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Immediate non-occlusal versus delayed loading of mandibular first molars. Five-year results from a randomised controlled trial. 即刻非咬合与延迟上颌第一磨牙。随机对照试验的5年结果。
Q1 Dentistry Pub Date : 2018-01-01
Silvio Mario Meloni, Edoardo Baldoni, Marco Duvina, Milena Pisano, Giacomo De Riu, Marco Tallarico

Purpose: To compare outcomes of immediate non-occlusal loading with delayed implant loading in the bilateral replacement of mandibular first molars.

Materials and methods: This study was designed as a split-mouth, randomised controlled trial. Twenty patients with bilaterally missing mandibular first molars randomly received immediately or conventionally loaded single implants. One molar was restored with a non-occlusal temporary crown within 24 hours after implant placement (immediate loading group, IL) while the contralateral molar was restored with a definitive crown 4 to 5 months later (delayed loading group, DL). A total of 40 implants were installed. All implants were inserted in healed bone with an insertion torque between 35 and 45 Ncm. Outcome measures were implant failure, complications, radiographic marginal bone level changes, probing pocket depths (PPDs) and bleeding on probing (BOP). Clinical data were collected at implant placement, and after 6, 12 and 60 months.

Results: No patients dropped out and no implant failed. Only minor prosthetic complications were observed (two provisional acrylic crown fractures in the IL group and four ceramic chipping in the DL group). Two patients had bilateral peri-implant mucosal inflammation with BOP after 6 months. The differences between groups were not statistically significant (OR = 0.500; 95% CI: 0.045 to 3.489; P = 0.6831). At the 1-year follow-up examination, the mean marginal bone level was 0.83 ± 0.16 mm (95% CI: 0.75 to 0.91) in the IL group and 0.86 ± 0.16 mm (95% CI: 0.78 to 0.94) in the DL group, with no statistically significant differences between groups (difference = 0.03 ± 0.15 mm; 95% CI: -0.07 to 0.07; P = 0.53). After 5 years, mean marginal bone level was 1.06 ± 0.38 mm (95% CI: 0.97 to 1.15) in the IL group and 1.07 ± 0.32 mm (95% CI: 0.95 to 1.16) in the DL group, with no statistically significant differences between groups (difference = 0.01 ± 0.22 mm; 95% CI: -0.10 to 0.10; P = 0.96). The mean marginal bone loss after 5 years was 0.62 ± 0.45 mm in the IL group and 0.69 ± 0.33 mm in the DL group (difference = 0.07 ± 0.32 mm; 95% CI: -0.10 to 0.18; P = 0.567). At the 5-year follow-up the mean PPD and BOP values were 2.82 ± 0.65 mm and 1.17 ± 0.92 in the IL group, and 2.85 ± 0.53 mm and 1.17 ± 0.86 in the DL group, respectively. No significant differences were found (difference = 0.03 ± 0.15 mm; 95% CI: -0.15 to 0.21; P = 0.990; and 0.01 ± 0.07; 95% CI: -0.06 to 0.08; P = 1.000, respectively).

Conclusions: Within the limitations of this study, the present data seem to confirm the hypothesis that the clinical outcome of immediate versus delayed loading of implants in mandibular fist molar sites is comparable.

