- 學位論文
以人造骨研究植體設計與鑽孔規則對於植體穩定度參數之影響
Effect of Implant Macrodesign and Drilling Protocol on Implant Primary Stability Measurements in Artificial Bone
摘要
實驗目的
近年來骨整合植體已經是臨床上訂定重建治療計畫中很重要的應用。雖然植 體表面處理技術進步，即便植體在初期穩定度未達理想的情況下，仍能得到骨整 合的最終結果，但是提升初期穩定度仍然可提高植體成功率，也是植體能否立即 受力 (immediate loading) 的必要條件。植體穩定度就定義上來說，是植體受力時 的微移動量(micromotion)，但目前臨床上無法直接量測此數值，必須藉由其他方 式如植體置入扭力值、共振頻率分析(ISQ)或撞擊阻尼值(PTV)等來代表植體穩定 度。本實驗想要探討在骨質條件不佳的情形下，改變鑽孔規則是否會影響植體穩 定度?皮質骨的有無，對於植體穩定度的表現又會有何影響?
實驗材料與方法
本實驗使用 Sawbone® (Pacific Research Laboratories, Inc. Vashon, Washington, USA)所生產的 “biomechanical test block"來模擬人體骨頭的樣本。選擇骨塊密度 為 10 pcf (0.16 g/cc) 代表海綿骨，以 1mm 厚 50 pcf (0.80 g/cc)之薄層覆蓋在 test block 上模擬皮質骨。植體選擇具有相同的表面處理但不同形狀的三種 Nobel Biocare AB (Göteborg, Sweden)植體，分別為 MKIII (∅4.0*10mm)、MKIV (∅4.0*10mm)和 NobelActive (∅4.3*10mm)。測試骨塊依皮質骨之有無，參考植體 廠商於軟質骨塊所建議的標準鑽孔規則(standard drilling protocols)以及本實驗修改 過後的鑽孔規則(modified drilling protocols)進行植入區製備。並以連接至 Strain Gauge Transducer Indicator (SR1 Strain Gauge Indicator, Advance Instrument Inc., Taiwan)之扭力板手(torque wrench, Sensor Development Inc., MI, USA)，紀錄植體 置入後的 final insertion torque (IT)，NobelActive 植體則另外紀錄置入過程中的 peak insertion torque (PIT)。然後在置入後的植體接上相對應 smart peg，使用 Osstell® ISQ (Integration Diagnostics, Göteborg, Sweden)測量 ISQ (implant stability quotient)值。再將植體接上相對應之高度 5mm 癒合支台，使用 Periotest®
III
(Siemens AG, Bensheim, Germany)水平敲擊癒合支台，得到 Periotest value (PTV)。最後將植入植體之骨塊固定於微移動測量儀載具。施力裝置 (Dynamic Loading Machine, Advance Instrument Inc., Taiwan)以逐漸增加至 10N 之水平力施 加於連接在植體上之 5mm 癒合支台頂端，同時以線性位移計[micro miniature LVDT (Linear Variable Differential Transformer), Singer Instruments Control Ltd, Israel]置放於 5mm 癒合支台底端處，紀錄植體移動量(Micromotion, MM)。將三種 植體隨機分配位置，置入五組測試骨塊，每組實驗骨塊的 ISQ、PTV 和 MM 皆重 複測量三次。
實驗結果
(1) 在低密度且沒有皮質骨的骨塊中(10 pcf)，三種不同的植體皆可以觀察到改變 鑽孔規則會改變植體置入扭力值(IT)、ISQ、PTV 及植體微移動量(MM)的現象。 不使用最後的鑽針(final drill)或是改用 Astra 公司出產的較小直徑 1.9/2.5mm 鑽針(undersized drill)，有利於提升植體置入扭力值，不過只有 NobelActive 植 體的 MM 降低，其他兩種植體則因植體置入不易，反而造成 MM 上升。ISQ 和 PTV 變化則未達統計上顯著差異。
(2) 在低密度的骨塊中，無論有無皮質骨且無論鑽孔規則為何，植體置入扭力值的 大小順序皆為 MKIII
並列摘要
Research goal The purpose of this study was to investigate the effects of implant macrodesign and drilling protocols, in low-density artificial bone blocks, on implant primary stability parameters: implant insertion torque (IT); implant stability quotient (ISQ); periotest value (PTV) and implant micromotion (MM). Materials and methods 1. Polyurethane cellular-typed (10-pcf, density: 0.16 g/cc) sawbone blocks (30mm x15mm x19mm) combined with and without 1-mm lamination (50-pcf, density: 0.80 g/cc) were used to simulate cancellous bone with and without a thin cortical layer. 2. Three types of implant macrodesign (Nobel Biocare AB, Göteborg, Sweden) were used in this study: Nobelbiocare MKIII (4.0mm x 10mm; ø x length), MKIV (4.0mm x 10mm; ø x length) and NobelActive (4.3mm x 10mm; ø x length) implants. 