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Biodegradable composite implants.

Biodegradable implants are established in the field of operative sports medicine. So-called composite implants are increasingly used. The idea to improve biocompatibility and osteoconductivity of biodegradable polymers by modifying them with a ceramic component, has led to the development of these composite implants. Today, an increasing variety of composite implants are available. They have substantially different material characteristics, which depend on matrix polymer choice and the additional ceramic. The material characteristics influence the mechanical properties, in vivo degradation, the osseous replacement and the host-tissue response. It is important to understand their biologic base for a better knowledge of the advantages and risks associated with using composite implants in the field of operative sports medicine. The purpose of this review is to focus on current developments in biodegradable composite implants and their biologic base.

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Significance of biodegradable implants in case of midfacial fractures.

The purpose of this prospective clinical study was to evaluate new resorbable implants for bone fixation. The plates and screws are made of poly (D, L)lactide (PDLLA). Bioresorbable osteosynthesis and fixation (ResorbX) has been applied in 22 patients. Indications for operations were craniofacial trauma (malar, orbital-floor or frontal bone fractures) or orthognathic procedures (Le Fort-I-osteotomies) as well as the surgical correction in case of craniofacial syndromes. In the initial follow up, the first patients showed clinically and radiologically uneventful fixation and healing of the bone. There were no implant material related complications. Overall, the advantages of PDLLA-implants appear to be their ease of use, radiolucency and resorption, although further experience is needed to determine the longterm benefits of biodegradable implants.

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Plates, screws, and children: their relationship in craniomaxillofacial trauma.

The ideal modality for fixation of pediatric craniomaxillofacial fractures remains elusive for a number of reasons. Surgeons who manage these injuries have replaced wiring techniques with the introduction of some form of reconstructive implant. The most commonly used implants are either resorbable or semi-rigid titanium. This presentation is a synopsis of the past 30 years of the English-speaking scientific literature including plastic and reconstructive surgery, otolaryngology, head and neck surgery, oral and maxillofacial surgery, pediatric, trauma, craniofacial, materials, and biomaterials publications. While no consensus on ideal management was observed, various implant treatment options are discussed, including their indications, contraindications, considerations, and consequences after implant placement.

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Comparative study of buccal dehiscence defects in immediate, delayed, and late maxillary implant placement with collagen membranes: clinical healing between placement and second-stage surgery.

BACKGROUND: Implants can be placed at the time of tooth extraction (immediate), after several weeks (delayed), or after complete healing (late). The purpose of this study was to evaluate clinical bone healing of buccal dehiscence-type defects around maxillary implants placed together with bioabsorbable collagen barrier membranes and bone graft at the 3 time points. METHODS: Three implant placement protocols were compared: immediate procedures primarily closed by a rotated split palatal flap (19 patients, 23 implants; group 1); delayed sites closed by a rotated (full-thickness) palatal flap at the time of tooth extraction (25 patients, 39 implants; group 2); and late implantation (22 patients, 40 implants; group 3). One to 3 proximal implants were simultaneously placed. Defect height and width were measured at the time of implant placement and at second-stage surgery. Surface area was calculated as half ellipses. RESULTS: The best results were obtained with delayed implantation. The mean percentage of the reduced defect height for groups 1, 2, and 3 was 77.4%+/-16.92%, 88.8%+/-15.29%, and 75.2%+/-17.99%, respectively, and the mean percentage area of the reduced defect was 90.2%+/-9.15%, 95.6%+/-8.73%, and 87.6%+/-11.48%, respectively. Differences between groups were statistically significant. The mean percentage of the reduced defect height and area was significantly smaller when there was spontaneous implant cover screw exposure. Single rather than multiple implant placement led to significantly better results. CONCLUSIONS: Timing of placement, number of simultaneously placed implants, and spontaneous implant exposure significantly influence clinical bone healing around maxillary implants placed together with augmentation procedures.

