Int J Oral Maxillofac Implants. 2021 Jan-Feb;36(1):165-176. doi: 10.11607/jomi.8333.
This study sought to define the tissue responses at different implant-abutment interfaces by studying bone and peri-implant mucosal changes using a 5-year prospective randomized clinical trial design study. The conus interface was compared with the flat-to-flat interface and platform-switched implant-abutment systems.
One hundred forty-one subjects were recruited and randomized to the three treatment groups according to defined inclusion and exclusion criteria. Following implant placement and immediate provisionalization in healed alveolar ridges, clinical, photographic, and radiographic parameters were measured at 6 months and annually for 5 years. The calculated changes in marginal bone levels, peri-implant mucosal zenith location, papillae lengths, and peri-implant Plaque Index and bleeding on probing were statistically compared.
Forty-eight conus interface implants, 49 flat-to-flat interface implants, and 44 platform-switched implants were placed in 141 subjects. Six platform-switched interface and eight flatto- flat interface implants failed, most of them within 3 months. After 5 years, 33 conical interface, 28 flat-to-flat interface, and 27 platform-switched interface implants remained for evaluation. Calculation of marginal bone level change showed a mean marginal bone loss of -0.16 ± 0.45 (-1.55 to 0.65), -0.92 ± 0.70 (-2.90 to 0.20), and -0.81 ± 1.06 (-3.35 to 1.35) mm for conical interface, flat-to-flat interface, and platform-switched interface implants, respectively (P < .0005). The peri-implant mucosal zenith changes were minimal for all three interface designs (0.10 mm and +0.08 mm, P > .60). Only 16% to 19% of the surfaces had presence of bleeding on probing, with no significant differences (P > .81) between groups. Interproximal tissue changes were positive and similar among the implant interface designs.
Over 5 years, the immediate provisionalization protocol resulted in stable peri-implant mucosal responses for all three interfaces. Compared with the flat-to-flat and platform-switched interfaces, the conical interface implants demonstrated significantly less early marginal bone loss. The relationship of marginal bone responses and mucosal responses requires further experimental consideration.
本研究通过对种植体-基台界面的骨组织和种植体周围黏膜组织变化进行研究,采用 5 年前瞻性随机临床试验设计,旨在明确不同种植体-基台界面的组织反应。对锥形界面与平-平界面和平台转换种植体-基台系统进行比较。
根据纳入和排除标准,招募了 141 名受试者并将其随机分为三组。在愈合牙槽嵴中植入种植体并即刻临时修复后,在 6 个月和每年测量临床、影像学和摄影参数,为期 5 年。对边缘骨水平、种植体周围黏膜顶点位置、牙间乳头长度和种植体周围菌斑指数和探诊出血的变化进行统计学比较。
在 141 名受试者中,分别植入 48 个锥形界面种植体、49 个平-平界面种植体和 44 个平台转换界面种植体。6 个平台转换界面和 8 个平-平界面种植体失败,其中大多数在 3 个月内失败。5 年后,33 个锥形界面、28 个平-平界面和 27 个平台转换界面植入物仍可用于评估。计算边缘骨水平变化显示,锥形界面、平-平界面和平台转换界面种植体的平均边缘骨损失分别为-0.16±0.45(-1.55 至 0.65)、-0.92±0.70(-2.90 至 0.20)和-0.81±1.06(-3.35 至 1.35)mm(P<.0005)。所有三种界面设计的种植体周围黏膜顶点变化均较小(0.10mm 和+0.08mm,P>.60)。只有 16%至 19%的表面有探诊出血,各组之间无显著差异(P>.81)。种植体界面设计之间的近中组织变化呈阳性且相似。
在 5 年的时间里,即刻临时修复方案使所有三种界面的种植体周围黏膜组织均保持稳定。与平-平界面和平台转换界面相比,锥形界面种植体的早期边缘骨丧失明显较少。边缘骨反应与黏膜反应的关系需要进一步的实验考虑。