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PubMed2004

Biocompatible Nb2O5 thin films prepared by means of the sol-gel process.

Thin biocompatible oxide films with an optimised composition and structure on the surface of titanium and its alloys can improve the implant integration. The preparation of these thin oxide layers with the intended improvement of the surface properties can be realised by means of the sol-gel process. Nb2O5 is a promising coating material for this application because of its extremely high corrosion resistance and thermodynamic stability. In this study, thin Nb2O5 layers ( < 200 nm) were prepared by spin coating of polished discs of cp-titanium with a sol consisting of a mixture of niobium ethoxide, butanol and acetylacetone. The thickness, phase composition, corrosion resistance and the wettability of the oxide layers were determined after an optimisation of the processing parameters for deposition of oxide without any organic impurities. The purity of the oxide layer is an important aspect in order to avoid a negative response to the cell adhesion. The biocompatibility of the oxide layers which was investigated by in vitro tests (morphology, proliferation rate, WST-1, cell spreading) is improved as compared to uncoated and TiO2 sol-gel coated cp-titanium concerning the spreading of cells, collagen I synthesis and wettability.

3T3 Cells↗

PubMed2004

Evaluation of magnetic behaviour and in vitro biocompatibility of ferritic PM2000 alloy.

PM2000 is a ferritic alloy obtained by powder metallurgy and is being investigated for potential applications as a biomaterial. This work aimed to assess the biological compatibility and to determine the influence of the processing route and further recrystallisation treatment on the magnetic behaviour. The magnetic behaviour has been analysed as a function of the hysteresis loop obtained by using an inductive method. The biocompatibility has been tested using human osteoblast-like cells seeded onto discs of PM2000. The ability of cells, on its surface, to attach, grow, and produce alkaline phosphatase (ALP) was determined. It is shown that PM2000 is a soft magnetic material irrespective of its material condition, its remanent magnetisation being very low (up to about 3% for the recrystallised swaged material). Fields close to 200 Oe are required to saturate the material. The saturation magnetisation is about 135 emu g(-1). In vitro tests indicate that cells are able to attach and grow onto its surface, and produce ALP, a specific marker of cells with bone-forming activity. In this respect, PM2000 holds promise as a suitable substrate for bone integration. These properties could make PM2000 a useful candidate for the preparation of medical devices where biocompatible and soft magnetic materials are sought. Applications for dental magnetic attachments could be envisaged.

Aluminum↗

PubMed2004

Comparative investigation of the biocompatibility of various silicon nitride ceramic qualities in vitro.

There is a controversy about the biocompatibility of silicon nitride ceramics contained in the literature, which appears to be related to a factor of the individual chemical composition of different qualities of silicon nitride ceramics and of the different surface properties. This study attempts to investigate the cytotoxicity of different qualities of industrial silicon nitride ceramics applying an L929-cell culture model in a direct contact assay combined with a cell viability assessment. Five different qualities of industrial standard silicon nitride ceramics were chosen for in vitro testing. The chemical composition was determined by EDS analysis. Different biomedically approved aluminium oxide qualities, a titanium alloy, glass and polyvinylchloride (PVC) served as control materials. L929 mice fibroblasts were incubated directly on the materials for 24 h, stained with bisbenzimide and propidium iodine for double fluorochromasia viability testing, and evaluated by inversion-fluorescence microscopy to control cell morphology, viability and cell counts compared to empty well values. Scanning electron microscopy was applied to additionally investigate cell morphology. There was no observation of cytotoxic effects on the silicon nitride ceramic samples; moreover cell morphology remained the same as on aluminium oxide and titanium. Viability testing revealed the presence of avital cells exclusively on PVC, which served as a negative control. Cell counts on all polished surfaces showed significantly higher numbers, whereas some rough surface samples showed significantly lower numbers. We conclude that silicon nitride ceramics show no cytotoxic effects and should be considered for biomedical application owing to its favourable physiochemical properties, especially its superior resistance to mechanical stress, which would be useful for compression loaded conditions. Polished surfaces would appear to promote advanced biocompatibility.

