Single dental implant retained mandibular complete dentures--influence of the loading protocol: study protocol for a randomized controlled trial.
Single dental implant retained mandibular complete dentures--influence of the loading protocol: study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-15-186
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发表时间：
2014-05-24
期刊：
影响因子：
2.5
通讯作者：
Kern M
中科院分区：
文献类型：
--
作者：
Passia N;Brezavšček M;Fritzer E;Kappel S;Kern T;Luthardt RG;Frfr von Maltzahn N;Mundt T;Rädel M;von Stein-Lausnitz A;Kern M
多年来，在牙科领域有一个强烈的共识，即至少需要两个种植体来保持下颌全口义齿。几项临床试验表明，当使用延迟加载时，单个正中种植体可以很好地保持下颌覆盖义齿长达5年，而不会发生种植体失效。然而，其他试验报告了相互矛盾的结果，部分相当大的失败率时，立即加载。因此，当前随机临床试验的目的是测试以下假设：立即加载带有覆盖义齿的单个下颌中线种植体将产生与使用延迟加载标准方案相当的临床结果。这项前瞻性9中心随机对照临床试验仍在进行中。最后一名患者将于2016年完成试验。总共有180名年龄在60岁至89岁之间的无牙颌患者有足够的全口义齿，将在无牙颌下颌骨中植入一个正中种植体，该种植体将使用球形附着体保留现有的全口义齿。在植入种植体后立即加载正中种植体（实验组）或在第二阶段手术时延迟3个月的浸没愈合（对照组）。在植入物加载后，将对患者进行24个月的随访。主要结局指标是实验组与对照组相比的种植体成功率的非劣效性。次要结局指标包括临床、技术和主观变量。该研究由德国研究基金会（KE 477/8-1）资助。这项多中心临床试验将提供关于单个正中种植体在立即加载时保持下颌全口义齿的能力的信息。如果可行，这种治疗方案将大大改善日常牙科实践。自2012年8月23日起，该试验已在德国临床试验注册中心（Deutsches Register Klinischer Reichen）注册，DRKS-ID：DRKS 00003730。(http：www.germanctr.de）的示例。
Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de).
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影响因子：
3
作者：
OLTHOFF, LW;VANDERBILT, A;KLEIZEN, HH
通讯作者：
KLEIZEN, HH
DOI：
10.1016/0197-2456(82)90024-1
发表时间：
1982-01-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
BLACKWELDER, WC
通讯作者：
BLACKWELDER, WC
影响因子：
4.6
作者：
Cordioli, C;Majzoub, Z;Castagna, S
通讯作者：
Castagna, S
影响因子：
1.9
作者：
John, MT;Patrick, DL;Slade, GD
通讯作者：
Slade, GD
影响因子：
4.4
作者：
Harder, Soenke;Wolfart, Stefan;Kern, Matthias
通讯作者：
Kern, Matthias