3. Implant site preparations were performed according to manufacturer’s soft-bone drilling protocol. n In standard drilling protocol(SDP), MKIII, MKIV and NobelActive were by step drilling with 2-mm, 2.4/2.8-mm drill in 10 mm depth in non-laminated group. Counterbore drill was extra used for MKIII and MKIV in laminated sawbone blocks. NobelActive was with final drill 2.8/3.2-mm in 10mm depth in laminated group. n In modified drilling protocol 1 (MDP1), MKIII, MKIV and NobelActive were with 2-mm drill as the final drill in non-laminated group and with 2-mm, 2.4/2.8 twist step drill in laminated group. n In modified drilling protocol 2 (MDP2), MKIII, MKIV and NobelActive were by step drilling with 2-mm, 1.9/2.5 twist step drill in 10 mm depth in non- laminated group, and counterbore drill was extra used for MKIII and MKIV in laminated sawbone blocks. NovelActive was by step drilling 2-mm, 2.4/2.8- mm in 10 mm depth and then counterbore drill in laminated group. 4. MK III, MK IV, NobelActive implants were inserted into sawbone blocks by hand torque wrench and final insertion torque (IT) were recorded. 5. ISQ was recorded with Osstell® ISQ (Integration Diagnostics, Göteborg, Sweden) by connecting implant with a smart peg. 6. A 5-mm healing abutment was connected to the implant for measuring Periotest® (Siemens AG, Bensheim, Germany). 7. Bone block was then fixed in the vehicle, micromotion was measured 1mm above implant platform at the opposite side of the healing abutment with micro-miniature VI linear variable differential transformer (LVDT), (Singer Instruments Control Ltd, Israel) when a lateral force 10N applied to the top of healing abutment by a Dynamic Loading Machine (Advance Instrument Inc., Taiwan). Results: (1) In the low-density cancellous bone block (10 pcf), implant insertion torque (IT); implant stability quotient (ISQ); periotest value (PTV) and implant micromotion (MM) were effected by drilling protocols. This trend could be observed in all three types of implant design. Not using the final drill or using the Astra® undersized drill (1.9/2.5mm) could increase IT. However, micromotion was decreased only in NobelActive implant. As for the ISQ and PTV, no significant differences were found statistically. (2) In the low-density cancellous bone block (10pcf), IT was MKIII< MKIV< NobelActive, whether with cortical bone or not and regardless of drilling protocols. NobelActive had highest ISQ and MKIII had highest micromotion. (3) Comparing to non-laminated bone blcoks, the low-density cancellous bone block laminated with 1mm cortical layer (1+10 pcf), three types of implant macrodesign had statistically significant incresed IT and ISQ and decreased micromotion. PTV were decreased in MKIII and NobelActive. (4) In the low-density cancellous bone block laminated with 1 mm cortical layer (1+10 pcf), MKIV and NobelActive had statisticaaly decreased IT and increased micromotion while using counterbore drill to prepare cortical bone. ISQ and PTV of three types of implant macrodesigns had no significant differences whether using counterbore drill or not. Conclusion: (1) IT, ISQ, PTV and implant micromotion were affected by drilling protocol. (2) Based on the same bone quality and drilling protocol, MKIII implant had the lowest implant IT and highest micromotion among the three implant designs. (3) Based on the same implant macrodesign and drilling protocol, IT was increased and micromotion was decreased in bone blocks laminated with cortical bone. (4) Based on the same bone quality and implant macrodesign, IT was decreased and micromotion was increased while using counterbore drill to prepare cortical bone.