Gualini Federico, Salina Sergio, Rigotti Fabio, Mazzarini Cristian, Longhin Diego, Grigoletto Mauro, Trullenque-Eriksson Anna, Sbricoli Luca, Esposito Marco
Eur J Oral Implantol. 2017;10(1):73-82.
To evaluate whether there are some clinical benefits by placing single dental implants either 0.5 or 1.5 mm subcrestally in healed bone crests.
Sixty partially edentulous patients requiring two single implant-supported crowns had both sites randomly allocated either to 0.5 mm or 1.5 mm subcrestal implant placement according to a split-mouth design at six centres. Implants were submerged in aesthetic areas or non-submerged in non-aesthetic areas for 3 months. Provisional acrylic crowns were delivered and were replaced after 2 months by definitive metal-ceramic crowns. Patients were followed to 1 year after loading. Outcome measures were: crown and implant failures; complications; aesthetics assessed using the pink esthetic score (PES); peri-implant marginal bone level changes; and patient preference, recorded by blinded assessors.
One patient dropped out. One patient lost both implants to infection at impression taking. Three complications affected three patients of the 0.5 mm group and two complications affected two patients of the 1.5 mm subcrestally placed implants. One patient had complications at both implants. There were no statistically significant differences for complications between group (difference of proportion = 0.02; 95% CI -0.06 to 0.09; P (McNemar test) = 1.000). At delivery of definitive crowns, 2 months after loading, the mean aesthetic score was 11.22 ± 1.91 and 11.12 ± 1.59 for the 0.5 and 1.5 mm group, respectively. At 1 year after loading, the mean aesthetic score was 12.09 ± 1.66 and 12.10 ± 1.52 for the 0.5 and 1.5 mm group, respectively. There were no statistically significant differences between the two groups at 2 months (P (paired t test) = 0.626) or at 1 year (P (paired t test) = 0.920). One year after loading, patients of the 0.5 mm lost on average 0.21 ± 0.51 mm and those of the 1.5 mm group 0.11 ± 0.36 mm, the difference being not statistically significant (difference = 0.10; 95% CI -0.01 to 0.20; P (paired t test) = 0.078). Patients did not prefer any depth of the implant placement over the other. There were no differences in outcomes between centres.
No statistical or clinical differences were noticed when placing implants 0.5 mm or 1.5 mm subcrestally, therefore clinicians can do as they prefer. Conflict-of-interest statement: Anthogyr (Sallanches, France), the manufacturer of the implants used in this investigation, partially funded this trial and donated the implants and the prosthetic components, however data belonged to the authors and by no means did the sponsor interfere with the conduct of the trial or the publication of its results.
评估在愈合的牙槽嵴中，将单个牙种植体置于牙槽嵴顶下0.5毫米或1.5毫米处是否具有临床益处。
60例需要两个单颗种植体支持冠的部分牙列缺损患者，在六个中心按照分口设计，将两个种植部位随机分配为牙槽嵴顶下0.5毫米或1.5毫米的种植体植入。种植体在美观区域采用潜入式或在非美观区域采用非潜入式放置3个月。交付临时丙烯酸冠，2个月后更换为最终的金属烤瓷冠。患者在加载后随访1年。观察指标包括：冠和种植体失败情况；并发症；使用粉色美学评分（PES）评估美观程度；种植体周围边缘骨水平变化；以及由盲法评估者记录的患者偏好。
1例患者退出。1例患者在取印模时因感染失去两颗种植体。0.5毫米组有3例并发症影响3名患者，牙槽嵴顶下1.5毫米植入种植体的患者中有2例并发症影响2名患者。1例患者两颗种植体均出现并发症。两组并发症之间无统计学显著差异（比例差异 = 0.02；95%可信区间 -0.06至0.09；P（McNemar检验） = 1.000）。在加载后2个月交付最终冠时，0.5毫米组和1.5毫米组的平均美学评分为分别为11.22 ± 1.91和11.12 ± 1.59。在加载后1年，0.5毫米组和1.5毫米组的平均美学评分为分别为12.09 ± 1.66和12.10 ± 1.52。两组在2个月时（P（配对t检验） = 0.626）或1年时（P（配对t检验） = 0.920）均无统计学显著差异。加载后1年，0.5毫米组患者平均骨吸收0.21 ± 0.51毫米，1.5毫米组患者平均骨吸收0.11 ± 0.36毫米，差异无统计学意义（差异 = 0.10；95%可信区间 -0.01至0.20；P（配对t检验） = 0.078）。患者对种植体植入的任何深度均无偏好。各中心之间的结果无差异。
将种植体置于牙槽嵴顶下0.5毫米或1.5毫米时，未观察到统计学或临床差异，因此临床医生可根据自己的偏好进行操作。利益冲突声明：本研究中使用的种植体制造商Anthogyr（法国萨朗什）为本试验提供了部分资金，并捐赠了种植体和修复组件，但数据归作者所有，赞助商绝不干涉试验的进行或结果的发表。
