Frequently Asked Questions (FAQ)
Dental Products
Geistlich Bio-Oss® is made from the mineral part of bovine bone. The strictly controlled manufacturing process ensures high quality and safety standards by:
- defined origin of the raw material
- country of origin: Australia (and for some countries also New Zealand) which is historically and currently free of BSE
- selected and certified slaughterhouses
- pre- and post-mortem health inspection for each individual animal
- extremity bone (according to WHO Guideline on tissue infectivity classified as tissues with no detected infectivity or infectious prions)
- effective inactivation methods with 15h treatment at high temperature and cleaning with strong alkaline solutions
- sterilization, double sterile packaging
- official controls by international authorities
References:
- Gielkens PF, et al.: Clin Oral Implants Res 2008; 19(5) : 516-21.
- Tal H, et al.: Clin Oral Implants Res 2008; 19(3): 295-302.
- Becker J, et al.: Clin Oral Implants Res 2009; 20(7): 742-49.
1.0 cc Geistlich Bio-Oss Pen®: ~1.0 ml
1.5 cc Geistlich Bio-Oss Pen®: ~1.5 ml
References:
- Gielkens PF, et al.: Clin Oral Implants Res 2008; 19: 516-21.
- Tal H, et al.: Clin Oral Implants Res 2008; 19: 295-302.
- Becker J, et al.: Clin Oral Implants Res 2009; 20(7): 742-49.
References:
- Perelmann-Karmon, et al.: Int J Periodontics Restorative Dent 2012; 32(4): 459-65.
Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® share the same indications. These products may be used interchangeably in the following procedures:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for Guided BoneRegeneration (GBR).
Geistlich Bio-Oss Collagen® is recommended for reconstruction of bone defects in the following procedures:
- Augmentation/reconstruction of alveolar ridges.
- Filling of extraction sockets.
- Preparation of implant sites, filling of bone dehiscences, and sinus floor augmentations.
- Filling of periodontal bone defects, membrane support during guided bone regeneration (GBR) and guided tissue regeneration (GTR).
References:
- Perelman-Karmon M, et al.: Int J Periodontics Restorative Dent 2013, 32(4): 459-65.
References:
- Cardaropoli D, et al.: Int J Periodontics Restorative Dent 2012, 32(4): 421-30.
Geistlich Bio-Gide® is a membrane with a unique bilayer structure. It combines optimal bone formation with complication-free wound healing and predictable outcomes. The native collagen of Geistlich Bio-Gide® leads to significantly less soft tissue dehiscences compared to artificially cross-linked membranes.1 A significant number of scientific publications and proven long-term clinical success support the safety and efficacy of Geistlich Bio-Gide®.
References:
- Tal H, et al.: Clin Oral Impl Res 2008; 19: 295-302.
- Becker J, et al.: Clin Oral Impl Res 2009; 20(7): 742-49.
- Schwarz F, et al.: Clin Oral Impl Res 2008; 19(4): 402-15.
Expert clinicians have estimated that a membrane used in Guided Bone Regeneration should maintain its barrier function until the provisional matrix and woven bone are present. Barrier duration is considered to be necessary for 7 to 14 days in most cases. Optimal barrier function now means that occlusiveness is maintained until the wound heals – a process which normally takes about 2 weeks.
Geistlich Bio-Gide® has proven to support bone regeneration on an equivalent level as membranes with a longer barrier function, with a reduction of complications during wound healing.1-3
References:
- Tal H, et al.: Clin Oral Implants Res 2008; 19(5): 295-302.
- Becker J, et al.: Clin Oral Implants Res 2009; 20(7): 742-49.
- Schwarz F, et al.: Clin Oral Implants Res 2008; 19(4): 402-15.
References:
- Schwarz F, et al.: Clin Oral Impl Res 2008; 19(4): 402-15.
References:
- Tal H, et al.: Clin. Oral Implants Res 2008; 19: 295-302.
- Zitzmann NU, et al.: Int J Oral Maxillofac Implants 1997; 12: 844-52.
- Becker J, et al.: Clin. Oral Implants Res 2009; 20(7): 742-93.
