5-year randomized multicenter clinical trial on single dental implants placed in the midline of the edentulous mandible
5-year randomized multicenter clinical trial on single dental implants placed in the midline of the edentulous mandible
复制标题
无牙下颌骨中线单牙种植体5年随机多中心临床试验
DOI：
10.1111/clr.13692
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发表时间：
2020-12-26
影响因子：
4.3
通讯作者：
Passia, Nicole
中科院分区：
文献类型：
--
作者：
Kern, Matthias;Behrendt, Christoph;Passia, Nicole
目的通过多中心随机对照临床试验，探讨无牙下颌骨中线单颗种植体的加载方式对种植体存活或修复维护的影响。材料与方法158例无牙下颌骨中线单颗种植体的患者随机分为即刻加载组（n = 81）和延迟加载组（n = 77）。结果5年后，102例患者接受了随访调查。在5年的观察期内，在无牙下颌骨中线立即加载的单个种植体的存活率在统计学上显著低于传统加载的种植体。在即刻加载组中，9个种植体在种植体加载的前三个月内失败。该组未记录到进一步的植入物丢失。延迟加载组中有两个种植体失败，而一个种植体不得不在第二阶段手术中取出，第二个种植体加载后五年取出。与延迟加载组相比，即刻加载组中线种植体的存活率不具有非劣效性（p = 0.79，CI即刻加载：74.9%; 100.0%，CI延迟加载：73.0%; 100.0%）。随着时间的推移，两个治疗组之间的种植体生存观察到的差异是统计显着的。结论本研究的结果表明，立即加载的一个单一的下颌种植体在无牙下颌骨应被认为是只有在例外情况下。
Objectives This multicenter randomized controlled clinical trial was conducted to investigate whether the loading protocol of single dental implants placed in the midline of edentulous mandibles will influence the implant survival or prosthetic maintenance.Materials and Methods In total, 158 patients were randomly assigned either to the immediate loading group (n = 81) or to the delayed loading group (n = 77). All implants were loaded with an overdenture retained by a ball attachment.Results After 5 years, 102 patients attended the follow-up investigation. Immediately loaded single implants in the midline of the edentulous mandible revealed a statistically significant lower survival rate than implants loaded conventionally over an observation period of 5 years. In the immediate loading group, 9 implants failed within the first three months of implant loading. No further implant loss was recorded for this group. Two implants failed in the delayed loading group, whereas one implant had to be removed during second-stage surgery and the second five years after implant loading. Non-inferiority of the survival rate of the midline implant of the immediate loading group, compared with the delayed loading group, could not be shown (p = .79, CI immediate loading: 74.9%; 100.0%, CI delayed loading: 73.0%; 100.0%). The observed difference in implant survival between the two treatment groups over time was statistically significant.Conclusions The results of the present study indicate that immediate loading of a single mandibular implant in the edentulous mandible should be considered only in exceptional cases.