目的:比较即刻无咬合负荷与延迟种植体负荷在双侧下颌第一磨牙置换术中的效果。材料与方法:本研究采用裂口、随机对照试验设计。20例双侧下颌第一磨牙缺失患者随机接受即刻或常规单颗种植。其中一颗磨牙在种植后24小时内用无咬合临时冠修复(即刻加载组,IL),对侧磨牙在4 ~ 5个月后用确定冠修复(延迟加载组,DL)。总共安装了40个植入物。所有种植体均在愈合骨内植入,植入扭矩在35 ~ 45 Ncm之间。结局指标为种植体失败、并发症、x线片边缘骨水平改变、探针袋深度(PPDs)和探针出血(BOP)。在种植体放置时、6个月、12个月和60个月后收集临床数据。结果:无患者退出,无种植失败。仅观察到轻微的假体并发症(IL组2例临时丙烯酸冠骨折,DL组4例陶瓷碎裂)。2例患者6个月后出现双侧种植体周围粘膜炎症伴BOP。组间差异无统计学意义(OR = 0.500;95% CI: 0.045 ~ 3.489;P = 0.6831)。随访1年,IL组平均骨缘水平为0.83±0.16 mm (95% CI: 0.75 ~ 0.91), DL组平均骨缘水平为0.86±0.16 mm (95% CI: 0.78 ~ 0.94),组间差异无统计学意义(差异= 0.03±0.15 mm;95% CI: -0.07 ~ 0.07;P = 0.53)。5年后,IL组平均边缘骨水平为1.06±0.38 mm (95% CI: 0.97 ~ 1.15), DL组平均边缘骨水平为1.07±0.32 mm (95% CI: 0.95 ~ 1.16),组间差异无统计学意义(差异= 0.01±0.22 mm;95% CI: -0.10 ~ 0.10;P = 0.96)。IL组5年平均骨边缘丢失0.62±0.45 mm, DL组5年平均骨边缘丢失0.69±0.33 mm(差异= 0.07±0.32 mm;95% CI: -0.10 ~ 0.18;P = 0.567)。随访5年,IL组平均PPD和BOP分别为2.82±0.65 mm和1.17±0.92 mm, DL组平均PPD和BOP分别为2.85±0.53 mm和1.17±0.86。差异无统计学意义(差异= 0.03±0.15 mm;95% CI: -0.15 ~ 0.21;P = 0.990;0.01±0.07;95% CI: -0.06 ~ 0.08;P = 1.000)。结论:在本研究的局限性内,目前的数据似乎证实了在下颌第一磨牙位置立即和延迟加载种植体的临床结果是相似的假设。
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引用次数: 0
CBCT vs other imaging modalities to assess peri-implant bone and diagnose complications: a systematic review. CBCT与其他成像方式评估种植体周围骨和诊断并发症:系统回顾。
Q1 Dentistry Pub Date : 2018-01-01
Reinhilde Jacobs, Myrthel Vranckx, Tony Vanderstuyft, Marc Quirynen, Benjamin Salmon

Aim: The objective of this systematic review was to evaluate the diagnostic value of CBCT compared with 2D imaging and clinical gold standard techniques in peri-implant bone defect detection and measurement.

Materials and methods: Literature search was performed using MEDLINE, Embase and Web of Science databases up to July 2017. Clinical, ex vivo, in vitro and animal studies that assessed and measured peri-implant bone defects using different imaging modalities were included in this review. Two reviewers performed data extraction and qualitative analysis. The methodological quality of each study was reviewed using the QUADAS-2 tool.

Results: The initial search revealed 2849 unique papers. Full-text analysis was performed on 60 articles. For the present review, nine studies were considered eligible to be included for qualitative analysis. CBCT performed similar to intraoral radiography in mesiodistal defect detection and measurements. Additional buccolingual visualisation and volumetric and morphological assessment of peri-implant bone defects are major advantages of 3D visualisation with CBCT. Nevertheless, one must be aware of metal artefacts masking osseointegration, shallow bony defects and other peri-implant radiolucencies, thus impeding early diagnosis of intrabony lesions.

Conclusions: The present review did not provide evidence to support the use of CBCT as standard postoperative procedure to evaluate peri-implant bone. Up to date, we are clinically forced to remain with intraoral radiography, notwithstanding the inherent limitations related to restricted field of view and two-dimensional overlap. A 3D imaging approach for postoperative implant evaluation is crucial, making further development of an optimised and artefact-free CBCT protocol indispensable.