- Schwarz F, et al.: Clin Oral Implants Res. 2014, 25(9): 1010-15.
Geistlich Bio-Gide® Shape is indicated for the treatment of non-intact extraction sockets. Geistlich Mucograft® Seal is recommended in extraction sockets with intact buccal bone walls.1
Reference:
- Geistlich Mucograft Seal Advisory Board Meeting Report, 2013. Data on file, Geistlich Pharma AG, Wolhusen, Switzerland.
Geistlich Fibro-Gide® is intended to be used for soft-tissue regeneration at the alveolar ridge. Indications of Geistlich Fibro-Gide® are insufficient soft-tissue volume and recession defects.1
- Instructions for Use. Geistlich Fibro-Gide®. Geistlich Pharma AG, Wolhusen, Switzerland.
Geistlich Fibro-Gide® is a porous, resorbable and volume-stable porcine collagen matrix specifically designed for soft-tissue regeneration.1 The matrix is made of reconstituted collagen and undergoes smart chemical cross-linking to improve volume stability of the device while maintaining its excellent biocompatibility.1-3
- Instructions for Use. Geistlich Fibro-Gide®. Geistlich Pharma AG, Wolhusen, Switzerland.
- Thoma DS et al. J Clin Periodontol. 2016 Oct; 43(10): 874–85.
- Thoma DS et al. Clin Oral Implants Res. 2015 Mar; 26(3): 263–70.
Animal models show gradual resorption and integration of Geistlich Fibro-Gide® into host tissue while maintaining volume stability.1
- Thoma DS. et al. Clin Oral Implants Res. 2012.
Geistlich Fibro-Gide® is an alternative to autologous connective tissue grafts (CTG) for soft tissue volume augmentation around dental implants and natural teeth.1,2 Geistlich Fibro-Gide® obviously has the advantage of reducing patient morbidity since there is no additional harvest site. Furthermore, there is minimal risk of necrosis when using Geistlich Fibro-Gide® compared to CTG.3
- Thoma DS et al. J Clin Periodontol 2016.
- Zeltner M et al. J Clin Periodontol 2017.
- Data on file. Geistlich Pharma AG, Wolhusen, Switzerland.
Geistlich Fibro-Gide® is ready to be applied in a dry or wet state to the defect and does not need pretreatment or conditioning before application. Geistlich Fibro-Gide® possesses excellent hydrophilic characteristics that lead to a rapid hydration of the collagen matrix (patient’s own blood and/or sterile saline).1 When applied dry to the defect site, the matrix will hydrate easily by soaking up the patient’s own blood and/or sterile saline if applied to the matrix, very quickly.1
- Data on file. Geistlich Pharma AG, Wolhusen, Switzerland.
Geistlich Fibro-Gide® can be applied either in a dry or wet state subject to individual preference: pre-wetting can be done with blood and/or sterile saline.1,2 Geistlich Fibro-Gide® can be cut and trimmed both in a dry or wet state, using scissors and/or a scalpel.1,2 The scalpel is recommended for dry handling.1,2 Using a scalpel will help to obtain smooth edges and tapers for improved wound adaptation and precise fit of the matrix.1,2
- Instructions for Use. Geistlich Pharma AG, Wolhusen, Switzerland.
- Data on file. Geistlich Pharma AG, Wolhusen, Switzerland.
The device will gain approximately 25% in volume once wet. This increase in volume has to be taken into account when deciding to trim the matrix and determining its dimension prior to implatation.1 A generous flap design is the key to full submersion of the matrix.
- Data on file. Geistlich Pharma AG, Wolhusen, Switzerland.
Clinical experience has shown that tension-free wound closure is a key factor in preventing dehiscence. In open flap procedures for augmentation at the alveolar ridge a horizontal mattress suture is recommended to stabilize the matrix (5.0-6.0).1 In recession coverage, single sutures (7.0) have been used for stabilization.1
- Data on file. Geistlich Pharma AG, Wolhusen, Switzerland.