Aluminum Oxide↗

PubMed1994

Electroanalytical and biocompatibility studies on carboxylated poly(vinyl chloride) membranes for microfabricated array sensors.

Potassium ion-selective and pH membrane electrodes based on neutral carrier ionophores for K+ (valinomycin) and H+ (TDDA and ETH 5294), respectively, immobilized in carboxylated PVC (PVC-COOH) with normal (classical) and reduced amounts of plasticizer, were investigated with respect to their general analytical performances (linear range, slope, detection limit, selectivity, internal membrane resistance), their biocompatibility and cellular responses. The analytical performance of potassium selective electrodes was not affected by reducing the plasticizer content from 66% (m/m) to about 33% (m/m) while that of pH electrodes was significantly changed at the lower plasticizer concentration level. The adhesive properties of PVC-COOH membranes to an inert substrate such as polyimide-coated Kapton are greatly improved by reducing the plasticizer content of the membrane. In addition, as was reported earlier by this group, improved biocompatibility was observed with these membranes relative to those with increased plasticizer content. A ratio of 1:1 m/m for PVC-COOH to plasticizer is recommended for the construction of planar ISEs without massive use of internal solution.

Animals↗

PubMed2006

Improving the biocompatibility of in vivo sensors via nitric oxide release.

The continuous, real-time monitoring of clinically important analytes (e.g., PO2, PCO2, pH, K+, Na+, glucose, and lactate) is of great importance to human health care. Despite considerable efforts spanning several decades, the use of in vivo sensors clinically remains limited due to inadequate biocompatibility. The discovery of nitric oxide (NO) as an effective inhibitor of platelet and bacterial adhesion has opened a new direction of research related to designing the next generation of in vivo sensors. In this Highlight article, recent progress in designing more biocompatible in vivo sensors is described, with a particular focus on preparing interfaces that resist biofouling via controlled NO release.

Bacterial Adhesion↗

PubMed1998

The biocompatibility of non-amalgam dental filling materials.

Non-amalgam filling materials may release substances which have been shown to be toxic in cytotoxicity tests and implantation studies. However, results from systemic toxicity tests do not indicate any unacceptable risk to the patient's general health, but data for non-amalgam dental filling materials are scarce in comparison to amalgam. Although estrogen-like effects of one fissure sealant have been claimed, no conclusions can be drawn at present for the patient from these in vitro data because of the limitation of the test methods and materials used. Some components of composite resins/dentin adhesives and a resin-modified glass ionomer cement were mutagenic mainly in in vitro tests. Due to the limitations of the test systems and the comparatively high concentrations needed to elicit the reactions, no unacceptable risk can yet be derived from those data for the patient. However, a no-touch technique is recommended for the dental personnel. As with amalgam, local reactions of the pulp are not expected with alternative filling materials, if the pulp tissue is not exposed and if bacterial penetration is avoided. The latter requirement is still difficult to fulfill, especially for composite resin systems and related materials in posterior teeth situations. Slight gingival reactions to alternative filling materials and to amalgams are mainly attributed to plaque accumulation. From all these data it can be concluded that, for the time being, it is not possible to rank dental filling materials in respect to their biocompatibility, and it is evident that biocompatibility must be considered to the same extent for both amalgams and commonly used or recommended alternative filling materials.

Adhesives↗

PubMed2003

Biocompatibility of dental materials used in contemporary endodontic therapy: a review. Part 1. Intracanal drugs and substances.

Irrigation solutions and intracanal medicaments are used within the root canal to clean and aid in disinfecting the dentinal walls. Although these materials are intended to be contained within the root canal, they invariably contact the periapical tissues, either through inadvertent extrusion through the apex or leaching. This paper is a review on the methodology involved in biocompatibility testing followed by a discussion on biocompatibility of contemporary intracanal drugs and substances used in endodontics.

