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一项评估原位形成的合成可生物降解膜用于犬引导性骨再生的可行性研究。

A feasibility study evaluating an in situ formed synthetic biodegradable membrane for guided bone regeneration in dogs.

作者信息

Jung Ronald E, Lecloux Geoffrey, Rompen Eric, Ramel Christian F, Buser Daniel, Hammerle Christoph H F

机构信息

Department of Fixed and Removable Prothodontics and Dental Material Science, University of Zurich, Zurich, Switzerland.

出版信息

Clin Oral Implants Res. 2009 Feb;20(2):151-61. doi: 10.1111/j.1600-0501.2008.01633.x.

Abstract

PURPOSE

The aim was (1) to evaluate the soft-tissue reaction of a synthetic polyethylene glycol (PEG) hydrogel used as a barrier membrane for guided bone regeneration (GBR) compared with a collagen membrane and (2) to test whether or not the application of this in situ formed membrane will result in a similar amount of bone regeneration as the use of a collagen membrane.

MATERIAL AND METHODS

Tooth extraction and preparation of osseous defects were performed in the mandibles of 11 beagle dogs. After 3 months, 44 cylindrical implants were placed within healed dehiscence-type bone defects resulting in approximately 6 mm exposed implant surface. The following four treatment modalities were randomly allocated: PEG+autogenous bone chips, PEG+hydroxyapatite (HA)/tricalcium phosphate (TCP) granules, bioresorbable collagen membrane+autogenous bone chips and autogenous bone chips without a membrane. After 2 and 6 months, six and five dogs were sacrificed, respectively. A semi-quantitative evaluation of the local tolerance and a histomorphometric analysis were performed. For statistical analysis, repeated measures analysis of variance (ANOVA) and subsequent pairwise Student's t-test were applied (P<0.05).

RESULTS

No local adverse effects in association with the PEG compared with the collagen membrane was observed clinically and histologically at any time-point. Healing was uneventful and all implants were histologically integrated. Four out of 22 PEG membrane sites revealed a soft-tissue dehiscence after 1-2 weeks that subsequently healed uneventful. Histomorphometric measurement of the vertical bone gain showed after 2 months values between 31% and 45% and after 6 months between 31% and 38%. Bone-to-implant contact (BIC) within the former defect area was similarly high in all groups ranging from 71% to 82% after 2 months and 49% to 91% after 6 months. However, with regard to all evaluated parameters, the PEG and the collagen membranes did not show any statistically significant difference compared with sites treated with autogenous bone without a membrane.

CONCLUSION

The in situ forming synthetic membrane made of PEG was safely used in the present study, revealing no biologically significant abnormal soft-tissue reaction and demonstrated similar amounts of newly formed bone for defects treated with the PEG membrane compared with defects treated with a standard collagen membrane.

摘要

目的

本研究旨在(1)评估用作引导骨再生(GBR)屏障膜的合成聚乙二醇(PEG)水凝胶与胶原膜相比的软组织反应,以及(2)测试这种原位形成的膜的应用是否会产生与使用胶原膜相似的骨再生量。

材料与方法

在11只比格犬的下颌骨中进行拔牙及骨缺损制备。3个月后,在愈合的裂开型骨缺损内植入44枚圆柱形种植体,使种植体表面约6mm暴露。随机分配以下四种治疗方式:PEG+自体骨屑、PEG+羟基磷灰石(HA)/磷酸三钙(TCP)颗粒、可吸收胶原膜+自体骨屑以及无膜的自体骨屑。2个月和6个月后,分别处死6只和5只犬。进行局部耐受性的半定量评估和组织形态计量分析。统计分析采用重复测量方差分析(ANOVA)及随后的两两Student t检验(P<0.05)。

结果

在任何时间点,与胶原膜相比,PEG均未观察到临床和组织学上的局部不良反应。愈合过程顺利,所有种植体在组织学上均实现整合。22个PEG膜部位中有4个在1 - 2周后出现软组织裂开,随后顺利愈合。垂直骨增量的组织形态计量测量显示,2个月时的值在31%至45%之间,6个月时在31%至38%之间。在原缺损区域内,所有组的骨与种植体接触(BIC)同样较高,2个月后在71%至82%之间,6个月后在49%至91%之间。然而,就所有评估参数而言,与无膜自体骨治疗部位相比,PEG膜和胶原膜均未显示出任何统计学上的显著差异。

结论

本研究中安全使用了由PEG制成的原位形成合成膜,未发现具有生物学意义的异常软组织反应,并且与标准胶原膜治疗的缺损相比,PEG膜治疗的缺损显示出相似数量的新形成骨。

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