Prospective evaluation of immediate temporized implants

描述（由申请人提供）：本修订后的申请是一项临床试验，旨在评估种植体放置到拔牙部位并立即预备时冠骨水平的变化。上颌门牙的拔除是一种常见的程序，记录在我们学校的诊所。拔牙后的传统治疗包括一段时间的愈合，然后放置种植体。我们的初步数据表明，超过50%的病例延迟入路导致唇骨丢失，导致水平缺失，需要硬软组织移植才能达到功能效果。额外的初步数据表明，移植拔牙部位和/或立即植入和预备种植体可导致功能恢复，无需额外的辅助移植手术。目前尚不清楚在种植体植入前拔牙部位愈合过程中冠骨水平如何变化，与立即种植体植入相比，立即用冠固定种植体。我们假设即刻放置、延迟放置或拔牙后立即放置的种植体在嵴骨水平（主要终点）和软组织水平和指数（次要终点）上存在差异，与延迟放置组（对照组）相比，即刻放置组（实验）的骨质流失更多。长期目标是确定拔牙后的牙冠骨重塑或种植体的顶端位置是否决定了牙冠骨的最终水平。将对两组45名患者进行评估。所有受试者将拔除一颗单根上颌牙。其中一组将在牙槽内植入矿化骨，并在植入前4个月进行移植。这组患者的冠骨在种植体植入前的四个月愈合期间进行了重塑。第二组将在拔牙后立即放置种植体，因此在种植体和立即放置的临时修复体存在的情况下，冠骨将重塑，作为一个阶段的过程。对于这两组，种植体放置后将立即用冠暂时固定。在提取前收集标准化的硬软组织数据作为基线，然后在本试验中至少进行两年的前瞻性比较和对比。

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.