Animals↗

PubMed1998

Bioreactivity and biocompatibility of a vitamin E-modified multi-layer hemodialysis filter.

BACKGROUND: The present study was designed to test the biocompatibility of a new vitamin E-modified multi-layer membrane (CL-E filter), as well as its ability to protect against oxygen free radicals during hemodialysis (HD). METHODS: We investigated, both in vitro and in vivo, the bioreactivity of the filter with respect to the blood antioxidants and its ability to prevent lipoperoxidation. The effects on the leukocyte respiratory burst were also studied. Cuprammonium rayon was used as a comparison material (CL-S filter). RESULTS: The in vitro results demonstrated that, under controlled conditions, CL-E is able to preserve blood antioxidants, and particularly vitamin E, from the spontaneous consumption observed in the incubation with CL-S filters and in control incubations. In accordance with this observation, the rate of the oxidative demolition of lipids either in plasma and red blood cells (RBC) or from rat brain homogenate decreased after the exposure to CL-E filters in comparison with the CL-S filter. Moreover, in the absence of any significant cytotoxic effects due to both the types of material studied, the production of oxygen free radicals and nitric oxide (NO) by leukocytes was higher after their in vitro exposure to CL-S, but was quite similar to that of the control leukocytes after exposure to CL-E. In vivo, a one-month treatment with the CL-E filter increased plasma vitamin E by 84.3% with respect to treatment with CL-S; this gain slightly decreased to 68.9% when CL-E treatment was prolonged to three months. In the RBC, vitamin E was found to have increased by 76.7% and 113.4% at one and three months, respectively. Plasma glutathione (GSH) levels determined at three months were significantly increased from 0.10 +/- 0.02 to 0.33 +/- 0.12 mumol/ml, while the erythrocyte GSH was only slightly increased. The leukocyte function estimated as responsiveness to soluble chemical stimuli in CL-S-treated patients was significantly improved both qualitatively and quantitatively after CL-E treatment. The presence of an increased number of mononuclear cells undergoing programmed cell death (apoptosis) in CL-S-treated patients (18.8 +/- 1.7% vs. a control value of 6.5 +/- 2.3%) as well as the apoptogenic effect of their plasma in vitro on U937 cells was significantly corrected after CL-E treatment (mean decrease in apoptotic mononuclear cells at 24 hours of culture, 25.5% and 27.1% at 1 and 3 months, respectively). The anti-apoptogenic effect of CL-E treatment showed a close dependence on the increase in vitamin E in the blood cell compartment. CONCLUSIONS: This study suggests that this vitamin E-modified membrane can be considered a highly biocompatible material, the antioxidant properties of which can exert a site-specific and timely scavenging function against oxygen free radicals in synergy with a hypostimulatory action on the PMN respiratory burst.

Aged↗

PubMed2000

Selection of a polyurethane membrane for the manufacture of ventricles for a totally implantable artificial heart: blood compatibility and biocompatibility studies.

Membranes made from 4 commercial poly(carbonate urethanes): Carbothane (CB), Chronoflex (CF), Corethane 80A (CT80), and Corethane 55D (CT55), and from 2 poly(ether urethanes): Tecoflex (TF) and Tecothane (TT) were prepared by solution casting and sterilized by either ethylene oxide (EO) or gamma radiation. Their biocompatibility was evaluated in vitro in terms of proliferation, cell viability, and adhesion characteristics of human umbilical veins (HUVEC), monocytes (THP-1), and skin fibroblasts, and by measuring complement activation through the generation of the C3a complex. Their hemocompatibility was determined by measuring the level of radiolabeled platelet, neutrophil, and fibrin adhesion in an ex vivo arteriovenous circuit study in piglets as well as via an in vitro hemolysis test. The results of this study showed no endothelial cell proliferation on any of the materials. The cell viability study revealed that the CB, CF, and TF membranes sterilized by EO maintained the highest percentage of monocyte viability after 72 h of incubation (>70%) while none of the gamma-sterilized membranes displayed any cell viability. The fibroblast adhesion and C3a generation assays revealed that none of the materials supported any cell adhesion or activated complement, regardless of the sterilization method. The hemolysis test also confirmed that the 4 poly(carbonate urethanes) were hemolytic while none of the poly(ether urethanes) were. Finally, the ex vivo study revealed that significantly more platelets adhered to the CB and CT55 membranes while the levels of neutrophil and fibrin deposition were observed to be similar for all 6 materials. In conclusion, the study identified the CF and TF membranes as having superior biocompatibility and hemocompatibility compared to the other polyurethanes.

