beta-tricalcium phosphate

β - 磷酸三钙
  • 文章类型: Journal Article
    引言在脊柱融合手术时通过抗原刺激触发免疫系统可能会增强骨形态发生并导致成功的骨关节固定术。我们试图证明可以通过手术融合部位的抗原免疫刺激来增强骨形态发生。方法新西兰白兔进行非仪器化的L5-6后外侧融合,植入免疫活化移植物(惰性β-磷酸三钙)或收获的自体移植物。使用平片评估融合,显微计算机断层扫描(CT),机械触诊,和生物力学测试。最终评估在术后12周进行。结果8只兔子接受了免疫激活的移植物;10只接受了自体移植物,并作为历史对照。组间融合率相同(均为50%)。融合肿块的X线片和显微CT显示组间无显著差异,两者均显示横突良好地结合到融合块中,影像学证据证实了小梁形成和骨重建。然而,融合部位的机械测试表明,接受免疫激活移植物的兔子具有优异的融合强度,在屈曲/伸展上接近2倍,横向弯曲,和轴向旋转。在未融合的抗原处理的标本中几乎没有或没有移植材料。结论长期需要一种可以替代自体骨的移植材料,由于与自体骨采集有关的负面临床后果和财务成本。迄今为止,尚无同种异体骨替代品能够可靠地复制已收获的自体骨移植的成功。这项研究表明,惰性β-磷酸三钙的免疫增强可能是同种异体移植骨的替代品,可以达到甚至超过收获的自体移植骨的成功。
    Introduction Triggering the immune system via antigenic stimulation at the time of spinal fusion surgery may enhance bone morphogenesis and result in successful bony arthrodesis. We sought to demonstrate that bone morphogenesis could be enhanced via antigenic immunologic stimulation of a surgical fusion site. Methods New Zealand white rabbits underwent non-instrumented posterolateral fusion of L5-6 with implantation of either an immunologically activated graft (inert beta-tricalcium phosphate) or harvested autograft. Fusion was evaluated using plain radiographs, micro-computed tomography (CT), mechanical palpation, and biomechanical testing. The final evaluation was carried out at 12 weeks postoperatively. Results Eight rabbits received immunologically activated grafts; 10 received autografts and served as historical controls. Fusion rates were identical between groups (both 50%). Radiographs and micro CT of the fusion mass showed no significant difference between groups, and both showed good incorporation of the transverse processes into the fusion masses with radiographic evidence confirming trabeculation and bone remodeling. However, mechanical testing of the fusion sites showed superior fusion strength in the rabbits that received immunologically activated grafts, approaching a factor of two on flexion/extension, lateral bending, and axial rotation. Little to no graft material was appreciable in the non-fused antigen-treated specimens. Conclusions There is a long-standing need for a graft material that can replace autograft bone, due to the negative clinical consequences and financial costs pertaining to autologous bone harvesting. No allograft bone substitute to date has been able to reliably replicate the success of harvested autograft bone. This study suggests that immunological enhancement of inert beta-tricalcium phosphate can potentially be a substitute for allograft bone that can meet and even exceed the success of harvested autograft bone.
