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支抗固位种植体早期负荷于下颌后牙区:一项前瞻性多中心研究的 3 年结果。

Early loading of splinted implants in posterior mandible: Three-year results of a prospective multicenter study.

机构信息

Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, China.

Department of Prosthodontics, Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China.

出版信息

Clin Oral Implants Res. 2019 Oct;30(10):1049-1058. doi: 10.1111/clr.13518. Epub 2019 Aug 16.

Abstract

OBJECTIVE

To evaluate the clinical outcomes of an early loading protocol of splinted implants with a fluoride-modified nanostructure surface and a tapered apex design for the therapy of posterior partial edentulism of mandible.

MATERIALS AND METHODS

One hundred and seven implants were placed in the mandible of 45 subjects at three centres in China. A minimum of two and a maximum of three implants were placed in an edentulous region using a one-stage protocol. Each subject received a screw-retained, splinted and fixed permanent prosthesis 6-8 weeks after surgery. Marginal bone level (MBL) change, implant survival and soft tissue health were assessed at 6, 12, 24 and 36 months after loading. A total of 92 implants from 40 subjects were recalled and investigated in this clinical trial.

RESULTS

After three-year loading, the survival rate of implant was 100%. On a subject level, there was a mean (±SD) marginal bone gain of 0.23 ± 0.48 mm at 36-month recall and the change in MBL was statistically significant (p = .00061) compared with time of loading. On an implant level, the change in MBL was statistically significant (p = .03914, p = .01494, p = .00000) at 12, 24 and 36 months of loading compared with time of loading.

CONCLUSION

Three-year data indicate that early loading protocol of splinted implants with a fluoride-modified nanostructure surface and a tapered apex design is feasible and safe for the therapy of partial edentulism in posterior mandible, which may contribute to bone gain when the suitable occlusal load and oral hygiene maintenance are kept.

摘要

目的

评估氟改性纳米结构表面和锥形尖端设计的带支架种植体的早期负载方案在治疗下颌后牙部分缺牙中的临床效果。

材料和方法

在中国的三个中心,45 名患者的下颌共植入了 107 枚种植体。采用一期手术方案,在无牙区植入 2 至 3 枚种植体。术后 6-8 周,每位患者均接受了螺丝固位、带支架和固定的永久修复体。在负载后 6、12、24 和 36 个月,评估边缘骨水平(MBL)变化、种植体存活率和软组织健康状况。本临床试验共召回并调查了 40 名受试者的 92 枚种植体。

结果

经过三年的负载,种植体的存活率为 100%。在个体水平上,在 36 个月的随访中,MBL 平均(±SD)有 0.23±0.48mm 的骨增量,与负载时间相比,变化具有统计学意义(p=.00061)。在种植体水平上,与负载时间相比,在 12、24 和 36 个月的负载时,MBL 的变化具有统计学意义(p=.03914,p=.01494,p=.00000)。

结论

三年的数据表明,氟改性纳米结构表面和锥形尖端设计的带支架种植体的早期负载方案对于治疗下颌后牙部分缺牙是可行且安全的,如果保持合适的咬合负荷和口腔卫生维护,可能有助于骨增量。

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