使用彈性奈米陶瓷材料修復磨耗齒列之長期臨床表現與磨耗評估－臨床調查

Abstract

實驗目的： 本研究目的為觀察磨耗齒列使用彈性奈米陶瓷做為?復材料時，在長期追蹤下（最高達18個月），其臨床表現及病患滿意度。並觀察此材料存活率、成功率，及併發症出現機率、呈現方式、嚴重程度、易發於哪些口腔環境及生理習慣（例如有無不良習癖）、修補後之臨床表現等，並比較此材料與自然齒質之磨耗程度差異。 材料與方法： 自2020年2月起，本研究陸續招募37位（11名男性，26名女性，平均年齡53.65±12.27歲）被診斷為齒質磨耗且有?復需求之受試者，確認其參加之意願後，以彈性奈米陶瓷（Cerasmart; GC Corporation, Japan）製作?復體，?復體總數82個。?復體裝戴完成後之定期回診時間為?復治療後第1個月、?復治療後第3個月、?復治療後第6個月、?復治療後第12個月、?復治療後第18個月（平均追蹤月份術13 ± 5.22）。本研究以Visual Analogue Scale（VAS）主觀調查問卷評估受試者術前及術後各追蹤時間之滿意度。客觀評估方面，以修正後的F?d?ration Dentaire Internationale（FDI） World Dental Federation clinical criteria評估量表，由三位經過校正的術者之一評估?復體裝戴後各追蹤時間之臨床表現，另以口內掃描機（TRIOS 3 Intraoral Scanner, 3Shape, Denmark）取得?復體裝戴後各追蹤時間之掃描記錄，並利用掃描檔案之疊合來比較?復體本身、對咬之自然齒質、及參考之自然齒質，三者之磨耗量。 經過追蹤後，整理各回診時間所得之VAS主觀問卷（內涵6項評估項目）及FDI客觀量表（內涵三大類共15項評估項目）得分及?復體與自然對咬牙之磨耗量。以統計軟體（SAS 9.4）進行統計分析，藉由Pair-T test進行各項目在不同時間點之比較；並基於FDI客觀評估量表之結果，計算追蹤時間內的成功率、存活率，並繪出Kaplan-Meier存活曲線。磨耗量分析方面，以Anova及Pair-T test比較?復體、對咬之自然齒質、及參考之自然齒質，各追蹤時間之磨耗量差異。 實驗結果： 在此追蹤期內，在VAS主觀調查問卷方面，6項評估項目在術後各追蹤時間皆顯著比術前高。外型之術後各追蹤時間呈現緩升。顏色、表面光澤於3個月時下降，之後緩升。對黏膜之刺激、清潔容易度大致持平，於18個月時略降。咀嚼效率於6個月前呈現緩升，6個月後呈緩降。在FDI客觀評估量表方面，三大類共15項評估項目中，染色程度略為增加，顏色穩定度較低，磨耗之FDI評分有顯著增加。?復體、對咬牙、參考牙於各追蹤時間之磨耗量皆介於30至50?m，三者之間於各追蹤時間皆無統計上顯著差異（p < 0.05），各追蹤時間之前後比較也無統計上之顯著差異（p < 0.05）。37位受試者共82個?復體中，有5位受試者共6個?復體出現併發症，形式皆為可修復或不可修復之?復體缺損。此5位受試者中，3位為重度磨耗者，另1位有緊咬及單側咀嚼（?復體側）之習癖。此6個?復體中，4個為可修復之小範圍缺損（其中1個修磨量不足），2個為需要置換之大範圍缺損。整體之3個月成功率為98.78%，6個月成功率為97.5%，12個月成功率為94.59%，18個月成功率為85.76%，整體存活率為96.6%。 結論： 使用彈性奈米陶瓷作為磨耗齒列之?復材料在此研究之追蹤期中有可接受的受試者滿意度、臨床結果、與高存活率。在嚴重磨耗之受試者與有特殊習癖之受試者則出現併發症之可能性略高，其中大多為可修復之小範圍缺損，極少數為不可修復之大範圍缺損。在此長期追蹤中，染色情形略為增加，顏色表現則隨著時間下降，磨耗量則隨著時間增加，與對咬自然牙及參考牙之磨耗量與磨耗速率皆相似。基於本實驗之果，可得之此材料使用於磨耗齒列仍有可接受之臨床結果。

