Prospective evaluation of immediate temporized implants

描述（由申请人提供）：本修订申请是一项临床试验，旨在评价将种植体放置到拔牙部位并立即进行临时修复时的牙槽嵴水平变化。拔除上颌门齿是一种常见的程序，记录在我们的学校诊所。拔牙时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，延迟入路会导致唇侧骨质丢失，超过50%的病例会导致水平缺损，需要硬组织和软组织移植才能获得功能性结果。额外的初步数据表明，拔牙部位移植和/或即刻种植体放置和临时化可实现功能性修复，而无需额外的连续移植手术。目前尚不清楚种植体植入前拔牙部位愈合过程中牙槽嵴水平的变化，与即刻种植体植入相比，使用牙冠即刻临时修复。我们假设，即刻种植体之间的牙槽嵴水平（主要终点）以及软组织水平和指数（次要终点）存在差异，延迟或拔牙后即刻种植体之间存在差异，即刻种植体组（实验组）的骨丢失多于延迟种植体组（对照组）。长期目标是确定拔牙后的牙槽骨重建或种植体的顶端位置是否决定了牙槽骨的最终水平。将对两组45名患者进行评价。所有受试者将拔除一颗牙根上颌牙。其中一组将在牙槽植入矿化骨，并在种植体植入前4个月植入。 在种植体植入前的四个月愈合期间，该组中的牙槽嵴骨将重塑。第二组将在拔牙后立即放置种植体，因此，作为一个阶段的程序，在种植体和立即放置的临时修复体的存在下，牙槽骨将重塑。对于两组，在种植体植入后，立即用牙冠对种植体进行临时处理。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收集至少两年，以比较和对比这些方法。

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.