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Biocompatibility of dental materials is an important consideration for the patient, clinician, laboratory technician and manufacturer. This paper examines biocompatibility testing methods and the biocompatibility of posterior restorative materials, including amalgam, casting alloys, resin composites, dentin bonding agents, cements, porcelains and ceramics.
Polyvinylacohol (PVA) gel cross linked by gamma irradiation was assessed as a possible vitreous substitute. In our previous, reports, elevation of intraocular pressure and inflammatory changes in the vitreous cavity after operation were observed in some of the experimental animals. Four types of PVA gel (sol) were produced by a newly refined method. We improved the gel systhesis process to remove the monomer and contamination. Colored rabbits were used for this experiment. Vitreous replacement was performed after vitrectomy. This was followed clinically by ophthalmoscopy, tonometry, fundus photography, electroretinogram, chemotaxis, and laser-flare-cell-metering. Histopathological examination by light microscopy was performed after 3 months. PVA gel has good biocompatibility in the vitreous cavity, and gel with a network similar to that of the vitreous body showed the best biocompatibility. Although it is necessary to investigate the biocompatibility over the long term and to evaluate the tamponade effect, PVA gel will be a bood candidate for a vitreous substitute.
INTRODUCTION: Postdilution hemofiltration with a polyamide membrane is a renal replacement technique widely used, but very little information is available regarding the biocompatibility of this treatment. In this paper we report the results of an acute study of the biocompatibility of polyamide hemofiltration. PATIENTS AND METHODS: Complement activation such as C3a and C5a Des Arg (RIA), granulocyte degranulation like alpha 1 elastase intradialytic increase (ELISA) and the expression of high affinity membrane receptors for IL-2 (anti-TAC) were determined. Beta 2-microglobulin (RIA) intradialytic decrease, as well as its convective removal, was evaluated. The nature of protein layer adsorbed onto the polyamide membrane, at the end of the dialytic session was investigated with a new immunohistochemical technique. Cell-associated cytokine concentration (like IL-1 beta and IL-1Ra - ELISA) was determined on mononuclear cell lysates. RESULTS: A low degree of complement activation was detected with the polyamide membrane when data were adjusted for hemoconcentration and for 1 m2 of membrane surface area. An important convective removal not only of Beta 2-microglobulin (258+/-20 mg/session), but also of the activated anaphylatoxins (225+/-76 ng/ml for C3a and 22.5+/-4 ng/ml for C5a) was revealed. A marked deposition of all coagulation factors with no detectable amount of immunoglobulins and complement factors was revealed on the polyamide membrane at the end of the dialytic session. No intradialytic (for IL-1beta) (from 14. 1+/-3.0 to 13.5+/-2.9 pg/2.5 x 10(6) cell) and interdialytic (for IL-1Ra) (from 4572+/-1076 to 5408+/-615 pg/2.5 x 10(6) cell) cell-associated cytokine expression was induced by hemofiltration. DISCUSSION AND CONCLUSION: Polyamide hemofiltration is a highly biocompatible technique due to the use of a synthetic membrane with a sterile reinfusion fluid and the convective removal of the activated anaphylatoxins and Beta 2-microglobulin.
The ability of human fibroblasts to remove and reorganize fibronectin (FN) bound on material surfaces was studied as a novel feature of material surface biocompatibility. Other traditional parameters of biocompatibility analyzed included cell spreading, clustering of fibronectin receptors into focal adhesions, development of stress fibers, and cell growth. Five different materials with surface wettability ranging from hydrophilic (underwater contact angle 25 degrees) to hydrophobic (underwater contact angle 111 degrees) were used, i.e., clean glass (GLASS), aminopropylsilane (APS), octadecylsilane (ODS), polylactate (PL), and silicone (SI). When cells were cultured on these materials in serum-containing medium, formation of FN receptor-rich focal adhesions and actin stress fibers were more evident on the hydrophilic surfaces (GLASS and APS) compared to the hydrophobic ones (PL, ODS, and SI). Cell growth showed a similar pattern, that is, increased cell proliferation with increasing material surface wettability. Preadsorption of FN on the material surfaces increased subsequent cell spreading and cytoskeletal reorganization on hydrophobic surfaces except SI. Removal and reorganization of FN from the material surfaces into extracellular matrixlike structures occurred on GLASS but not on less wettable surfaces, suggesting that this removal/reorganization process may be more sensitive to changes in surface wettability than other parameters of biocompatibility.