Geistlich Mucograft® = Compact and spongy layer
Geistlich Fibro-Gide® = Porous layer
Geistlich Mucograft® = Reconstituted collagen: No cross-linking
Geistlich Fibro-Gide® = Reconstituted collagen: Smart cross-linking
Geistlich Mucograft® = Reduced volume stability
Geistlich Fibro-Gide® = Good volume stability
Geistlich Mucograft® = Open-healing & submerged healing
Geistlich Fibro-Gide® = Submerged healing only
Geistlich Mucograft® Treatment Option:
- Gain of keratinized tissue
- Socket Seal
- Vestibuloplasty
- Recession Coverage
Geistlich Fibro-Gide® Treatment Option:
- Soft-tissue volume augmentation around dental implants and natural teeth, and under pontics
- Recession Coverage
Clinical studies have shown a physiological increase in thickness when using CTG as the gold standard of 0.35 to 3.2 mm.1-3 Clinical studies have shown that treatment with Geistlich Fibro-Gide® results in an increase of 1-2 mm of thickness4,5 which is equivalent to results obtained with CTG4. Geistlich Fibro-Gide® is provided with a thickness of 6 mm which gives freedom to the surgeon to trim it to the desired size and to use the collagen matrix for thickening of tissues under pontics where more volume might be required. For lateral soft-tissue augmentation, it is recommended to reduce the thickness of Geistlich Fibro-Gide® in order to achieve a tension-free, primary wound closure.
- Eghbali A et al. Clin Implant Dent Relat Res. 2016.
- Thoma DS et al. Periodontol 2000. 2014.
- De Bruyckere T et al. J Clin Periodontol. 2015.
- Thoma DS et al. J Clin Periodontol 2016.
- Chappuis V et al. Manuscript in preparation.
1. Gain of Keratinized Tissue: Open healing is recommended when Geistlich Mucograft® is used to increase the width of keratinized tissue. The innovative design of Geistlich Mucograft® allows excellent healing in open healing situations1.
2. Recession Coverage: Geistlich Mucograft® should remain completely submerged under the flap to avoid premature resorption of the collagen.2-4 Direct blood supply is important.
References:
- Sanz M, et al.: J Clin Periodontol 2009; 36(10): 868-76.
- McGuire MK & Scheyer ET: J Periodontol 2010; 81(8): 1108-17.
- Cardaropoli D, et al.: J Periodontol 2012; 83(3): 321-28.
- Rotundo R & Pini-Prato G: Int J Periodontics Restorative Dent 2012; 32(4): 413-19.
1. Gain of keratinized tissue: Geistlich Mucograft® should be applied on a periosteal bed1,2 as direct blood supply is important. In open healing, the blood is supplied through the edges of the device from the surrounding tissue and from the periosteum.
2. Recession Coverage: Geistlich Mucograft® can be used partially or completely over bone.3-5 Blood is supplied through the edges of the device from the surrounding tissue and from the flap completely covering the matrix.
References:
- Sanz M, et al.: J Clin Periodontol 2009; 36(10): 868-76.
- Lorenzo R, et al.: Clin Oral Impl Res 2012; 23(3): 316-24.
- McGuire MK & Scheyer ET : J Periodontol 2010; 81(8): 1108-17.
- Cardaropoli D, et al.: J Periodontol 2012; 83(3): 321-28.
- Rotundo R & Pini-Prato G: Int J Periodontics Restorative Dent 2012; 32(4): 413-19.
References:
- Sanz M, et al.: J Clin Periodontol 2009; 36(10): 868-76.
- Herford AS, et al.: J Oral Maxillofac Surg 2010; 68(7): 1463-70.
- Cardaropoli D, et al.: J Periodontol 2012; 83(3): 321-28.
- McGuire MK & Scheyer ET : J Periodontol 2010; 81(8): 1108-17.
References:
- Data on file, Geistlich Pharma AG, Wolhusen, Switzerland
References:
- Sanz M, et al.: J Clin Periodontol 2009; 36(10): 868-76.
- Lorenzo R, et al.: Clin. Oral Impl. Res 2012; 23(3): 316-24.
- Nevins M, et al.: Int J Periodontics Restorative Dent 2011; 31(4): 367-73.
- McGuire MK & Scheyer ET : J Periodontol 2010; 81(8): 1108-17.
