Shulman L B
Department of Implant Research, Forsyth Dental Center, Boston, MA 02115.
J Dent Educ. 1988 Dec;52(12):712-20.
Standardized prospective clinical trials are uncommon in implant dentistry. Aside from the Brånemark and staple trials; both restricted to edentulous jaws, and two blade trials in their early and as yet inconclusive stages, most implant studies are retrospective. As such, they lack uniformity in patient selection, methodology, evaluation, and definitions of success and do not yield the information needed for critical clinical decisions. There are data to compare treatments for edentulous jaws, but virtually none for the partially edentulous patient. Decisions, out of necessity, involve retrospection and interpolation. In the absence of a definitive data base, added attention must be paid to patient safety and informed consent. Patient selection, implant selection, site selection, and surgical and prosthetic management--all of which influence implant efficacy and safety--are highlighted. It is the opinion of this author, based upon the benefit/risk information reviewed, that osseointegrated root forms are the implants of choice when adequate bone is available, and that blade implants and subperiosteal implants are indicated when bone space is restricted. Prospective clinical trials must be given the highest priority in planning for implant research.
标准化的前瞻性临床试验在种植牙领域并不常见。除了局限于无牙颌的布兰emark试验和钉试验,以及处于早期且尚无定论阶段的两项叶片试验外,大多数种植牙研究都是回顾性的。因此,它们在患者选择、方法、评估以及成功的定义方面缺乏一致性,无法提供关键临床决策所需的信息。有数据可用于比较无牙颌的治疗方法,但对于部分无牙患者几乎没有相关数据。出于必要,决策涉及回顾和推断。在缺乏明确数据库的情况下,必须更加关注患者安全和知情同意。患者选择、种植体选择、部位选择以及手术和修复管理——所有这些都会影响种植体的疗效和安全性——都受到了强调。基于所审查的获益/风险信息,本文作者认为,当有足够的骨量时,骨结合根形种植体是首选的种植体;而当骨空间受限的时候,则适合使用叶片种植体和骨膜下种植体。在种植牙研究规划中,前瞻性临床试验必须被置于最高优先级。