The passive biocompatibility of silicon-based electrode arrays was studied in feline cortical tissue. Three types of arrays were used: uncoated, coated with polyimide, and coated with polyimide over an adhesion promoter. Fifteen arrays were implanted for 24 h to determine early tissue reaction to the implantation procedure, and twelve arrays were implanted for 6 months to determine structural and material biocompatibility. Edema and hemorrhage were present around the short-term implants, but involved less than 6% of the total area of the tissue covered by the array. With chronic implants, leukocytes were rarely present and macrophages were found around roughly one-third of the tracks. Remnants of foreign material from the electrodes could be identified in less than 10% of the tracks. Gliosis was found around all tracks, forming an annulus between 20 and 40 microns thick. A capsule was not always present, and never exceeded a thickness of 9 microns. These results suggest that the implantation procedure produces limited amounts of tissue damage, and that the arrays are biocompatible. However, the arrays insulated with polyimide over a primer had significantly greater involvement of macrophages, gliosis, and capsule formation than uncoated arrays and arrays insulated with polyimide without printer, perhaps indicating a reaction to aluminum oxide in the primer.
The study of microcapsule biocompatibility is hindered by their uneven distribution and low recovery when implanted into the peritoneum. We evaluated the use of the rat epididymal fat pad as a microcapsule implantation site for biocompatibility studies. The recovery rate of microcapsules containing 85Sr-labeled microspheres was 99.6 +/- 0.75%. Microcapsules made from the same batch of nonpurified alginate, were injected into both fat pads of male Lewis rats (n = 18) and retrieved 14 days later. A semiquantitative fibrosis score scaled from 0 to 3.0 showed that the pericapsular reaction was uniform throughout a fat pad, and that the results of the two fat pads were equivalent because the null hypothesis of inequivalence was rejected (P < .001). Thus, this method can be used to compare the biocompatibility of microcapsule of differing compositions.
A biodegradable composite (GGT) containing tricalcium phosphate ceramic particles and genipin crosslinked gelatin was developed for use as a bone substitute. The objective of this study was to assess the biocompatibility and the osteoconductivity of the GGT composite on new bone formation in vitro. Additionally, biodegradation and biocompatibility of the GGT composite in animals were investigated. Results of the GGT composites cocultured with osteoblasts showed that the concentration of genipin used as a crosslinking agent should be <0.5 wt % to avoid cytotoxicity. For in vivo degradation studies, we found that when the concentration of genipin in the composite <0.5 wt % was not enough to fully crosslink the gelatin, it results in a rapid degradation of the gelatin-genipin mixture. However, we also found that the foreign body capsule surrounding the GGT composite containing 1.0 wt % of the genipin was much thicker than that in the other three groups, that is, the composites containing 0.05, 0.1, and 0.5 wt % of the genipin. We therefore concluded that the ideal concentration of genipin used in the GGT was 0.5 wt %. Finally, we examined the organ culture units, which were maintained in cultured medium for 5 weeks. Morphology of tissue was observed and the quantitative evaluation of the regenerated bone was determined. We found that the GGT composites containing 0.5 wt % of the genipin had an excellent biocompatibility and could produce osteoconduction for the regenerating bone tissues.