- Cardaropoli D, et al.: J Periodontol 2012; 83(3): 321-28.
- Rotundo R & Pini-Prato G: Int J Periodontics Restorative Dent 2012; 32(4): 413-19.
References:
- Rocchietta I, et al.: Int J Periodontics Restorative Dent 2012; 32(1): e34-40.
- Ghanaati S, et al.: Biomed Mater 2011; 6(1): 015010.
Geistlich Mucograft® Seal should be sutured using non-resorbable sutures; tissue adhesives should not be used1. The close adaptation of the device to the soft-tissue borders can be accomplished by single-interrupted, double-interrupted or cross-stitch suturing.
The finest possible suture material comfortably used by the surgeon should be selected: for single-interrupted suturing, a 5.0 or 6.0 suture size is recommended; for cross-stitch suturing, a 5.0 suture size is appropriate1.
References:
- Geistlich Mucograft Seal Advisory Board Meeting Report, 2013. Data on file Geistlich Pharma AG, Wolhusen, Switzerland.
No. Geistlich Mucograft® Seal has limited elongation properties and should always be sutured tension-free.
The compact macro-structure should face outward, away from underlying bone, with the spongeous micro-structure facing the bone or soft-tissue wound bed. Geistlich Mucograft® Seal spongeous micro-structure is grooved for easier differentiation of the two sides. The grooved spongeous micro-structure should face the bone.
Our measurements indicate that the matrix does not expand further following hydration (90-minute period examined)1.
References:
- Data on file, Geistlich Pharma AG, Wolhusen, Switzerland
Geistlich Biomaterials recommends the handling and application of Geistlich Mucograft® Seal be done in a dry state. The matrix is easy to trim and easy to pre-suture.
Geistlich Mucograft® Seal is ready to be applied and does not need pre-treatment or hydration before application. Due to its excellent hydrophilicity, the matrix will hydrate quickly following placement into the site with the patient’s blood.
The collagen of Geistlich Mucograft® will be replaced by newly formed soft-tissue. The matrix is rapidly vascularized and colonized by soft-tissue cells1,2. This leads to a good integration of the matrix without any signs of foreign body reaction3,4.
References:
- Rocchietta I, et al.: Int J Periodontics Restorative Dent 2012; 32(1): e34-40.
- Ghanaati S, et al.: Biomed Mater 2011 Feb; 6(1): 015010.
- Nevins M, et al.: Int J Periodontics Restorative Dent 2011; 31(4): 367-73.
- Camelo M, et al.: Int J Periodontics Restorative Dent 2012; 32(2): 167-73.
Geistlich Mucograft® Seal consists of porcine collagen and is specifically designed for soft-tissue regeneration. The matrix is built up of a compact macro-structure that gives stability while allowing open healing, and a spongy micro-structure that supports blood clot stabilization and ingrowth of soft-tissue cells.
The hydrophilic properties of Geistlich Mucograft® Seal result in a rapid moistening of the device with either saline or blood.
The resorption time of every biomaterial including Geistlich Mucograft® Seal depends on multiple factors: defect size, metabolism and general health of the patient, among other variables. In order to determine an average resorption time of Geistlich Mucograft® Seal in humans, biopsies of the healing soft-tissues would be needed following tooth extraction at different time points. This procedure is not ethically possible to conduct and thus the average resorption time cannot be measured. However, single histologic evaluations indicate that after 8 weeks Geistlich Mucograft® Seal is completely integrated into the newly formed soft-tissue.
Geistlich Mucograft® Seal is specifically designed for soft-tissue regeneration1. The collagen of Geistlich Mucograft® Seal is specially processed to support immediate blood clot stabilization. This leads to early vascularization1,3, facilitates soft-tissue cell ingrowth2 and excellent integration of the collagen matrix with surrounding tissues2,3. In contrast to other collagen products on the market, Geistlich Mucograft® and Geistlich Mucograft® Seal have been scientifically documented with proven clinical benefits.
References:
- Biocompatibility according to ISO 10993-12001. Data on file Geistlich PharmaAG, Wolhusen, Switzerland.