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  • 文章类型: Case Reports
    背景:β-磷酸三钙(β-TCP)是一种广泛用于口腔再生领域的生物相容性陶瓷材料。由于其优异的生物和机械性能,它越来越多地用于牙槽脊增强或引导骨再生(GBR)。随着计算机辅助设计和制造(CAD/CAM)的最新进展,β-TCP现在可以以数字设计的患者特定支架的形式使用,用于两阶段植入治疗概念中的高级缺陷的定制骨再生(CBR)。在遵循CARE病例报告指南的病例报告中,我们提出了一种患者特异性β-TCP支架在植入前下颌牙槽脊增强中的新应用。
    方法:一名63岁女性患者在后下颌骨有明显的水平骨丢失,在两阶段后计划植入治疗的背景下,采用定制的β-TCP支架进行治疗。增强后9个月,锥形束计算机断层扫描显示支架成功整合到周围的骨骼中,允许植入物放置。最初手术后两年的随访显示口腔和种植体周围的健康状况良好。
    结论:该案例突出了患者特异性β-TCP支架用于牙槽脊增强的潜力及其相对于传统技术的优势,包括避免异种,allow-,和自体移植物。结果为其在临床实践中的使用提供了令人鼓舞的证据。患者特异性β-TCP支架可能是临床医生寻求为患者提供安全,可预测的,和有效的牙槽脊增强导致定制的骨再生程序。
    BACKGROUND: Beta-tricalcium phosphate (β-TCP) is a biocompatible ceramic material widely used in the field of oral regeneration. Due to its excellent biological and mechanical properties, it is increasingly utilized for alveolar ridge augmentation or guided bone regeneration (GBR). With recent advances in computer-aided design and manufacturing (CAD/CAM), β-TCP can now be used in the form of digitally designed patient-specific scaffolds for customized bone regeneration (CBR) of advanced defects in a two-stage implant therapy concept. In this case report following the CARE case report guidelines, we present a novel application of a patient-specific β-TCP scaffold in pre-implant mandibular alveolar ridge augmentation.
    METHODS: A 63-year-old female patient with significant horizontal bone loss in the posterior mandible was treated with a custom β-TCP scaffold in the context of a two-stage backward-planned implant therapy. Cone-beam computed tomography nine months after augmentation showed successful integration of the scaffold into the surrounding bone, allowing implant placement. Follow-up until two years after initial surgery showed excellent oral and peri-implant health.
    CONCLUSIONS: This case highlights the potential of patient-specific β-TCP scaffolds for alveolar ridge augmentation and their advantage over traditional techniques, including avoidance of xeno-, allo-, and autografts. The results provide encouraging evidence for their use in clinical practice. Patient-specific β-TCP scaffolds may be a promising alternative for clinicians seeking to provide their patients with safe, predictable, and effective alveolar ridge augmentation results in customized bone regeneration procedures.
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  • 文章类型: Journal Article
    简介:骨缺损仍然是临床医生必须面对的棘手挑战。目前,3D打印制备的支架越来越多地应用于骨组织修复领域。聚乳酸(PLA)具有良好的热塑性,可加工性,生物相容性,和生物降解性,但是PLA是脆性的并且具有差的成骨性能。β-磷酸三钙(β-TCP)具有良好的力学性能和成骨诱导性能,这可以弥补PLA的缺点。方法:在本研究中,以光固化可生物降解聚乳酸(bio-PLA)为原料制备不同β-TCP含量的PLA/β-TCP浆料(β-TCP用量为0%,10%,20%,30%,35%的PLA用量,分别)。采用液晶显示(LCD)光固化3D打印技术制备PLA/β-TCP支架。评估了支架的特征,并评价了具有最佳抗压强度的支架的生物活性。通过CCK-8测定评估支架的生物相容性,血液相容性测定和活死染色实验。通过茜素红染色评价支架对MC3T3-E1细胞的成骨分化能力,碱性磷酸酶(ALP)检测,免疫荧光实验,和RT-qPCR测定。结果:制备的支架具有三维网络结构,随着β-TCP数量的增加,更多的β-TCP颗粒粘附在支架表面。随着β-TCP用量的增加,PLA/β-TCP支架的抗压强度呈现先升高后降低的趋势,在10%的β-TCP含量下达到52.1MPa的最大值。降解率曲线结果表明,随着时间的推移,支架的降解速率逐渐增加,降解过程中支架的pH值呈碱性。此外,活/死染色和血液相容性实验表明,制备的PLA/β-TCP支架显示出优异的生物相容性。CCK-8实验表明PLA/β-TCP基团促进细胞增殖,所制备的PLA/β-TCP支架在体外显示出显著增强MC3T3-E1细胞成骨分化的能力。讨论:3D打印LCD光固化PLA/β-TCP支架可以提高表面生物活性并导致更好的成骨作用,这可能为在骨科应用中开发生物活性植入物提供独特的策略。
