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在非人灵长类动物模型中评估抗压胶原蛋白基质软组织填充的安全性和有效性。

Evaluation of the Safety and Efficacy of Soft Tissue Augmentation With a Compressive-Resistant Collagen Matrix in a Nonhuman Primate Model.

作者信息

Herford Alan S, Nguyen Katina, Miller Meagan, Tandon Rahul, Signorino Fabrizio

机构信息

Professor and Chair, Department of Oral and Maxillofacial Surgery, Loma Linda University, Loma Linda, CA.

Resident, Department of Oral and Maxillofacial Surgery, Loma Linda University, Loma Linda, CA.

出版信息

J Oral Maxillofac Surg. 2019 Mar;77(3):615-628. doi: 10.1016/j.joms.2018.08.025. Epub 2018 Sep 1.

DOI:10.1016/j.joms.2018.08.025
PMID:30267705
Abstract

PURPOSE

The purpose of the present study was to evaluate the safety and efficacy of the compression-resistant collagen-based cross-linked matrix for augmentation of maxillary and mandibular soft tissue defects in an animal model.

MATERIALS AND METHODS

Six rhesus macaque monkeys were subjected to soft tissue grafting in 4 sites intraorally; the anterior maxilla was subjected to hard and soft tissue grafting with implant placement. Each site was randomly assigned 1 of 3 treatments: a compressive-resistant collagen matrix membrane (CM), a subepithelial connective tissue autograft (SCTG), or sham treatment, in which a partial-thickness flap was elevated and then sutured closed with no further treatment (control). The following methods were used for data collection: in vivo evaluation by periodontal probing, ultrasound, shear modulus elasticity, polyether impressions for volumetric analysis, and in vitro analysis by histologic biopsy examinations. In vitro analysis provided by histologic measurements and evaluations was performed on nondecalcified sections. The follow-up period was 6 months.

RESULTS

The SCTG and CM showed favorable tissue integration. No adverse reaction to or deviation from the normal healing processes was detected. The CM integrated well in all sites, with a variable range of soft tissue volume increases. Volumetric discrepancies were appreciated in the histologic analyses and differences were found when the CM and SCTG were applied in the anterior maxilla in combination with hard tissue grafting and implant placement. Histologic evaluation showed favorable integration, no immunogenic response to the CM, and stable volumetric retention in autograft and CM sites during the experimental period.

CONCLUSION

The compressive-resistant CM could be a safe and efficacious alternative for soft tissue augmentation by obviating a donor site and the consequent morbidity. Although a similar performance between the CM and SCTG was observed, further studies will be necessary to estimate the clinical potentiality and describe the limits of the technique.

摘要

目的

本研究旨在评估抗压性胶原基交联基质用于在动物模型中增大上颌和下颌软组织缺损的安全性和有效性。

材料与方法

对6只恒河猴进行口腔内4个部位的软组织移植;对上颌前部进行硬组织和软组织移植并植入种植体。每个部位随机分配3种治疗方法中的1种:抗压性胶原基质膜(CM)、上皮下结缔组织自体移植(SCTG)或假治疗,即掀起部分厚度皮瓣然后缝合关闭,不再进行进一步治疗(对照)。采用以下方法收集数据:通过牙周探诊、超声、剪切模量弹性进行体内评估,用聚醚印模进行体积分析,以及通过组织学活检检查进行体外分析。由组织学测量和评估提供的体外分析在未脱钙切片上进行。随访期为6个月。

结果

SCTG和CM显示出良好的组织整合。未检测到对正常愈合过程的不良反应或偏差。CM在所有部位均整合良好,软组织体积增加范围各异。在组织学分析中观察到体积差异,并且当CM和SCTG与硬组织移植和种植体植入联合应用于上颌前部时发现了差异。组织学评估显示整合良好,对CM无免疫原性反应,并且在实验期间自体移植部位和CM部位的体积保持稳定。

结论

抗压性CM通过避免供区及随之而来的发病率,可能是软组织增大的一种安全有效的替代方法。尽管观察到CM和SCTG之间有相似的性能,但仍需要进一步研究来评估其临床潜力并描述该技术的局限性。

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