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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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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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Safety and effectiveness of maxillary early loaded titanium implants with a novel nanostructured calcium-incorporated surface (Xpeed): 1-year results from a pilot multicenter randomised controlled trial.
Esposito, M, Grusovin, MG, Pellegrino, G, Soardi, E, Felice, P
European journal of oral implantology. 2012;(3):241-9
Abstract
PURPOSE To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant (Xpeed, MegaGen Implant Co. Limited, Gyeongbuk, South Korea). MATERIALS AND METHODS Sixty patients were randomised to receive either 1 to 6 calcium-incorporated or control titanium implants in the maxilla according to a parallel group design at 2 different centres. Implants were submerged and exposed at 3 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. One year after loading, no drop-outs and no prosthesis or implant failures occurred. There were no statistically significant differences between groups for complications (P = 0.61; difference in proportions = -0.27; 95% CI -0.71 to 0.18) and mean marginal bone level changes (P = 0.64; mean difference -0.04 mm; 95% CI -0.22 to 0.13). CONCLUSIONS Nanostructured calcium-incorporated titanium implants seem to be at least as effective and safe as conventional titanium implants.
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A 5-year prospective multicenter clinical trial of non-submerged dental implants with a titanium plasma-sprayed surface in 200 patients.
Cochran, DL, Jackson, JM, Jones, AA, Jones, JD, Kaiser, DA, Taylor, TD, Weber, HP, Higginbottom, FL, Richardson, JR, Oates, T
Journal of periodontology. 2011;(7):990-9
Abstract
BACKGROUND Endosseous dental implants are a popular treatment to replace missing teeth. Although many advances have occurred and affected the macrogeometry and surface characteristics of dental implants, among other aspects, it is important to document how the implants perform in patients over time. Such evaluations are helpful not only to document the clinical survival of the implants but also patient satisfaction over an extended period. METHODS A formal prospective multicenter human clinical was performed at five centers involving 200 patients and 626 implants. Specific inclusion and exclusion criteria were used and detailed data collected at specified times using case report forms. An independent study monitor reviewed all study data before entry into the study database. Two implant designs were used in two different clinical indications. A non-submerged titanium plasma-sprayed (TPS) hollow cylindrical implant with a smooth transgingival collar was evaluated in the maxillary anterior sextant and a non-submerged TPS solid screw implant with similar collar in the mandible. RESULTS Over the course of the 5-year clinical trial, there was one early failure occurring before definitive prosthesis delivery. Three late failures were documented, one occurring at each of the 6, 12, and 18 months postoperative visits. Life table analysis at 5 years revealed a 99.4% survival rate and a 92.5% success rate. Patient satisfaction was rated as good to excellent for 96.1% of implants in regards to esthetics after 5 years; 98.8% for appearance; and 99.4% for prosthesis comfort, ability to chew and taste, fit, and general satisfaction. No serious adverse events were reported. CONCLUSIONS Implant success and survival was over 92% and 99%, respectively, in a formal 5-year prospective multicenter clinical trial involving 200 patients and 626 non-submerged TPS implants. These implants included hollow cylinder implants in the anterior maxilla and solid screw implants placed in the mandible. These findings document the predictability and patient satisfaction of tooth replacement using a non-submerged surgical technique involving a tissue-level, rough surfaced endosseous dental implant.