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The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.
Hasegawa, T, Ushirozako, H, Shigeto, E, Ohba, T, Oba, H, Mukaiyama, K, Shimizu, S, Yamato, Y, Ide, K, Shibata, Y, et al
Spine. 2020;(15):E892-E902
Abstract
STUDY DESIGN A multicenter, randomized, open-label, parallel-group trial. OBJECTIVE To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery. SUMMARY OF BACKGROUND DATA Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages. METHODS During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index. RESULTS The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups. CONCLUSION Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage. LEVEL OF EVIDENCE 1.
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Bioabsorbable magnesium versus standard titanium compression screws for fixation of distal metatarsal osteotomies - 3 year results of a randomized clinical trial.
Plaass, C, von Falck, C, Ettinger, S, Sonnow, L, Calderone, F, Weizbauer, A, Reifenrath, J, Claassen, L, Waizy, H, Daniilidis, K, et al
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association. 2018;(2):321-327
Abstract
BACKGROUND For the treatment of hallux valgus commonly distal metatarsal osteotomies are performed. Persistent problems due to the hardware and the necessity of hardware removal has led to the development of absorbable implants. To overcome the limitations of formerly used materials for biodegradable implants, recently magnesium has been introduced as a novel implant material. This is the first study showing mid-term clinical and radiological (MRI) data after using magnesium implants for fixation of distal metatarsal osteotomies. MATERIAL AND METHODS 26 patients with symptomatic hallux valgus were included in the study. They were randomly selected to be treated with a magnesium or standard titanium screw for fixation of a modified distal metatarsal osteotomy. The patients had a standardized clinical follow up and MRI investigation 3 years' post-surgery. The clinical tests included the range of motion of the MTP 1, the AOFAS, FAAM and SF-36 scores. Further on the pain was evaluated on a VAS. RESULTS Eight patients of the magnesium group and 6 of the titanium group had a full clinical and MRI follow up 3 years postoperatively. One patient was lost to follow-up. All other patients could be interviewed, but denied full study participation. There was a significant improvement for all tested clinical scores (AOFAS, SF-36, FAAM, Pain-NRS) from pre-to postoperative investigation, but no statistically relevant difference between the groups. Magnesium implants showed significantly less artifacts in the MRI, no implant related cysts were found and the implant was under degradation three years postoperatively. CONCLUSION In this study, bioabsorbable magnesium implants showed comparable clinical results to titanium standard implants 3 years after distal modified metatarsal osteotomy and were more suitable for radiologic analysis. LEVEL OF EVIDENCE 2.
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Safety and effectiveness of early loaded maxillary titanium implants with a novel nanostructured calcium-incorporated surface (Xpeed): 3-year results from a pilot multicenter randomised controlled trial.
Felice, P, Grusovin, MG, Barausse, C, Grandi, G, Esposito, M
European journal of oral implantology. 2015;(3):245-54
Abstract
PURPOSE To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant surface (Xpeed, MegaGen Implant Co., Gyeongbuk, South Korea). MATERIALS AND METHODS Sixty patients were randomised to receive one to six implants in the maxilla with either calcium-incorporated (Xpeed) or control resorbable blasted media (RBM) surfaces, according to a parallel group design at two centres. Implants were submerged and exposed at three different endpoints in equal groups of 20 patients, each at 12, 10 and 8 weeks, respectively. Within 2 weeks, implants were functionally loaded with provisional or definitive prostheses. Outcome measures were prosthesis failures, implant failures, any complications and peri-implant marginal bone level changes. RESULTS Thirty patients received 45 calcium-incorporated implants and 30 patients received 42 control titanium implants. Three years after loading four patients dropped-out from the Xpeed group and one from the RBM group. No prosthesis or implant failures occurred. There were no statistically significant differences between the groups for complications (P = 0.91; difference in proportions = 0.79 %; 95% CI -0.71 to 2.29) and mean marginal bone level changes (P = 0.88; mean difference = -0.02 mm; 95% CI -0.26 to 0.22). CONCLUSIONS Both implant surfaces provided good clinical results and no significant difference was found when comparing titanium implants with a nanostructured calcium-incorporated surface versus implants with RBM surfaces.