The purpose of this study was to investigate the in vitro-in vivo degradation and tissue compatibility of three novel biopolymers viz. polymerized rosin (PR), glycerol ester of polymerized rosin (GPR) and pentaerythritol ester of polymerized rosin (PPR) and study their potential as implant matrix for the delivery of ciprofloxacin hydrochloride. Free films of polymers were used for in vitro degradation in PBS (pH 7.4) and in vivo in rat subcutaneous model. Sample weight loss, molecular weight decline, and morphological changes were analyzed after periodic intervals (30, 60, and 90 days) to monitor the degradation profile. Biocompatibility was evaluated by examination of the inflammatory tissue response to the implanted films on postoperative days 7, 14, 21, and 28. Furthermore, direct compression of dry blends of various polymer matrices with 20%, 30%, and 40% w/w drug loading was performed to investigate their potential for implant systems. The implants were characterized in terms of porosity and ciprofloxacin release. Biopolymer films showed slow rate of degradation, in vivo rate being faster on comparative basis. Heterogeneous bulk degradation was evident with the esterified products showing faster rates than PR. Morphologically all the films were stiff and intact with no significant difference in their appearance. The percent weight remaining in vivo was 90.70 +/- 6.2, 85.59 +/- 5.8, and 75.56 +/- 4.8 for PR, GPR, and PPR films respectively. Initial rapid drop in Mw was demonstrated with nearly 20.0% and 30.0% decline within 30 days followed by a steady decline to nearly 40.0% and 50.0% within 90 days following in vitro and in vivo degradation respectively. Biocompatibility demonstrated by acute and subacute tissue reactions showed minimal inflammatory reactions with prominent fibrous encapsulation and absence of necrosis demonstrating good tissue compatibility to the extent evaluated. All implants showed erosion and increase in porosity that affected the drug release. Increase in drug loading significantly altered the ciprofloxacin release in extended dissolution studies. PPR produced drug release >90% over a period of 90 days promising its utility in implant systems. The results demonstrated the utility of novel film forming biopolymers as implant matrix for controlled/sustained drug delivery with excellent biocompatibility characteristics.
Cell culture is a valuable method of evaluating the biocompatibility of new dental materials. The purpose of this study was to compare the in vitro biocompatibility of an experimental fluoride composite resin with fluoride and non-fluoride-releasing materials currently available. The dental materials tested were: MQ Silicate (silicate cement), KETAC-CEM and FUJI (type II glass ionomer cements), VISIO DISPERS (a light-cured, nonfluoridated, microfilled composite resin), and FR-17 (an experimental fluoride-releasing composite resin). The Smulow-Glickman (S-G) human gingival epithelial cell line, which exhibits semidifferentiated characteristics, was used in the study as a test system. Biocompatibility was quantified by counting the viable cells per unit area remaining after 24 and 48 h at two radial distances from cured specimens immersed in the cell culture medium. The test materials were observed to be most toxic to cells nearest the materials. A Time-Distance Cytotoxicity Index (TDCI) was calculated to relate the percentage of dead cells to viable cells at each diffusion distance for each exposure time compared to a nontoxic control. The relative toxicity ranking of the materials tested based on the TDCI was VISIO DISPERS (91%), FUJI (82%), FR-17 (30%), MQ Silicate (23%), and KETAC-CEM (10%), which exhibited the least toxicity. The cytotoxicity of the experimental resin FR-17 was within the range of cytotoxicity of currently accepted restorative materials.
Biodegradable and biocompatible materials are the basis for tissue engineering. As an initial step for developing vascular grafts, the in vitro biocompatibility of poly(epsilon-caprolactone) (PCL), recently suggested for several clinical applications, was evaluated in this study using L929 mouse fibroblasts. Different cellular aspects were analyzed in order to know the cell viability during cell culture on PCL films: adhesion, proliferation, morphology, LDH release and mitochondrial function. Since topography and other surface characteristics of materials play an essential part in cell adhesion, PCL membranes with either smooth or rough surface were prepared, characterized and used to carry out cell cultures. During short culture times, PCL produced a significant stimulation of mitochondrial activity evaluated by reduction of the MTT reagent. The results provide evidences of good adhesion, growth, viability, morphology and mitochondrial activity of cells on PCL films. Therefore, it can be concluded that PCL is a suitable and biocompatible material as a scaffold for vascular graft development.
