Merli Mauro, Moscatelli Marco, Mariotti Giorgia, Pagliaro Umberto, Raffaelli Eugenia, Nieri Michele
Eur J Oral Implantol. 2018;11(4):441-452.
The objective of this 3-year post-loading parallel randomised controlled trial is to compare two bone substitutes and resorbable membranes in a one-stage procedure for horizontal bone augmentation: anorganic bovine bone and porcine collagen membranes (BB group) versus synthetic resorbable bone graft substitute made of pure β-tricalcium phosphate and porcine pericardium collagen membranes (CJ group).
Patients in need of implant treatment having at least one site with horizontal osseous defect at a private clinic in Rimini, Italy, were included in this study. Patients were randomised to receive either BB or CJ in a one-stage procedure for horizontal bone augmentation in a submerged approach. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Patients and the outcome assessor were blinded to group assignment. The abutment connection was made after 6 months of healing. The application of the provisional prosthesis was performed after abutment connection and a definitive metal-ceramic prosthesis was placed 6 months post-loading. The patients were followed-up to 3 years post-loading. Primary outcome measures were: implant failure, complications and peri-implant margin bone level changes. Secondary outcome measures were: visual analogue scale (VAS) for functional and aesthetic satisfaction and pink aesthetic score (PES).
Twenty-five patients with 32 implants were randomly allocated to the BB group and 25 patients with 29 implants to the CJ group. All 50 randomised patients received the treatment as allocated and there were 7 drop-outs in the BB group and 11 drop-outs in the CJ group up to 3 years' post-loading. There were no implant failures. There were six complications in five patients of the BB group and three complications in three patients of the CJ group (relative risk: 1.32, 95% CI from 0.37 to 4.64, P = 1.0000). Radiographic bone loss was 1.61 mm for the BB group and 1.02 mm for the CJ group (difference 0.54 mm, 95% CI from -0.53 to 1.60, P = 0.3100). The functional VAS was 9.0 for the BB group and 9.6 for the CJ group (difference 0.6, 95% CI from -0.4 to 1.5, P = 0.2393). The aesthetic VAS was 9.4 for the BB group and 9.6 for the CJ group (difference 0.2, 95% CI from -0.5 to 0.8, P = 0.6141). PES was 8.7 for the BB group and 8.5 for the CJ group (difference -0.1, 95% CI from -2.9 to 2.7, P = 0.9360).
No significant differences were observed in this randomised controlled trial comparing anorganic bovine bone with porcine collagen membranes versus synthetic resorbable bone made of pure β-tricalcium phosphate with pericardium collagen membranes for horizontal augmentation.
这项为期3年的加载后平行随机对照试验的目的是比较两种骨替代物和可吸收膜在水平骨增量一期手术中的效果：无机牛骨和猪胶原膜（BB组）与由纯β-磷酸三钙制成的合成可吸收骨移植替代物和猪心包胶原膜（CJ组）。
在意大利里米尼的一家私人诊所，需要进行种植治疗且至少有一个部位存在水平骨缺损的患者被纳入本研究。患者被随机分配接受BB或CJ治疗，采用一期手术进行水平骨增量的潜入式方法。随机分组由计算机生成，通过不透明的顺序编号密封信封进行分配隐藏。患者和结果评估者对分组情况不知情。在愈合6个月后进行基台连接。在基台连接后应用临时假体，并在加载后6个月放置最终的金属陶瓷假体。对患者进行加载后3年的随访。主要观察指标为：种植体失败、并发症和种植体周围边缘骨水平变化。次要观察指标为：功能和美学满意度的视觉模拟评分（VAS）以及粉色美学评分（PES）。
25例患者的32颗种植体被随机分配至BB组，25例患者的29颗种植体被分配至CJ组。所有50例随机分组的患者均按分配接受了治疗，至加载后3年，BB组有7例退出，CJ组有11例退出。未发生种植体失败。BB组5例患者出现6例并发症，CJ组3例患者出现3例并发症（相对风险：1.32，95%CI为0.37至4.64，P = 1.0000）。BB组的影像学骨吸收为1.61mm，CJ组为1.02mm（差异0.54mm，95%CI为 -0.53至1.60，P = 0.3100）。BB组的功能VAS为9.0，CJ组为9.6（差异0.6，95%CI为 -0.4至1.5，P = 0.2393）。BB组的美学VAS为9.4，CJ组为9.6（差异0.2，95%CI为 -0.5至0.8，P = 0.6141）。BB组的PES为8.7，CJ组为8.5（差异 -0.1，95%CI为 -2.9至2.7，P = 0.9360）。
在这项随机对照试验中，比较无机牛骨与猪胶原膜和由纯β-磷酸三钙与心包胶原膜制成的合成可吸收骨用于水平增量时，未观察到显著差异。
