Starch-Jensen T, Bruun N H, Spin-Neto R
Department of Oral and Maxillofacial Surgery, Aalborg University Hospital and Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Aalborg, Denmark.
Unit of Clinical Biostatistics, Aalborg University Hospital, Aalborg, Denmark.
Int J Oral Maxillofac Surg. 2023 Nov;52(11):1205-1215. doi: 10.1016/j.ijom.2023.03.009. Epub 2023 Mar 29.
The objective of this study was to assess endo-sinus bone gain (ESBG) following osteotome-mediated sinus floor elevation with Bio-Oss Collagen (test) compared with no grafting material (control) using two- and three-dimensional radiographic methods, as part of a randomized controlled trial (ClinicalTrials.gov, NCT04618900). Forty healthy patients who met the necessary eligibility criteria were allocated by block randomization to either the test group (20 patients) or control group (20 patients). Cone beam computed tomography scans were obtained at enrolment (T0), immediately after surgery (T1), at delivery of the prosthetic rehabilitation (T2), and 1 year after functional implant loading (T3). Mean differences were expressed with the 95% confidence interval; significance was set at P < 0.05. ESBG was significantly increased with Bio-Oss Collagen compared with no grafting material at T1, T2, and T3 (P < 0.001). A gradual decrease in ESBG was observed over time with both treatment modalities (P < 0.001), which diminished the difference between the test and control groups at T2 and T3. ESBG was observed to be positively correlated with implant protrusion length and negatively correlated with the residual bone height. In osteotome-mediated sinus floor elevation, the application of Bio-Oss Collagen underneath the elevated Schneiderian membrane improved ESBG significantly when compared with no grafting material. However, the increased ESBG seems not to have positively improved the treatment outcomes in terms of the implant stability quotient or the survival of the implants or suprastructures.
作为一项随机对照试验（ClinicalTrials.gov，NCT04618900）的一部分，本研究的目的是使用二维和三维放射学方法，评估与不使用移植材料（对照组）相比，使用Bio-Oss骨胶原（试验组）进行骨凿介导的上颌窦底提升术后的窦内骨增量（ESBG）。40名符合必要入选标准的健康患者通过区组随机化分配到试验组（20例患者）或对照组（20例患者）。在入组时（T0）、手术后即刻（T1）、进行修复性义齿修复时（T2）以及功能性种植体加载后1年（T3）进行锥形束计算机断层扫描。平均差异以95%置信区间表示；显著性设定为P < 0.05。与不使用移植材料相比，在T1、T2和T3时，使用Bio-Oss骨胶原的ESBG显著增加（P < 0.001）。两种治疗方式均观察到ESBG随时间逐渐降低（P < 0.001），这使得试验组和对照组在T2和T3时的差异减小。观察到ESBG与种植体突出长度呈正相关，与剩余骨高度呈负相关。在骨凿介导的上颌窦底提升术中，与不使用移植材料相比，在提升的施奈德膜下方应用Bio-Oss骨胶原可显著改善ESBG。然而，就种植体稳定性商数、种植体或上部结构的存活率而言，增加的ESBG似乎并未对治疗结果产生积极改善。
