单相比双相 β-TCP 在两段式鼻窦提升术中的应用——一项前瞻性随机临床试验。

Monophasic ß-TCP vs. biphasic HA/ß-TCP in two-stage sinus floor augmentation procedures - a prospective randomized clinical trial.

机构信息

Private Practice, Opatja, Croatia.

Department of Craniomaxillofacial and Plastic Surgery, University Hospital of Cologne, Cologne, Germany.

出版信息

Clin Oral Implants Res. 2017 Oct;28(10):e175-e183. doi: 10.1111/clr.12983. Epub 2016 Sep 29.

DOI:10.1111/clr.12983

PMID:27683073

Abstract

OBJECTIVES

To compare a monophasic (100% ß-TCP) and a biphasic (60% HA and 40% ß-TCP) bone substitute material (BSM) regarding biocompatibility, osteoconductivity and implant stability using histological, radiological and resonance frequency analysis.

MATERIAL AND METHODS

Sixty-seven sinus floor elevations were performed in 60 patients. One patient group (monophasic bone substitute [MBS], 30 patients, 32 sinuses) was augmented by the use of the monophasic material (Bioresorb , Sybron Implant Solutions, Bremen, Germany), while the second group (biphasic bone substitute (BBS), 30 patients, 35 sinuses) received a biphasic material (Maxresorb , Botiss Biomaterials, Berlin, Germany). Cone beam CT images were taken immediately after augmentation and prior to implant placement after 6 months. Trephines were harvested, while the implant bed was prepared. Resonance frequency analysis was performed immediately after implant placement and 6 months later. Descriptive analysis was performed on all augmented sinus (n = 67). For statistical comparison of the groups, one sinus of each bilaterally treated patient was randomly excluded, resulting in 30 sinuses grafted with MBS and 30 sinuses grafted with BBS (n = 60).

RESULTS

Histomorphometrical analysis of all sinuses displayed comparable results for both groups regarding new bone matrix (MBS 36.16 ± 19.37%, BBS 38.42 ± 12.61%), residual BSM (MBS 30.26 ± 11.7%, BBS 32.66 ± 12.57%) and non-mineralized tissue (MBS 34.29 ± 18.32%, BBS 28.92 ± 15.04) %) (P > 0.05, respectively). Radiological volume of BBS was significantly more stable (volume loss of 22.2% for MBS, 6.66% for BBS; P < 0.001), and homogeneity of the graft after 6 months was higher for BBS than that for MBS (P < 0.05). Resonance frequency analysis endorsed a higher implant stability quotient for BBS after 6 months than that for MBS (MBS 78.31 ± 5.81, BBS 80.42 ± 6.31; P < 0.05, Mann-Whitney U-test, respectively).

CONCLUSION

Both monophasic and biphasic materials show good biocompatibility and osteoconductivity with satisfactory support on implant stability. BBS remains more stable in terms of volume maintenance and radiological graft homogeneity after a healing period of 6 months.

摘要

目的

通过组织学、影像学和共振频率分析比较单相（100%β-TCP）和双相（60%HA 和 40%β-TCP）骨替代材料（BSM）的生物相容性、骨诱导性和植入物稳定性。

材料和方法

在 60 名患者中进行了 67 例鼻窦提升术。一组患者（单相骨替代物 [MBS]，30 名患者，32 个窦腔）使用单相材料（Bioresorb，Sybron Implant Solutions，不来梅，德国）进行了增强，而第二组患者（双相骨替代物 [BBS]，30 名患者，35 个窦腔）使用了双相材料（Maxresorb，Botiss Biomaterials，柏林，德国）。在增强后立即和 6 个月后植入前拍摄锥形束 CT 图像。在准备植入物时取出环钻。在植入后立即和 6 个月后进行共振频率分析。对所有增强窦（n=67）进行描述性分析。为了对两组进行统计学比较，从双侧治疗的每位患者中随机排除一个窦，从而得到 30 个用 MBS 增强的窦和 30 个用 BBS 增强的窦（n=60）。

结果

对两组所有窦的组织形态计量学分析显示，新骨基质方面的结果相似（MBS 36.16±19.37%，BBS 38.42±12.61%），残余 BSM（MBS 30.26±11.7%，BBS 32.66±12.57%）和非矿化组织（MBS 34.29±18.32%，BBS 28.92±15.04%）（分别为 P>0.05）。BBS 的影像学体积稳定性明显更高（MBS 体积损失 22.2%，BBS 体积损失 6.66%；P<0.001），6 个月后 BBS 移植物的均匀性高于 MBS（P<0.05）。共振频率分析显示，6 个月后 BBS 的种植体稳定性商数高于 MBS（MBS 78.31±5.81，BBS 80.42±6.31；P<0.05，Mann-Whitney U 检验）。