    Introduction: Bone defects remain a thorny challenge that clinicians have to face. At present, scaffolds prepared by 3D printing are increasingly used in the field of bone tissue repair. Polylactic acid (PLA) has good thermoplasticity, processability, biocompatibility, and biodegradability, but the PLA is brittle and has poor osteogenic performance. Beta-tricalcium phosphate (β-TCP) has good mechanical properties and osteogenic induction properties, which can make up for the drawbacks of PLA. Methods: In this study, photocurable biodegradable polylactic acid (bio-PLA) was utilized as the raw material to prepare PLA/β-TCP slurries with varying β-TCP contents (β-TCP dosage at 0%, 10%, 20%, 30%, 35% of the PLA dosage, respectively). The PLA/β-TCP scaffolds were fabricated using liquid crystal display (LCD) light-curing 3D printing technology. The characterization of the scaffolds was assessed, and the biological activity of the scaffold with the optimal compressive strength was evaluated. The biocompatibility of the scaffold was assessed through CCK-8 assays, hemocompatibility assay and live-dead staining experiments. The osteogenic differentiation capacity of the scaffold on MC3T3-E1 cells was evaluated through alizarin red staining, alkaline phosphatase (ALP) detection, immunofluorescence experiments, and RT-qPCR assays. Results: The prepared scaffold possesses a three-dimensional network structure, and with an increase in the quantity of β-TCP, more β-TCP particles adhere to the scaffold surface. The compressive strength of PLA/β-TCP scaffolds exhibits a trend of initial increase followed by decrease with an increasing amount of β-TCP, reaching a maximum value of 52.1 MPa at a 10% β-TCP content. Degradation rate curve results indicate that with the passage of time, the degradation rate of the scaffold gradually increases, and the pH of the scaffold during degradation shows an alkaline tendency. Additionally, Live/dead staining and blood compatibility experiments suggest that the prepared PLA/β-TCP scaffold demonstrates excellent biocompatibility. CCK-8 experiments indicate that the PLA/β-TCP group promotes cell proliferation, and the prepared PLA/β-TCP scaffold exhibits a significant ability to enhance the osteogenic differentiation of MC3T3-E1 cells in vitro. Discussion: 3D printed LCD photocuring PLA/β-TCP scaffolds could improve surface bioactivity and lead to better osteogenesis, which may provide a unique strategy for developing bioactive implants in orthopedic applications.
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  • 文章类型: Journal Article
    方法:系统文献综述。
    目的:分析使用脱矿质骨基质(DBM)的单节或双节段颈前路椎间盘切除术和融合术(ACDF)中可报告的并发症的证据,羟基磷灰石(HA),或β-磷酸三钙(β-TCP)。
    方法:使用PubMed对文献进行系统回顾,EMBASE,科克伦图书馆,和ClinicalTrials.gov数据库于2020年8月进行,以确定使用DBM报告一级或二级ACDF手术并发症的研究,HA,或β-TCP。该研究是根据系统评价和荟萃分析(PRISMA)指南的首选报告项目进行报告的。
    结果:共纳入1857例患者,981名男性和876名女性,共17篇文章;5篇前瞻性,12回顾我们注意到纳入的研究中涉及研究设计和其中使用的移植材料的组合的异质性。然而,我们注意到在使用DBM的融合构建体中,邻近节段疾病(17.7%)和假关节(9.3%)的发生率较高.使用β-TCP的研究报告假关节病(28.2%)和植入物失败(17.9%)的发生率更高。
    结论:使用DBM进行一级或二级ACDF手术治疗退行性宫颈疾病,HA,或β-TCP伴或不伴宫颈板与并发症相关,如相邻节段疾病,吞咽困难,和假关节.然而,由于研究设计和研究的临床异质性,不可能将这些并发症与所使用的任何特定移植材料准确关联。需要进一步精心设计的前瞻性研究来正确了解用于在ACDF中实现融合的每个移植物的相关发病率。
    METHODS: Systematic literature review.