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Regeneration procedures in immediate transmucosal implants: an animal study.

The aim of the present study was to evaluate bone regeneration around nonsubmerged implants placed immediately in extraction sites in the canine mandible using a combination of synthetic hydroxyapatite (HA) and collagen membranes. Ten beagle dogs were used in this study. After the second and third mandibular premolars were extracted, hollow-screw implants were placed in the distal extraction sockets. In each animal, one site received no treatment (control site), while other defects received randomly 1 of the following treatments: grafting with porous HA in the peri-implant region, collagen membrane adapted to the implant cervical collar covering the peri-implant defects, or a combination of the 2 treatments, i.e., HA grafting and membrane placement. After 4 months of healing, block biopsies were obtained and prepared for histologic analysis using the cutting-grinding technique. The histometric evaluation took into account the number of integrated screw threads, the extent of bone-to-implant contact, and the density of peri-implant bone. At sites covered by membrane alone or by membrane and HA, the number of integrated threads was statistically higher than sites treated only with HA. The extent of bone-to-implant contact was significantly different between treatments. However, the use of bioabsorbable materials did not significantly enhance peri-implant bone regeneration in immediate implantation.

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[Assembly and evaluation of tissue engineered human cellular alveolar bony implanting materials in vitro].

OBJECTIVE: To assembly human cellular alveolar bony implanting materials in vitro and evaluate their osteogenic activities. METHODS: Human alveolar bone cells were separated from alveolar bone around the third impacted teeth of 3 patients by enzyme digestion and cultured in alpha-MEM containing beta-glycerophosphate and Dexamethasone at 5% CO2, 37 degrees C for 21-28 days. Confirmed osteoblasts-like cells were then seeded onto 3 kinds of degradable biomaterials of polyglycolic acid scaffold, collagen sponge, and L-lactic acid/epsilon-caprolactone to form the cell-scaffold complexes. The 3 types of complexes were continued to culture for 21-28 days at the same conditions. The cell proliferation, morphological changes, ALPase activity and mineral nodule formation on scaffolds were measured and observed at 3 days intervals. RESULTS: The results indicated that the cultured human alveolar bone origin cells from 3 patients could successfully express the osteoblasts phenotype in single layered culturing after stimulated by beta-glycerophosphate and Dexamethasone. The cultured osteoblast-like cells seeded on PGAS matrix had the highest attachment, proliferative and osteogenic activities, suggesting a good bio-affinity between the human alveolar osteoblast-like cells and the PGAS matrix. The statistical analysis (ANOVA) showed that there were significant differences between PGAS- osteoblasts complex and CLGS or LACT complexes on osteogenic activities (P < 0.05). CONCLUSION: PGAS-osteoblast complex is worth to be further developed into a tissue-engineered cellular artificial bony implant for reconstructing the oral-maxillofacial bony defects.

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Repair of the perforated sinus membrane with a resorbable collagen membrane: a human study.

PURPOSE: The purpose of this study was to evaluate the results of the repair of perforated sinus membranes with resorbable collagen membrane. MATERIALS AND METHODS: A split-mouth design was followed. Twelve subjects requiring bilateral sinus grafting were included in the study; one site had been accidentally perforated during sinus augmentation and the other site had not been perforated. The perforated sites were repaired with a resorbable collagen membrane. Dental implants were placed during a second surgery, and biopsy samples were harvested from both sinuses during implant placement. New bone formation was measured for all sites. Implant survival was recorded at second-stage surgery. Panoramic radiographs were taken before and after sinus grafting and after implant placement. RESULTS: Nonperforated sites demonstrated significantly more bone formation (33.58% +/- 7.45%) than perforated sites (14.17% +/- 7.06%) (P < .0001). Perforated sites demonstrated significantly more soft tissue formation (63.58% +/- 12.96%) than nonperforated sites (48.5% +/- 12.57%) (P = .006). In nonperforated sites, residual graft particles had more of their surface in contact with bone (40.17% +/- 14.92%) than perforated sites (14.5% +/- 12.03%) (P < .0001). The implant survival rate at second-stage surgery was superior for nonperforated sites (100%) in comparison to perforated sites (69.56%) (P = .0028). DISCUSSION: This study suggested that repairing the perforated site of the sinus membrane with a resorbable collagen membrane may result in reduced bone formation and implant survival rate. A different technique and/or materials than those used in the current study may offer better results for the repair of the perforated sinus membrane. CONCLUSION: The study demonstrated that perforation and repair of the sinus membrane may compromise new bone formation and implant survival.

