Two techniques for the preparation of cell-scaffold constructs suitable for sinus augmentation: Steps into clinical application
Two techniques for the preparation of cell-scaffold constructs suitable for sinus augmentation: Steps into clinical application
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DOI：
10.1089/ten.2006.12.2649
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发表时间：
2006-09-01
影响因子：
--
通讯作者：
Wiltfang, Jorg
中科院分区：
文献类型：
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作者：
Springer, Ingo N.;Nocini, Pier F.;Wiltfang, Jorg
本临床试验的目的是分析2种自体骨移植工程方法，用于上颌窦提升并二期种植体植入。第1组（8例患者，12个鼻窦）：下颌骨骨膜细胞培养在良好的生产实践实验室（2周）与自体血清，然后转移到胶原基质。一周后，这些复合材料被移植到鼻窦中。2A组（2例患者，3个鼻窦），取上颌骨细胞，用自体血清培养2周，接种于直径8 mm的天然骨矿（NBM）块上，继续培养1.5个月。这些复合材料被移植到鼻窦中。2B组（对照组，3例患者，5个鼻窦）仅接受NBM阻滞。在种植体植入6个月（第1组）和8个月（第2组）后，进行芯活检。第1组的临床随访期为1至2.5年，第2A和2B组的临床随访期约为7年。在所有病例中发现新的活骨，组1中的中位密度为38%（n = 12），组2A中的中位密度为32%（n = 3），组2B中的中位密度为25%（n = 5）。第1组和第2B组以及第2A组和第2B组之间的差异具有统计学显著性（p = 0.025）。未见不良反应。所描述的所有方法都能够产生具有足够稳定性的新骨组织，以成功植入种植体。
The objective of this clinical trial was the analysis of 2 methods for engineering of autologous bone grafts for maxillary sinus augmentation with secondary implant placement. Group 1 (8 patients, 12 sinuses): cells of mandibular periosteum were cultured in a good manufacturing practice laboratory (2 weeks) with autologous serum and then transferred onto a collagen matrix. After another week, these composites were transplanted into the sinuses. In group 2A (2 patients, 3 sinuses), cells of maxillary bone were cultivated with autologous serum for 2 weeks, seeded onto natural bone mineral (NBM, diameter [O] 8 mm) blocks, and cultivated for another 1.5 months. These composites were transplanted into the sinuses. Group 2B (control, 3 patients, 5 sinuses) received NBM blocks alone. In the course of implant placement 6 (group 1) and 8 (group 2) months later, core biopsy were taken. Clinical follow-up period was 1 to 2.5 years in group 1 and approximately 7 years in groups 2A and 2B. New vital bone was found in all cases at median densities of 38% (n = 12) in group 1, 32% in group 2A (n = 3), and 25% in group 2B (n = 5). Differences between group 1 and 2B as well as 2A and 2B were statistically significant (p = 0.025). No adverse effects were seen. All methods described were capable of creating new bone tissue with sufficient stability for successful implant placement.