    OBJECTIVE: To analyze the evidence available reporting complications in single or two-level anterior cervical discectomy and fusion (ACDF) using a demineralized bone matrix (DBM), hydroxyapatite (HA), or beta-tricalcium phosphate (β-TCP).
    METHODS: A systematic review of the literature using PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov databases was performed in August 2020 to identify studies reporting complications in one or two-level ACDF surgery using DBM, HA, or β-TCP. The study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.
    RESULTS: A total of 1857 patients were included, 981 male and 876 female, across 17 articles; 5 prospective, and 12 retrospectives. We noted heterogeneity among the included studies concerning the study design and combination of graft materials utilized in them. However, we noted a higher incidence of adjacent segment disease (17.7%) and pseudoarthrosis (9.3%) in fusion constructs using DBM. Studies using β-TCP reported a higher incidence of pseudoarthrosis (28.2%) and implant failures (17.9%).
    CONCLUSIONS: Degenerative cervical conditions treated with one or two-level ACDF surgery using DBM, HA, or β-TCP with or without cervical plating are associated with complications such as adjacent segment disease, dysphagia, and pseudarthrosis. However, consequent to the study designs and clinical heterogeneity of the studies, it is not possible to correlate these complications accurately with any specific graft material employed. Further well-designed prospective studies are needed to correctly know the related morbidity of each graft used for achieving fusion in ACDF.
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  • 文章类型: Journal Article
    可注射骨替代(IBS)材料通常用于填充非承重区域中的不规则形状的骨空隙,并且比预制粉末中的材料具有更大的实用性。颗粒,或阻止形式。这项工作研究了液固比(LSR)对由生物活性玻璃颗粒和甘油和聚(乙二醇)(PEG)中的β-磷酸三钙(β-TCP)配制的IBS的流变学和细胞相容性的影响。制备不同LSR的IBS制剂,并将其包装在3cc开孔注射器中,并通过γ射线(10kGy,25kGy)。具有高PEG含量的经γ照射的制剂需要来自注射器的注射的最高(73N)机械力。振荡粘度测量表明样品的粘度与甘油含量成正比。PEG和甘油对样品的抗冲洗性和粘结性显示出竞争效应,基于介质中的总重量损失和Ca2+离子释放,分别。10kGyγ灭菌和25kGyγ辐照样品的24小时提取物中的细胞活力分别为22.94%和56.53%,分别。该研究强调了IBS组分对IBS流变学的复杂相互作用,此外,基于β-磷酸三钙的可注射骨替代物的细胞毒性行为的体外实验。
    Injectable bone substitute (IBS) materials are commonly used to fill irregular-shaped bone voids in non-load-bearing areas and can offer greater utility over those which are in prefabricated powder, granule, or block forms. This work investigates the impact of liquid-to-solid ratio (LSR) on the rheology and cytocompatibility of IBSs formulated from bioactive glass particles and β-tricalcium phosphate (β-TCP) in glycerol and poly(ethylene glycol) (PEG). IBS formulations of varying LSR were prepared and packed in 3 cc open-bore syringes and sterilized via gamma irradiation (10 kGy, 25 kGy). Gamma-irradiated formulations with high PEG content required the highest (73 N) mechanical force for injection from syringes. Oscillatory viscosity measurements revealed that the viscosity of samples was directly proportional to glycerol content. PEG and glycerol displayed competing effects on the washout resistance and cohesiveness of samples, which were based on total weight loss in media and Ca2+ ion release, respectively. Cell viability in 24-h extracts of 10 kGy gamma-sterilized and 25 kGy gamma-irradiated samples were 22.94% and 56.53%, respectively. The research highlights the complex interplay of IBS components on IBS rheology and, moreover, the cytotoxicity behaviors of beta-tricalcium phosphate-based injectable bone substitutes by in vitro experiments.
