Tallarico Marco, Xhanari Erta, Pisano Milena, Gatti Fulvio, Meloni Silvio Mario
Eur J Oral Implantol. 2017;10(2):169-178.
To test the hypothesis that there is no difference in clinical, radiographic and aesthetic outcomes positioning single post-extractive 7 mm-diameter implants or waiting 4 months after molar extraction and socket preservation procedure.
Patients requiring one implant-supported single restoration to replace a failing tooth in the molar region of both maxilla and mandible were selected. Patients were randomised according to a parallel group design into two arms: implant installation in fresh extraction sockets grafted with cortico-cancellous heterologous bone and porcine derma (group A) or delayed implant installation 4 months after tooth extraction and socket preservation using the same materials (group B). Implants were submerged for 4 months. The primary outcome measures were the success rates of the implants and prostheses and the occurrence of any surgical and prosthetic complications during the entire follow-up. Secondary outcome measures were: peri-implant marginal bone level (MBL) changes, resonance frequency analysis (ISQ) and pink esthetic score (PES) values at implant placement (baseline) up to 1 year after loading.
Twelve patients were randomised to group A and 12 to group B. No patient dropped out within 1 year after loading. No implant and prosthesis failed and no complications occurred during the entire follow-up. One year after loading, statistically significant higher mean MBL loss was experienced in group A (0.63 mm ± 0.31 mm) compared to group B (0.23 mm ± 0.06 mm); difference 0.41 mm (95% CI 0.17-0.53; P = 0.001). Six months after implant placement, mean ISQ value was 78.8 ± 2.8 for group A and 79.9 ± 3.6 for group B, showing no statistically significant difference between groups (difference 1.1; 95% CI: 0.04 to 2.96; P = 0.422). One year after loading, mean PES was 10.6 ± 1.8 [range: 8 to13] in group A and 12.2 ± 1.2 [range: 11 to 14] in group B. The difference was statistically significant (1.6 ± 2.7; 95% CI -0.55-2.55; P = 0.019) with better results for group B.
Within the limitations of this study, both procedures achieved successful results over the 1-year follow-up period, but waiting 4 months after tooth extraction and socket preservation procedure was associated with less marginal bone loss and a better aesthetic outcome. Conflict-of-interest statement: Dr Marco Tallarico is Research Project Manager of Osstem AIC Italy. However no company supported this study and all authors declare no conflicts of interest.
验证以下假设：在单颗磨牙拔除后即刻植入直径7 mm的种植体，与拔牙及牙槽窝保存术后等待4个月再植入种植体相比，二者在临床、影像学及美学效果方面无差异。
选取需要通过种植体支持的单冠修复来替换上颌和下颌磨牙区患牙的患者。根据平行组设计将患者随机分为两组：在新鲜拔牙窝内植入种植体，并用皮质松质异体骨和猪真皮进行移植（A组）；拔牙及牙槽窝保存术后4个月，使用相同材料进行延期种植体植入（B组）。种植体埋入4个月。主要观察指标为种植体和修复体的成功率，以及整个随访期间任何手术和修复并发症的发生情况。次要观察指标为：种植体植入时（基线）至加载后1年期间种植体周围边缘骨水平（MBL）的变化、共振频率分析（ISQ）值和粉色美学评分（PES）值。
12例患者被随机分配至A组，12例至B组。加载后1年内无患者退出。整个随访期间无种植体和修复体失败，也未发生并发症。加载后1年，A组平均MBL丧失量（0.63 mm ± 0.31 mm）与B组（0.23 mm ± 0.06 mm）相比，差异有统计学意义；差值为0.41 mm（95%CI 0.17 - 0.53；P = 0.001）。种植体植入后6个月，A组平均ISQ值为78.8 ± 2.8，B组为79.9 ± 3.6，两组间差异无统计学意义（差值1.1；95%CI：0.04至2.96；P = 0.422）。加载后1年，A组平均PES为10.6 ± 1.8[范围：8至13]，B组为12.2 ± 1.2[范围：11至14]。差异有统计学意义（1.6 ± 2.7；95%CI - 0.55 - 2.55；P = 0.019），B组效果更好。
在本研究的局限性范围内，两种方法在1年随访期内均取得了成功结果，但拔牙及牙槽窝保存术后等待4个月与较少的边缘骨丧失和更好的美学效果相关。利益冲突声明：Marco Tallarico博士是意大利奥齿泰AIC的研究项目经理。然而，没有公司支持本研究，所有作者均声明无利益冲突。
