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萎缩性后牙颌骨增量骨中4毫米长与更长种植体的比较:一项多中心随机对照试验的加载后4个月结果

Four mm-long versus longer implants in augmented bone in atrophic posterior jaws: 4-month post-loading results from a multicentre randomised controlled trial.

作者信息

Esposito Marco, Zucchelli Giovanni, Barausse Carlo, Pistilli Roberto, Trullenque-Eriksson Anna, Felice Pietro

出版信息

Eur J Oral Implantol. 2016;9(4):393-409.

PMID:27990507
Abstract

PURPOSE

To evaluate whether 4-mm long dental implants could be an alternative to augmentation with equine bone blocks and the placement of at least 10-mm long implants in atrophic posterior jaws.

MATERIALS AND METHODS

Forty patients with atrophic posterior (premolar and molar areas) mandibles having 5 to 6 mm bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 5 mm below the maxillary sinus, were randomised according to a parallel group design to receive one to three 4.0 mm-long implants or one to three implants, which were at least 10 mm long, in augmented bone at two centres. All implants had a diameter of 4.0 or 4.5 mm. Mandibles were vertically augmented with interpositional equine bone blocks and resorbable barriers. Implants were placed 4 months after interpositional grafting. Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers, and implants were placed simultaneously. Implants were not submerged and were loaded after 4 months with provisional prostheses. Four months later, screw-retained reinforced acrylic restorations were delivered, and then replaced after 4 months by definitive screw-retained metal-composite prostheses. Patients were followed up to 4-months post-loading. Outcome measures included prosthesis and implant failures, any complication and peri-implant marginal bone level changes.

RESULTS

No patient dropped out. In six augmented mandibles (30%), it was not possible to place implants which were at least 10.0-mm long, therefore shorter implants had to be placed instead. In particular, one mandible fractured and the patient did not want to go ahead with the treatment. One implant of the patient with the mandible fracture from the augmented group failed versus two 4.0 mm implants in two patients from the short implant group. In the maxillae, three short implants failed in two patients versus five long implants in three patients (two long implants and one short implant dropped into the maxillary sinus). Two prostheses on short implants (one mandibular and one maxillary) were placed at a later stage because of implant failures versus four prostheses (one mandibular and three maxillary) at augmented sites. In particular, three patients of the augmented group (one mandible and two maxillary) were not prosthetically rehabilitated. There were no statistically significant differences in implant failures (P (chi-square test) = 1.000; difference in proportion = 0; 95% Cl: -0.13 to 0.13 or prostheses failures (P (chi-square test) = 0.399; difference in proportion = 0.05; 95% Cl: -0.06 to 0.16). At mandibular sites, nine augmented patients were affected by complications versus one patient treated with short implants (P (chi-square test) = 0.003; difference in proportion = 0.40; 95% Cl: 0.16 to 0.64), with the difference being statistically significant. No significant differences were found for the maxillae: eight sinus lift patients versus three patients rehabilitated with maxillary short implants were affected by complications (P (chi-square test) = 0.077; difference in proportion = 0.25; 95% Cl: -0.02 to 0.52). Patients with mandibular short implants lost on average 0.40 mm of peri-implant bone at 4 months and patients with 10 mm or longer mandibular implants lost 0.52 mm. Patients with short maxillary implants lost on average 0.48 mm peri-implant bone at 4 months and patients with 10 mm or longer maxillary implants lost 0.50 mm. The difference was statistically significant in the mandibles (mean difference: -0.12 mm, 95% CI: -0.20 to -0.04, P (ANCOVA) = 0.006), but not in the maxillae (mean difference: -0.02 mm, 95% CI: -0.10 to 0.07, P (ANCOVA) = 0.711).