- Ghanaati S, et al.: Biomed Mater 2011; 6(1): 015010.
- Roccietta I, et al.: Int J Periodontics Restorative Dent 2012; 32(1): e34-40.
Geistlich vallomix™ is the first conveniently co-packed xenogeneic / allogeneic validated bone substitute1. Geistlich vallomix™ contains individually packaged Geistlich Bio-Oss® granules and vallos™ granules or fibers. Together, these products offer the opportunity to achieve optimal consistency and performance in demanding clinical situations.
References:
- Compiled DCI Osteoinductivity Validation Summary_2020. (data on file)
The combination of a validated allograft with osteoinductive potential1 and a volume preserving xenogeneic bone substitute can provide significant advantages in regenerative procedures, enabling the possibility of reduced time between tissue regeneration and implant placement. Geistlich vallomix™ simplifies combining a high quality demineralized cortical allograft, vallos™ with Geistlich Bio-Oss®, the leading xenogeneic bone substitute for regenerative dentistry worldwide2,3, with more than 35 years of scientific validation.
References:
- Compiled DCI Osteoinductivity Validation Summary_2020. (data on file)
- iData Research Inc., US Dental Bone Graft Substitutes and other Biomaterials Market, 2015.
- iData Inc., European Dental Bone Graft Substitutes and other Biomaterials Market, 2015.
vallos™ is an allogeneic bone in the form of granules, whereas vallos™f is an allogeneic bone in the form of fibers (shavings from cortical bone). vallos™f shows putty-like handling properties and can be easily molded by the clinician into a desirable shape for application to the defect site. vallos™f has also demonstrated 4-times higher osteoinductive potential compared to vallos™.1 Both vallos™ and vallos™f can be mixed with Geistlich Bio-Oss® in a dry or hydrated state.
References:
- Compiled DCI Osteoinductivity Validation Summary_2020. (data on file)
vallos™ and vallos™f are demineralized cortical freeze-dried allografts that offer osteoinductive potential and new vital bone formation after 18-20 weeks.1 Our allograft supplier meets the highest quality standards, is a federally certified organ procurement organization, and remains in control of all processes, from donor screening to all steps of allograft processing, to provide a state-of-the-art product. To counterbalance heterogeneity between different donors, every donor lot for vallos™ is tested to ensure osteoinductive potential. Moreover, adding Geistlich Bio-Oss® offers the potential for more consistent and predictable clinical outcomes.
References:
- Robert A Wood & Brian L Mealey: J Periodontol. 2012 Mar;83(3):329-36. (Clinical Study)
These allografts are not sold separately, today. Geistlich vallomix™ and Geistlich vallomix™f were designed to be conveniently co-packed, bringing together the verified osteoinductivity of vallos™1 with the volume stability of Geistlich Bio-Oss®.3-8 Together, these products bring the opportunity for optimal consistency and performance1-14 in demanding clinical situations.
References:
- Compiled DCI Osteoinductivity Validation Summary_2020. (data on file)
- Robert A Wood & Brian L Mealey: J Periodontol. 2012 Mar;83(3):329-36. (Clinical Study).
- Piattelli M et al.: Int J Oral Maxillofac Implants 1999; 14 (6), 835-40. (Clinical Study).
- Sartori S et al.: Clin Oral Implants Res 2003; 14 (3), 369-72. (Clinical Study).
- Maiorana C et al.: Int J Periodontics Restorative Dent 2005; 25 (1), 19-25. (Clinical Study).
- Orsini G et al.: Oral Dis 2007; 13 (6), 586-93. (Clinical Study).
- Lindgren C et al.: Int J Oral Maxillofac Implants 2009; 24 (6), 1093-100. (Clinical Study).
- Mordenfeld A et al.: Clin Oral Implants Res 2010; 21 (9), 961-70. (Clinical Study).
- Serrano CA et al.: Implant Dent. 2018 Aug; 27(4):467-473. (Clinical Study).
- NCBI Pubmed, Month Year, Search term “Bio-Oss” (1208 hits) (Market research).