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A novel polyethylene depot device for the study of PLGA and P(FASA) microspheres in vitro and in vivo.

Polymer microspheres (0.5-5.0 microm) are difficult to characterize in vivo because they degrade, migrate, and are endocytosed. A novel polyethylene mesh pouch containing microspheres allowed for retrieval of degraded polymeric products from rats without affecting the rate of degradation. Pouches containing poly(lactic-co-glycolic acid) (PLGA) or poly(fumaric-co-sebacic acid) (P(FASA)) microspheres were implanted intramuscularly, subcutaneously, and intraperitoneally and analyzed after 3, 7, 14, and 28 days. In vivo, subcutaneous or intraperitoneal implants experienced an immediate mass loss and a delayed decrease in molecular weight (Mw). Intramuscular implants behaved similarly to in vitro samples, decreasing in Mw immediately and lagging in mass loss. These results suggest that mass loss, which is usually dependent on Mw loss in vitro, may be directly due to enzymatic, rather than hydrolytic, degradation subcutaneously and intraperitoneally, while intramuscular implants appear to be mostly dependent on hydrolytic cleavage. This observation is further supported by histology. Additional experiments on pouches loaded with PLGA microspheres encapsulating osteoprotegerin, a protein drug used to prevent bone resorption, revealed that use of the device prevented the artifactual polymer compression inherent to microsphere centrifugation during release studies and allowed for the extraction of active protein from microspheres implanted for 3 days in vivo.

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Peri-implant bone regeneration using recombinant human bone morphogenetic protein-2 in a canine model: a dose-response study.

The objective of this study was to evaluate the effect of recombinant human bone morphogenetic protein-2 (rhBMP-2) dose on alveolar ridge augmentation and dental implant osseointegration. Bilateral, 5 mm supraalveolar, peri-implant defects were surgically created in 6 beagle dogs. rhBMP-2 (0.05, 0.1 or 0.2 mg/ml) in an absorbable collagen sponge (ACS) carrier was molded around the fixtures and wounds were closed. Treatment variations were alternated between animals (incomplete block design). Animals were sacrificed at week 8 postsurgery. Nine of twelve jaw quadrants healed uneventfully. Two jaw quadrants exhibited wound failure by week 4 and one by week 8 postsurgery. Radiographic bone regeneration was observed in defects without wound failure from week 4 postsurgery. Radiolucent voids of variable size and shape were observed and regressed over time. In weeks 6 through 8, there was an apparent increase in bone density and trabecular structure, while bone height and volume decreased. Histometric analysis revealed limited differences in bone regeneration between experimental conditions. Bone regeneration area averaged (+/- SD) 1.0 +/- 0.5, 3.5 +/- 1.4 and 2.3 +/- 0.4 mm2 for the 0.05, 0.1 and 0.2 mg/ml dose, respectively. There were no significant differences in osseointegration. Osseointegration in newly formed bone averaged 19 +/- 4%, 18 +/- 10% and 21 +/- 6% for the 0.05, 0.1 and 0.2 mg/ml rhBMP-2 sites, respectively. Collectively, the data suggest that there are no dramatic differences in bone induction and osseointegration within the selected dose and observation interval.

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Guided bone regeneration at immediate implant insertion and loading: a case report.