目的:本系统综述的目的是评价CBCT与二维成像和临床金标准技术在种植体周围骨缺损检测和测量中的诊断价值。材料与方法:检索截至2017年7月的MEDLINE、Embase和Web of Science数据库。本文综述了使用不同成像方式评估和测量种植体周围骨缺损的临床、离体、体外和动物研究。两名审稿人进行数据提取和定性分析。使用QUADAS-2工具对每项研究的方法学质量进行评估。结果:最初的搜索显示了2849篇独特的论文。对60篇文章进行全文分析。在本综述中,9项研究被认为有资格纳入定性分析。CBCT在中远端缺陷检测和测量方面的表现与口内x线摄影相似。额外的颊舌可视化和种植体周围骨缺损的体积和形态评估是CBCT三维可视化的主要优势。然而,人们必须意识到金属假物会掩盖骨整合、浅骨缺损和其他种植体周围的放射性,从而阻碍骨内病变的早期诊断。结论:本综述没有提供证据支持使用CBCT作为标准的术后程序来评估种植体周围骨。迄今为止,我们在临床上被迫继续使用口内x线摄影,尽管其固有的局限性与受限的视野和二维重叠有关。术后植入物评估的3D成像方法至关重要,这使得进一步开发优化的无伪影CBCT方案必不可少。
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引用次数: 0
Impact of asepsis technique on implant success. A review. 无菌技术对植入成功的影响。复习一下。
Q1 Dentistry Pub Date : 2018-01-01
Analia Veitz-Keenan, Debra M Ferraiolo, James R Keenan

Asepsis is described as a state free from microorganisms. In medicine, an aseptic environment is necessary and expected to avoid the spread of infection through contact between persons, sprays and splashes, inhalation, and sharps. Most dental procedures are performed in a "clean "environment with the common use of personal protective equipment (PPE) such as disposable gloves, masks and protective eyewear with disinfection of surfaces and sterilization of instruments. For surgical procedure such as the insertion of endosseous implants, the recommendations are not clear. The use of antimicrobials and antibiotics before and after the procedure remains a controversial issue The purpose of this literature review is to evaluate the current evidence as to what is generally expected and widely accepted in the use of aseptic techniques for the surgical placement of endosseous implants, and the impact on implant survival and overall success.

无菌被描述为没有微生物的状态。在医学中,无菌环境是必要的,并且可以避免通过人与人之间的接触、喷雾剂和飞溅物、吸入和尖锐物传播感染。大多数牙科手术是在“清洁”的环境中进行的,通常使用个人防护装备(PPE),如一次性手套、口罩和防护眼镜,并对表面进行消毒和对器械进行灭菌。对于外科手术,如植入术,建议尚不明确。手术前后抗菌剂和抗生素的使用仍然是一个有争议的问题。本文献综述的目的是评估目前的证据,即普遍期望和广泛接受使用无菌技术进行骨内植入物的手术放置,以及对植入物存活和总体成功的影响。
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引用次数: 0
Editorial. 社论。
Q1 Dentistry Pub Date : 2018-01-01
Marco Esposito, Reinhilde Jacobs, Michele Nieri
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引用次数: 0
Prosthetic complications with implant prostheses (2001-2017). 假体并发症(2001-2017)。
Q1 Dentistry Pub Date : 2018-01-01
Brian J Goodacre, Sarah E Goodacre, Charles J Goodacre

Aim: To present recent data regarding prosthetic complications with implant prostheses and crowns as well as compare this data with data presented in a 2003 publication.

Material and methods: An electronic Medline (PubMed) with MeSH terms search was performed, focussing on clinical studies that reported data on prosthetic complications associated with implant fixed complete dentures, implant overdentures, implant fixed partial dentures, and implant single crowns.

Results: There were nine prosthetic complications reported with implant fixed complete dentures, 17 with implant overdentures, four with implant fixed partial dentures, and six with implant single crowns. The greatest number of complications and the largest incidence of percentages occurred with implant overdentures. The lowest incidence percentages were recorded for implant single crowns. These findings are in agreement with the previous 2003 publication. It is of interest to note that some of the complications reported previously were not reported in this review, and some complications reported in this review were not listed in the 2003 publication, thereby limiting the number of direct comparisons between this paper and the earlier report. A surprising finding was that some complications associated with implant overdentures from the current data exceeded the incidence in 2003 (reactivation of the retentive attachment; mucosal hyperplasia; and the need for overdenture relines).