INTRODUCTION: Since their invention in the late 1960s, glass ionomer cements (GICs) have been used extensively in dentistry but recently they have also been utilised in ear nose and throat (ENT) surgery. Unfortunately, Al3+, a component of conventional ionomer glasses, has been linked to poor bone mineralisation and neurotoxicity. OBJECTIVE: The aim of the research was to modify a commercial ionomer glass composition by substituting Al2O3 with Fe2O3. METHODS: Glasses with the following molar compositions were fabricated: 4.5SiO2*3M2O3*XP2O5*3CaO*2CaF2 (M = Al or Fe, X = 0-1.5). The glasses were characterised using X-ray fluorescence (XRF) and X-ray powder diffraction (XRD). Cements were prepared using a standard ratio of; 1 g of glass powder: 0.2 g of dried polyacrylic acid: 0.3 g of 10% tartaric acid solution. Cement formation was assessed using a Gilmore needle and in vitro biocompatibility was investigated for novel cement formulations. RESULTS: XRF revealed that the Fe2O3-based glasses had Al2O3 contamination from the crucibles and also had undergone substantial F- losses. XRD gave peaks that corresponded to magnetite Fe3O4 (JCPDS # 19-629) in all compositions. Apatite Ca5(PO4)3(OH,F) (JCPDS # 15-876) was identified in P2O5 containing glasses. It was possible to fabricate cements from all of the Fe2O3-based ionomer glasses. Good in vitro biocompatibility was observed for the Fe2O3-based cements. CONCLUSION: Ionomer glasses may be prepared by entirely replacing Al2O3 with Fe2O3. Cement setting times appeared to be related to P2O5 content. Fe2O3-based cements showed good in vitro biocompatibility.
The purpose of this study was to compare the biocompatibility of amalgam, gray MTA and white MTA in the connective tissue of rats. We used 45 Sprague-Dawley rats in this study. The rats were divided into three groups. Root end filling materials were placed in polyethylene tubes and inserted into the rats' connective tissue through incisions. The rats were sacrificed after 3 days, 1 wk, and 3 wk, respectively. Histologic samples were sectioned in 5-mum thicknesses and stained with hematoxylin and eosin. Kruskal-Wallis test was used for statistical analysis. The results showed that after 3 days, white MTA was more biocompatible than gray MTA and amalgam. After 1 week, gray MTA was more biocompatible than white MTA and Amalgam. After 3 wk, there were no significant differences between experimental groups and the control group.
Proinflammatory cytokines, in addition to their role in host defence, may be considered mediators of disease; a reduction of cytokine synthesis or effects is, therefore, becoming a target of many diseases. IL-6 is a pro-inflammatory cytokine that may play a role in several clinical problems related to dialysis treatment. An enhanced spontaneous production of IL-6 by Peripheral Blood Mononuclear Cells (PBMC) harvested from ESRD patients dialyzed with a poor biocompatible membrane has been first demonstrated by our group. These results were also obtained in patients undergoing continuous peritoneal dialysis, in absence of peritonitis. We have also demonstrated that IL-6 release was inversely correlated with serum albumin changes. Biological activities of IL-6 may be modulated by two soluble circulating receptors, namely sIL-6R and sgp130. sIL-6R may enhance the inflammatory effects of IL-6 and is, therefore, an "agonistically" acting molecule. We have recently studied sIL-6R production in ESRD patients dialyzed with different membranes; the conclusion was that poor biocompatible membranes, via the sIL-6R, might further increase the inflammatory effects of IL-6. On the contrary, sgp130 can efficiently bind the IL-6/sIL-6R complex with "antagonistic" effects. We have evaluated plasma levels of sgp130 in 18 ESRD patients regularly dialyzed with hemophan membranes (HE) and in 15 patients dialyzed with more biocompatible synthetic membranes (BIO). Our results demonstrate that plasma levels of sgp130 in HE are 33% higher than in both healthy controls and BIO. Circulating levels of sgp130 were correlated positively with C-reactive protein (r: 0.338, p<0.05) and negatively with serum albumin (r: -0.334, p<0.05). These results suggest that higher circulating levels of sgp130 are likely associated with higher IL-6 levels. These higher amounts are probably insufficient to control the activity of IL-6 and may be considered only as a marker of PBMC activation.
