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PubMed1998

BIO-OSS--a resorbable bone substitute?

BIO-OSS is an allergen-free bone substitute material of bovine origin, used to fill bone defects or to reconstruct ridge configurations. Seventy one patients (39 female, 32 male) received 126 BIO-OSS implantations. Some health parameters or habits were documented to eliminate possible risk factors of influence. The diameter of jaw defects filled with BIO-OSS was measured. There was a significant influence of the defect size on the healing result. In X-ray controls, BIO-OSS served to identify the surrounding native bone. The density of the BIO-OSS areas was higher than in control sites. These radiological results were supported by bone biopsies. Histologically, the permanency of the BIO-OSS was still recognizable after 6 years and longer. The ingrowth of newly formed bone in the BIO-OSS scaffold explained the increased density of the implanted regions. There were no clinical signs of BIO-OSS resorption. Therefore, we can assume that form corrections achieved by BIO-OSS insertions will last.

Absorption↗
PubMed2005

A method of sealing perforated sinus membrane and histologic finding of bone substitutes: a case report.

To augment the atrophic posterior maxilla, a sinus bone graft has been widely used for sinus floor augmentation. Various bone substitutes have been developed and grafted in the maxillary sinus with and without membranes perforation, although autogenous bone is recommended as a gold standard of grafting materials. Membrane perforation is the most common complication associated with sinus bone graft. To repair a perforation, various methods have been developed. This case report is focused on histologic findings of 1 bovine hydroxyapatite (Bio-Oss; Geistlich Pharma AG, Wolhusen, Switzerland) and 2 kinds of human mineral allograft- Tutoplast cancellous microchips (TutoGen Medical GmbH, Neunkirchen am. Brand Germany), and irradiated allogeniccancellous bone and marrow (ICB; Rocky Mountain Tissue Bank, Aurora, CO) used for sinus graft in the same patient with membrane perforation after various healing periods. Mineral allograft showed favorable new bone regeneration with the repair of membrane perforation. This case report also describes a technique regarding how to repair completely perforated sinus membrane after the removal of a mucocele using human collagen membrane (Tutoplast pericardium; TutoGen Medical GmbH) and fibrin adhesive (Greenplast; Green Cross Co., Youngin, Korea) to stabilize collagen membrane.

Adult↗
PubMed2005

Bioactive bone cements containing nano-sized titania particles for use as bone substitutes.

Three types of bioactive polymethylmethacrylate (PMMA)-based bone cement containing nano-sized titania (TiO2) particles were prepared, and their mechanical properties and osteoconductivity are evaluated. The three types of bioactive bone cement were T50c, ST50c, and ST60c, which contained 50 wt% TiO2, and 50 and 60 wt% silanized TiO2, respectively. Commercially available PMMA cement (PMMAc) was used as a control. The cements were inserted into rat tibiae and allowed to solidify in situ. After 6 and 12 weeks, tibiae were removed for evaluation of osteoconductivity using scanning electron microscopy (SEM), contact microradiography (CMR), and Giemsa surface staining. SEM revealed that ST60c and ST50c were directly apposed to bone while T50c and PMMAc were not. The osteoconduction of ST60c was significantly better than that of the other cements at each time interval, and the osteoconduction of T50c was no better than that of PMMAc. The compressive strength of ST60c was equivalent to that of PMMAc. These results show that ST60c is a promising material for use as a bone substitute.

Animals↗
PubMed1996

Role of bone substitutes.

Approximately 500 million years ago, the Paleozoic era heralded an evolutionary marvel: the skeleton. Unique to this evolutionary development was the capacity for regeneration: the physiologic renewal of embryologically derived tissue. Many of the cellular and molecular components for bone regeneration have been identified (bone morphogenetic proteins), and their therapeutic manipulation will become common clinical practice. Moreover, synthetic materials produced in the laboratory and novel bone derivatives will be used to exploit the skeleton's capacity to regenerate and repair. The concept of repair may be viewed as the restoration of form and function to deficient osseous tissue. Materials that provoke repair can be categorized broadly as bone substitutes. In this review, bone substitutes are grouped into 2 categories, polymers and ceramics, and each is subclassified as biodegradable or nonbiodegradable. Examples of these materials are provided as well as some of their liabilities and virtues.