- Berglundh T & Lindhe J: Clin Oral Implants Res 1997; 8 (2), 117-24. (Preclincal Study).
- Weibrich G et al.: Mund Kiefer Gesichtschir 2000; 4 (3), 148-52. (Preclincal Study).
- Degidi M et al.: Oral Dis 2006; 12 (5), 469-75. (Clinical Study).
- Galindo-Moreno P et al.: Clin Oral Implants Res 2010; 21 (2), 221-7. (Clinical Study).
Demineralized allografts offer the potential of osteoinductivity1-3 as compared to mineralized allografts. While offering new bone formation capacity, demineralized bone matrices are subject to volume resorption during the healing process.4 Geistlich Bio-Oss® has shown to consistently maintain grafted bone volume over time.5-10 Thus, the demineralized vallos™ and Geistlich Bio-Oss® complement each other to obtain a bone graft that has osteoinductive potential while maintaining its volume.
References:
- Glowacki, J., S. Zhou, and S. Mizuno, J Craniofac Surg, 2009. 20 Suppl 1: p. 634-8
- Glowacki, J Oral Maxillofac Surg . 2015 Dec;73(12 Suppl):S126-31. doi: 10.1016/j.joms.2015.04.009.
- Urist, Marshall R. (1965). Science 12:150 (698): 893–899.
- Serrano CA et al.: Implant Dent. 2018 Aug; 27(4):467-473. (Clinical Study).
- Piattelli M et al.: Int J Oral Maxillofac Implants 1999; 14 (6), 835-40. (Clinical Study).
- Sartori S et al.: Clin Oral Implants Res 2003; 14 (3), 369-72. (Clinical Study).
- Maiorana C et al.: Int J Periodontics Restorative Dent 2005; 25 (1), 19-25. (Clinical Study).
- Orsini G et al.: Oral Dis 2007; 13 (6), 586-93. (Clinical Study).
- Lindgren C et al.: Int J Oral Maxillofac Implants 2009; 24 (6), 1093-100. (Clinical Study).
- Mordenfeld A et al.: Clin Oral Implants Res 2010; 21 (9), 961-70. (Clinical Study).
Numerous studies show that allografts demonstrate a high degree of heterogeneity that is associated with inter-donor variability.1-2 Inclusive of the state-of-the-art quality control and donor safety assessments, vallos™ and vallos™f are both tested for every donor lot on its osteoinductive potential. This offers the opportunity to obtain more predictable clinical outcomes3. This ensures that each lot has been processed, tested, and validated for osteoinductive potential, reducing lot-to-lot variability.
References:
- Urist, Marshall R. (1965). Science 12:150 (698): 893–899.
- Schwartz et al., J Periodontol. 1996 Sep;67(9):918-26. doi: 10.1902/jop.1996.67.9.918
- Serrano CA et al.: Implant Dent. 2018 Aug; 27(4):467-473. (Clinical Study).
Osteoinductive potential is assessed in vitro with the alkaline phosphatase activity (ALP) testing method on every donor lot for vallos™ and vallos™f. ALP is a commonly used indicator for bone formation processes in the synthesis of hydroxyapatite. The acceptance criteria for vallos™ and vallos™f are based on a measurement according to an osteoinductivity index, above which a donor lot can be considered osteoinductive positive based on the in vitro and in vivo (heterotopic bone formation) correlation studies1-2.
References:
- Compiled DCI Osteoinductivity Validation Summary_2020. (data on file)
- Han et al., 2003, J Orthop Res 21_648-654
The combination of allogeneic and xenogeneic bone has been well documented and widely used in clinical practice for many years1-2. Studies specific to Geistlich vallomix™ are in preparation.
References:
- Serrano CA et al.: Implant Dent. 2018 Aug; 27(4):467-473. (Clinical Study).
- Landi L. et al., Int J Periodontics Restorative Dent. 2000 Dec;20(6):574-83. PMID: 11203594.
Geistlich vallomix™ can be mixed, layered, or adjusted based on the clinical needs of the patient, providing flexibility for a range of therapeutic areas.