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The timing of significant arch dimensional changes with fixed orthodontic appliances: data from a multicenter randomised controlled trial.
Fleming, PS, Lee, RT, Mcdonald, T, Pandis, N, Johal, A
Journal of dentistry. 2014;(1):1-6
Abstract
OBJECTIVES To identify the timing of significant arch dimensional increases during orthodontic alignment involving round and rectangular nickel-titanium (NiTi) wires and rectangular stainless steel (SS). A secondary aim was to compare the timing of changes occurring with conventional and self-ligating fixed appliance systems. METHODS In this non-primary publication, additional data from a multicenter randomised trial initially involving 96 patients, aged 16 years and above, were analysed. The main pre-specified outcome measures were the magnitude and timing of maxillary intercanine, interpremolar, and intermolar dimensions. Each participant underwent alignment with a standard Damon (Ormco, Orange, CA) wire sequence for a minimum of 34 weeks. Blinding of clinicians and patients was not possible; however, outcome assessors and data analysts were kept blind to the appliance type during data analysis. RESULTS Complete data were obtained from 71 subjects. Significant arch dimensional changes were observed relatively early in treatment. In particular, changes in maxillary inter-first and second premolar dimensions occurred after alignment with an 0.014in. NiTi wire (P<0.05). No statistical differences in transverse dimensions were found between rectangular NiTi and working SS wires for each transverse dimension (P>0.05). Bracket type had no significant effect on the timing of the transverse dimensional changes. CONCLUSIONS Arch dimensional changes were found to occur relatively early in treatment, irrespective of the appliance type. Nickel-titanium wires may have a more profound effect on transverse dimensions than previously believed. CLINICAL SIGNIFICANCE On the basis of this research orthodontic expansion may occur relatively early in treatment. Nickel-titanium wires may have a more profound effect on transverse dimensions than previously believed.
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Clinical outcomes of magnesium-incorporated oxidised implants: a randomised double-blind clinical trial.
Pang, KM, Lee, JW, Lee, JY, Lee, JB, Kim, SM, Kim, MJ, Lee, JH
Clinical oral implants research. 2014;(5):616-21
Abstract
OBJECTIVES This study evaluated implant stability and clinical outcomes obtained with magnesium-incorporated oxidised implants (Mg titanate) and compared them to those blasted magnesium-incorporated oxidised implants (blasted Mg titanate). PATIENTS AND METHODS Mg titanate was manufactured using the microarc oxidation (MAO) process. To obtain blasted Mg titanate, the MAO process was performed after blasting with TiO₂ particles. The 15-month, randomised, double -blind clinical trial was conducted on 54 implants in 40 patients (Mg titanate, 27 implants in 18 subjects; blasted Mg titanate, 27 implants in 22 subjects), in whom 4.0 mm × 10 mm implants were placed to restore the unilateral loss of one or two molars in the mandible. The final prosthesis was attached 3 months postoperatively. Implant stability was measured by the implant stability quotient (ISQ) and periotest value (PTV) at the time of implant insertion, and 2, 3, and 15 months postoperatively. Marginal bone loss was evaluated at 2, 6, and 15 months postoperatively. Soft tissue analysis was performed at 15 months postoperatively. RESULTS Both implant systems showed high stability at all time points (>71). Mean marginal bone loss was 0.71 ± 0.65 mm and 0.75 ± 0.73 after 15 months in Mg titanate and blasted Mg titanate, respectively. There were no significant differences between the two implant surfaces with respect to ISQ(P = 0.988), PTV(P = 0.935), and marginal bone loss(P = 0.807) after 15 months. CONCLUSION The success rate after 1 year of follow-up was 100% for both magnesium-incorporated oxidised implants. There were no significant differences in the clinical outcomes between the two surfaces at 15 months follow-up.