Objective: The aim of this in vivo study is to observe the long term (18 months maximum) prosthetic treatment outcome of flexible nanoceramic used on worn dentition, and assess the clinical performance, patient satisfaction; calculate the success rate and survival rate; observe the complication mode and the risk factors ; and compare the wear amount between hybrid ceramic and natural tooth structure. Materials and Methods: Since February 2020, thirty-seven participants (11 males, 26 females, average age 53.65±12.27) with the need of prosthetic treatment, and were diagnosed as “worn dentition” were enrolled in the current study. After confirming the participants’ willingness to participate in our study, prosthetic treatments were done with flexible nanoceramic (Cerasmart; GC Corporation, Japan) (NTUH IRB number: 201912143RIPB), with a total of 82 restorations. After the restorations were delivered, the participants were asked to return on specific points of time (1 month after delivery, 3 months after delivery, 6 months after delivery, 12 months after delivery, and 18 months after delivery, average follow-up time 13 ± 5.22 months). The participants’ satisfaction (subjective evaluation) were recorded with Visual Analogue Scale (VAS) questionnaire (including 6 indices) before delivery, at the time of delivery, and on each follow-up appointments. The clinical performance (objective evaluation) of the restorations were evaluated according to the modified F?d?ration Dentaire Internationale (FDI) World Dental Federation clinical criteria (including 3 genres, 15 indices totally) on each follow-up appointments. Intra-oral scanning (TRIOS 3; 3Shape, Denmark) was done on each follow-up appointments. The wear amount of the restorations and the antagonists were compared with that of natural tooth structure. SAS software (SAS 9.4) was used for data analysis. The score of VAS (subjective) and FDI (objective) indices of each different follow-up appointments were compared with Pair-T test. P < 0.05 was considered as statistically different. Survival rate and success rate were calculated, and Kaplan-Meier survival curve was sketched. The wear amount of the restoration, antagonist, and the reference natural tooth were compared with Anova and Pair-T test. Results: During the follow-up interval, the VAS scores of the participants’ satisfaction after delivery were significantly higher than pre-treatment. The scores of morphology slowly ascend. The scores of color and surface luster decrease at 6 months follow-up, but slowly ascend after that. The scores of mucosal irritation and cleansability don’t change much after delivery, but decrease at 18 months follow-up. The scores of chewing efficiency ascend before 6 months follow-up, descend after 6 months follow-up. The clinical performance recorded with FDI scores shows a slight increase in staining, moderate decrease in color stability, evident increase in wear amount. The wear amount of the restoration, antagonist, and reference tooth of all follow-up interval were between 30 and 50 ?m. Among the 37 participants and 82 restorations, complications occurred on 5 participants and 6 restorations. The complications were all presented as fracture of restoration, 4 restorations were repairable, 2 of them were not. Among the 5 participants, 3 were classified as severe tooth wear, 1 was recorded as parafunction (clenching, prosthesis side chewing only). 3 months success rate was 98.78%, 6 months success rate was 97.5%, 12 months success rate was 94.59%, 18 months success rate was 85.76%, the overall survival rate was 96.6%. Conclusion: During the follow-up interval, restorations fabricated with flexible nanoceramics showed good participant satisfaction, good clinical performance, and high survival rate. Complications tends to occur on participants with severe tooth wear or parafunction, most of these complications were repairable, very few of these complications were non-repairable. After 18 months, staining slightly increases, color stability moderately decreases, wear amount increases. When compared with opposing natural tooth structure and reference tooth, flexible nanoceramic shows similar wear amount and wear rate. According to the results, flexible nanoceramic presented acceptable long term clinical performance, on participants with worn dentition.