- 學位論文
彈性奈米陶瓷在齒質磨耗病人中臨床使用之評估─臨床研究
Evaluation of Flexible Nano Ceramic on material characteristic and clinical use over tooth wear patients-a clinical study
摘要
實驗目的： 本研究旨在評估彈性奈米陶瓷使用在牙齒磨耗的病人口中的臨床表現及使用狀況，觀察材料的長期穩定性、成功率以及存活率。 材料與方法： 本研究包含27名有牙齒磨耗的病人(贋復體 n=67個)。在進行診斷評估並確認需要贋復體修復後，進行臨床試驗。受試者經過口內黏著彈性奈米陶瓷之後定期回診（黏著後第一次追蹤、黏著後三個月、黏著後六個月），並在術前以及術後每次回診讓受試者填寫VAS主觀調查問卷。術後每次的回診也會由本研究的研究醫師依據修正過的FDI criteria進行客觀條件評估。此外，本實驗也會探討彈性奈米陶瓷在六個月的觀察期間在受試者咀嚼過程中的總平均磨耗量，並與其對咬牙，以及受試者自然對咬齒質磨耗的總平均量作比較。 在得到各追蹤時間的主觀性的VAS分數以及客觀性的FDI分數之後，會以統計軟體（SAS 9.4）計算分析，以Sample Paired t-Test將VAS scale中6個評估項目及FDI critiera的15個評估項目在不同時間點的分數去作比較。最後再將FDI分數以Kaplan-Meier Analysis統計整體贋復體的成功率以及存活率；並以存活曲線來呈現這六個月追蹤期的成功率以及存活率變化。 實驗結果： 27名受試者中，大部分造成齒質磨耗的原因為咬硬物習慣以及磨牙症。在六個月的回診期間中，受試者填寫主觀問卷在術後的分數比起術前在各評估項目中皆有顯著增加。術後六個月受試者給予最高分數的項目是咀嚼效率；最低分為顏色表現。從客觀條件的分析下的FDI評估，少數贋復體在顏色表現上呈現掉色而需要補染色的情形。從整體的磨耗量平均值來看，贋復體、對咬牙，以及參考對咬自然齒質的磨耗量無太大差異。兩個贋復體在觀察期間斷裂，但範圍均不大皆可以於口內修復。Kaplan-Meier分析整體存活率為100%；而在三個月時的成功率為97.06%，在六個月時成功率為93.93%。 結論： 以彈性奈米陶瓷修復於牙齒磨耗的患者，在六個月的觀察期中表現出了臨床可接受的成功率以及高的存活率。受試者在修復贋復體過後的主觀評估項目，與術前相比皆明顯較滿意。然而，在患者贋復空間不足或異常咀嚼功能習慣等情況下，彈性奈米陶瓷使用於牙齒磨耗患者，仍可能會有輕微斷裂的情形。但由於其材料特性易於在口內修復。此外，也需要注意材料的顏色穩定度，使用的染色劑可能會較容易掉色或被磨耗掉。而以總磨耗量的平均值來看，彈性奈米陶瓷、對咬自然齒質、自然對咬齒質的磨耗量相近。因此基於本實驗的結果，彈性奈米陶瓷不會磨損太多對咬牙齒質，本身磨耗的狀況也與自然齒質類似，對於使用在牙齒磨耗患者身上比其他材料更具優勢。
並列摘要
Objective: The aim of the study was to evaluate the long-term clinical performance of flexible nano ceramic using on patients with worn dentition. And analyze the overall survival rate and success rate. Materials and Methods: Twenty-seven participants with worn dentition were enrolled in the present study. including 67 restorations (Cerasmart; GC Corporation, Tokyo, Japan) (NTUH IRB number: 201912143RIPB). All participants were followed up after restorations were placed. The time points of data collection: placement of restorations, 3, and 6 months follow up. Participants were asked to complete subjective questionnaire to evaluate 6 clinical parameters by VAS method. Additionally, all the restorations were assessed by two independent and calibrated evaluators using the modified criteria of the World Dental Federation (FDI) after placement of restorations, 3, and 6 months follow up. Modified FDI criteria were categorized into three groups: esthetic parameters (4 criteria), functional parameters (5 criteria) and biological parameters (6 criteria). Restorations were scored for clinical acceptability. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically unsatisfactory, but repairable, and (5) clinically poor, needed to be replaced. Score 4 and score 5 were recorded as clinically unacceptable.。Besides, overall wear amount of restorations was measured to compare with antagonists and referenced natural teeth. Data analysis was carried out using SAS software (SAS 9.4). The Sample Paired t-Test were asked to evaluate the difference among the different time points regarding subjective (VAS) and objective (FDI) indices. P<0.05 was considered statistical difference. Survival and success rate of restorations was represented by Kaplan-Meier curve. Results: All participants presented moderate to severe tooth wear. Comparing with subjective VAS scores before treatment, the scores of each assessments increased significantly. At 6 months follow up, the highest score was collected from chewing efficiency and the lowest one was observed for color performance. Several restorations were concerned as poor color stability. But most of the restorations performed stable color without significant difference among 3 time points. About the amount of wear, the result was similar with the prostheses and the referenced natural teeth and antagonist during the observed periods. Two restorations were considered as clinically failed due to fracture at the 3 month and 6 month. But these restorations were able to be repaired. The overall survival rate of Kaplan-Meier analysis was 100%. The success rate at three months was 97.06%, and the success rate at six months was 93.93%. Conclusions: Flexible nano ceramic showed a clinically acceptable success rate and a high survival rate on worn dentition patient during the six-month observation period. The participants were satisfied with the restorations compared with original condition. However, in the case of insufficient prosthetic space or parafunction, there was a risk of fracture. Because of the properties of material, it could be easy to repair directly. In addition, the color stability of the material was insufficient. And the amount of wear on prostheses were similar with those in antagonists and the referenced natural teeth. According to the findings of this clinical study, the flexible nano ceramic is considered to be indicated for patient with worn dentition.