after 30 days Soft tissue healing after 3 months (By courtesy of PD Dr. R. Jung) 2 Jung R et al., Clin Oral Implants Res Aug;17(4): Jung R et al., Clin Oral Implants Res Feb;20(2): Thoma D et al., Clin Oral Implants Res Jan;20(1): Jung R et al., Clin Oral Implants Res Feb;20(2):

8 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 preventing tissue ingrowth and at the same time is permeable for nutrients. This process is visible by in situ solidification. * * Formation of a molecular network The biodegradable 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 *Schematic representation of molecules. The image does not reflect the actual molecular architecture of the chemical compounds.

9 Straumann MembraGel handling 7

10 The Handling Preparation prior to alication Bring to room temperature. 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 min after taking out of the refrigerator. 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). 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 Connection of syringe holder It is beneficial to place both syringe holders on a rigid surface before connecting them. 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). Fig. 2 Connection of syringes Push both parts with sufficient force to ensure that the syringes click together and are firmly joined. 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. 3 Syringes and syringe holders must be firmly joined 8

11 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 First mixing procedure. 15 times back and forth. 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. The red button cannot be pressed until all material is in the glass syringes. Discard the empty plastic syringes. Fig. 5 Disconnection Attach the alicator tip to the PEG components. Make sure both parts are connected firmly. Fig. 6 Connection of the alicator tip The device is now ready to use. The material should be alied within 45 minutes after the mixing procedure. Fig. 7 Ready to use 9

12 Alication 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 4 5 mm distant to the defect region. Upon beginning the alication of the liquid through the alicator 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 alicator. Prevent saliva from entering the treatment site during alication. Remove excess blood. This will allow optimal adhesion of the membrane to bone walls. Blood or saliva will not, however, prevent formation of the membrane and will not dilute the PEG material during the gelation process. Fig. 8 It is advantageous to aly the membrane by first outlining the outer margin of the membrane. (see pictures below, by courtesy of Dr. Ronald Jung). Aly 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 aly Straumann membragel by extending at least 1 2 mm beyond the margins of the defect walls. Fig. 9 Then alying it in parallel lines from the bottom to the top of the area of alication. (see pictures below, by courtesy of Dr. Ronald Jung) 10

13 Try to keep the membrane as thin as possible and avoid alying 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. 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. 10 Freshly alied Straumann MembraGel Wherever possible, make sure that the mucoperiosteal flap is completely closed over Straumann membragel. As recommended for all GBR procedures, it is advisable to aly a combination of a deep horizontal mattress suture with simple interrupted sutures. Fig. 11 If necessary, the outer borders of the membrane and the thickness may be trimmed using a sharp scalpel. 11

14 Literature on Straumann membragel Pre-clinical studies with Straumann MembraGel 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 Aug;17(4): 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 Feb;20(2): 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 May;85(2): 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 Feb;20(2): 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 Jan;20(1):7-16 Randomized, controlled clinical trial with Straumann MembraGel 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 Feb;20(2):

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