一项使用SocketKAP(™)和SocketKAGE(™)评估牙槽嵴保存和修复的开放性随机对照临床试验：第1部分——研究模型的三维体积软组织分析
An open randomized controlled clinical trial to evaluate ridge preservation and repair using SocketKAP(™) and SocketKAGE(™) : part 1-three-dimensional volumetric soft tissue analysis of study casts.
作者信息
Zadeh Homayoun H, Abdelhamid Alaa, Omran Mostafa, Bakhshalian Neema, Tarnow Dennis
机构信息
Laboratory for Immunoregulation and Tissue Engineering (LITE), Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.
Dental Research Center (DRC) and Tissue Engineering and Biomaterials Research Unit (TEBRU), Qassim College of Dentistry, Qassim University, Qassim, Saudi Arabia.
出版信息
Clin Oral Implants Res. 2016 Jun;27(6):640-9. doi: 10.1111/clr.12714. Epub 2015 Nov 2.
OBJECTIVES
The aims of this study were to evaluate (i) the efficacy of ridge preservation and repair involving SocketKAP(™) and SocketKAGE(™) devices following tooth removal; and (ii) ridge contour changes at 6 months post-extraction in intact sockets and sockets with dehiscence defects.
MATERIAL AND METHODS
Thirty-six patients required a total of 61 teeth to be extracted. Five cohorts were established with groups A-C involving intact sockets and groups D and E involving facial dehiscence: (A) Negative Control; (B) SocketKAP(™) alone; (C) Anorganic Bovine Bone Mineral (ABBM) + SocketKAP(™) ; (D) Negative Control; and (E) ABBM + SocketKAP(™) + SocketKAGE(™) . Preoperative CBCT and laser-scanned casts were obtained. Teeth segmented from preoperative CBCT were merged with study cast images to allow for digital removal of teeth from the casts. Volumetric measurements of ridge contour were performed. Images of preoperative and 6 months post-operative casts were superimposed to measure ridge contour changes.
RESULTS
Post-extraction contour loss occurred in all sockets primarily in the crestal 3 mm but was also detected up to 6 mm from alveolar crest. For intact sockets, SocketKAP(™) or SocketKAP(™) + ABBM interventions led to greater percentages of remaining ridge contour when compared to controls. A significant difference favoring SocketKAP(™) + SocketKAGE(™) + ABBM treatment was observed for sockets with facial dehiscence when compared to controls.
CONCLUSION
SocketKAP(™) , with or without ABBM, significantly limited post-extraction ridge contour loss in intact sockets. In the absence of a group treated with only the SocketKAGE(™) , it is not possible to determine its efficacy, although the combination of SocketKAGE(™) + SocketKAP(™) + ABBM was effective in limiting post-extraction ridge contour loss in sockets with dehiscence defects.
目的
本研究旨在评估：（i）拔牙后使用SocketKAP(™)和SocketKAGE(™)装置进行牙槽嵴保存和修复的疗效；以及（ii）完整牙槽窝和存在骨开裂缺损的牙槽窝在拔牙后6个月时牙槽嵴轮廓的变化。
材料与方法
36例患者共需要拔除61颗牙齿。建立了五个队列，A - C组涉及完整牙槽窝，D组和E组涉及面部骨开裂：（A）阴性对照组；（B）仅使用SocketKAP(™)组；（C）无机牛骨矿物质（ABBM）+ SocketKAP(™)组；（D）阴性对照组；（E）ABBM + SocketKAP(™) + SocketKAGE(™)组。获取术前CBCT和激光扫描模型。将术前CBCT中分割出的牙齿与研究模型图像合并，以便从模型上进行数字化拔牙。进行牙槽嵴轮廓的体积测量。将术前和术后6个月模型的图像叠加以测量牙槽嵴轮廓变化。
结果
所有牙槽窝拔牙后轮廓均有丧失，主要发生在牙槽嵴顶3mm处，但在距牙槽嵴顶6mm处也有发现。对于完整牙槽窝，与对照组相比，SocketKAP(™)或SocketKAP(™) + ABBM干预导致剩余牙槽嵴轮廓的百分比更高。与对照组相比，对于存在面部骨开裂的牙槽窝，观察到SocketKAP(™) + SocketKAGE(™) + ABBM治疗有显著差异。
结论
无论有无ABBM，SocketKAP(™)均能显著限制完整牙槽窝拔牙后的牙槽嵴轮廓丧失。由于没有仅使用SocketKAGE(™)治疗的组，所以无法确定其疗效，尽管SocketKAGE(™) + SocketKAP(™) + ABBM的组合在限制存在骨开裂缺损的牙槽窝拔牙后牙槽嵴轮廓丧失方面是有效的。
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