The aim of the study was to prepare composites of poly(butylene terepthalate)/wollastonite (PBT/W), evaluate their properties and in vitro biocompatibility. Composites of PBT with wollastonite in two different proportions, viz. 70/30 (PW-30), 50/50 (PW-50) were prepared. The DSC studies indicate marginal changes in the melting behavior and enhanced crystallization in PBT/W composites. The mechanical properties of the composites such as tensile modulus shows remarkable improvement as a result of incorporation of wollastonite. SEM studies of fractured surfaces of impact samples showed no evidence of bonding between PBT and wollastonite. Water contact angle of PW30 and PW50 was 73.7 and 78.7, respectively. In vitro biocompatibility of PW-30 was evaluated as a representative composite. Direct cell contact test did not show deleterious effects on NIH3T3 fibroblast morphology and DNA integrity indicating its compatibility. Leach out products (LOP) of PW-30 were evaluated non-toxic as tested by MTT assay. Mouse peritoneal macrophages in contact with PW-30 showed comparable expression of CD 11b/18, CD45, CD14 and B7.2 to macrophages in contact with PTFE control indicating its non-activating nature. LOP did not induce proliferation of mouse splenic lymphocytes suggesting its immuno-tolerance. PW-30 also exhibited preliminary blood compatibility. These physical properties and biocompatibility of PBT/W composites show their suitability as potential biomaterials.
Determination of potential cytotoxicity is a central issue in current biocompatibility testing standards such as ISO and ASTM. Most of these tests do not assess biocompatibility of a biomaterial with regard to cell function. This study was aimed at screening a number of potential parameters that could be included in assessment of cell functional aspects of biocompatibility. Human umbilical vein endothelial cells (HUVEC) were seeded directly on titanium, NiCr alloy, CoCr alloy, PMMA, PE, PU, PVC, and silicone, or were exposed to the material extracts. Cytotoxicity was assessed for these materials through MTT conversion, crystal violet protein determination and Ki67 expression. In addition, expression of the cell adhesion molecules E-selectin, cadherin-5 and PECAM, as well as of the adhesion-associated proteins fibronectin and vinculin (focal adhesions), was determined by immunocytochemistry and western blotting. Cytotoxicity was not detected with the material extracts. Cells were able to adhere to bare metals, but not polymers. Fibronectin preadsorption resulted in adhesion and spreading also on the polymers. Cells were able to establish cell-cell contacts and focal adhesions. Western blotting, in combination with differential detergent extraction, indicated that linkage of cell-cell adhesion markers to the cytoskeleton may be used as an additional parameter relevant to cell function.
The in vitro toxicity of two EPDM rubbers (K 778 and K 4802) and one EPM rubber (K 740) was tested using human fibroblasts. The modulus of elasticity of each rubber was varied by exposure to different amounts of electron-beam radiation (0, 5 and 10 Mrad). The short-term in vitro toxicity was tested by culturing cells on polymer films. The long-term effect of ageing was simulated by growing fibroblasts in nutrient media prepared from extracts of heat-exposed materials. Cell cultures were studied both quantitatively and (ultra) structurally. Growth curves obtained in the toxicity test did not differ significantly from control values at any day of observation, and also showed that electron-beam radiation did not alter the biocompatibility. The same results were found for all but one material in the artificial ageing test. The number of cells in the K4802/10 Mrad extraction medium was decreased. Ultrastructurally no gross deviations from normal morphology were observed, either in the direct contact test or in the artificial ageing test. The most characteristic feature was a somewhat dilated endoplasmic reticulum. In summary, the in vitro biocompatibility of EPDM-rubbers as observed in this study is satisfactory and motivates further investigation of their biocompatibility in animal experiments.