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  • 文章类型: Journal Article
    创伤后的大骨重建对重建外科医生提出了重大挑战,导致卫生系统的医疗负担,患者的长期疼痛,和复杂的疾病,如难以解决的感染。对于大量的骨质流失,使用骨替代物是次优的,因为它们会引起局部萎缩,而且通常很弱,无法支撑负载。强聚己内酯(PCL)基支架的组合,平均通道尺寸为330µm,富含20%w/w的羟基磷灰石(HA),β-磷酸三钙(TCP),或生物玻璃45S5(生物玻璃),已在临界尺寸的绵羊股骨髁缺损模型中开发并测试了骨再生。6周后,使用X射线计算机断层扫描(XCT)分析组织向内生长,背散射电子显微镜(BSE),和组织形态计量学。在这一点上,所有材料都促进了新骨的形成。组织学分析显示不同生物材料之间无统计学差异(p>0.05),但是PCL-Bioglass支架比其他类型的材料更能增强支架中心的骨形成。这些材料显示出促进承重部位临界尺寸缺陷骨再生的潜力。
    Large bone reconstruction following trauma poses significant challenges for reconstructive surgeons, leading to a healthcare burden for health systems, long-term pain for patients, and complex disorders such as infections that are difficult to resolve. The use of bone substitutes is suboptimal for substantial bone loss, as they induce localized atrophy and are generally weak, and unable to support load. A combination of strong polycaprolactone (PCL)-based scaffolds, with an average channel size of 330 µm, enriched with 20% w/w of hydroxyapatite (HA), β-tricalcium phosphate (TCP), or Bioglass 45S5 (Bioglass), has been developed and tested for bone regeneration in a critical-size ovine femoral condyle defect model. After 6 weeks, tissue ingrowth was analyzed using X-ray computed tomography (XCT), Backscattered Electron Microscopy (BSE), and histomorphometry. At this point, all materials promoted new bone formation. Histological analysis showed no statistical difference among the different biomaterials (p > 0.05), but PCL-Bioglass scaffolds enhanced bone formation in the center of the scaffold more than the other types of materials. These materials show potential to promote bone regeneration in critical-sized defects on load-bearing sites.
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  • 文章类型: Journal Article
    这项体外研究的目的是使用原子力显微镜定量评估不同的酒精和非酒精饮料对用各种再矿化剂预处理的牙釉质表面形貌的影响。
    通过使用低速金刚石圆盘从内侧到远端表面切片,从60个新鲜提取的完整人类前磨牙制备了120个牙齿样本,并随机分配到研究组和对照组。I组标本,第二组和第三组用β-三磷酸钙预处理,生物活性玻璃和氟化胺分别4分钟,持续28天,然后储存在人工唾液中。使用原子力显微镜评估所有样品的表面粗糙度。然后将样品置于酒精和非酒精饮料中10分钟,持续4天,并再次通过原子力显微镜分析。通过使用参数的比例或频率分布进行描述性统计。然后根据专业分支对受访者进行分组,如果有的话,数据通过单向方差分析与事后评估,p值<0.005。
    在本研究中,在测试的再矿化剂中,发现生物活性玻璃比β-三磷酸钙和氟化胺更有效。在这项研究中使用的去矿质剂中,可口可乐的去矿化潜力最高,其次是用β-磷酸三钙预处理的葡萄酒和绿茶,生物活性玻璃和氟化胺。
    本研究得出结论,发现所有测试的再矿化剂都能有效抑制由各种酒精和非酒精饮料引起的脱矿质。在测试的再矿化剂中,发现生物活性玻璃比β-磷酸三钙和氟化胺更有效。
    UNASSIGNED: The aim of this in vitro study is to quantitatively evaluate the effect of different alcoholic and non alcoholic beverages on the tooth enamel surface topography pretreated with various remineralizing agents using Atomic Force Microscopy.