It is recommended to hydrate and mix Geistlich Bio-Oss® along with the vallos™ or vallos™f component. According to the package insert, vallos™ should be hydrated a minimum of 30 minutes. When preparing vallos™f gently mix for 30-60 seconds until completely hydrated. It is recommended that all freeze-dried allografts be hydrated in Ringer’s solution, normal saline, or other normal physiologic solution containing antibiotics of the clinicians’s preference. The decision to hydrate freeze-dried bone should be based upon the clinician’s preference. Please see the Package Insert for more information.
Clinician preference dictates which choice in biomaterials should be used. Geistlich vallomix™ embodies a combination of demineralized and mineralized bone material and can be considered a suitable replacement of demineralized and mineralized allograft material. Geistlich Bio-Oss® provides the mineralized component of Geistlich vallomix™ which has been attributed to beneficial volume stability over mineralized allografts1.
References:
- Lee et al., Int J Oral Maxillofac Implants. 2009 ; 24 :609-615
After many years of using both e-PTFE and d-PTFE membranes, Dr. Istvan Urban felt that for larger bone augmentations it was oftentimes challenging to achieve adequate vascularization of the outer sections of the graft due to the distance from the native bone. Dr. Urban began experimenting with perforating d-PTFE membranes, with the notion that the periosteum may be a source of angiogenesis and cell migration that can communicate with the graft. As a result, he was able to achieve clinically more vascularized augmented bone after the healing period.
RPM™ and Ti-reinforced PTFE membranes like Cytoplast™ are indicated for the treatment of alveolar bone defects. The rationale behind RPM™ is that the combination of macro-perforations and coverage with Geistlich Bio-Gide® will lead to better vascularization of the outer sections of the augmented bone. According to Osteogenics, Dr. Istvan Urban has been almost exclusively using RPM™ since it has been made available.
Although it is possible to use RPM™ alone, Geistlich Bio-Gide® provides additional protection of the graft from potential bacterial or soft tissue infiltration. Geistlich Bio-Gide® also increases tissue tolerance by providing a “buffer” for the soft tissue from the potentially sharp folds and edges of the RPM™. Geistlich Bio-Gide® enhances soft tissue cell migration and early re-epithelialization, which may minimize tissue dehiscence and improve healing. The additional layer of collagen membrane may also provide coverage for graft particles that are not completely protected and stabilized by RPM™
PTFE membranes have a long-standing history as barrier membranes for volume stabilization and are highly biocompatible1. Collagen membranes, such as Geistlich Bio-Gide®, have been shown to be beneficial for uneventful soft tissue healing2, 3 in GBR procedures resulting in protection against soft tissue ingrowth and lowered complication rates2.
References
1. Urban et al. Int J Periodontics Restorative Dent 2013
2. Becker et al. Clin Oral Implants Res. 2009
3. Tal et al. Clin Oral Implants Res. 2008
Yes. Tension-free primary closure is still crucial to clinical success when performing ridge augmentation procedures using RPM™ and Geistlich Bio-Gide®. Because of the macro-perforations of the RPM™, early tissue dehiscence may lead to bacterial infection through the mesh. Even though Geistlich Bio-Gide® provides additional barrier coverage, it can resorb prematurely in the event of exposure and not offer protection from bacteria.
Generally, for large augmentations (>6mm) it is recommended for the clinician to wait at least 9 months for the bone to mature enough prior to implant placement.
Either a screw or pin/tacking system could be used to fixate RPM™. Fixation through the titanium frame and/or the areas of macro perforations should be avoided. Geistlich Bio-Gide® does not need to be fixated over RPM™.
Even though RPM was designed for challenging GBR procedures like vertical ridge augmentation, it can certainly be used for horizontal augmentation, as well.
It has been shown that Geistlich Bio-Gide® is perfectly suited for horizontal GBR (i.e. Sausage Technique), however there are clinicians that prefer a more form-stable barrier for large augmentations. RPM™ in combination with Geistlich Bio-Gide® provides a perfect solution to that.
