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標題: | 氧化鋯於人工植牙手術之發展與應用 -從動物實驗到臨床試驗 The Development and Clinical Application of Zirconia in Dental Implantation: from Animal Study to Clinical Trial |
作者: | 林鴻穎 Hung-Ying Lin |
指導教授: | 章浩宏 Hao-Hueng Chang |
關鍵字: | 植牙,氧化鋯,人工牙根, dental implant,Zirconia,implant surgery, |
出版年 : | 2024 |
學位: | 博士 |
摘要: | 研究背景:
氧化鋯於牙科植體上應用,一直是此領域熱門之議題,從製作人工牙根植體本身,到相關手術鑽頭、補綴支台到人工牙冠等等,均為其優勢,惟綜觀文獻,仍未有一系列完整文獻探討其相較傳統植牙材料之優劣。 因此,本研究之目的,在於評估氧化鋯此材料於牙科植體中之開發與應用,:第一部分旨在調查對氧化鋯作為植牙手術時製備窩洞時之鑽針,並和傳統不鏽鋼植牙鑽針之物理性質磨耗程度、表面溫度上升程度,以及以細胞培養比較兩者之生物相容性有無差異。第二部分則以動物實驗模型評估氧化鋯人工牙根植體在癒合過程中骨整合的機轉,藉以了解氧化鋯植體是否具有類似於鈦合金植體類似的骨整合臨床表現;並以臨床試驗,評估氧化鋯植體與鈦金屬植體在植體在術後之牙周組織健康狀況與後續維護上是否有所差異。 材料與研究方法: 為了瞭解氧化鋯之性質,第一部份我們針對氧化鋯鑽針進行物理性質測試,評估具有相同直徑和相似形狀的氧化鋯和傳統不鏽鋼鑽針於模擬手術過程中之磨損情況。在植體窩洞製備的熱測試中,利用熱偶裝置嵌入的人工替代骨塊中,在沒有沖洗降溫的條件下,測試了氧化鋯和不鏽鋼鑽頭所產生的溫度上升情形。此外,我們也利用動物實驗中製備植牙窩洞時,收集骨屑進行細胞研究,通過XTT比色分析和碱性磷酸酶(ALP)活性測量來評估測試氧化鋯和不鏽鋼鑽頭對骨細胞活動的影響,比較其差異性。 第二部分為探討氧化鋯人工牙根植體之臨床潛能,我們使用一種新近開發以噴砂進行表面處理之氧化鋯植體為實驗組,並以一種已上市的氧化鋯植體作為對照組,進行動物試驗,我們以beagle dogs 為動物試驗模式,將兩種氧化鋯植體在分為4、9、13週組時間點,隨機植入下顎骨雙側無牙區,並打入不同顏色骨螢光染劑,在動物犧牲後取得非脫鈣標本,以觀察不同時間點之骨新生及骨螢光標定。同時配合計算切片觀察各周組別的骨-植體接觸比(BIC)觀察。同時在觀察期間以植體搖動度分析儀Periotest作非侵入性植體搖動度測試。此外,我們以新近開發之氧化鋯植體進行臨床試驗,並以已上市的人工鈦金屬牙根進行座位對照組進行牙周參數的比較,藉以了解氧化鋯植體與鈦金屬植體在植體牙周部份的牙周狀況維護是否有差異。 研究結果: 在鑽針物理性質測試中:在需要較少的力量、在重複切割測試中保持銳利度與切削穩定性,以及在鑽孔過程中產生較低溫度方面,氧化鋯鑽頭優於不鏽鋼鑽頭(不鏽鋼鑽頭:45.48±1.31℃;氧化鋯鍍覆鑽頭:32.98±1.21℃)。同時,兩種類型的鑽頭在XTT比色分析和碱性磷酸酶(ALP)活性測試中則無顯著差異,具有同等的生物相容性。 而在氧化鋯人工牙根植體研究結果顯示,我們使用的骨螢光標定完整記錄了氧化鋯骨癒合順序特性,發現在氧化鋯植體上的骨整合時程發生於4-9周,且會生長出一層由骨母細胞(Osteoblast)所分泌之類骨質(Osteoid),逐漸往植體螺紋空隙生長填滿。在定量試驗方面以BIC的數據作為輔助呈現。其BIC的表現於5-13周時逐漸有成長之趨勢,4周與13周數據有統計上差異(P = 0.045);臨床試驗的部分顯示氧化鋯植體,牙菌斑指數之比較顯示手術完後至術後三個月,均能維持在肉眼觀察無牙菌斑或可輕易剃除之少許牙菌斑之狀況,而鈦金屬植體則於術後仍會累積一定量的牙菌斑,牙菌斑指數的表現上,氧化鋯植體優於鈦金屬。 結論: 在植牙窩洞製備過程中,氧化鋯鑽頭比不鏽鋼鑽頭較不易發生產熱效應,並有統計上之顯著差異,應更有利於後續細胞活性之保存與後續傷口癒合。但於動物實驗中,其細胞學分析結果卻顯示:氧化鋯鑽針對骨細胞的活性影響與不鏽鋼鑽頭相似。依此結果推論為實際手術過程中:於窩洞製備此步驟時均會以生理食鹽水進行大量沖洗,因此可有效降溫抵銷鑽針切削骨頭產生的熱效應。因此,由此可以得出結論,氧化鋯鑽頭在各方面提供了與目前可用的不鏽鋼鑽頭相似的切割性能與同樣的生物相容性。 而對於氧化鋯人跟牙根之植體動物實驗評估,本研究建立出未脫鈣磨片輔以骨螢光標定的處理技術,完整記錄氧化鋯骨整合順序特性,此一部分是目前文獻鮮少提及之區域,在植體骨整合初期階段,骨細胞能沿附著植體表面生長,表面處理對於骨整合的初期發生有關鍵性的角色。其後的臨床試驗亦顯示氧化鋯植體相較於鈦金屬植體在植體牙周狀況維護,似乎略佔優勢,氧化鋯植體的臨床應用應具潛力。 Background and Purpose Zirconia has been a popular material in dental implantology with good biocompatibility. But few literatures include all aspect of serial research from cell study, animal study to clinical trial. The first part of this research includes mechanical study, animal study and clinical trial, which is aimed to investigate the physical, thermal, and biological effects on both zirconia and stainless-steel drills. And the subsequent animal study had sought to evaluate the osteointegration mechanisms of a newly developed zirconium implant and compare its clinical bone integration performance to that of titanium alloy implants. Furthermore, the peri-implant periodontal conditions of zirconium versus titanium implants were assessed in the clinical trial. Materials and methods In the physical property test, we assessed the wearing effect of zirconia and traditional stainless-steel drills with the same diameter and similar shape. For the thermal test during implant site preparation, both zirconia and stainless-steel drills were tested in resin-embedded bone using a thermal couple device without irrigation. Additionally, we performed a cell study by collecting bone cells in vivo during drilling with both zirconia and stainless-steel dental drills. The impact of the test drills on bone cell activity was evaluated through XTT colorimetric analysis and Alkaline Phosphatase (ALP) activity measurements. In the animal