目的:本研究评估了植入物的稳定性,体积变化,与未涂层的SLA植入物相比,羟基磷灰石(HA)纳米涂层喷砂/酸蚀(SLA)植入物的患者报告结果指标(PROMs)。
方法:招募40名患者并随机分配到HA纳米涂层SLA组(测试,n=20)和无涂层SLA组(对照,n=20)使用单盲/区组随机化。使用数字手术指南将植入物立即放置在上颌后部区域。在植入手术和术后1、2、3和4个月测量插入扭矩和植入物稳定性商(ISQ)。口内扫描,收集PROM和软组织炎症数据,并对ISQ进行多元线性回归分析。
结果:总计,分析了37名患者(测试;n=19,对照;n=18)的48个植入物(测试;n=24,对照;n=24)。尽管在手术中没有明显的组间差异,试验组的ISQ值高于对照组(76.53±4.17vs.71.32±4.79,p<0.01),3(77.45±4.41vs.73.85±4.69,p<0.05),和4个月(79.08±2.96vs.73.43±3.52,p<0.0001)术后。线性和体积变化没有显着差异,PROMs,两组软组织炎症分析。植入手术时的ISQ受植入水平的年龄和糖尿病(DM)以及患者水平的DM和预测的骨与植入物总接触面积的影响。
结论:与未涂覆的SLA植入物相比,HA纳米涂覆的SLA植入物在早期骨整合阶段促进了良好的即刻植入物稳定性,但显示出类似的尺寸变化,PROMs,和软组织炎症的结果。
背景:临床研究信息服务(CRIS),KCT0006364。2021年7月21日注册,https://cris。nih.走吧。kr/cris/search/detailSearch.do?seq=24221&search_page=L。
OBJECTIVE: This study evaluated the implant stability, volumetric changes, and patient-reported outcome measures (PROMs) of hydroxyapatite (HA) nano-coated sandblasted/acid-etched (SLA) implants compared to uncoated SLA implants.
METHODS: Forty patients were recruited and randomly allocated to HA nano-coated SLA group (test, n = 20) and uncoated SLA group (control, n = 20) using single-blinded/block randomization. Implants were immediately placed in maxillary posterior region using a digital surgical guide. Insertion torque and implant stability quotient (ISQ) were measured at implant surgery and 1, 2, 3, and 4 months postoperatively. Intraoral scans, PROMs and soft tissue inflammation data were collected, and multivariable linear regression analysis of ISQ was performed.
RESULTS: In total, 48 implants (test; n = 24, control; n = 24) in 37 patients (test; n = 19, control; n = 18) were analyzed. Despite no significant between-group difference at surgery, the test group showed higher ISQ values than the control group at 2 (76.53 ± 4.17 vs. 71.32 ± 4.79, p < 0.01), 3 (77.45 ± 4.41 vs. 73.85 ± 4.69, p < 0.05), and 4 months (79.08 ± 2.96 vs. 73.43 ± 3.52, p < 0.0001) postoperatively. There were no significant differences in linear and volumetric changes, PROMs, and soft tissue inflammation analysis between two groups. The ISQ at implant surgery was influenced by age and diabetes mellitus (DM) at the implant level and DM and predicted total bone-to-implant contact area at the patient level.
CONCLUSIONS: HA nano-coated SLA implants promoted favorable immediate implants stability during early osseointegration phase compared to uncoated SLA implants, but displayed similar dimensional changes, PROMs, and soft tissue inflammation outcomes.
BACKGROUND: Clinical Research Information Service (CRIS), KCT0006364. Registered 21 July 2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24221&search_page=L .