Animals↗

PubMed2000

Ex vivo biocompatibility of avidin-agarose: a new device for direct adsorption of biotinylated antibodies from human whole blood.

Radioimmunotherapy using radiolabeled antitumor antibodies (RAA) is limited by the toxicity of unbound antibodies in the circulation. Removal of excessive antibodies by affinity-adsorption could therefore allow the administration of increased dosages of RAA while decreasing their adverse effects. Recently, avidin-agarose (AA) minicolumns were used in animal experiments for the removal of biotinylated antibodies from whole blood exploiting the high affinity binding of biotin to avidin (pK 1015 M-1). This study was performed to evaluate the ex vivo biocompatibility of AA minicolumns with human blood. Ten ml AA minicolumns were perfused online ex vivo in the single pass mode with fresh blood from 8 healthy donors at a flow rate of 6.25 ml/min. The anticoagulation consisted of 0.5 IU heparin plus 0.0-2.1 mg citrate per ml of blood. In Part 1 of the study (40 min perfusion, n = 4), the optimal anticoagulation was found to be 0.5 IU heparin plus about 1 mg citrate per ml of blood. In Part 2 of the study, four 80 min test-runs were performed. No signs of hemolysis were found, and the thrombogenicity of the AA gel was negligible. Cell counts and column inlet pressures remained constant; toward the end of the 80 min test-runs, some activation of blood cells (elastase, beta-thromboglobulin), the complement system (C3a, C5a) and the plasmatic coagulation (thrombin-antithrombin complex) was detectable. A moderate initial bradykinin release rapidly subsided to very low levels. In summary, AA minicolumns showed good biocompatibility upon contact with human whole blood and merit further investigation in a closed-loop system for a potential application of direct tumor antibody removal by hemoperfusion.

Adsorption↗

PubMed2000

Biocompatibility of heparin-coated extracorporeal bypass circuits: new heparin bonded bioline system.

Biocompatibility of a new type of heparin-coated cardiopulmonary bypass equipment, the Bioline, was evaluated in coronary artery bypass surgery cases. The heparin-coated (H) group (n = 15; Quadrox Bioline oxygenator/reservior and Carmeda BioMedicus BP-80 centrifugal pump) was compared with the nonheparin-coated (N) group (n = 12; uncoated, otherwise similar oxygenator, centrifugal pump, tubing, and filter set). Both groups used full systemic heparinization. The peak values of neutrophil elastase, C3a, IL-6, and IL-8 at 2 h after cardiopulmonary bypass (CPB), and C3a levels at the end of CPB and at 2 h after CPB were significantly reduced in the H group compared with those of the N group. However, no statistically significant intergroup differences were observed in thrombin-antithrombin complex, D-dimer, beta-thromboglobulin, or platelet factor-4. No significant differences were observed in hemostasis time, postoperative 12 h blood loss, required amount of blood transfusion, or intubation time. In conclusion, the Bioline demonstrated partially improved biocompatibility, in terms of leukocyte and complement activation, and proinflammatory cytokine production. However, it did not improve platelet activation, coagulation, or fibrinolysis cascade under full systemic heparinization. As a result, the clinical beneficial impact seemed to be the minimum.

