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经皮质和侧窦底提升的放射学结果:一项双中心、平行臂随机试验的一年结果。

Radiographic outcomes of transcrestal and lateral sinus floor elevation: One-year results of a bi-center, parallel-arm randomized trial.

机构信息

Operative Unit of Dentistry, University-Hospital of Ferrara, Ferrara, Italy.

Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Ferrara, Italy.

出版信息

Clin Oral Implants Res. 2019 Sep;30(9):910-919. doi: 10.1111/clr.13497. Epub 2019 Jul 10.

DOI:10.1111/clr.13497
PMID:31240743
Abstract

OBJECTIVES

To comparatively evaluate the radiographic outcomes of transcrestal and lateral sinus floor elevation (tSFE and lSFE, respectively) when applied concomitantly with implant placement.

MATERIALS AND METHODS

Patients with at least 1 edentulous site with residual bone height (RBH) of 3-6 mm were enrolled in a bi-center, parallel-arm, randomized trial. Both tSFE and lSFE were associated with a bovine-derived xenograft, and implants were inserted concomitantly. In lSFE group, the antrostomy was covered with a resorbable collagen membrane. Marginal bone loss and the maturation of the grafted area were evaluated on periapical radiographs at 6 and 12 months. Twelve-month CT/CBCT was used to assess the effect of grafting procedures circumferentially around the implant. A per-protocol analysis was performed.

RESULTS

The per-protocol study population consisted of 26 patients in the tSFE group and 28 patients in the lSFE group. At 12 months, the median proportion of the implant surface in contact with the peri-implant radiopaque area was 100% in both groups, with no significant inter-group difference. Suboptimal bone-to-implant contact was observed in 13% and 3.6% of tSFE and lSFE cases, respectively. In both groups, marginal bone loss was minimal (≤1 mm) and infrequent, and the radiographic aspect was suggestive of an advanced stage of maturation.

CONCLUSIONS

At sites with RBH of 3-6 mm where implants are placed concomitantly with sinus floor elevation, tSFE and lSFE are both highly predictable in obtaining an implant surface completely embedded in a radiopaque area at 12 months post-surgery. (ClinicalTrials.gov ID: NCT02415946).

摘要

目的

比较经嵴顶和外侧窦底提升(分别为 tSFE 和 lSFE)与种植体同期植入时的影像学结果。

材料与方法

本研究纳入了至少有 1 个牙槽嵴顶高度(RBH)为 3-6mm 的无牙颌患者,采用双中心、平行臂、随机试验。tSFE 和 lSFE 均与牛来源的异种移植物联合应用,并同期植入种植体。在 lSFE 组,窦底开窗处覆盖可吸收胶原膜。在术后 6 个月和 12 个月,根尖片评估边缘骨吸收和移植物区域的成熟情况。12 个月时的 CT/CBCT 用于评估种植体周围环绕移植术的效果。进行了符合方案分析。

结果

符合方案研究人群包括 tSFE 组 26 例和 lSFE 组 28 例患者。在 12 个月时,两组的种植体表面与种植体周围不透射线区域的接触比例均为 100%,组间无显著差异。tSFE 和 lSFE 组分别有 13%和 3.6%的病例出现不理想的骨-种植体接触。两组的边缘骨吸收均最小(≤1mm)且少见,影像学表现提示处于成熟的晚期阶段。

结论

在 RBH 为 3-6mm 的部位,当种植体与窦底提升同期植入时,tSFE 和 lSFE 在术后 12 个月时均能高度预测获得完全埋入不透射线区域的种植体表面。(ClinicalTrials.gov 注册号:NCT02415946)。

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