A tapered-end, SLA- (sandblasted and acid-etched) surfaced ITI implant was placed in a compromised ridge at the time of tooth removal. After placement of nonautogenous regenerative materials, the implant was immediately loaded with a provisional restoration within 2 hours of implant insertion. Six-month reentry demonstrated regeneration of lostalveolar bone surrounding the implant and clinical implant immobility. Clinical ramifications of these findings are discussed.

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Resolution of bone defects of varying dimension and configuration in the marginal portion of the peri-implant bone. An experimental study in the dog.

BACKGROUND: It was demonstrated that a marginal defect of about 1 mm between the bone wall and the metal surface after implant installation can heal with a high degree of bone fill and osseointegration. OBJECTIVE: The aim of the present animal experiment was to study bone healing at implant sites with hard tissue defects of varying dimensions and configuration. MATERIAL AND METHODS: Four Labrador dogs were used. All mandibular premolars and first molars were extracted. After 3 months of healing, five experimental sites, two control (C1, C2) and three test (T1, T2, T3) sites, were identified. In all five sites, custom-made implants with a sand-blasted, large-grit, acid-etched (SLA) surface and with an outer dimension of 3.3x10 mm, were used. In site C1, traditional implant installation was performed. In site C2, the marginal 5 mm of the canal, prepared for the implant, was widened to 5.3 mm using a step-drill. Thus, following the installation of the implant, a circumferential gap occurred between the bone tissue and the metal rod that was 5 mm deep and between 1 and 1.25 mm wide. In test site T1, the canal was widened to establish a marginal gap of 2-2.25 mm. In test sites T2 and T3, the marginal 5 mm of the canal was first widened to 5.3 mm (T2) or 7.3 mm (T3). The buccal bone wall opposite the defect was subsequently removed. Following the placement of a cover screw in sites C2, T1, T2, and T3, a resorbable membrane was placed over the defect. All implants were submerged. After 4 months of healing, block biopsies of each implant site were dissected and processed for ground sectioning. RESULTS: The observations disclosed that four-wall defects of different dimensions (1-2.25 mm wide) that occurred in the marginal portion of the recipient sites following implant installation were resolved during healing. Further, at sites where the buccal bone wall during defect preparation was intentionally removed, healing resulted in defect resolution at the mesial, distal, and lingual aspects. At the buccal aspects, healing was incomplete but the dimension of the defect was reduced by the limited amounts of new bone formation extending from the lateral and apical borders of the defect. CONCLUSION: Wide marginal defects may during healing be filled with bone. In such defects a high degree of osseointegration may occur to implants designed with an SLA surface.

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Third-generation biomedical materials.

Whereas second-generation biomaterials were designed to be either resorbable or bioactive, the next generation of biomaterials is combining these two properties, with the aim of developing materials that, once implanted, will help the body heal itself.

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Effect of gamma, ethylene oxide, electron beam, and plasma sterilization on the behaviour of SR-PLLA fibres in vitro.

The aim of this study was to evaluate the effect of various sterilization processes on the physical and mechanical properties of self-reinforced bioabsorbable fibres made out of polylactide (PLLA). The samples were sterilized using plasma, ethylene oxide (one and two cycles), gamma (25 kGy at room temperature, 25 kGy in dry ice, and 2 x 25 kGy at room temperature), and electron beam (15, 25, and 55 kGy) sterilization. The intrinsic viscosity, crystallinity, and mechanical properties (modulus of elasticity, yield strength, and ultimate tensile strength) were tested before and immediately after each sterilization treatment, as well as up to 30 weeks in vitro. Compared with unsterilized fibres, the intrinsic viscosity was markedly decreased after radiation sterilization (gamma and electron beam) and the loss in mechanical properties was accelerated during in vitro degradation. Plasma and ethylene oxide (one and two cycles) did not markedly alter the properties of the samples after sterilization or during in vitro degradation. These data are important for determining the effect of various sterilization processes on the physical and mechanical properties of polylactide-based materials and can be used to predict how fast degradation of the mechanical properties of the self-reinforced PLLA will occur. They can also be used to tailor the degradation kinetics to optimize implant design.

