Division of Restorative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Graz, Austria.
Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Graz, Austria.
Clin Oral Implants Res. 2024 Feb;35(2):155-166. doi: 10.1111/clr.14209. Epub 2023 Nov 21.
To assess in a prospective randomized trial two phycogenic bone substitutes-biphasic calcium phosphate (BCP) versus almost pure hydroxyapatite (HA)-for their volume stability and clinical implications after sinus floor elevation (SFE).
Twenty patients requiring lateral-window SFE 6 months prior to implant surgery were randomized to a BCP or HA group. As primary outcome, the grafts were analyzed for volume stability, using four cone-beam computed tomography scans obtained immediately/6/12/24 months after SFE. Secondary outcomes were implant survivval, success, periotest values, oral-health-related quality of life (OHIP-G14), and pain (VAS).
Kolmogorov-Smirnov goodness-of-fit test revealed normal distribution of samples (p = .200). At 6/12/24 months, the augmented volumes decreased to 96/92/90% (HA) or 99/96/96% (BCP). Volume changes were significantly a factor of time (p < .001; generalized linear model with repeated measures) and reached significantly lower values in HA group (p = .018). Significant intergroup difference in volume losses was notable at 24 months (p = .021; t-test for independent samples). Periotest values decreased from -3/-4.1 (HA/BCP) after implant placement to -6.3/-4.5 (HA/BCP) after 6 months. OHIP scores diverged at 2 months (HA: 9.5; BCP: 5.2) and largely resolved by 24 months (HA: 1.3; BCP: 1.9). VAS scores were comparable, 2.2 at 1 week after SFE being their highest mean level.
After 2 years, both groups experienced no biological or technical complications, demonstrating a consistent healing trajectory without notable symptoms. Although no significant differences were observed in implant stability and survival, BCP demonstrated higher volume stability than HA.
在一项前瞻性随机试验中评估两种藻酸钙骨替代物（BCP）与近乎纯羟基磷灰石（HA）在鼻窦提升（SFE）后的体积稳定性及其临床意义。
20 名需要在植入手术前 6 个月进行侧开窗 SFE 的患者被随机分为 BCP 或 HA 组。主要结果是使用 SFE 后即刻/6/12/24 个月获得的 4 次锥形束 CT 扫描，分析移植物的体积稳定性。次要结果是种植体存活率、成功率、牙周测试值、口腔健康相关生活质量（OHIP-G14）和疼痛（VAS）。
Kolmogorov-Smirnov 拟合优度检验显示样本呈正态分布（p=0.200）。在 6/12/24 个月时，增强体积分别减少到 96/92/90%（HA）或 99/96/96%（BCP）。体积变化是时间的显著因素（p<0.001；重复测量的广义线性模型），HA 组的数值明显更低（p=0.018）。24 个月时，两组间的体积损失存在显著差异（p=0.021；独立样本 t 检验）。种植体放置后牙周测试值从-3/-4.1（HA/BCP）降至 6 个月时的-6.3/-4.5（HA/BCP）。OHIP 评分在 2 个月时出现差异（HA：9.5；BCP：5.2），24 个月时基本解决（HA：1.3；BCP：1.9）。VAS 评分相当，SFE 后 1 周达到最高平均水平 2.2。
2 年后，两组均未出现生物学或技术并发症，表现出一致的愈合轨迹，无明显症状。虽然在种植体稳定性和存活率方面没有观察到显著差异，但 BCP 显示出比 HA 更高的体积稳定性。