Conclusions: Implant overdentures are associated with more complications than implant fixed complete dentures, implant fixed partial dentures, and implant single crowns. The lowest incidence of complications was reported with implant single crowns. The most common complication reported with implant fixed complete dentures was denture tooth fracture. The most common complication associated with implant overdentures was the need for adjustments. Porcelain veneer fracture/chipping was the most common complication identified in the studies of implant fixed partial dentures. The most common complication reported with implant single crowns was abutment screw loosening.

目的:介绍种植体和牙冠并发症的最新数据,并将此数据与2003年发表的数据进行比较。材料和方法:通过电子医学检索(PubMed)进行MeSH术语搜索,重点关注与种植固定全口义齿、种植覆盖义齿、种植固定局部义齿和种植单冠相关的义肢并发症的临床研究。结果:种植固定全口义齿9例,种植覆盖义齿17例,种植固定局部义齿4例,种植单冠义齿6例。种植覆盖义齿的并发症最多,发生率最高。单冠种植体的发生率最低。这些发现与2003年发表的文章一致。值得注意的是,之前报道的一些并发症在本综述中没有报道,并且本综述中报道的一些并发症没有在2003年的出版物中列出,从而限制了本文与早期报道之间直接比较的数量。一个令人惊讶的发现是,从目前的数据来看,与种植覆盖义齿相关的一些并发症的发生率超过了2003年的发生率(固位附着体的重新激活;粘膜增生;以及对覆盖假牙线的需求)。结论:种植覆盖义齿并发症发生率高于种植固定全口义齿、种植固定局部义齿和种植单冠义齿。单冠种植的并发症发生率最低。种植固定全口义齿最常见的并发症是义齿断裂。种植覆盖义齿最常见的并发症是需要调整。烤瓷贴面断裂/脱落是种植固定部分义齿研究中最常见的并发症。单冠种植最常见的并发症是基牙螺钉松动。
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引用次数: 0
One-stage horizontal guided bone regeneration with autologous bone, anorganic bovine bone and collagen membranes: Follow-up of a prospective study 30 months after loading. 自体骨、无有机牛骨和胶原膜一期水平引导骨再生:加载后30个月的前瞻性研究随访。
Q1 Dentistry Pub Date : 2018-01-01
Silvio Mario Meloni, Sascha Alexander Jovanovic, Milena Pisano, Giacomo De Riu, Edoardo Baldoni, Marco Tallarico

Purpose: To present the medium-term results of one-stage guided bone regeneration (GBR) using autologous bone and anorganic bovine bone, placed in layers, in association with resorbable collagen membranes, for the reconstruction of horizontal bony defects.

Materials and methods: This study was designed as an uncontrolled prospective study. Partially edentulous patients, having less than 6.0 mm and more than 4.0 mm of residual horizontal bone width were selected and consecutively treated with simultaneously implant installation and bone regeneration by using 2.0 mm of autologous bone and 2.0 mm of anorganic bovine bone that was placed in layers and then covered with a resorbable collagen membrane. Outcome measures were: implant and prosthesis failures, any complications, peri-implant marginal bone level changes, probing pocket depth (PPD) and bleeding on probing (BOP).

