- 學位論文
ITI植體效益25年追踪存活分析評估
Evaluating the Efficacy of ITI Implants with 25-Year Follow-up
摘要
背景與目的 Straumann ITI（International Team for Oral Implantology）植體系統應用於牙科領域至今已過四十餘載，其良好臨床表現不論是針對局部或全口缺牙患者之重建，在過往研究文獻中也被所多記載。而考量時間資訊的存活分析和隨時間植牙失敗風險（hazard rate），皆與患者口內植體功能性年限和預後，有臨床上高度相關，亦需長時間追蹤預後分析。因此，本論文目的，在分析接受某牙周專科醫師植牙之病患的長期追蹤資料，以存活分析方法探討ITI植體成功率，並探索與植體存活相關之風險因子重要性，以進行不同植體失敗風險危險分層。 研究方法 本研究為回溯性世代研究，包含187名患者從1995年8月至2019年5月接受過一次以上ITI植牙手術病患。觀察主要事件為植體脫落 （implant loss）之發生，次要事件為植體脫落之發生或罹患植體囊袋 （peri-implant pocketing）。統計存活分析採Kaplan-Meier方法估算植體存活率 （survival rate）和成功率 （success rate），並以Cox回歸模型評估相關風險因子對植體臨床表現的效應。 結果 本世代研究追蹤超過25年，總計收納了638顆ITI植體，平均每位病患被植入3.41顆ITI植體，而每顆植體追蹤期的平均值（標準差）為7.1（5.7）年。在638顆植體當中，23顆（3.6%）被分類為發生植牙脫落，79顆（12.3%）為罹患植體囊袋，而94顆（14.7%）為發生植牙脫落或罹患植體囊袋。 藉由計算Kaplan-Meier估計值，針對主要事件，即發生植體脫落，在植體層次之累積存活率（cumulative survival rate）於第5、10、15、20、25年分別為97.6%、96.5%、94.4%、89.7%和89.7%；在患者層次之累積存活率於第5、10、15、20年則分別為95.5%、92.5%、89.5%和78.3%。而針對次要事件，亦即發生植體脫落或罹患植體囊袋，在植體層次之累積存活率於第5、10、15、20、25年分別為87.2%、81.9%、77.5%、73.9%和73.9%；在患者層次之累積存活率於第5、10、15、20年則分別為76.0%、65.4%、60.8%、60.8%。 藉由使用Cox回歸模型，結果顯示過去曾有嚴重牙周病史的患者（Roccuzzo score >26, Hazard ratio（HR）=8.56, 95% CI 2.62-27.97）有較高的植牙失敗風險（即發生植體脫落或罹患植體囊袋）並達統計顯著，而女性患者（HR=0.57, 0.36-0.90）則有較高的植牙成功率並達統計上顯著。 結論 本研究以回溯世代研究分析ITI植體25年存活率幾近90%，未發生植牙脫落或植體囊袋25年存活率則幾近75%，有嚴重牙周病史與術後感染為重要危險因子，而女性預後較男性為佳。對不同個案植牙失敗評估，有助於牙科臨床個案管理的術前評估與預測，給予對病人最適切的精準治療。
並列摘要
Background and Aims The dental implant system of International Team for Oral Implantology（ITI） Straumann have been in use for tooth replacement worldwide in dental clinical practice. Although the well performance of such a dental implementation regarding the fraction of implements remains in place and has been reported in previous studies, the time to implement failure and the corresponding hazard rate of failure, both of which were of great clinical relevance to the functionality of implement has barely been studied. The aim of this study was therefore, using data from a periodontist in private practice by the method of survival analysis, to investigate the success rate of ITI system in Taiwan and explore the detrimental factors of implant survival. Methods The present retrospective study of a longitudinal observational cohort with 187 patients was done on all ITI implants performed by a single periodontist from Aug 1995 to May 2019. The main outcome variables of this study were implant loss and peri-implant pocketing. By using the Kaplan-Meier survivor function and Cox model, estimates of cumulative survival rate and hazard ratio with relevant predictors were calculated. Results A total of 638 ITI implants was included in this study with a mean（standard deviation）follow-up of 7.1（5.7）years. Of the 638 implants, 23（3.6%）were classified as implant failure, 79（12.3%）as peri-implant pocketing and 94（14.7%）as peri-implant pocketing or implant loss. According to Kaplan-Meier estimates of survival analysis, at implant level the cumulative survival rate（CSR）at 5, 10, 15, 20 and 25 years was 97.6%、96.5%、94.4%、89.7% and 89.7%, respectively. At patient level, the CSR at 5, 10, 15 and 20 years was 95.5%、92.5%、89.5% and 78.3%, respectively. In regard to the disease-free survival for implant failures or peri-implantitis, the cumulative success rate（SR）was 87.2%、81.9%、77.5%、73.9% and 73.9% at 5, 10 , 15, 20 and 25 years, respectively. As for patient level, the SR at 5, 10, 15 and 20 years was 76.0%、65.4%、60.8% and 60.8%, respectively. By using the Cox regression model, a history of periodontally compromised patient（for score>26, HR=8.56, 2.62-27.97）was associated with a greater risk of implant failure, while female recipient（HR=0.57, 0.36-0.90）were associated with the higher success rate. Conclusions By using data on the cohort of dental implement with a 25-year longitudinal follow-up in Taiwan, we demonstrate the favourable implement survival and the composite event of disease-free survival with a time-to-event approach taking into account hierarchical structure. All relevant factors, particularly periodontal conditions, associated with the force of implement failure were examined. Our empirical evidence supports the dental practice on addressing the history of treated severe periodontitis prior to the implant placement to avoid implement failure.