CONCLUSIONS

Four months after loading 4.0 mm-long implants achieved similar results, if not better, than longer implants in augmented jaws, but were affected by fewer complications. Short implants might be a preferable choice to bone augmentation, especially in mandibles, since the treatment is less invasive, faster, cheaper, and associated with less morbidity; however, 5- to 10-year post-loading data is necessary before making reliable recommendations. Conflict-of-interest statement: Global-D (Brignais, France) partially supported this trial and donated the implants and prosthetic components; however, data property belonged to the authors and by no means did Global-D interfere with the conduct of the trial or the publication of the results.

摘要

目的

评估4毫米长的牙种植体是否可替代马骨块植骨以及在萎缩性后牙颌中植入至少10毫米长的种植体。

材料与方法

40例下颌后牙区(前磨牙和磨牙区)萎缩且下颌管上方骨高度为5至6毫米的患者,以及40例上颌窦下方骨高度为4至5毫米的上颌骨萎缩患者,根据平行组设计随机分组,在两个中心接受一至三颗4.0毫米长的种植体,或在植骨后接受一至三颗至少10毫米长的种植体。所有种植体直径为4.0或4.5毫米。下颌骨通过置入马骨块和可吸收屏障进行垂直植骨。在置入性植骨4个月后植入种植体。上颌窦通过经覆盖可吸收屏障的侧窗置入颗粒状猪骨进行植骨,并同时植入种植体。种植体不进行埋入,4个月后用临时修复体加载。4个月后,交付螺丝固位的增强丙烯酸修复体,4个月后再由最终的螺丝固位金属复合修复体替代。对患者进行加载后4个月的随访。观察指标包括修复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

无患者退出。在6例植骨的下颌骨(30%)中,无法植入至少10.0毫米长的种植体,因此不得不植入较短的种植体。特别是,1例下颌骨骨折,患者不想继续治疗。植骨组下颌骨骨折患者的1颗种植体失败,而短种植体组2例患者的2颗4.0毫米种植体失败。在上颌骨中,2例患者的3颗短种植体失败,而3例患者的5颗长种植体失败(2颗长种植体和1颗短种植体掉入上颌窦)。由于种植体失败,短种植体上的2个修复体(1个下颌和1个上颌)在后期放置,而植骨部位为4个修复体(1个下颌和3个上颌)。特别是,植骨组的3例患者(1例下颌和2例上颌)未进行修复。种植体失败率(P(卡方检验)=1.000;比例差异=0;95%CI:-0.13至0.13)或修复体失败率(P(卡方检验)=0.399;比例差异=0.05;95%CI:-0.06至0.16)无统计学显著差异。在下颌部位,9例植骨患者出现并发症,而短种植体治疗的患者为1例(P(卡方检验)=0.003;比例差异=0.40;95%CI:0.16至0.64),差异具有统计学显著性。在上颌骨中未发现显著差异:8例上颌窦提升患者与3例上颌短种植体修复患者出现并发症(P(卡方检验)=0.077;比例差异=0.25;95%CI:-0.02至0.52)。下颌短种植体患者在4个月时种植体周围骨平均吸收0.40毫米,下颌10毫米或更长种植体患者吸收0.52毫米。上颌短种植体患者在4个月时种植体周围骨平均吸收0.48毫米,上颌10毫米或更长种植体患者吸收0.50毫米。在下颌骨中差异具有统计学显著性(平均差异:-0.12毫米,95%CI:-0.20至-0.04,P(协方差分析)=0.006),但在上颌骨中无差异(平均差异:-0.02毫米,95%CI:-0.10至0.07,P(协方差分析)=0.711)。

结论

加载后4个月,4.0毫米长的种植体在植骨颌中取得了相似甚至更好的效果,且并发症更少。短种植体可能是植骨的更优选择,尤其是在下颌骨,因为该治疗侵入性更小、速度更快、成本更低且发病率更低;然而,在做出可靠推荐之前,需要5至10年的加载后数据。利益冲突声明:Global-D(法国布里尼亚)部分支持了该试验,并捐赠了种植体和修复部件;然而,数据所有权属于作者,Global-D绝未干扰试验的进行或结果的发表。

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