Aged↗

PubMed1998

Postdialysis fatigue: lack of effect of a biocompatible membrane.

Tumor necrosis factor-alpha (TNF-alpha) has been shown to have somnogenic properties. Plasma levels of this cytokine have been found to increase significantly during dialysis with a bioincompatible (cuprophane) membrane in patients with postdialysis fatigue (PDF). We conducted a crossover study with random assignment to ascertain whether a biocompatible membrane might attenuate the increase of TNF-alpha and severity of PDF. Sixteen patients on maintenance hemodialysis underwent dialysis with either cuprophane (n = 8) or polymethylmethacrylate (PMMA; n = 8) membranes for 1 week and then switched to the opposite membrane during the second week. Predialysis and postdialysis measurements of plasma TNF-alpha levels were performed during the first and last dialysis treatments of each week. A fatigue score was determined from the sum of duration of fatigue and sleep within 6 hours of the completion of dialysis. TNF-alpha levels increased by an average of 18.3% during dialysis with cuprophane membranes but only 2.4% with PMMA membranes (P = 0.04). Despite this, fatigue scores remained unaltered (approximately 4 of 6). Hence, the biocompatible membrane, PMMA, failed to alleviate PDF. This suggests that dialytic stimulation of TNF-alpha plays no substantial role in the pathogenesis of PDF.

Biocompatible Materials↗

PubMed1997

Biocompatibility reflected by haemostasis variables during cardiopulmonary bypass using heparin-coated circuits.

Cardiopulmonary bypass (CPB) is associated with haemostatic disturbances and signs of acute inflammatory response, most likely related to poor biocompatibility of the artificial surfaces. Some haemostatic variables are known as markers of acute-phase reaction, blood cell trauma, and endothelial damage. The aim of the study was to evaluate the effect of heparin-coating of artificial surfaces on those variables of hemostasis. 14 patients operated on with elective coronary artery revascularization were randomized into two groups. In group H (n = 7), heparin-coated CPB circuits and in control group C (n = 7), noncoated CPB sets were used. Patients in group C received normal heparinization, e.g. bolus 300 IU/kg and additional doses to maintain activated coagulation time (ACT) over 400 sec during CPB. In group H, a bolus heparin dose was reduced by 25% (to 225 IU/kg) in order to compensate for the amount of heparin immobilized on circuit surfaces and the corresponding ACT limit was 300 sec. There were significant increases of the von Willebrand factor (vWf), plasminogen activator inhibitor-1 (PAI) and tissue-plasminogen activator (tPA) starting at CPB end and rising to about twice the baseline levels postoperatively. This reaction was less evident in group H, as indicated by significantly lower levels of tPA compared to group C at CPB end (135% +/- 9 in group H versus 241% +/- 15 in group C, p < 0.0005) and at two hours postoperatively. The rates of tPA and vWF increase were lower in group H, also indicating reduced endothelial damage in this group. Marginally significant, a higher value of PAI was found in the C group early after CPB onset. Group H showed significantly lower concentrations of circulating complex between elastase and alpha 1-antitrypsin at CPB end and postoperatively, implicating a reduced granulocyte activation (60 min after protaminization 41 micrograms/L +/- 5 in group H versus 256 micrograms/L +/- 55 in group C, p < 0.05). It was concluded that the heparin-coated CPB circuits demonstrated improved biocompatibility which may be related to less disturbed haemostasis.

Anticoagulants↗

PubMed1993

[Biocompatibility of silicone intraocular lenses].