    UNASSIGNED: 120 tooth specimens were prepared from 60 freshly extracted intact human premolars by sectioning from mesial to distal surfaces using low speed diamond discs and were randomly assigned to study groups and control group. Specimens of Group I, Group II and Group III were pre-treated with β-Tri calcium phosphate, bioactive glass and amine fluoride respectively for 4 minutes for 28 days, followed by storage in artificial saliva. All the specimens were evaluated for surface roughness using Atomic Force Microscopy. The specimens were then placed in alcoholic and non-alcoholic beverages for 10 minutes for 4 days and were again analyzed by Atomic Force Microscopy.Descriptive statistics was performed by using the proportional or frequency distribution of the parameters. The respondents were then grouped according to the branch of specialty if any and the data was evaluated by the one-way ANOVA with post-hoc, with p value <0.005.
    UNASSIGNED: In the present study, among the remineralizing agents tested, bioactive glass was found to be more effective than β-Tri Calcium Phosphate and Amine Fluoride. Among the demineralizing agents used in this study, the demineralization potential of Coca Cola was found to be highest, followed by wine and green tea pretreated with β-tricalcium phosphate, bioactive glass and amine fluoride.
    UNASSIGNED: The present study concluded that all the remineralizing agents tested were found to be effective in inhibiting the demineralization caused by various alcoholic and non alcoholic beverages. Among the remineralizing agents tested, bioactive glass was found to be more effective than β-tri calcium phosphate and amine fluoride.
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  • 文章类型: Journal Article
    一颗牙齿脱落后,牙槽骨吸收是不变的,使区域缺乏足够的骨质量和质量,以成功和令人满意的植入物或任何其他牙科治疗。为了治疗这种不可逆的骨质流失,骨移植是主要的解决方案和公认的技术。近年来,骨移植程序的使用有所增加。这篇综述是关于目前可用的各种骨移植技术和位置最佳的材料以及它们的王牌和局限性。在关于骨移植材料及其替代品的深入讨论中,一种合金材料比任何其他材料都表现出不败和最令人满意的性能,“磷酸二钙”(BCP)。BCP是羟基磷灰石(HA)和β-磷酸三钙(B-TCP)的混合物,通常通过在或高于700°C下烧结缺钙磷灰石(CDA)或通过其他方法如水解或沉淀获得。评论还显示了为了解效果而进行的比较研究,最充分的平衡,以及HA/B-TCP比率对性能的影响,结构,和这种材料的成功率。这篇综述的目的是启发目前最有可能使用的骨移植材料的主要特征,即,BCP。BCP最无可挑剔的特点是它的骨整合能力,这导致了一个优越的接口。这个界面描述了一个动态过程,包括物理化学反应,晶体-蛋白质相互作用,细胞和组织定植,和骨骼重塑。BCP具有某些基本特性,可以作为其优于任何其他替代品的优势。这些特性包括生物活性,骨整合,骨诱导,成骨,和生物降解,这主要是通过修改HA/B-TCP比率来控制的。BCP的其他应用是可行的,例如在药物管理和组织工程支架中。
    After a loss of a tooth, alveolar bone resorption is immutable, leaving the area devoid of sufficient bone quality and mass for a successful and satisfactory implant or any other dental treatment. To treat this problem of irreversible bone loss, bone grafting is the primary solution and a well-accepted technique. The use of bone grafting procedures has increased in recent years. This review is about the various bone grafting techniques and best-situated material available currently along with their trump cards and limitations. In the thorough discussion regarding bone grafting materials and their substitutes, one alloplastic material has shown unbeaten and the most satisfactory properties than any other material, \"bicalcium phosphate\" (BCP). BCP is a mixture of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) usually obtained through sintering calcium-deficient apatite (CDA) at or above 700°C or by other methods such as hydrolysis or precipitation. The review also shows comparative studies done to understand the effect, most adequate balance, and impact of ratios of HA/B-TCP on the properties, structure, and success rate of this material. The objective of the review is to enlighten the principal characteristic of the most likely used bone graft material presently, i.e., BCP. The most impeccable characteristic of BCP is its capability to osteointegrate, which results in a superior interface. This interface depicts a dynamic process that includes physicochemical reactions, crystal-protein interactions, cell and tissue colonization, and bone remodeling. BCP has certain essential properties that could be put forth as its advantage over any other substitute. These properties include bioactivity, osteointegration, osteoinduction, osteogenesis, and biodegradation, which are mostly governed by modifying the HA/B-TCP ratio. Other applications of BCP are feasible, such as in drug administration and scaffolds for tissue engineering.
