Department of Periodontics, University of Texas Health Science Center at San Antonio, San Antonio, TX.
J Periodontol. 2011 Jul;82(7):990-9. doi: 10.1902/jop.2011.100464. Epub 2011 Jan 14.
Endosseous dental implants are a popular treatment to replace missing teeth. Although many advances have occurred and affected the macrogeometry and surface characteristics of dental implants, among other aspects, it is important to document how the implants perform in patients over time. Such evaluations are helpful not only to document the clinical survival of the implants but also patient satisfaction over an extended period.
A formal prospective multicenter human clinical was performed at five centers involving 200 patients and 626 implants. Specific inclusion and exclusion criteria were used and detailed data collected at specified times using case report forms. An independent study monitor reviewed all study data before entry into the study database. Two implant designs were used in two different clinical indications. A non-submerged titanium plasma-sprayed (TPS) hollow cylindrical implant with a smooth transgingival collar was evaluated in the maxillary anterior sextant and a non-submerged TPS solid screw implant with similar collar in the mandible.
Over the course of the 5-year clinical trial, there was one early failure occurring before definitive prosthesis delivery. Three late failures were documented, one occurring at each of the 6, 12, and 18 months postoperative visits. Life table analysis at 5 years revealed a 99.4% survival rate and a 92.5% success rate. Patient satisfaction was rated as good to excellent for 96.1% of implants in regards to esthetics after 5 years; 98.8% for appearance; and 99.4% for prosthesis comfort, ability to chew and taste, fit, and general satisfaction. No serious adverse events were reported.
Implant success and survival was over 92% and 99%, respectively, in a formal 5-year prospective multicenter clinical trial involving 200 patients and 626 non-submerged TPS implants. These implants included hollow cylinder implants in the anterior maxilla and solid screw implants placed in the mandible. These findings document the predictability and patient satisfaction of tooth replacement using a non-submerged surgical technique involving a tissue-level, rough surfaced endosseous dental implant.
骨内牙科种植体是一种替代缺失牙齿的常用治疗方法。尽管已经取得了许多进展，并影响了牙科种植体的宏观几何形状和表面特性等方面，但重要的是要记录随着时间的推移种植体在患者中的表现。这些评估不仅有助于记录种植体的临床存活率，还有助于记录患者在较长时间内的满意度。
在五个中心进行了一项正式的前瞻性多中心人体临床研究，涉及 200 名患者和 626 个种植体。使用了特定的纳入和排除标准，并使用病例报告表在特定时间收集详细数据。一名独立的研究监测员在将所有研究数据输入研究数据库之前对其进行了审查。两种种植体设计用于两种不同的临床适应证。在上颌前六区评估了一种非潜入式钛等离子喷涂（TPS）空心圆柱形种植体，具有光滑的龈下颈圈，在下颌使用了具有类似颈圈的非潜入式 TPS 实心螺钉种植体。
在为期 5 年的临床试验过程中，在最终义齿交付前发生了一次早期失败。记录了 3 次晚期失败，分别发生在术后 6、12 和 18 个月的随访中。5 年的寿命表分析显示，存活率为 99.4%，成功率为 92.5%。5 年后，96.1%的患者对种植体的美观、98.8%的患者对外观、99.4%的患者对义齿舒适度、咀嚼和味觉、适配度和总体满意度的评价为良好到优秀。没有报告严重不良事件。
在一项涉及 200 名患者和 626 个非潜入式 TPS 种植体的正式 5 年前瞻性多中心临床试验中，种植体的成功率和存活率分别超过 92%和 99%。这些种植体包括在上颌前区的空心圆柱种植体和在下颌植入的实心螺钉种植体。这些发现证明了使用非潜入式手术技术，包括组织水平、粗糙表面的骨内牙科种植体进行牙齿替代的可预测性和患者满意度。