Animals↗
PubMedDate not supplied

In vitro osteoclast resorption of bone substitute biomaterials used for implant site augmentation: a pilot study.

PURPOSE: This observational study examined the resorptive behavior of normal neonatal rabbit osteoclasts grown on slices of bovine cortical bone as compared to samples of commercially available bone substitute biomaterials. It also examined the surface characteristics of these materials. MATERIALS AND METHODS: The 11 materials tested fell into 3 groups: (1) bone-derived, including freeze-dried human rib block, human demineralized freeze-dried bone, and deproteinated bovine bone; (2) synthetic hydroxyapatites (HA); and (3) synthetic non-HA, including coated methacrylates and coated silica glass. After 4 days in culture, 1 group of samples of each material underwent scanning electron microscopy (SEM) to evaluate resorptive pitting versus controls, while another group underwent tartrate-resistant acid phosphatase staining and light microscopy to examine osteoclast numbers and morphology. The 2 bovine-derived HA materials also underwent immunohistochemical staining and surface chemistry analysis. RESULTS: While most of these materials supported osteoclast attachment, some spreading, and survival in culture, only the bone-derived materials, with the exception of sintered deproteinated bovine bone, showed large scalloped-edged resorption pits with trails and exposed collagen when examined by SEM, although not to the same extent as unprocessed natural bone material. The HA materials and the sintered deproteinated bovine bone showed evidence of etching with smaller pits but no evidence of resorptive trail formation. The non-HA materials showed no evidence of pit formation or trails. Under immunohistochemical staining, Bio-Oss appeared to be positive for type I collagen after osteoclast activity on its surface, while Osteograf/N showed no positive staining. Surface chemistry analysis revealed nitrogen present in Bio-Oss specimens (0.17% to 0.47%), while there was no nitrogen detected in the Osteograf/N (0.00%); the percent nitrogen observed in normal bovine bone controls was 6.01% to 9.25%. DISCUSSION: The bone-derived materials supported osteoclast activity on the material surface in a way that facilitated formation of the more complex resorption pits in vitro. Assuming the rate of pit formation observed in vitro mimics that observed in vivo, the quantity and type of osteoclastic remodeling seen on non-bone-derived materials--and perhaps sintered bone-derived materials--would be extremely slow to negligible. Physiologic removal of non-bone-derived bone substitutes in vivo may occur by methods other than osteoclast resorption. CONCLUSIONS: Allogenous and xenogenous bone-derived materials that undergo delayed physiologic resorption may be more appropriately used with a staged surgical approach when used in sites intended to support osseointegrated dental implants. The combination of collagen staining and the presence of nitrogen suggest that there may be residual protein in Bio-Oss.

Acid Phosphatase↗
PubMed2000

Maxillary sinus augmentation using xenogenic bone substitute material Bio-Oss in combination with venous blood. A histologic and histomorphometric study in humans.

The aim of the present study was to evaluate bone formation following maxillary sinus augmentation using bovine bone substitute material Bio-Oss in combination with venous blood by means of histologic and histomorphometric examination of human biopsies. This involved a total of 15 sinus floor elevation procedures being carried out on 11 patients (average age of 49.6 years) according to the technique described by Tatum (1986). The subantral sinus cavity was augmented using bovine apatite combined with venous blood. After an average healing phase of 6.8 months, trephine burrs were used to take 22 bone biopsies from the augmented sinus region. Then 38 Brånemark implants were inserted in both the osteotomies resulting from bone sampling and in regular sites in the augmented posterior maxilla. Histomorphometric analysis of ground sections from the bone biopsies prepared according to the standard method of Donath & Breuner (1982) produced an average percentage of newly-formed bone of 14.7% (+/- 5.0%) and a proportion of residual xenogenic bone substitute material of 29.7% (+/- 7.8%). Some 29.1% (+/- 8.1%) of the surface of the Bio-Oss granulate was in direct contact with newly-formed bone. Histologically, newly-developed bone became evident, partly invaginating the particles of apatite and forming bridges in the form of trabeculae between the individual Bio-Oss particles. Despite the absence of osteoclastic activity, the inward growth of bone indicates slow resorption of the xenogenic bone graft material. When the implants were uncovered, after an average healing phase of 6 months, 4 of the 38 implants had become loose. Of these 4 implants, 1 had to be subsequently explanted, while the others remained as "sleeping implants" and were not included in the implants superstructure. Thus, the resulting clinical survival rate, prior to prosthetic loading, was 89.5%.