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  • 文章类型: Journal Article
    背景:骨折和骨肿瘤手术后经常观察到骨缺损。他们的治疗在技术上很困难,有时会导致负面的临床和经济结果。修复骨缺损,通过从自体骨或人造骨中选择移植材料来植入骨移植物。每种方法都有其优点和缺点。与自体骨移植的金标准相比,骨移植替代物不受收获的移植物数量的限制,并且避免了供体部位的并发症。ORB-03是一种由β-磷酸三钙(β-TCP)和生物可吸收聚合物组成的新型棉状骨移植替代品,聚乳酸-羟基乙酸共聚物(PLGA)。ORB-03易于成型,可以填充各种骨缺损形状,其三维微纤维支架能增强成骨细胞分化,促进成骨。我们调查了疗效,易于处理,以及ORB-03作为骨移植替代物的安全性。一个多中心,开放标签,在6个机构进行了单组研究.
    方法:在2018年7月至2019年8月之间,60例骨折引起的骨缺损患者,良性肿瘤,本研究纳入了骨采集的髂骨供体部位;最终纳入了54例患者进行安全性分析,48例患者进行图像分析.手术期间,将ORB-03与患者的血液混合并塑造成骨缺损。为了评估ORB-03的功效,每隔一段时间进行X线摄影和计算机断层扫描(CT),直到手术后24周。
    结果:根据术后24周的疗效标准计算有效率及其准确的双侧95%置信区间(CI)。评估了在手术中处理ORB-03的容易性。评估手术后发生的不良事件,并检查了与ORB-03相关的那些。骨融合在所有情况下都很好,X线摄影和CT有效率分别为100.0%和91.5%,分别。在所有情况下处理都很容易。有四个不良事件,这些都不是临床问题。
    结论:发现ORB-03易于处理,安全,并有效作为骨缺损的骨移植替代品。
    BACKGROUND: Bone defects are often observed after surgery for fractures and bone tumors. Their treatment is technically difficult and sometimes results in negative clinical and economic outcomes. To repair bone defects, a bone graft is implanted by selecting a transplant material from an autologous or artificial bone. Each method has its advantages and disadvantages. Compared to the gold standard of autologous bone graft, bone graft substitutes are not limited by the amount of harvested graft and avoid complications at the donor site. ORB-03 is a new cotton-like bone graft substitute composed of beta-tricalcium phosphate (β-TCP) and a bioabsorbable polymer, polylactic-co-glycolic acid (PLGA). ORB-03 is easy to mold and can fill various bone defect shapes, and its three-dimensional microfiber scaffold can enhance the differentiation of osteoblasts and promote osteogenesis. We investigated the efficacy, ease of handling, and safety of ORB-03 as a bone graft substitute. A multicenter, open-label, single-group study was conducted at six institutions.
    METHODS: Between July 2018 and August 2019, 60 patients with bone defects caused by fracture, benign tumors, or an iliac donor site from bone harvesting were enrolled in this study; 54 patients were finally included for the safety analysis and 48 patients for the image analysis. During surgery, ORB-03 was mixed with the patient\'s blood and molded into a bone defect. To evaluate the efficacy of ORB-03, radiography and computed tomography (CT) were performed at intervals until 24 weeks after surgery.
    RESULTS: The effective rate and its accurate bilateral 95% confidence interval (CI) were calculated based on the efficacy criteria at 24 weeks postoperatively. The ease with which ORB-03 could be handled in surgery was evaluated. Adverse events that occurred after surgery were evaluated, and those associated with ORB-03 were examined. Bone fusion was good in all cases, and the radiography and CT effective rates were 100.0% and 91.5%, respectively. Handling was easy in all cases. There were four adverse events, none of which were clinically problematic.