Results: In total, 45 consecutive patients (20 male, 25 female) with a mean age of 52.1 years each received at least one GBR procedure, with contemporary placement of 63 implants. At the 3-year follow-up examination, no patient had dropped out and no deviation from the original protocol had occurred. No implant or prosthesis failed. In six patients (13.3%) the collagen membrane was slightly exposed 1 to 2 weeks after bone reconstruction. Four of these patients were moderate smokers. Post-hoc analysis using Fisher's exact test found significant association (P = 0.0139) between a smoking habit and early membrane exposure. Mean marginal bone loss experienced between initial loading and 30 months afterwards was 0.60 ± 0.20 mm (95% CI 0.54 - 0.66). The mean BOP values measured at the definitive restoration delivery were 1.23 ± 0.93, while 2 years later they were 1.17 ± 0.78. The difference was not statistically significant (-0.06 ± 0.76; P = 0.569). The mean PPD values measured at the definitive restoration delivery were 2.62 ± 0.59 mm, while 2 years later they were 2.60 ± 0.54 mm. The difference was not statistically significant (-0.03 ± 0.62; P = 0.765).

Conclusions: Within the limitations of the present study, the use of a 2.0 mm layer of particulated autologous bone on the implant threads, and a 2.0 mm layer of anorganic bovine to cover the resorbed ridge, in combination with the resorbable collagen membrane, seems to be a viable treatment option for the reconstruction of horizontal bony defects.

目的:介绍利用自体骨和无有机牛骨分层放置,结合可吸收胶原膜,一期引导骨再生(GBR)重建水平骨缺损的中期效果。材料和方法:本研究设计为非对照前瞻性研究。选择残余水平骨宽度小于6.0 mm和大于4.0 mm的部分无牙患者,采用2.0 mm的自体骨和2.0 mm的无有机牛骨分层放置,然后覆盖可吸收胶原膜,连续进行种植体安装和骨再生的同时治疗。结果测量:种植体和假体失败,任何并发症,种植体周围边缘骨水平改变,探针口袋深度(PPD)和探针出血(BOP)。结果:总共有45例患者(20例男性,25例女性),平均年龄52.1岁,每人接受至少一次GBR手术,同时放置63个种植体。在3年的随访检查中,没有患者退出,也没有发生偏离原方案的情况。无种植体或假体失败。6例(13.3%)患者在骨重建后1 ~ 2周有少量胶原膜暴露。其中4名患者是中度吸烟者。使用Fisher精确检验的事后分析发现,吸烟习惯与早期膜暴露之间存在显著关联(P = 0.0139)。从首次装载到30个月后的平均边缘骨损失为0.60±0.20 mm (95% CI 0.54 - 0.66)。最终修复交付时测量的平均BOP值为1.23±0.93,而2年后测量的BOP值为1.17±0.78。差异无统计学意义(-0.06±0.76;P = 0.569)。最终修复交付时测得的平均PPD值为2.62±0.59 mm, 2年后测得的平均PPD值为2.60±0.54 mm。差异无统计学意义(-0.03±0.62;P = 0.765)。结论:在本研究的限制范围内,在种植体螺纹上使用2.0 mm的颗粒化自体骨层,并使用2.0 mm的无机牛骨层覆盖可吸收的嵴,结合可吸收的胶原膜,似乎是重建水平骨缺损的可行治疗选择。
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引用次数: 0
Long-term clinical outcome of implants with different surface modifications. 不同表面修饰种植体的长期临床效果。
Q1 Dentistry Pub Date : 2018-01-01
Ann Wennerberg, Tomas Albrektsson, Bruno Chrcanovic

The aim of the present systematic review was to evaluate reported survival rate and marginal bone (MBL) loss of implants with different surface roughness and followed up for 10 years or longer. For the majority of the 62 included clinical studies, no direct comparison between different surfaces was made, thus our report is mainly based on reported survival rates and marginal bone loss for individual implant brands with known surface roughness. The survival rate was 82.9 to 100% for all implants after 10 or more years in function and the marginal bone loss was, on average, less than 2.0 mm for all implant surfaces included, i.e. turned, titanium plasma sprayed (TPS), blasted, anodised, blasted and acid-etched but the turned surface in general demonstrated the smallest MBL. However, the survival rates were in general higher for moderately rough surfaces. The roughest TPS surface demonstrated the highest probability for failure, while the anodised showed the lowest probability. In conclusion, the present systematic review demonstrates that it is possible to achieve very good long-term results with all types of included surfaces.