Adult↗
PubMed2001

Protein-chemical analysis of Bio-Oss bone substitute and evidence on its carbonate content.

The natural bone substitute Bio-Oss is used in periodontal and maxillofacial surgery to fill bone defects and permit reossification. Recent reports have suggested the presence of TGFbeta and of substantial amounts of protein in Bio-Oss and have questioned its position as a biologically inert material and its safety in clinical applications (Hönig et al., Plast Reconstr Surg 1999;103:1324; Schwartz et al., J Periodontol 2000;71:1258). Bio-Oss was therefore subjected to a detailed biochemical, histochemical and biophysical analysis. In three different types of extracts of Bio-Oss no evidence for the presence of protein based on SDS-PAGE and silver staining was detected. In addition, as shown by Western blotting, there was no immunochemical evidence for the presence of the potential growth-inducing factor TGFbeta. Furthermore, micropolished sections of Bio-Oss failed to be stained with McNeal's Tetrachrome as did microtome sections treated with Goldner's Trichrome. However, Bio-Oss was strongly stained with the protein dye Coomassie blue. This staining was virtually irreversible and is attributed to the carbonate content of Bio-Oss which was detected by thermogravimetry-mass spectrometry. Thus, within the limits of the assay conditions, Bio-Oss does not contain protein material to a measurable extent.

Blotting, Western↗
PubMed1990

Hydroxyapatite ceramic as a bone substitute.

We have used hydroxyapatite ceramic as a bone substitute for grafting in extensive bone replacement. Hydroxyapatite is composed of calcium phosphate and is incorporated into bone as a physiological mineral. It is not antigenic, carcinogenic or osteogenic. The material used in this study differs from other hydroxyapatite ceramics in that it is an interconnected porous system. Between 1981 and 1986 we used this material on forty five occasions in 44 patients. It was combined with autologous cancellous bone graft in 38 cases and used alone in a further seven. It was usually employed to fill defects after removal of bone cysts and for long fusions in patients with scoliosis. It was also used to fill bone defects after trauma, for non-union in the lumbosacral area, for anterior vertebral fusions, in limb sparing operations for malignant bone tumours, and in exchange operations after failed joint endoprostheses. We have not seen incompatibility or rejection of the implanted material. The rate of postoperative infection was higher than usual due to the selection of patients, but did not appear to be connected with the use of hydroxyapatite ceramic. We were able to review 36 patients up to sixty months after operation. The results are encouraging with no difference in progress compared with patients in whom simple autologous bone grafts had been used.

Adolescent↗
PubMed2005

Autogenous bone grafts and bone substitutes--tools and techniques: I. A 20,000-case experience in maxillofacial and craniofacial surgery.