    CONCLUSIONS: ORB-03 was found to be easy to handle, safe, and effective as a bone graft substitute for bone defects.
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  • 文章类型: Journal Article
    目的:先前的努力导致开发了两种具有抗菌光动力表面活性的用于牙周再生的不同聚合物生物材料。本研究旨在研究两种材料在绵羊模型中的骨整合和骨形成。
    方法:两种生物材料:1)基于氨基甲酸酯二甲基丙烯酸酯的生物材料1(BioM1)和2)基于三臂低聚酯-氨基甲酸酯甲基丙烯酸酯的生物材料2(BioM2)富含β-三磷酸钙和光敏剂内消旋四(羟基苯基)氯(mTHPC)。将这些材料植入绵羊股骨(n=16)和胫骨(n=8)的非关键尺寸骨缺损中。空缺陷作为对照(n=16)。在基线和3、6和12个月后进行荧光染料顺序骨标记。12个月后处死动物。固定骨标本(n=40),并进行显微断层扫描分析(µCT),以评估骨体积分数(BV/TV),小梁数量和小梁厚度。随后,安排组织学切片,并通过共聚焦激光扫描显微镜(cLSM)分析多荧光染料顺序骨标记。
    结果:cLSM分析显示,在研究期间的后半期(6-12个月)发生了最高的重建和骨形成活性。与BioM1(6.01±2.99%)和BioM2(6.45±2.12%)相比,对照组(2.71±1.26%)的胫骨骨形成显着降低;(p=0.006,p=0004)。显微计算机断层扫描显示,充满BioM1的股骨缺损中的BV/TV体积分数为44.72±9.01%,明显高于对照组(32.27±7.02%;p=0.01)。骨结构(小梁数量,小梁厚度)与自愈缺损没有显着差异。
    结论:两种生物材料,尤其是BioM1显示出良好的骨结合和骨形成特征,可推荐用于牙周再生研究中的进一步检查。
    OBJECTIVE: Previous efforts led to the development of two different polymeric biomaterials for periodontal regeneration with antibacterial photodynamic surface activity. The present study aimed to investigate osseointegration and bone formation of both materials in an ovine model.
    METHODS: Both biomaterials: 1) urethane dimethacrylate-based Biomaterial 1 (BioM1) and 2) tri-armed oligoester-urethane methacrylate-based Biomaterial 2 (BioM2) are enriched with beta-tri-calcium phosphate and the photosensitizer meso-tetra(hydroxyphenyl)chlorin (mTHPC). These materials were implanted in non-critical size bone defects in the sheep femur (n = 16) and tibia (n = 8). Empty defects served as controls (n = 16). Polyfluorochrome sequential bone labeling was carried out at baseline and after 3, 6, and 12 months. Animals were sacrificed after 12 months. Bone specimens (n = 40) were fixed and subjected to microtomographic analysis (µCT) for the evaluation of the bone-volume-fraction (BV/TV), trabecular number and trabecular thickness. Subsequently, histological sections were arranged and polyfluorochrome sequential bone labeling was analyzed by confocal laser scanning microscopy (cLSM).
    RESULTS: cLSM analysis revealed that highest remodeling and bone formation activity occurred during the second half of the study period (6-12 months). Bone formation in the tibia was significantly lower for the control (2.71 ± 1.26%) as compared to BioM1 (6.01 ± 2.99%) and BioM2 (6.45 ± 2.12%); (p = 0.006, p = 0004). Micro-computed tomography revealed a BV/TV volume fraction of 44.72 ± 9.01% in femur defects filled with BioM1 which was significantly higher compared to the control (32.27 ± 7.02%; p = 0.01). Bone architecture (trabecular number, trabecular thickness) did not significantly differ from the self-healed defects.
    CONCLUSIONS: Both biomaterials, especially BioM1 showed good osseointegration and bone formation characteristics and can be recommended for further examination in periodontal regeneration studies.
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