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传统钻与压电手术准备在上颌无牙颌中植入四颗即刻负重颧骨肿瘤种植体的比较:1年分口随机对照试验结果

Conventional drills vs piezoelectric surgery preparation for placement of four immediately loaded zygomatic oncology implants in edentulous maxillae: results from 1-year split-mouth randomised controlled trial.

作者信息

Esposito Marco, Barausse Carlo, Balercia Andrea, Pistilli Roberto, Ippolito Daniela Rita, Felice Pietro

出版信息

Eur J Oral Implantol. 2017;10(2):147-158.

Abstract

PURPOSE

To compare the outcome of site preparation for zygomatic oncology implants using conventional preparation with rotary drills or piezoelectric surgery with dedicated inserts for placing two zygomatic implants per zygoma according to a split-mouth design.

MATERIALS AND METHODS

Twenty edentulous patients with severely atrophic maxillas not having sufficient bone volume for placing dental implants and less than 4 mm of bone height subantrally had their hemi-maxillas randomised according to a split-mouth design into implant site preparation with conventional rotational drills or piezoelectric surgery. Two zygomatic oncology implants (unthreaded coronal portion) were placed in each hemi-maxilla. Implants that achieved an insertion torque superior to 40 Ncm were immediately loaded with screw-retained metal reinforced acrylic provisional prostheses. Outcome measures were: prosthesis and implant failures, any complications, time to place the implants, presence of post-operative haematoma, and patient's preference by independent assessors. All patients were followed up to 1 year after loading.

RESULTS

In two patients drills had also to be used at the piezoelectric surgery side to enable implant sites to be prepared. One implant for the conventional drill group did not achieve an insertion torque superior to 40 Ncm since it fractured the zygoma. No patients dropped out and two distal oncology implants failed in the same patient (one per group), who was not prosthetically rehabilitated. Six complications occurred at drilled sites and three at piezoelectric surgery sites (two patients had bilateral complications), the difference being not statistically significant (P (McNemar's test) = 0.375; odds ratio = 4.00; 95% CI of odds ratio: 0.45 to 35.79). Implant placement with convention drills took on average 14.35 ± 1.76 min and with piezoelectric surgery 23.50 ± 2.26 min, implant placement time being significantly shorter with conventional drilling (difference = 9.15 ± 1.69 min; 95%CI: 8.36 to 9.94 min; P < 0.001). Post-operative haematomas were more frequent at drilled sites (P = 0.001), and 16 patients found both techniques equally acceptable, while four preferred piezoelectric surgery (P = 0.125).

CONCLUSIONS

Both drilling techniques achieved similar clinical results, but conventional drilling required 9 min less and could be used in all instances, although it was more aggressive. These results may be system-dependent, therefore they cannot be generalised to other zygomatic systems with confidence. Conflict-of-interest statement: This study was partially supported by Southern Implants (Irene, South Africa), the manufacturer of the zygomatic implants and the conventional drills evaluated in this study. However, data property belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of its results. Drs Felice and Pistilli developed the piezoelectric surgery zygomatic insert used in the present study.

摘要

目的

采用传统旋转钻制备种植位点与使用专用刀片的压电手术按照双侧对照设计为每侧颧骨植入两枚颧骨肿瘤种植体,比较二者的效果。

材料与方法

20例上颌骨严重萎缩的无牙患者,其骨量不足以植入牙种植体且上颌窦下骨高度不足4 mm,根据双侧对照设计将其半侧上颌骨随机分为使用传统旋转钻或压电手术进行种植位点制备。每侧半侧上颌骨植入两枚颧骨肿瘤种植体(无螺纹冠状部)。植入扭矩超过40 Ncm的种植体立即用螺丝固位的金属增强丙烯酸临时义齿加载。观察指标包括:义齿和种植体失败情况、任何并发症、种植体植入时间、术后血肿的发生情况以及独立评估者对患者偏好的评价。所有患者在加载后随访1年。

结果

两名患者在压电手术侧也需使用钻头以制备种植位点。传统钻组有一枚种植体因导致颧骨骨折而未达到超过40 Ncm的植入扭矩。无患者退出研究,同一患者的两枚远端肿瘤种植体失败(每组各一枚),该患者未进行修复。传统钻制备位点出现6例并发症,压电手术位点出现3例并发症(两名患者双侧均有并发症),差异无统计学意义(P(McNemar检验)= 0.375;优势比 = 4.00;优势比的95%置信区间:0.45至35.79)。使用传统钻植入种植体平均耗时14.35 ± 1.76分钟,压电手术为23.50 ± 2.26分钟,传统钻植入种植体的时间明显更短(差异 = 9.15 ± 1.69分钟;95%置信区间:8.36至9.94分钟;P < 0.001)。术后血肿在传统钻制备位点更常见(P = 0.001),16例患者认为两种技术均可接受,4例患者更倾向于压电手术(P = 0.125)。

结论

两种钻孔技术均取得了相似的临床效果,但传统钻孔耗时少9分钟且在所有情况下均可使用,尽管其操作更具侵入性。这些结果可能因系统而异,因此不能自信地推广到其他颧骨系统。利益冲突声明:本研究部分由Southern Implants(南非艾琳)资助,该公司为本研究中评估的颧骨种植体和传统钻的制造商。然而,数据所有权属于作者,制造商绝未干预试验的进行或结果的发表。费利斯博士和皮斯蒂利博士研发了本研究中使用的压电手术颧骨刀片。

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