Cell adhesion, cell growth and cell activities of macrophages and fibroblasts, cultured on newly developed degradable multiblock-copolyesters were studied to examine the biocompatibility and the possible use of these polymers for medical applications. The biocompatibility and the biodegradability of the polymers were confirmed by subcutaneous implantation of polymer foils in rats. The newly developed polymers, two polyesters (DegraPol/bsc43 and DegraPol/bsd43) and a polyesterether (DegraPol/bst41), were found to exhibit good cell compatibility; the cell-to-substrate interactions induced neither cytotoxic effects nor activation of macrophages. The adhesion and growth of fibroblasts and macrophages were different among the substrate. Fibroblasts adhered on the polyesters to about 60% of control cell cultured on tissue culture polystyrene (TCPS) and proliferated in the same doubling time as on TCPS. On the polyetherester cells exhibited weak adhesion; however, they proliferated up to day 4 after plating at the same doubling time as on TCPS (of about 42 h), and then decreased their doubling time to 27 h. Macrophages attached to the polyesters to about 40-60% of TCPS but no significant change was seen in the doubling time of cells cultured on TCPS and the polyesters. Again on the polyetherester, macrophages exhibited relatively low adhesion (25% of TCPS) and high doubling time (about 100 h). Fibroblasts produced high amounts (up to 500% of control cells) of collagen type I and type IV, and fibronectin. Macrophages responded to lipopolysaccharide treatment by the production of nitric oxide (NO) and tumour necrosis factor-alpha (TNF-alpha), indicating that the cell-to-polymer interactions allow fibroblasts and macrophages to maintain their phenotype. All three test polymers exhibit favourable tissue compatibility. The formed capsule was just a few cell layers thick (<30 microm). After 2 months implanted subcutaneously in rats, the molecular weight of the test polymers was reduced by >20% depending on their chemical structure. Taken collectively, the present data demonstrate that the newly developed multiblock copolyesters are biocompatible and biodegradable.
For biomedical applications the physico-chemical properties of oxide layers, always present in titanium-based materials, are of special interest because the biological system is in direct contact only with these oxides. Using electrochemical impedance spectroscopy and galvanostatic polarization it is shown that the different compositions of c.p.-titanium, Ti6Al4V, and Ti6Al7Nb result in different physico-chemical properties of air formed passive layers and anodic oxide layers. This may have a direct impact on the biocompatibility of these materials. Results of impedance spectroscopy distinctly differ in the flatband potentials as well as in the donor densities of air-formed passive layers with Ti6Al7Nb showing an approximately 50% smaller donor density than the other materials. Anodic galvanostatic polarization results in voltage-charge density curves with distinct differences in the Faraday efficiency epsilon of the oxide formation between Ti6Al7Nb and c.p.-titanium/Ti6Al4V, especially for low current densities. These effects correlate strongly with the donor densities in the air formed passive films of the examined materials. SEM-images of anodic oxide layers show a blister containing surface morphology of the outer part of the oxide layers for all materials. This morphology is probably caused by oxygen evolution, a process which relies on the transfer of electrons through the growing anodic oxide layers and strongly depends on the donor density in the air formed passive layers. Again, the much more pronounced morphology on c.p. titanium/Ti6Al4V agrees with the different donor densities in the air formed passive layers on the materials. These findings correlate with the good biocompatibility of Ti6Al7Nb and suggest that conduction mechanisms, in air formed passive layers and anodic oxide layers, contribute to processes that determine the biocompatibility of these materials.