Alloplastic bone substitutes can be used to alter facial contour. In contrast, autogenous bone grafts have a successful 80-year history of restoring facial contour as well as the basic functional support of the craniofacial skeleton. The traditional procedures for harvesting and using autogenous bone grafts are not obsolete. During the past 30 years, the techniques have been refined and new sources have been found, such as calvarial grafts. New tools were required and have been designed to make harvesting of grafts easier and faster for the surgeon and safer and less expensive for the patient. Four short articles under the heading of "Techniques and Tools" are presented addressing the harvesting of (1) iliac, (2) costal, (3) tibial, and (4) calvarial grafts. These articles are based on the experience of six surgeons using the same technique and instruments in more than 20,000 autogenous bone grafting procedures. (These figures represent the group experience as of 2001. Since then, one of the junior coauthors has retired, but the remaining five continue to harvest autogenous bone grafts on a regular basis. So, the group experience as of 2004 is in the range of 23,000 procedures). The-senior surgeon's experience of 9500 procedures spans a period of 50 years (from 1946 to 1996). For the other surgeons (10,500 procedures combined), the collection period was 25 years (from 1975 to 2000).

Bone Substitutes↗
PubMed2004

Effects of platelet-rich plasma on bone healing in combination with autogenous bone and bone substitutes in critical-size defects. An animal experiment.

OBJECTIVES: An animal study was carried out to investigate the influence of platelet-rich plasma (PRP) on the regeneration of bony defects. MATERIAL AND METHODS: Critical-size defects in the forehead region of a mini-pig were filled with randomly distributed combinations of autogenous bone, tricalcium-phosphate granules (CeraSorb), bovine spongious blocks (BioOss) and a bovine bone inducing collagenous sponge (Colloss) with and without PRP in two preparations (Cusasan, 3i). The animals were killed after 2, 4 and 12 weeks. The specimens were evaluated microradiographically and immunohistologically. RESULTS: Autologous bone (38 +/- 9.9%) and Colloss (52.6 +/- 4.0%) showed the highest remineralization rates at 2 weeks. The initial high expression of BMP-2 in the Colloss-group gives evidence of an early initiation of bony regeneration. At 2 weeks PRP ad modum 3i was able to enhance bone healing significantly (P=0.028) only when applied in combination with autogenous bone (62.8 +/- 1.6%). Four weeks after surgery, both PRP preparations did no longer increase bony regeneration in the autogenous groups. The osteoconductive effect of Bio-Oss (38.7 +/- 5.5%) and CeraSorb (41+/-4.9%) was remarkable as well 4 weeks after surgery. Nevertheless, the addition of PRP hardly influenced bony regeneration, ceramic degradation or cytokine expression when bone substitutes were applied. At 12 weeks, the level of reossification had adjusted similarly in all groups. CONCLUSION: PRP did not add additional benefit when xenogenic bone substitutes were used. However, a significant effect on bone regeneration was found in the autogenous group initially when PRP is added.

Animals↗
PubMed1996

Initial biocompatibility studies of a novel degradable polymeric bone substitute that hardens in situ.

Clinical management of osseous defects often requires bone grafts. The standard for treatment is autogenous bone harvested from sites such as either the iliac crest or the outer table of the calvaria. In addition to the problem of donor site morbidity and the limited supply of graft material, there is the additional operating time associated with harvesting procedures. A synthetic, bone graft substitute that can match the clinical performance of autogenous bone could alleviate these deficiencies. Therefore, a polymeric bone substitute was developed that consists of a four-armed star polymer of poly(dioxanone-co-glycolide) endcapped at each termini with a biocompatible lysine-based diisocyanate crosslinker. The polymer can be mixed with inorganic fillers such as either hydroxyapatite or tricalcium phosphate to form either injectable or moldable putty. The addition of a catalyst (for example, diethylaminoethanol and water) to the polymer produces a crosslinking reaction causing the combination to harden. This reaction is nontoxic, normo-thermic and can be performed in situ. During the course of the polymerization, carbon dioxide is liberated, producing an interconnected porous network within the implant, suitable for bone ingrowth. This paper will describe a preliminary biocompatibility assay of the bone substitute.

Animals↗
PubMed2001

In vitro biocompatibility of resorbable experimental glass ceramics for bone substitutes.