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Fracture resistance of titanium and zirconia abutments: an in vitro study.
Foong, JK, Judge, RB, Palamara, JE, Swain, MV
The Journal of prosthetic dentistry. 2013;(5):304-12
Abstract
STATEMENT OF PROBLEM Little information comparing the fracture resistance of internal connection titanium and zirconia abutments exists to validate their use intraorally. PURPOSE The purpose of this study was to determine the fracture resistance of internal connection titanium and zirconia abutments by simulating cyclic masticatory loads in vitro. MATERIAL AND METHODS Twenty-two specimens simulating implant-supported anterior single crowns were randomly divided into 2 equal test groups: Group T with titanium abutments and Group Z with zirconia abutments. Abutments were attached to dental implants mounted in acrylic resin, and computer-aided design/computer-aided manufacturing (CAD/CAM) crowns were fabricated. Masticatory function was simulated by using cyclic loading in a stepped fatigue loading protocol until failure. Failed specimens were then analyzed by using scanning electron microscopy (SEM) and fractographic analysis. The load (N) and the number of cycles at which fracture occurred were collected and statistically analyzed by using a 2-sample t test (α=.05). RESULTS The titanium abutment group fractured at a mean (SD) load of 270 (56.7) N and a mean (SD) number of 81 935 (27 929) cycles. The zirconia abutment group fractured at a mean (SD) load of 140 (24.6) N and a mean (SD) number of 26 296 (9200) cycles. The differences between the groups were statistically significant for mean load and number of cycles (P<.001). For the titanium abutment specimens, multiple modes of failure occurred. The mode of failure of the zirconia abutments was fracture at the apical portion of the abutment without damage or plastic deformation of the abutment screw or implant. CONCLUSIONS Within the limitations of this in vitro study, 1-piece zirconia abutments exhibited a significantly lower fracture resistance than titanium abutments. The mode of failure is specific to the abutment material and design, with the zirconia abutment fracturing before the retentive abutment screw.
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Effect of nanoscale topography of titanium implants on bone vessel network, osteocytes, and mineral densities.
Traini, T, Murmura, G, Piattelli, M, Scarano, A, Pettinicchio, M, Sinjari, B, Caputi, S
Journal of periodontology. 2013;(10):e40-7
Abstract
BACKGROUND Chemical and physical properties of an implant surface have a major influence on the structure of peri-implant bone and thus may influence the clinical performance of the implant. This study aims to evaluate the bone microstructure around implants with and without added nanometer-sized calcium phosphate particles. METHODS An implant with dual acid-etched surface (control) and an implant with dual acid-etched surface and CaP nanoparticles (test) were placed in the posterior maxilla of 15 patients. Bone microstructure was evaluated for osteocyte density (OD), bone vessel volume density (BVVD), and bone mineral density (BMD). RESULTS BVVD was 1.806 ± 0.05 for test implants and 1.533 ± 0.10 for control implants (P <0.001). BMDlow was 17.4 × 10(4) µm(2) for test implants and 15.0 × 10(4) µm(2) for control implants (P = 0.025). Results from the BMDhigh comparison, test versus control, were not statistically significant (P >0.05). OD was 575.6 ± 63.7 mm(2) for test implants and 471.2 ± 61.9 mm(2) for control implants (P <0.001). CONCLUSIONS After 8 weeks of healing, the bone microstructure around test implants appeared to be significantly more organized. Clinical implications of these results include shortened healing time and indication for earlier loading protocols.
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Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study.
Windhagen, H, Radtke, K, Weizbauer, A, Diekmann, J, Noll, Y, Kreimeyer, U, Schavan, R, Stukenborg-Colsman, C, Waizy, H
Biomedical engineering online. 2013;:62
Abstract
PURPOSE Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. METHODS Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. RESULTS No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. CONCLUSION The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities.
