一项为期 3 年的前瞻性随机临床试验，评估了使用两种不同同种异体骨移植材料进行牙槽嵴保存后 4 个月植入种植体的临床功能 1、2 和 3 年时牙槽嵴顶反应和临床参数。
A 3-year prospective randomized clinical trial of alveolar bone crest response and clinical parameters through 1, 2, and 3 years of clinical function of implants placed 4 months after alveolar ridge preservation using two different allogeneic bone-grafting materials.
机构信息
Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Specialty Dental Practice Limited to Periodontology and Implant Dentistry, Hamburg, Germany.
出版信息
Int J Implant Dent. 2022 Feb 1;8(1):5. doi: 10.1186/s40729-022-00402-w.
PURPOSE
The aim of this study was to longitudinally evaluate changes in alveolar bone crest (ABC) levels and differences in resorption rates (RR) between the tested grafting materials following alveolar ridge preservation (ARP) after tooth extraction after 1, 2, and 3 years (T1-T8) of clinical function.
METHODS
Patients were randomly assigned to two different bone allografts (group 1 maxgraft, group 2 Puros) for ARP. Non-restorable teeth were minimal traumatically extracted. Sockets were augmented with the tested materials and covered with a pericardium membrane. After 4 months of healing, 36 implants were placed and sites were clinically and radiographically monitored in the mesial (ABC-M), the distal (ABC-D, T1-T8), the bucco-lingual (ABC-BL), buccal (ABC-B) and oral (ABC-O) aspect (T1-T4).
RESULTS
Changes in (ABC-M), (ABC-D), (ABC-BL), (ABC-B), and (ABC-O) levels showed statistically highly significant differences between T1 and T2 for both bone allografts (p < 0.001). Changes at the ABC-M and ABC-BL levels between T2 and T3 of group 1 showed a statistically significant difference (p < 0.001). Both groups achieved and maintained increased ABC levels without statistically significant differences throughout the monitoring periods of 1-3 years (T6-T8) of clinical function. No failures or adverse events were observed.
CONCLUSIONS
To the best of our knowledge, this study is within its limitations the first study to directly compare ABC-changes and differences in RR of two different allogeneic grafting materials for a period of 3 years after ARP. It was demonstrated to be, despite significant differences in RR, a successful method of preserving increased ABC levels through 1, 2, and 3 years of clinical function. Trial registration DRKS00013010, registered 07/30/2018, http://apps.who.int/trialsearch.
目的
本研究旨在纵向评估拔牙后牙槽嵴保存（ARP）后，经过 1、2、3 年（T1-T8）临床功能，两种测试移植物的牙槽嵴顶（ABC）水平变化和吸收率（RR）差异。
方法
患者被随机分配到两种不同的同种异体骨移植物（组 1 maxgraft，组 2 Puros）进行 ARP。非保留牙齿微创拔除。用测试材料进行牙槽窝扩增，并覆盖心包膜。愈合 4 个月后，植入 36 颗种植体，并在近中（ABC-M）、远中（ABC-D，T1-T8）、颊舌（ABC-BL）、颊侧（ABC-B）和口内（ABC-O）方向（T1-T4）进行临床和放射学监测。
结果
两种同种异体骨移植物在 T1 与 T2 之间，（ABC-M）、（ABC-D）、（ABC-BL）、（ABC-B）和（ABC-O）水平的变化均具有统计学高度显著差异（p<0.001）。组 1 在 T2 与 T3 之间，ABC-M 和 ABC-BL 水平的变化具有统计学显著差异（p<0.001）。两组在 1-3 年（T6-T8）的临床功能监测期间，均实现并维持 ABC 水平增加，无统计学显著差异。未观察到失败或不良反应。
结论
据我们所知，本研究在其局限性内，首次直接比较了两种不同同种异体移植物材料在 ARP 后 3 年的 ABC 变化和 RR 差异。结果表明，尽管 RR 存在显著差异，但该方法仍是一种成功的方法，可以通过 1、2、3 年的临床功能，维持 ABC 水平的增加。试验注册 DRKS00013010，于 2018 年 7 月 30 日注册，http://apps.who.int/trialsearch。
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