Tricalcium phosphate ceramics (TCPs) are increasingly used as bone substitutes. They demonstrate good biocompatibility and degrade relatively slowly. New glass ceramics based on calcium alkali orthophosphates (Ca(2)KNa(PO(4))(2)) were developed that degrade faster than TCP but could have reduced biocompatibility due to their high solubility. Therefore, they were modified by a neutralizing surface treatment. The aim of this study was to evaluate the biocompatibility of some of these ceramics, GB1a, GB9, and GB14, which differ in the amount of added Na, K, Mg, or Si ions, with standard and modified surfaces. The in vitro cytotoxicity of the ceramics GB1a, GB9, and GB14 was determined by the agar diffusion and filter test and the microculture tetrazolium (MTT) assay. In order to investigate the influence of surface modification, these three ceramics were compared to their surface-treated counterparts, GB1aN, GB9N, and GB14N. GB1a, the ceramic with the highest in vitro solubility, showed the strongest toxic influence in all cell culture tests. GB9 and GB14 produced better results. In contrast, the counterparts with modified surfaces exhibited no (GB9N, GB14N) or weak (GB1aN) signs of cytotoxicity. It is concluded that the toxicity of the ceramics GB1a, GB9, and GB14 depends on their solubility. A positive influence of the surface treatment on in vitro biocompatibility was demonstrated. Therefore, the surface-treated glass ceramics could be promising materials for bone replacement.

3T3 Cells↗
PubMed2006

Molecular basis for action of bioactive glasses as bone graft substitute.

Bone grafting procedures are undergoing a major shift from autologous and allogeneic bone grafts to synthetic bone graft substitutes. Bioactive glasses are a group of synthetic silica-based bioactive materials with bone bonding properties first discovered by Larry Hench. They have several unique properties compared with other synthetic bioresorbable bioactive ceramics, such as calcium phosphates, hydroxyapatite (HA) and tricalcium phosphate (TCP). Bioactive glasses have different rates of bioactivity and resorption rates depending on their chemical compositions. The critical feature for the rate of bioactivity is a SiO2 content < 60% in weight. In vivo, the material is highly osteoconductive and it seems to promote the growth of new bone on its surface. In a recent study, the activity of the material was found even to overshadow the effect of BMP-2 gene therapy. In vivo, there is a dynamic balance between intramedullary bone formation and bioactive glass resorption. Recent studies of molecular biology have shown that bioactive glass induces a high local turnover of bone formation and resorption. Many osteoporotic fracture patients are candidates for concurrent treatment with bisphosphonates and bioceramic bone graft substitutes. Since osteopromotive silica-based bioactive glasses induce accelerated local bone turnover, adjunct antiresorptive agents may affect the process. However, a recent study showed that an adjunct antiresorptive therapy (zoledronic acid) is even beneficial for bone incorporation of bioactive glass. Based on these observations, bioactive glasses are a promising group of unique biomaterials to act as bone graft substitutes.

Biocompatible Materials↗
PubMed2001

Plaster of Paris as bone substitute in spinal surgery.

In order to assess the effectiveness of calcium sulphate (plaster of Paris; POP) as a substitute for autologous bone graft, we performed lumbar intervertebral fusion in mature sheep using POP and a variety of other graft materials, and reviewed the literature. The osteoconductivity of the POP grafts was compared to that of grafts carried out with autogenous iliac crest, frozen allogeneic bone, and ProOsteon 500 coralline bone. We also compared the osteogenicity of POP to admixtures of autogenous iliac crest bone with POP and coralline bone, and to an osteoinductive demineralized sheep bone preparation (DBM). The substrates were loaded into tubular titanium mesh, implanted into excavated disc spaces and recovered after a period of 4 months. Fusion mass segments tested in flexion and tension showed that POP was equal to autogenous bone and most other substrates. The POP fusions were significantly tougher than the DBM fusions, even though histomorphometry failed to reveal differences in the amount of trabecular bone. We conclude that POP can be used to achieve a biomechanically stable interbody lumbar vertebral fusion. In addition, our literature review indicated that POP can be used as a vehicle for local delivery of antibiotics in bone infections.