BACKGROUND: In order to the biocompatibility of silicone intraocular lenses, which is described contradictory in literature, we compared IOLs made of silicone caoutchouc and PMMA-IOLs with regards to the presence of macrophages (i.e. giant cells or spindle-shaped cells) in a prospective, randomized study. PATIENTS AND METHODS: Totally 125 patients were examined 2 months post-operatively with the slitlamp in the refractive zone. The single-piece PMMA-IOLs with an open haptic used in this study had a 6 mm optical zone and a total diameter of 11 mm; the silicone-IOLs were disc-shaped lenses with a total diameter of 9.75 mm and an optical zone of 6 or 5.5 mm, resp. RESULTS: Giant cells were observed with 16% of PMMA-lenses and 19% of the silicone-lenses. The maximal density of the giant cells on the PMMA-lenses at the median was 3/mm2 compared to 2/mm2 on the silicone IOLs. Small and spindle-shaped cells were found in 54% of the PMMA-IOLs and 46% of the silicone-lenses. The maximal cell density at the median was 10/mm2 with both lens types. CONCLUSIONS: The differences between the two lens materials are statistically non-significant. Thus, silicone caoutchouc and PMMA possess a comparable biocompatibility when used as material for intraocular lenses.

Aged↗

PubMed1990

[Biocompatibility and pharmacokinetics of hydroxypropyl methylcellulose (HPMC) in the anterior chamber of the rabbit eye].

The biocompatibility and pharmacokinetics of hydroxypropylmethylcellulose (HPMC) 2% (Adatocel) and Tylose 2% (MH 1000) were investigated. A modified anterior chamber implantation test on the rabbit eye is suitable for testing both the biocompatibility and the pharmacokinetics of visco-surgical substances. Both substances were well tolerated. From the fourth day onward, HPMC was no longer detectable in the anterior chamber by infrared spectroscopy.

Animals↗

PubMed2001

AcrySof acrylic intraocular lens implantation in children: clinical indications of biocompatibility.

PURPOSE: To assess the clinical biocompatibility of AcrySof (Alcon, Ft Worth, Tex) acrylic intraocular lenses (IOLs) in the highly reactive eyes of infants and children. METHODS: A database of 230 pediatric IOL implantations was queried to allow retrospective review of all eyes implanted with an AcrySof IOL. Eyes implanted with polymethyl methacrylate (PMMA) IOLs were also reviewed and were used as a historical comparison group. Follow-up examinations were conducted by the surgeon on postoperative day 1, day 7, week 4, and week 8 and every 3 months during the first year and every 6 months thereafter. The presence of synechiae, lens deposits, and posterior capsule opacification were noted in the record at each visit. Examination notes were photocopied, and data were extracted from each visit note and entered into a computerized database. RESULTS: One hundred and ten eyes had an AcrySof IOL at an average age of 60.4 months and had an average postoperative follow-up of 64.6 weeks. In comparison, 120 eyes had PMMA IOLs inserted at an average age of 71.9 months with an average postoperative follow-up of 136.9 weeks. IOL cell deposits were seen at the slit lamp in 7 of 110 (6.4%) AcrySof lenses as compared with 26 of 120 (21.75%) PMMA lenses (P =.002). Posterior synechiae were seen in 5 of 110 (4.5%) AcrySof lenses as compared with 23 of 120 (19.2%) PMMA lenses (P =.001). Twenty-two AcrySof-implanted eyes had an intact posterior capsule. Twenty-eight PMMA-implanted eyes had an intact posterior capsule. The YAG laser capsulotomy rate was similar in the 2 groups at 45.4% for AcrySof and 50% for PMMA (P =.973). The average time from surgery to YAG posterior capsulotomy was 18.6 months with an AcrySof lens and 18.3 months with a PMMA lens (P =.951; t test). A total of 60 patients (68%) implanted with AcrySof IOLs were able to cooperate for Snellen visual acuities. Of their 67 eyes, 48 (72%) had a 20/40 or better visual acuity at the last follow-up examination, and 63 eyes (94%) had a 20/100 or better visual acuity. Thirty-five eyes (52%) required amblyopia therapy, and patching continues as needed. CONCLUSIONS: The AcrySof IOL is representative of a new group of foldable IOLs made from flexible hydrophobic acrylic material. The AcrySof IOL appears clinically to be biocompatible when placed in the eyes of children despite the increased tissue reactivity known to occur in young patients.