experiments, we used zirconium implants, with one group subjected to a newly developed sandblasting surface treatment technique and the other using a commercially available zirconium implant. Beagle dogs were used as the animal model. Implants were randomly placed in bilateral edentulous mandibular sites and evaluated at 4, 9, and 13 weeks. Non-decalcified specimens were collected post-sacrifice to observe bone regeneration and fluorescence labelling at various time points. Histological observations calculated the Bone-Implant Contact ratio (BIC), and implant stability was assessed non-invasively with a Periotest device. Clinical trials compared the peri-implant parameters of the newly developed zirconium implant with a control group of commercially available titanium metal root implants to assess peri-implant periodontal condition maintenance. Results The Zirconia drill outperforms the Stainless-Steel drill in terms of requiring less force, maintaining stability over repeated cutting tests, and generating lower temperatures during drilling (stainless-steel drill: 45.48±1.31℃;zirconia-coated drill: 32.98±1.21℃). Meanwhile, both types of drills show similar results in XTT colorimetric analysis, and ALP activity test. Animal experimental outcome indicate that bone fluorescence labelling comprehensively documents zirconium bone integration kinetics. Zirconium implant osteointegration was observed between weeks 4-9th , accompanied by osteoid deposition. BIC data supported these findings, with a statistically significant difference between the 4th-week and 13th-week data (P = 0.045). Clinical trials revealed that zirconium implants maintained minimal plaque postoperatively for up to three months, while titanium implants accumulated more plaque. In terms of plaque index, zirconium implants outperformed titanium implants. However, in the subsequent long-term surveillance clinical trial, we found that the 5-yr survival rate of this one-piece zirconia implant was slightly lower than which has been reported in those existing literatures. We have feedback the findings to the manufacturer about the direction of improving the abutment design and surface treatment. We hope this newly-developed dental implant could be more clinically efficient and satisfactory then. Conclusion As the mechanical test showed, the thermal effect is more favourable in the Zirconia drill than the stainless still drill, with a significant difference. Cytological analysis results indicate that the impact on cells is similar with that of stainless-steel drills. It seemed that copious irrigation on application stainless steel drills might compensate for the unfavourable physical and thermal effect. Therefore, from these three tests, it can be concluded that Zirconia drills offer the same cutting performance as currently available stainless-steel drills in various aspects. The animal experiment provides a comprehensive insight to the osseointegration of the zirconia implants. During early stage of implantation, the surrounding bone cells exhibited affinity for the implant surface, emphasizing the role of surface treatment. And the clinical trials suggest that zirconia implants may offer a slight advantage in maintaining peri-implant periodontal conditions compared to titanium implants, making them a promising choice for clinical applications. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/91673 |
DOI: | 10.6342/NTU202400621 |
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顯示於系所單位: | 臨床牙醫學研究所 |
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