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Lysine requirement of finishing pigs administered porcine somatotropin by sustained-release implant.

To alleviate the need for daily injection of porcine somatotropin (pST), a sustained-release implant (pSTSR) was devised that continuously delivers a daily dose of 2 mg of pST for 42 d. Ninety-six white composite (Large White x Landrace) finishing barrows (83.6 +/- 1.2 kg BW) were assigned to receive zero or two pSTSR implants (4 mg pST/d) and to consume one of six diets differing in total Lys concentration (0.29, 0.52, 0.75, 0.98, 1.21, or 1.44%, as-fed basis). Diets were formulated to be isocaloric and based on the ideal protein concept. Pigs were housed individually, allowed ad libitum access to feed and water, and slaughtered at 112 kg of BW. The pSTSR affected neither ADG (P = 0.88) nor 10th rib LM area (LMA; P = 0.51), but it decreased (P < 0.01) ADFI, average backfat thickness, 10th rib fat depth, weights of leaf fat and ham fat, improved (P < 0.05) G:F, and increased (P < 0.01) weights of four trimmed lean cuts (T-cuts), and percentages of ham lean and bone. Increasing total Lys increased ADG (quadratic; P < 0.05) and ADFI (linear; P < 0.01). The G:F, plasma urea N concentrations (PUN), and T-cuts were affected by the interaction pSTSR x dietary Lys (P < 0.01). Without pSTSR, the G:F did not differ (P = 0.37) among pigs fed 0.52% and greater total Lys. With pSTSR, the G:F was less (P < 0.05) for pigs fed 0.52% than 0.98 and 1.44% total Lys. Increases in dietary total Lys resulted in increased PUN (P < 0.01), and incremental increases were less in pSTSR-implanted pigs. Maximal yield of T-cuts was at 0.98% dietary total Lys in nonimplanted pigs and 1.21% total Lys in pSTSR-implanted pigs. Estimates of total Lys requirements of pigs without and with pSTSR, respectively, were 0.52 and 0.86% for growth (ADG and G:F) and 0.73 and 0.88% for lean production (LMA and T-cuts). Equivalent apparent ileal digestible Lys requirements of pigs without and with pSTSR, respectively, were 0.44 and 0.68% for growth, and 0.62 and 0.75% for lean production. With ADFI of 3.5 kg daily, an intake of approximately 26.1 g of total daily Lys (0.75%) or 22.4 g of apparent ileal digestible Lys is needed to maximize lean production in finishing barrows receiving 4 mg pST/d via sustained-release implant.

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NuGen Fx bioabsorbable screws: a preliminary report of their use in foot surgery.

A single prospective group study in adults was performed using a new bioabsorbable screw, the NuGen Fx screw (Linvatec Biomaterials Ltd, Tampere, Finland). This multisite study included five sites and 50 patients (10 patients per site). The goal of this study was to evaluate the efficiency and safety of the NuGen Fx screw system in the fixation of osteotomies, arthrodeses, and fractures in the foot and ankle. We discuss our own results from 12 patients treated at the Kentucky Podiatric Residency Program at Norton Audubon Hospital, Louisville. The number of patients in the study, screw sizes, instrumentation, radiologic evaluation findings, and our overview of this implant are presented.

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Immediate transmucosal implant placement: a report of 2 cases.

Immediate placement of implants into fresh extraction sockets has the advantages of decreasing the recommended period of healing, reducing the resorption of the alveolar bone, and achieving optimal esthetic results. A high rate of success with immediately placed implants has been reported in the literature. Conventional intervention involves 2 or 3 surgical visits, and this may not be accepted by the patient or may be of some inconvenience. The technique described involves only one surgical visit at which a transmucosal endosseous root-form implant is inserted, followed by application of a resorbable membrane.

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