植牙導航系統學習曲線與臨床試驗之誤差分析

研究背景植牙手術導航系統是一套基於醫學影像搭配光學定位技術的植牙手術輔助系統，本產品將植牙手術器械、醫學影像、光學定位裝置與植牙術前規劃軟體整合，並依據術前規劃的結果，以臨床適用之介面即時顯示並導引使用者鑽削至術前規劃的位置。透過此系統，牙醫師可以在術前參考所測得的數據，制訂完善的植牙計畫，增加精準度進而助於降低植牙失敗的風險。臨床上的使用經驗也證實植牙手術導航系統的應用確實是可以信賴的而且可以常規用於牙科的植牙手術。但現今文獻多為探討整體誤差，並無研究探討學習曲線對於操作植牙導航系統的影響。研究目的本研究主要是探討植牙導航系統學習曲線與精準度，並比較植牙輔助系統與傳統植牙手術於臨床之精準度的差異。研究方法本實驗利用台灣植體科技股份有限公司AqNavi植牙導航定位系統，比較單人與多人使用AqNavi次數多寡以取得其適合之學習曲線所造成的精準度差異，每次試驗需針對一組上下顎牙模進行鑽孔，每組牙模含六個模擬缺牙，分五次進行相關測試並記錄時間。臨床試驗在高雄醫學大學人體試驗委員會批准(IRB code:KMUH-IRB-2013-08-01(1))下進行，比較三種植牙輔助系統與傳統植牙手術在精準度上的差異，每一組皆有32顆植牙手術紀錄。使用JMP14.0與STATA統計軟體進行統計分析與比較。研究結果單人與多人操作之研究結果以Total error, Longitudinal error與Angular error誤差值之平均數標準差可知，隨著操作次數的增加，操作時間與精準度隨之減少與提升。臨床試驗則發現植牙導航系統搭配手術導板組、植牙導航組、手術導板組與傳統植牙手術組其total error為0.98±0.19 mm、1.25±0.09 mm、1.49±0.08 mm和1.89±0.09°，longitudinal error為0.52±0.20 mm、0.79±0.13 mm、1.00±0.15 mm與1.42±0.25°，angular error為2.20±0.38 mm、3.24±0.36 mm、4.54±0.29 mm與6.12±0.12°。由此可知，植牙導航系統搭配手術導板組精準度相較於傳統植牙手術組來的優越。結論: 植牙導航系統可使上下顎精準度維持一定之水準，如能有效調整植入時之手勢與位置，加強操作熟練度，必更能提升其精準度上的落差。建立植牙導航系統之學習曲線，能有效降低牙醫師習得植牙手術之學習門檻，並能減少醫療糾紛的發生與提升醫療品質水準。以植牙導航系統搭配手術導板模組進行臨床試驗，能有效提升上下顎與不同牙位之植牙精準度，如此可知本研究之系統能有效運用於臨床手術中使用。

關鍵字

學習曲線；精準度；植牙導航系統

並列摘要

Background Dental implant navigation systems, which are used as an aid in dental implant surgeries, employ medical imaging and optical positioning technology. Specifically, it is a combination of surgical instruments, medical imaging devices, optical positioning devices, and preoperative planning software. On the basis of preoperative planning, the systems provide users with an interface with real-time display suitable for application in clinical settings; moreover, they guide users in performing drilling at the positions outlined in the preoperative plans. Dentists can refer to the measured data before surgeries and in developing comprehensive surgical plans to enhance the precision of the implantation and reduce the risk of implantation failure. The reliability of these systems and their applicability for routine use in dental implant surgeries has been established. However, most studies have focused on the discussion of total error in the operation of these systems, disregarding the impact of the learning curves. Study Objective The present study investigated the precision of dental implant navigation systems and the learning curves involved in their operations. Moreover, the precision of three combinations of surgical aids were compared with those of conventional dental implant surgeries in a clinical setting. Method The present study employed the AQ Navi Dental Implant Navigation System. To quantify the learning curves, the number of operation cycles under the single-user and multi-user modes was compared. Furthermore, the resultant differences in precision were investigated. In each experimental trial, drilling must be performed using a set of maxillary and mandibular dental models, with six simulations of missing teeth under each model. The measurements were performed over five trials, and the time taken was recorded. The study protocol was approved by the Institutional Review Board of Kaohsiung Medical University (code: KMUH-IRB-2013-08-01[1]). The differences in precision between three combinations of surgical aids and conventional dental implant surgery were compared, with surgical records of 32 dental implants examined in each group. JMP14.0 and STATA software were used for statistical analyses and comparisons. Results The results for single-user and multi-user operation were expressed using the standard deviation of the mean values of total error, longitudinal error, and angular error. With an increase in operation cycles, the operation time gradually decreased, whereas the precision gradually increased. In this study, the total error of the dental implant navigation system plus the surgical guide set, dental implant navigation system alone, surgical guide set alone, and conventional dental implant surgery was 0.98 ± 0.19 mm, 1.25 ± 0.09 mm, 1.49 ± 0.08 mm, and 1.89° ± 0.09°, respectively. The corresponding longitudinal error for the four methods was 0.52 ± 0.20 mm, 0.79 ± 0.13 mm, 1.00 ± 0.15 mm, and 1.42° ± 0.25°, respectively. The corresponding angular error was 2.20 ± 0.38 mm, 3.24 ± 0.36 mm, 4.54 ± 0.29 mm, and 6.12° ± 0.12°, respectively. The results indicated that precision was higher when the dental implant navigation system was used in conjunction with the surgical guide set than when conventional dental implant surgery was performed. Conclusion Overall, the dental implant navigation system enhanced surgical precision, maintaining that of both maxillary and mandibular dental implantation at various tooth positions at a decent level. The discrepancy in precision can be reduced and surgical efficiency increased if hand gestures and positions are adjusted properly during operations. The establishment of the learning curves of the navigation system can help lower the threshold at which dentists master dental implant surgery, reduce the potential occurrence of medical disputes, and enhance the quality of care. In sum, the present results demonstrate that the AQ Navi Dental Implant Navigation System can be effectively used in clinical settings.