Orthopedics, Department of Clinical and Experimental Medicine, Faculty of Medicine, Linköping University, Linköping, Sweden.
Department of Oral and Maxillofacial Surgery, Linköping University Hospital, Linköping, Sweden.
Clin Oral Implants Res. 2019 Jan;30(1):49-58. doi: 10.1111/clr.13391. Epub 2018 Dec 30.
The objective of this clinical study was to evaluate the effect of a bisphosphonate coating on a titanium implant on the implant stability quotient (ISQ) and the radiographic marginal bone levels at implants during early healing (2-8 weeks).
In a randomized double-blind trial with internal controls, 16 patients received a dental implant coated with zoledronate and one uncoated implant as a control. The coated and uncoated implants which were visually indistinguishable were bone level titanium implants with a moderately rough surface and a microthreaded neck. ISQ values were obtained at insertion and at 2, 4, 6, and 8 weeks. Radiographs were obtained at insertion and at 8 weeks. The primary outcome was the difference in ISQ values between the coated implants and the control implants at 4 and 6 weeks, corrected for insertion values. The secondary outcome was loss of marginal bone level from insertion to 8 weeks.
Implant stability quotient values remained largely constant over the 8 weeks, and there was no significant difference between coated and uncoated implants at any time point. There was 0.12 (SD 0.10) mm marginal bone loss at the control implants and 0.04 (SD 0.08) mm at the coated implants. The difference was 0.17 mm; SD 0.14; p < 0.006). On blind qualitative scoring, 13 of the 15 control implants and two of 15 coated implants showed small marginal bone defects (p = 0.003).
There were no statistically significant differences observed in ISQ values between the coated and uncoated implants during the early healing. There was less marginal bone loss at the coated implants.
本临床研究的目的是评估在早期愈合(2-8 周)期间,双膦酸盐涂层对钛种植体的种植体稳定性(ISQ)和种植体周围边缘骨水平的影响。
在一项具有内部对照的随机双盲试验中,16 名患者接受了唑来膦酸涂层的牙科种植体和一个未涂层的种植体作为对照。涂层和未涂层的种植体在外观上无法区分,均为具有中度粗糙表面和微螺纹颈部的骨水平钛种植体。ISQ 值在植入时和植入后 2、4、6 和 8 周时获得。在植入时和 8 周时拍摄 X 光片。主要结果是在 4 周和 6 周时,校正植入值后,涂层种植体和对照种植体之间的 ISQ 值差异。次要结果是从植入到 8 周时的边缘骨水平损失。
ISQ 值在 8 周内基本保持稳定,在任何时间点,涂层种植体和未涂层种植体之间均无显著差异。对照种植体的边缘骨损失为 0.12(SD 0.10)mm,涂层种植体为 0.04(SD 0.08)mm。差异为 0.17mm;SD 0.14;p<0.006)。在盲法定性评分中,15 个对照种植体中的 13 个和 15 个涂层种植体中的 2 个显示出小的边缘骨缺损(p=0.003)。
在早期愈合期间,涂层种植体和未涂层种植体的 ISQ 值之间没有观察到统计学上的显著差异。涂层种植体的边缘骨损失较少。