Acrylic Resins↗

PubMed2002

New tubular bioabsorbable knitted airway stent: biocompatibility and mechanical strength.

OBJECTIVE: This study examines the biocompatibility and suitability of a new tubular bioabsorbable knitted stent made of poly-L -lactic acid in normal rabbit airways and examines the mechanical strength of this stent in vitro. METHODS: A tubular knitted airway stent (group B, n = 15) made of poly-L -lactic acid wire was implanted operatively in New Zealand White rabbits intratracheally; silicone stents served as controls (group A, n = 8). The cervical trachea was exposed, and the stent was implanted. Up to 40 weeks after stent implantation, the rabbits were killed, at which time bronchoscopy, histologic examination, and scanning electron microscopic study was done. We tested poly-L -lactic acid stents and silicone stents for their mechanical strength in vitro. We subjected stents to area loads and measured their mechanical strengths. RESULTS: In group A, which received silicone stents, 3 (37.5%) rabbits died within 4 weeks of stent implantation as a result of airway obstruction by secretions inside the stent lumen. In group B, poly-L -lactic acid stents, 1 (6.7%) rabbit died 3 weeks after implantation because of weakness caused by anorexia. In the remaining animals, except for 1 animal with stent trouble, the bronchial lumen was fully open until the 40th week after implantation. After 40 weeks of follow-up, the stents disappeared, except for nonabsorbable suture in the bronchial wall. None of the animals in group B died of airway complication. Histologic examination and scanning electron microscopic examination of the group A silicone stents showed marked regression of ciliated cells under the stent. In group B the ciliated epithelium was preserved, and there were numerous capillary blood vessels in the submucosa. In scanning electron microscopy of the group B poly-L -lactic acid stents, the ciliated cells were preserved between the mesh holes of the stent. For diameters between 4 and 6 mm, the mechanical strength of silicone stents was greater than that of poly-L -lactic acid stents. However, the mechanical strength of poly-L -lactic acid stents increased as a function of their diameter. CONCLUSION: A new tubular bioabsorbable stent made of poly-L -lactic acid is biocompatible in normal rabbit airways, indicating that poly-L -lactic acid is a promising material for airway stents for clinical use.

Absorbable Implants↗

PubMed2005

Biocompatibility of vitallium as ossicular reconstruction material in the middle ear: experimental animal study.

CONCLUSION: Although long-term data will be necessary for confirmation, the result of this preliminary study indicates that vitallium may be a good alternative material for ossicular replacement prostheses in the middle ear. OBJECTIVES: To investigate the biocompatibility of vitallium (Co-Cr-Mo) as ossicular reconstruction material in the rabbit middle ear, and to compare the results with those obtained with titanium, well known as a highly biocompatible material, and non-implanted control groups. MATERIAL AND METHODS: Eighteen female New Zealand White rabbits were anesthetized. The tympanomeatal flap was elevated and 12 vitallium and 12 titanium implants were placed in the bulla away from the ossicles in 24 middle ears. Six rabbits were used as non-implanted controls. All animals were sacrificed under general anesthesia on the 180th day after implantation. The temporal bones were removed, fixed in 10% buffered paraformaldehyde and decalcified for a week in EDTA. Tissue samples were then prepared using an Autotechnicon and embedded in paraffin. Sections (30-microm thick) were cut with a microtome, stained with hematoxylin-eosin, von Gieson's stain and fibroblast growth factor (FGF) and examined under a light microscope. The numbers of lymphocytes, collagen fibers and FGF-positive cells were determined in all three groups. RESULTS: There was no significant difference in the numbers of collagen fibers between the groups (p > 0.05). No significant differences were found in the numbers of lymphocytes and FGF-positive cells between the titanium and vitallium groups (p > 0.05). The differences in the numbers of lymphocytes and FGF-positive cells between the control and other groups were found to be significant (p <0.05).

Animals↗