本系统综述的目的是评估不同表面粗糙度种植体的存活率和边缘骨(MBL)损失,并随访10年或更长时间。在纳入的62项临床研究中,大多数没有对不同表面进行直接比较,因此我们的报告主要基于已知表面粗糙度的单个种植体品牌的报告存活率和边际骨质流失。所有种植体在使用10年或更长时间后的存活率为82.9至100%,所有种植体表面(即旋转、钛等离子喷涂(TPS)、喷砂、阳极氧化、喷砂和酸蚀)的边际骨损失平均小于2.0 mm,但旋转表面通常表现出最小的MBL。然而,对于中等粗糙的表面,存活率一般较高。最粗糙的TPS表面失效概率最高,而阳极氧化的TPS表面失效概率最低。总之,目前的系统综述表明,所有类型的包含表面都有可能获得非常好的长期结果。
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引用次数: 0
Editorial: The European Journal of Oral Implantology becomes the International Journal of Oral Implantology Editorial. 社论:《欧洲口腔种植杂志》改为《国际口腔种植杂志》。
Q1 Dentistry Pub Date : 2018-01-01
Marco Esposito
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引用次数: 0
Computer-guided vs freehand placement of immediately loaded dental implants: 5-year postloading results of a randomised controlled trial. 计算机引导与徒手放置立即加载的牙种植体:加载后5年的随机对照试验结果
Q1 Dentistry Pub Date : 2018-01-01
Marco Tallarico, Marco Esposito, Erta Xhanari, Marco Caneva, Silvio Mario Meloni

Purpose: To compare planning and patient rehabilitation using 3D implant planning software and dedicated surgical templates with conventional freehand implant placement for the rehabilitation of partially or fully edentulous patients using flapless or mini-flap procedures and immediate loading.

Materials and methods: Patients requiring at least two implants to be restored with a single prosthesis, having at least 7 mm of bone height and 4 mm in bone width were consecutively enrolled. Patients were randomised according to a parallel group study design into two groups: computerguided group or conventional freehand group. Implants were loaded immediately with a provisional prosthesis, replaced by a definitive prosthesis 4 months later. Outcome measures assessed by a blinded independent assessor were: implant and prosthesis failures, any complications, marginal bone levels, number of treatment sessions, duration of treatment, post-surgical pain and swelling, consumption of pain killers, surgical and prosthetic time, time required to solve complications, and patient satisfaction. Patients were followed up to 5 years after loading.

Results: Ten patients (32 implants) were randomised to the computer-guided group and 10 patients (30 implants) were randomised to the freehand group. At the 5-year follow-up examination one patient of the computer-guided group and one of the freehand group dropped-out (both moved to another country). No prostheses failed during the entire follow-up. Two implants failed in the conventional group (6.6%) vs none in the computer-guided group (P = 0.158). Ten patients (five in each group) experienced 11 complications (six in the computer-guided group and five in the freehand group), that were successfully solved. Differences between groups for implant failures and complications were not statistically significant. Five years after loading, the mean marginal bone loss was 0.87 mm ± 0.40 (95% CI: 0.54 to 1.06 mm) in the computer-guided group and 1.29 mm ± 0.31 (95% CI: 1.09 to 1.51 mm) in the freehand group. The difference was statistically significant (difference 0.42 mm ± 0.54; 95% CI: 0.05 to 0.75; P = 0.024). Patient self-reported post-surgical pain (P = 0.037) and swelling (P = 0.007) were found to be statistically significant higher in patients in the freehand group. Number of sessions from patient's recruitment to delivery of the definitive prosthesis, number of days from the initial CBCT scan to implant placement, consumption of painkillers, averaged surgical, prosthetic, and complication times, were not statistically significant different between the groups. At the 5-year followup, all the patients were fully satisfied with the function and aesthetics of their definitive prostheses.