Exposure without purulence – Weekly monitoring and cleaning with chlorhexidine gel and gentle brushing. If exposure occurs before 2 months post-operatively, the mesh should stay in place 6-8 weeks before removal. If exposure occurs after 2 months post-operatively, monitor until full graft maturation if possible4
Exposure with purulence – Antibiotics can be prescribed at the practitioner’s discretion and the mesh and all non-incorporated graft particles and granulomatous tissue should be removed. If exposure occurs before 2 months post-operatively, all of the graft may be compromised and require removal. If exposure occurs after 2 months post-operatively, there may be some consolidated regenerated tissue underneath the infected or granulomatous areas4
Please note that the above guidelines describe the management of exposed conventional titanium-reinforced D-PTFE membranes. Exposed RPM™ may be more prone to infection due to the presence of macro perforations.
Reference
4. Gallo et al. J Oral Maxillofacial Implants 2019
Some customization and adjustment to the size/shape of the material is often necessary to ensure placement without contacting adjacent teeth or other anatomical structures.
Trimming can be done with surgical scissors. Care should be taken during cutting to avoid delamination of the material. Cutting through the areas of macro perforations or titanium frame may weaken the material.
Obtaining tension-free primary closure is crucial to the healing process and success of the graft. Over augmentation can make flap management and primary closure difficult. The clinician should use sound judgment to ensure that an adequate amount of graft is applied without significantly interfering with the clinician’s ability to close the tissue.
Since RPM™ is a new product that was launched in 2019, there is no published research at this time. Dr. Istvan Urban has been using the product exclusively for 2 years (as of 2020) and is currently working on a clinical case series to be published in the near future.
The mandible SKUs were designed with perforations only on the buccal side of the mesh. This allows perfusion of blood and osteogenic cells to the buccal aspects of the graft. The non-perforated lingual side allows easier removal from the lingual aspect, as there is no tissue infiltration
Have you ever seen non-vital or non-incorporated bone graft when you remove the membrane due to lack of vascularity in the outer sections of the bone graft? The perforations of RPM allow dual vascularization (from bone and periosteum) to increase the vitality of the bone graft.
Dental Therapeutic Area
Geistlich Mucograft® Seal needs the support of Geistlich Bio-Oss Collagen® underneath for good healing of both the soft and the hard-tissues in order to preserve the ridge volume. After 8 weeks, the soft-tissues are healed but the mixture of the blood clot, Geistlich Bio-Oss Collagen® and the newly forming bone is still soft. Nevertheless, the implant can be drilled carefully into the socket and the remaining Geistlich Bio-Oss Collagen® will support the volume preservation of the ridge.
- Type 1: simultaneous to extraction (immediate)
- Type 2: 4-8 weeks after extraction (early implantation)
- Type 3: 12-16 weeks after extraction (delayed implantation)
- Type 4: more than 16 weeks after extraction (late implantation)1
References:
- Chen S, Buser D: ITI Treatment Guide Vol 3.
References:
- Cardaropoli D, et al.: Int J Periodont Rest Dent 2012; 32(4) : 421-430
References:
- Araujo M, et al.: Int J Periodont Rest Dent 2008; 28(2):123-135.
- Fickl S, et al.: Journal Clin Periodontol 2008; 35:356-363.
References:
- Huynh-Ba G, et al.: Clin Oral Implants Res 2010; 21(1): 37-42.
- Januario AL, et al.: Clin Oral Implants Res 2011; 22(10): 1168-71.
- Araujo MG, Lindhe J: Journal Clin Periodontol 2005; 32(2): 212-18.
References:
- Cardaropoli D, et al.: Int J Periodontics Restorative Dent 2012; 32(4) :421-30.
References:
- Perelman-Karmon M, et al.: Int J Periodontics Restorative Dent 2012; 32(4): 459-65.
- Geistlich Mucograft Seal Advisory Board Meeting Report, 2013. Data on file, Geistlich Pharma AG, Wolhusen, Switzerland.
- Gingival recession over a period of five years1
- Soft-tissue attachment loss2
- Increased plaque accumulation lingually1
- Inflammation of the soft tissue2
- More frequent bleeding1
- Schrott AR, et al.: Clin Oral implants Res 2009; 20(10): 1170-17.
- Chung DMT, et al.: J Periodontol 2006; 77(8): 1410-20.