Yang Fan, Chen Jianping, Cao Ruijue, Tang Qingwei, Liu Haiyan, Zheng Yuchen, Liu BeiLei, Huang Min, Wang Zhenshi, Ding Yude, Wang Linhong
Center for Plastic & Reconstructive Surgery, Department of Stomatology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou, China.
Department of Stomatology, Zhejiang Chinese Medicine University, Hangzhou, China.
Clin Implant Dent Relat Res. 2024 Dec;26(6):1149-1161. doi: 10.1111/cid.13375. Epub 2024 Aug 19.
Robot-assisted implant surgery has emerged as a novel digital technology, and the accuracy need further assessment.
This study aimed to compare the accuracy of single dental implant placement between a novel semi-active robot-assisted implant surgery (RAIS) method and the conventional free-hand implant surgery (FHIS) method through a multicenter, randomized controlled clinical trial.
Patients requiring single dental implant placement were recruited and randomized into RAIS and FHIS group. Deviations at the platform, apex, and angle between the planned and final implant positions were assessed in both groups. Additionally, the evaluation of instrument and surgical complications was examined.
A total of 140 patients (median age: 35.35 ± 12.55 years; 43 males, 97 females) with 140 implants from four different research centers were included, with 70 patients (70 implants) in the RAIS group and 70 patients (70 implants) in the FHIS group. In the RAIS and FHIS groups, the median platform deviations were 0.76 ± 0.36 mm and 1.48 ± 0.93 mm, respectively (p < 0.001); median apex deviations were 0.85 ± 0.48 mm and 2.14 ± 1.25 mm, respectively (p < 0.001); and median angular deviations were 2.05 ± 1.33° and 7.36 ± 4.67°, respectively (p < 0.001). Similar significant difference also presented between RAIS and FHIS group in platform vertical/horizontal deviation, apex vertical/horizontal deviation. Additionally, implants with self-tapping characteristics exhibited significantly larger deviations compared with those without self-tapping characteristics in the RAIS group. Both RAIS and FHIS methods demonstrated comparable morbidity and safety pre- and post-operation.
The results indicated that the RAIS method demonstrated superior accuracy in single dental implant placement compared with the FHIS method. Specifically, RAIS exhibited significantly smaller deviations in platform, apex, and angular positions, as well as platform and apex vertical/horizontal deviations. This clinical trial was not registered prior to participant recruitment and randomization. https://www.chictr.org.cn/showproj.html?proj=195045.
机器人辅助种植手术已成为一种新型数字技术,其准确性有待进一步评估。
本研究旨在通过一项多中心、随机对照临床试验,比较一种新型半主动机器人辅助种植手术(RAIS)方法与传统徒手种植手术(FHIS)方法在单颗牙种植植入准确性方面的差异。
招募需要进行单颗牙种植的患者,并随机分为RAIS组和FHIS组。评估两组计划种植位置与最终种植位置在平台、根尖和角度方面的偏差。此外,还对器械和手术并发症进行了评估。
共纳入来自四个不同研究中心的140例患者(年龄中位数:35.35±12.55岁;男性43例,女性97例),植入140颗种植体,其中RAIS组70例患者(70颗种植体),FHIS组70例患者(70颗种植体)。在RAIS组和FHIS组中,平台偏差中位数分别为0.76±0.36mm和1.48±0.93mm(p<0.001);根尖偏差中位数分别为0.85±0.48mm和2.14±1.25mm(p<0.001);角度偏差中位数分别为2.05±1.33°和7.36±4.67°(p<0.001)。RAIS组和FHIS组在平台垂直/水平偏差、根尖垂直/水平偏差方面也存在类似的显著差异。此外,在RAIS组中,具有自攻丝特性的种植体与不具有自攻丝特性的种植体相比,偏差明显更大。RAIS和FHIS方法在术前和术后的发病率和安全性方面表现相当。
结果表明,与FHIS方法相比,RAIS方法在单颗牙种植植入方面具有更高的准确性。具体而言,RAIS在平台、根尖和角度位置以及平台和根尖垂直/水平偏差方面的偏差明显更小。本临床试验在招募参与者和随机分组之前未进行注册。https://www.chictr.org.cn/showproj.html?proj=195045。