Conclusions: Both approaches achieved successful results over the 5-year follow-up period. Statistically higher post-operative pain and swelling were experi

目的:比较使用3D种植体规划软件和专用手术模板与传统徒手种植体放置在部分或完全无牙患者中使用无瓣或迷你瓣手术和立即加载的康复计划和患者康复。材料与方法:连续入组骨高不低于7mm,骨宽不低于4mm,且需要至少两个种植体使用单个假体修复的患者。患者按照平行组研究设计随机分为两组:计算机引导组和传统徒手组。种植体立即装载临时假体,4个月后更换最终假体。由盲法独立评估者评估的结果指标包括:种植体和假体失败、任何并发症、边缘骨水平、治疗次数、治疗持续时间、术后疼痛和肿胀、止痛药的消耗、手术和假体时间、解决并发症所需的时间和患者满意度。患者在加载后随访5年。结果:10例患者(32个种植体)随机分为计算机引导组,10例患者(30个种植体)随机分为徒手组。在5年的随访检查中,电脑指导组和徒手组各有一名患者退出(两人都搬到了另一个国家)。在整个随访期间没有假体失败。常规组2例植入失败(6.6%),计算机引导组1例失败(P = 0.158)。10例患者(每组5例)出现11例并发症(电脑引导组6例,徒手组5例),均成功解决。两组间种植体失败和并发症的差异无统计学意义。加载后5年,计算机引导组的平均边缘骨丢失为0.87 mm±0.40 (95% CI: 0.54 ~ 1.06 mm),徒手组的平均边缘骨丢失为1.29 mm±0.31 (95% CI: 1.09 ~ 1.51 mm)。差异有统计学意义(差异0.42 mm±0.54;95% CI: 0.05 ~ 0.75;P = 0.024)。徒手组患者自我报告的术后疼痛(P = 0.037)和肿胀(P = 0.007)有统计学意义。从患者招募到交付最终假体的疗程数,从初始CBCT扫描到植入假体的天数,止痛药的消耗,平均手术,假体和并发症时间,两组之间没有统计学上的显著差异。在5年的随访中,所有患者对最终假体的功能和美观都非常满意。结论:在5年的随访期间,两种方法均取得了成功的效果。统计上,徒手皮瓣抬高部位术后疼痛和肿胀较高。在5年的随访中,计算机引导组观察到较少的边缘骨丢失(0.4 mm)。
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引用次数: 0
Early loading of maxillary titanium implants with a nanostructured calcium-incorporated surface (Xpeed): 5-year results from a multicentre randomised controlled trial. 上颌钛种植体纳米结构钙结合表面(Xpeed)的早期加载:来自多中心随机对照试验的5年结果。
Q1 Dentistry Pub Date : 2017-01-01
Giorgio Gastaldi, Maria Gabriella Grusovin, Pietro Felice, Carlo Barausse, Daniela Rita Ippolito, Marco Esposito

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: In total, 60 patients were randomised to receive one to six titanium 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 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: A total of 30 patients received 45 calcium-incorporated implants and 30 patients were given 42 control titanium implants. Five years after loading, eight patients dropped-out from the Xpeed group and nine left the RBM group. No prosthesis or implant failures occurred. Two patients were affected by three complications in the Xpeed group vs five patients from the RBM group, who experienced eight complications; the difference between groups being not statistically significant different (P = 0.187; difference in proportions = 14.7%; 95% CI: -10.7% to 39.4%). Five years after loading patients with Xpeed implants lost on average 1.19 ± 0.48 mm of peri-implant marginal bone vs 1.43 ± 0.98 mm of patients with RBM implants, the difference being not statistically significant (P = 0.35; mean difference: -0.23 mm; 95% CI: -0.73 to 0.27 mm).

Conclusions: Both implant surfaces provided good clinical results and no significant difference was found when comparing titanium implants with a nanostructured calcium-incorporated surface with implants with an RBM surface. Conflict-of-interest statement: MegaGen partially supported this trial and donated the implants and prosthetic components. The study design was negotiated with MegaGen Implant Co, Gyeongbuk, South Korea, however, data property belonged to the authors and by no means did MegaGen interfere with the conduct of the trial or the publication of its results.

