Department of Surgical Sciences, University of Genova, Genoa, Italy.
Department of Biomedical, Surgical, and Dental Sciences, University of Milan, Milan, Italy.
Clin Implant Dent Relat Res. 2023 Oct;25(5):974-983. doi: 10.1111/cid.13236. Epub 2023 Jun 8.
Different biomaterials were suggested for sinus floor augmentation (SFA). Recently, new materials were launched showing true bone formation without remnants.
The aim of this prospective study was to evaluate an hydroxyapatite-based, sugar cross-linked collagen sponge (OSSIX™ Bone) in transcrestal SFA (t-SFA).
Twenty-four patients with edentulous posterior maxilla and residual bone height (RBH) >4 mm underwent t-SFA with OSSIX™ Bone as grafting material and simultaneous implant placement. The implant Stability Quotient (ISQ) was measured by resonance frequency analysis (RFA) directly after implant insertion and at 6 months. Differences in bone height (BH) and volume were determined in CBCT and x-rays at baseline versus 1 year of follow-up. Graft volume was evaluated by tridimensional reconstructions. Linear regression analysis was used to evaluate the effect of bucco-palatal sinus dimension, RBH, and length of the implant protruding (PIL) into the sinus, on the graft height (GH) changes up to 1 year, and on the graft volume at 1 year. Autocorrelation between time lag and augmented bone volume was evaluated through time series analysis correlograms. Health-related quality-of-life outcomes were captured.
Twenty-two patients completed the study. The mean RBH measured at baseline was 5.81 ± 2.2 mm. The mean graft volume was 1085.8 ± 733.4 mm . The mean GH, measured in the immediate post-operative period, at 6 and 12 months respectively, was 7.24 mm ±1.94; 6.57 mm ± 2.30; 5.46 mm ± 2.04. The mean ISQ measured after the implant placement was 62.19 ± 8.09, and 6 months later was 76.91 ± 4.50. There was a significant correlation between buccolingual dimension and graft volume at 1 year. Neither buccolingual volume nor RBH had a significant effect on GH change, while the PIL showed a significant positive correlation (P = 0.02 and P = 0.03 at 6 and 12 months, respectively). The correlograms indicated no significant correlation, meaning that there is no tendency for graft volume to increase or decrease over time, therefore suggesting graft stability, at least up to one year of follow-up. 86% of patients had no chewing interference.
Within the limitations of the study, OSSIX™ Bone could be considered a valid material for SFA due to its manageability and its positive results in promoting new bone formation with long-term stability. T-SFA is confirmed as a less invasive and less painful method.
不同的生物材料被推荐用于鼻窦底提升（SFA）。最近，推出了新的材料，显示出真正的骨形成而没有残留。
本前瞻性研究的目的是评估一种基于羟磷灰石的、糖交联胶原海绵（OSSIX™ Bone）在经牙槽嵴 SFA（t-SFA）中的应用。
24 名上颌后牙缺失且剩余骨高度（RBH）>4mm 的患者接受 t-SFA 治疗，使用 OSSIX™ Bone 作为移植物，并同时植入种植体。植入物稳定性量子（ISQ）通过共振频率分析（RFA）直接在植入物插入后和 6 个月时进行测量。通过 CBCT 和 X 射线在基线和 1 年随访时确定骨高度（BH）和体积的差异。通过三维重建评估移植物体积。线性回归分析用于评估颊-腭窦尺寸、RBH 和植入物进入窦腔的长度（PIL）对 1 年内移植物高度（GH）变化以及 1 年内移植物体积的影响。通过时间序列分析相关图评估时间滞后和增强骨体积之间的自相关。捕捉健康相关生活质量结果。
22 名患者完成了研究。基线时平均 RBH 为 5.81±2.2mm。平均移植物体积为 1085.8±733.4mm³。分别在术后即刻、6 个月和 12 个月测量的平均 GH 为 7.24mm±1.94；6.57mm±2.30；5.46mm±2.04。植入物放置后测量的平均 ISQ 为 62.19±8.09，6 个月后为 76.91±4.50。1 年内颊-腭窦体积与移植物体积呈显著正相关。颊侧体积和 RBH 均与 GH 变化无显著相关性，而 PIL 呈显著正相关（6 个月和 12 个月时分别为 P=0.02 和 P=0.03）。相关图表明没有显著相关性，这意味着移植物体积没有增加或减少的趋势，因此至少在 1 年的随访中提示移植物稳定。86%的患者无咀嚼干扰。
在研究的限制范围内，OSSIX™ Bone 可被视为 SFA 的一种有效材料，因为其具有可管理性，并具有促进新骨形成的积极效果，且具有长期稳定性。t-SFA 被证实为一种侵入性更小、疼痛更小的方法。