Animals↗
PubMedDate not supplied

Evaluation of a novel poly(epsilon-caprolactone)-organosiloxane hybrid material for the potential application as a bioactive and degradable bone substitute.

A novel poly(epsilon-caprolactone)-organosiloxane hybrid material containing calcium salt (Si-O-PCL) was prepared and evaluated as a bioactive and degradable bone substitute material. The Si-O-PCL hybrid was synthesized by the end-capping of 3-isocyanatopropyl triethoxysilane with alpha,omega-hydroxyl PCL following sol-gel reaction with calcium nitrate tetrahydrate. Its tensile mechanical properties were evaluated, and additional specimens were exposed to simulated body fluid (SBF) for the time range from 3 h to 7 days. The SBF exposure led to the deposition of a layer of apatite crystals on the surface of the Si-O-PCL hybrid within 9 h of soaking. The tensile strength was around 18 MPa, Young's modulus was around 200 MPa, and the strain at break was around 290%. This material is likely to have a potential application as a bioactive and degradable bone substitute because of its apatite forming ability, biodegradability, and mechanical properties comparable to those of human cancellous bone.

Absorbable Implants↗
PubMed1998

Resorbable calcium phosphate bone substitute.

The in vitro and in vivo properties of a novel, fully resorbable, apatitic calcium phosphate bone substitute (ABS) are described. The ABS was prepared from calcium phosphate precursors that were hydrated to form an injectable paste that hardens endothermically at 37 degrees C to form a poorly crystalline apatitic calcium phosphate (PCA). The PCA reaction product is stable in vivo as determined by FTIR and XRD analysis of rabbit intramuscular implants of ABS retrieved 4, 7, and 14 days postimplantation. Bone formation and resorption characteristics of the ABS material were characterized in a canine femoral slot defect model. Femoral slot defects in dogs were filled with either autologous bone implants or the ABS material. Sections of femoral bone defect site from animals sacrificed at 3, 4, 12, 26, and 52 weeks demonstrated that new bone formation proceeded similarly in both autograft and ABS filled slots. Defects receiving either material were filled with trabecular bone in the first 3 to 4 weeks after implantation; lamellar or cortical bone formation was well established by week 12. New bone formation in ABS filled defects followed a time course comparable to autologous bone graft filled defects. Histomorphometric evaluation of ABS resorption and new bone formation indicated that the ABS material was greater than 99% resorbed within 26 weeks; residual ABS occupied 0.36+/-0.36% (SEM, n = 4) of the original defect area at 26 weeks. Quantitatively and qualitatively, the autograft and ABS were associated with similar new bone growth and defect filling characteristics.

Animals↗
PubMed1996

[A comparative morphometric and histologic study of five bone substitute materials].

OBJECTIVE: To investigate and compare the osteogenesis of bone substitute materials. METHODS: 52 Chbb: ch rabbits were divided into 5 groups. Five different porous biomaterials, including natural bovine hydroxyapatite (Bio-OSS, BK V/1), semi-synthetic coral hydroxyapatite interpore 500, synthetic tricalcium phosphate CEROS 82 and glass POROLITH, were implanted together with free periosteum into the muscle of rabbits for up to 3 and 6 weeks. Undecalcified sections were prepared for microradiography, light and UV microscopy, and morphometry. RESULTS: Bone ingrowth was present in all such implantats. Bone formation was limited to the periphery of the Ceros blocks, that are lack of pore interconnection, while the other 4 materials with an interconnected porous system were infiltrated by bone into the centrum. Planimetric analyses showed that the specimens were composed of 6.5%-19.0% new bone at the 3rd week and 14.2%-25% at the 6th week respectively. The difference of bone ingrowth was only significant between Bio-OSS and BK V/1 at the 3rd week. No statistically significant difference of bone volume was found within the 6 week groups. There was a positive correlation between the new bone volume and the porosity of the materials. CONCLUSION: For the bone ingrowth, the structure of the materials, specifically the pore and pore interconnections, is more impatant than the chemical composition.

Animals↗