Prospective evaluation of immediate temporized implants

描述(由申请人提供)：这项修订后的申请是一项临床试验，旨在评估种植体被放置到拔牙部位并立即临时性地植入时，顶骨水平的变化。根据我们学校诊所的记录，拔除上颌门牙是一种常见的程序。传统的拔牙治疗包括一段时间的治愈期，然后植入种植体。我们的初步数据表明，延迟入路导致唇骨丢失并导致50%以上的病例水平缺失，需要硬组织和软组织移植才能达到功能效果。更多的初步数据表明，移植拔牙部位和/或立即植入和预置植入物可以恢复功能，而不需要额外的辅助移植程序。目前尚不清楚种植体植入前拔除部位愈合期间顶骨水平如何变化，与即刻种植相比，即刻植入冠即刻暂时性植入不同。我们假设即刻放置、延迟放置或拔牙后立即放置的种植体之间的顶骨水平(主要终点)以及软组织水平和指数(次级终点)将存在差异，与延迟放置组(对照)相比，立即放置组(试验组)的骨丢失更多。长期目标是确定拔牙后的顶骨重塑还是种植体的根尖位置决定顶骨的最终水平。将对两组45名患者进行评估。所有受试者都将拔除一颗单根上颌牙齿。其中一组将植入矿化骨，并在种植前四个月允许植入。在种植体植入前的四个月的愈合过程中，这组患者的顶骨将会重塑。第二组将在拔牙后立即植入种植体，因此顶骨将在种植体存在的情况下进行重塑，并立即放置临时修复，这是一个一阶段的过程。对于两组，种植体放置后将立即用牙冠暂时性种植。标准化的硬组织和软组织数据将在拔牙前收集作为基线，然后在本试验中前瞻性地至少持续两年，以比较和对比各种方法。

DESCRIPTION (provided by applicant): This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized. Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics. Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant. Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50% of cases, requiring hard and soft tissue grafting to achieve a functional result. Additional preliminary data indicates that grafting the extraction site and/or immediate implant placement and provisionalization results in a functional restoration, without the need for additional adjunctive grafting procedures. It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement, in contrast to immediate implant placement, with immediate provisionalization with a crown. We hypothesize that there will be differences in the crestal bone levels (primary endpoint), and differences in soft tissue levels and indices (secondary endpoints) between implants immediately temporized, placed either delayed or immediately after tooth extraction, with more bone loss in the immediate placement group (experimental) compared to the delayed placement group (control). The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone. Two groups of 45 patients will be evaluated. All subjects will have a single rooted maxillary tooth extracted. One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement. The crestal bone in this group will have remodeled during the four months of healing prior to implant placement. The second group will have the implant placed immediately after tooth extraction, thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration, as a one-stage procedure. For both groups, the implants will be immediately temporized with a crown after implant placement. Standardized hard and soft tissue data will be collected preextraction as baseline, and then prospectively for at least two years in this trial, to compare and contrast the methods.