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采用新型含纳米结构钙钛表面的5×5毫米种植体或在增量骨中使用更长种植体支持的假体修复后牙萎缩颌骨。一项随机对照试验的一年结果。

Posterior atrophic jaws rehabilitated with prostheses supported by 5 x 5 mm implants with a novel nanostructured calcium-incorporated titanium surface or by longer implants in augmented bone. One-year results from a randomised controlled trial.

作者信息

Pistilli Roberto, Felice Pietro, Piattelli Maurizio, Gessaroli Manlio, Soardi Elisa, Barausse Carlo, Buti Jacopo, Corvino Valeria

出版信息

Eur J Oral Implantol. 2013 Winter;6(4):343-57.

Abstract

PURPOSE

To evaluate whether 5 × 5 mm dental implants with a novel nanostructured calciumincorporated titanium surface could be an alternative to implants at least 10 mm long placed in bone augmented with bone substitutes in posterior atrophic jaws.

MATERIALS AND METHODS

A total of 40 patients with atrophic posterior (premolar and molar areas) mandibles having 5 to 7 mm of bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 6 mm below the maxillary sinus, were randomised according to a parallel group design to receive one to three 5 mm implants or one to three at least 10 mm-long implants in augmented bone at two centres. All implants had a diameter of 5 mm. Mandibles were vertically augmented with interpositional bovine bone blocks and resorbable barriers. Implants were placed after 4 months. Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously. All implants were submerged and loaded after 4 months with provisional prostheses. Four months later, definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered. Patients were followed up to 1 year post-loading and the outcome measures were prosthesis and implant failures, any complications and peri-implant marginal bone level changes.

RESULTS

One maxillary grafted patient dropped out before the 1-year evaluation. In mandibles, 1 grafted patient did not want to go ahead with the treatment because of multiple complications and graft failure, and another grafted patient did not receive his prostheses due the loss of 2 implants. In maxillae, one 5 × 5 mm implant failed with its provisional crown 3 months post-loading. There were no statistically significant differences in prostheses and implant failures. Significantly more complications occurred at both mandibular and maxillary grafted sites: 17 augmented patients were affected by complications versus 8 patients treated with short implants in the mandible (P = 0.0079; difference in proportion = -0.45; 95% CI -0.67 to -0.15), and 5 sinus-lift patients versus none treated with maxillary short implants (P = 0.047; difference in proportion = -0.25; 95% CI -0.44 to -0.06). Patients with mandibular short implants lost on average 0.94 mm of peri-implant bone at 1 year and patients with 10 mm or longer mandibular implants lost 1.03 mm. Patients with maxillary short implants lost on average 0.87 mm of peri-implant bone at 1 year and patients with 10 mm or longer maxillary implants lost 1.15 mm. There were no statistically significant differences in bone level changes up to 1 year between short and longer implants in maxillae (mean difference -0.28 mm, 95% CI -0.56 to 0.01, P = 0.051) and in mandibles (mean difference -0.09 mm, 95% CI -0.26 to 0.08, P = 0.295).

CONCLUSIONS

One year after loading, 5 × 5 mm implants achieved similar results compared to longer implants placed in augmented bone. Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster, cheaper and associated with less morbidity, however 5 to 10 years of post-loading data are necessary before making reliable recommendations.

CONFLICT-OF-INTEREST STATEMENT: MegaGen partially supported this trial and donated implants and prosthetic components used in this study, whereas Tecnoss donated the biomaterials. The data belonged to the authors and by no means did the manufacturers interfere with the conduct of the trial or the publication of its results.

摘要

目的

评估一种新型纳米结构含钙钛表面的5×5毫米牙科种植体是否可替代至少10毫米长的种植体,后者植入后牙萎缩颌骨中用骨替代物增强的骨内。

材料与方法

共有40例下颌后牙区(前磨牙和磨牙区)萎缩患者,下颌管上方骨高度为5至7毫米,以及40例上颌萎缩患者,上颌窦下方骨高度为4至6毫米,根据平行组设计随机分组,在两个中心接受一至三颗5毫米种植体或一至三颗至少10毫米长的种植体植入增强骨内。所有种植体直径均为5毫米。下颌骨通过植入牛骨块和可吸收屏障进行垂直增强。4个月后植入种植体。上颌窦通过外侧窗口用颗粒状猪骨增强,覆盖可吸收屏障,同时植入种植体。所有种植体均为潜入式,4个月后用临时假体加载。4个月后,交付最终的螺丝固位或临时粘结的金属陶瓷或氧化锆假体。对患者进行加载后1年的随访,观察指标包括假体和种植体失败情况、任何并发症以及种植体周围边缘骨水平变化。

结果

1例上颌植骨患者在1年评估前退出。在下颌骨中,1例植骨患者因多种并发症和植骨失败而不想继续治疗,另1例植骨患者因2颗种植体丢失未接受假体。在上颌骨中,1颗5×5毫米种植体在加载后3个月与其临时冠一起失败。假体和种植体失败情况无统计学显著差异。在下颌骨和上颌骨植骨部位发生的并发症明显更多:17例增强患者受到并发症影响,而下颌骨中接受短种植体治疗的患者为8例(P = 0.0079;比例差异 = -0.45;95%可信区间 -0.67至 -0.15),上颌窦提升患者为5例,而上颌短种植体治疗患者无并发症(P = 0.047;比例差异 = -0.25;95%可信区间 -0.44至 -0.06)。下颌短种植体患者在1年时种植体周围骨平均吸收0.94毫米,下颌10毫米或更长种植体患者骨吸收1.03毫米。上颌短种植体患者在1年时种植体周围骨平均吸收0.87毫米,上颌10毫米或更长种植体患者骨吸收1.15毫米。上颌骨和下颌骨中短种植体和长种植体在1年时骨水平变化无统计学显著差异(平均差异 -0.28毫米,95%可信区间 -0.56至0.01,P = 0.051)以及(平均差异 -0.09毫米,95%可信区间 -0.26至0.08,P = 0.295)。

结论

加载后1年,5×5毫米种植体与植入增强骨内的较长种植体取得了相似的结果。短种植体可能是骨增强的更优选择,尤其是在下颌后牙区,因为治疗更快、更便宜且发病率更低,然而在做出可靠推荐之前,还需要5至10年的加载后数据。

利益冲突声明

MegaGen部分支持了该试验,并捐赠了本研究中使用的种植体和修复部件,而Tecnoss捐赠了生物材料。数据属于作者,制造商绝未干扰试验的进行或结果的发表。

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