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Surface corrosion and fracture resistance of two nickel-titanium-based archwires induced by fluoride, pH, and thermocycling. An in vitro comparative study.
Perinetti, G, Contardo, L, Ceschi, M, Antoniolli, F, Franchi, L, Baccetti, T, Di Lenarda, R
European journal of orthodontics. 2012;(1):1-9
Abstract
The present comparative study aimed to evaluate the surface corrosion and fracture resistance of two commercially available nickel-titanium (NiTi)-based archwires, as induced by a combination of fluoride, pH, and thermocycling. One hundred and ten rectangular section NiTi-based archwires were used, 55 of each of the following: thermally activated Thermaloy® and super-elastic NeoSentalloy® 100 g. Each of these was divided into five equal subgroups. One of these five subgroups did not undergo any treatment and served as the control, while the other four were subjected to 30 days of incubation at 37°C under fluoridated artificial saliva (FS) at 1500 ppm fluoride treatment alone (two subgroups) or combined with a session of thermocycling (FS + Th) treatment at the end of incubation (two subgroups). Within each of the Thermaloy® and NeoSentalloy® groups, the FS and FS + Th treatments were performed under two different pH conditions: 5.5 and 3.5 (each with one subgroup per treatment). Analysis of the surface topography and tensile properties by means of scanning electron microscopy (a single sample per subgroup), atomic force microscopy, and a universal testing machine for ultimate tensile strength were carried out once in each of the control subgroups or immediately after the treatments in the other subgroups for 10 of the archwires. Non-parametric tests were used in the data analysis. Significant effects in terms of surface corrosion, but not fracture resistance, were seen mainly for the Thermaloy® group at the lowest pH, with no effects of Th irrespective of the group or pH condition. Different NiTi-based archwires can have different corrosion resistance, even though the effects of surface corrosion and fracture resistance appear not to be significant in clinical situations, especially considering that thermocycling had no effect on these parameters.
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Computed micro-tomographic evaluation of glide path with nickel-titanium rotary PathFile in maxillary first molars curved canals.
Pasqualini, D, Bianchi, CC, Paolino, DS, Mancini, L, Cemenasco, A, Cantatore, G, Castellucci, A, Berutti, E
Journal of endodontics. 2012;(3):389-93
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Abstract
INTRODUCTION X-ray computed micro-tomography scanning allows high-resolution 3-dimensional imaging of small objects. In this study, micro-CT scanning was used to compare the ability of manual and mechanical glide path to maintain the original root canal anatomy. METHODS Eight extracted upper first permanent molars were scanned at the TOMOLAB station at ELETTRA Synchrotron Light Laboratory in Trieste, Italy, with a microfocus cone-beam geometry system. A total of 2,400 projections on 360° have been acquired at 100 kV and 80 μA, with a focal spot size of 8 μm. Buccal root canals of each specimen (n = 16) were randomly assigned to PathFile (P) or stainless-steel K-file (K) to perform glide path at the full working length. Specimens were then microscanned at the apical level (A) and at the point of the maximum curvature level (C) for post-treatment analyses. Curvatures of root canals were classified as moderate (≤35°) or severe (≥40°). The ratio of diameter ratios (RDRs) and the ratio of cross-sectional areas (RAs) were assessed. For each level of analysis (A and C), 2 balanced 2-way factorial analyses of variance (P < .05) were performed to evaluate the significance of the instrument factor and of canal curvature factor as well as the interactions of the factors both with RDRs and RAs. RESULTS Specimens in the K group had a mean curvature of 35.4° ± 11.5°; those in the P group had a curvature of 38° ± 9.9°. The instrument factor (P and K) was extremely significant (P < .001) for both the RDR and RA parameters, regardless of the point of analysis. CONCLUSIONS Micro-CT scanning confirmed that NiTi rotary PathFile instruments preserve the original canal anatomy and cause less canal aberrations.