目的:评价一种新型含钙钛种植体的临床安全性和有效性(Xpeed, MegaGen implant Co. Limited, Gyeongbuk, South Korea)。材料和方法:根据两个中心的平行组设计,总共有60名患者被随机分配在上颌骨接受1至6个钛种植体,其中包括钙结合(Xpeed)或对照可吸收爆破介质(RBM)表面。20名患者分别在12周、10周和8周时,在三个不同的终点浸泡和暴露植入物。在2周内,植入物被功能加载临时或最终假体。结果测量假体失败、种植体失败、任何并发症和种植体周围边缘骨水平变化。结果:30例患者接受45颗钙结合种植体,30例患者接受42颗对照种植体。5年后,8名患者退出了Xpeed组,9名患者退出了RBM组。无假体或种植体失效。Xpeed组2例患者出现3种并发症,RBM组5例患者出现8种并发症;组间差异无统计学意义(P = 0.187;比例差异= 14.7%;95% CI: -10.7%至39.4%)。加载5年后,Xpeed种植体患者种植体周围边缘骨平均损失1.19±0.48 mm, RBM种植体患者种植体周围边缘骨平均损失1.43±0.98 mm,差异无统计学意义(P = 0.35;平均差值:-0.23 mm;95% CI: -0.73 ~ 0.27 mm)。结论:两种种植体表面均具有良好的临床效果,纳米结构钙结合表面钛种植体与RBM表面钛种植体比较无明显差异。利益冲突声明:MegaGen部分支持该试验,并捐赠了植入物和假体部件。研究设计是与韩国庆北MegaGen Implant Co .协商完成的,但数据所有权归作者所有,MegaGen没有干涉试验的进行或结果的发表。
{"title":"Early loading of maxillary titanium implants with a nanostructured calcium-incorporated surface (Xpeed): 5-year results from a multicentre randomised controlled trial.","authors":"Giorgio Gastaldi,&nbsp;Maria Gabriella Grusovin,&nbsp;Pietro Felice,&nbsp;Carlo Barausse,&nbsp;Daniela Rita Ippolito,&nbsp;Marco Esposito","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate clinical safety and effectiveness of a novel calcium-incorporated titanium implant (Xpeed, MegaGen Implant Co. Limited, Gyeongbuk, South Korea).</p><p><strong>Materials and methods: </strong>In total, 60 patients were randomised to receive one to six titanium 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 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.</p><p><strong>Results: </strong>A total of 30 patients received 45 calcium-incorporated implants and 30 patients were given 42 control titanium implants. Five years after loading, eight patients dropped-out from the Xpeed group and nine left the RBM group. No prosthesis or implant failures occurred. Two patients were affected by three complications in the Xpeed group vs five patients from the RBM group, who experienced eight complications; the difference between groups being not statistically significant different (P = 0.187; difference in proportions = 14.7%; 95% CI: -10.7% to 39.4%). Five years after loading patients with Xpeed implants lost on average 1.19 ± 0.48 mm of peri-implant marginal bone vs 1.43 ± 0.98 mm of patients with RBM implants, the difference being not statistically significant (P = 0.35; mean difference: -0.23 mm; 95% CI: -0.73 to 0.27 mm).</p><p><strong>Conclusions: </strong>Both implant surfaces provided good clinical results and no significant difference was found when comparing titanium implants with a nanostructured calcium-incorporated surface with implants with an RBM surface. Conflict-of-interest statement: MegaGen partially supported this trial and donated the implants and prosthetic components. The study design was negotiated with MegaGen Implant Co, Gyeongbuk, South Korea, however, data property belonged to the authors and by no means did MegaGen interfere with the conduct of the trial or the publication of its results.</p>","PeriodicalId":49259,"journal":{"name":"European Journal of Oral Implantology","volume":"10 4","pages":"415-424"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35651337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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European Journal of Oral Implantology
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