CN106580493A - 新型牙科修复用二氧化锆全瓷桩/钉制备方法 - Google Patents
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Abstract
本发明提供了一种新型牙科修复用二氧化锆全瓷桩/钉制备方法，所述的二氧化锆全瓷桩/钉的头部为圆锥体，中段为圆柱体，尾部为扁平形的长方体，所述的二氧化锆全瓷桩/钉的制备方法包括如下步骤：1）以二氧化锆粉和聚乙烯醇缩丁醛PVB作为用于桩/钉生产的粉料，按比例配制、混合、干燥、造粒，聚乙烯醇缩丁醛PVB的添加量以能让二氧化锆粉粘结即可；2）制备固定尺寸的桩钉成型模具；3）按预定尺寸压制形成统一规格的锆棒；4）在二氧化锆结晶炉中将锆棒烧结成型。本发明是一种更加精准高效的二氧化锆全瓷桩/钉制备方法，为牙齿修补提供了高强防腐耐用的材料，它制造使用方便，生物相容性和美观效果俱佳，是一种理想的牙科修复新材料。
Description
技术领域
本发明涉及一种医用器材的制备方法，尤其是一种牙科修复材料的制备方法，具体地说是一种新型的牙科修复用二氧化锆全瓷桩/钉制备方法。
背景技术
因龋齿或外伤所致的牙体大面积缺损，由于剩余牙体组织薄弱，充填物极易折断或脱落。临床上最常用的解决办法是采用金属钉或纤维桩增强固位。金属钉体很容易被口腔内唾液、牙本质小管内液等液体腐蚀，继而引起牙体和修复体变色以及固位钉松脱，导致修复失败。纤维桩强度差、与牙体组织及树脂材料粘接效果不明确，容易折断，且纤维桩末端呈圆柱体，镊子夹持时容易脱落引发误吞误吸等医疗差错。
二氧化锆全瓷材料是近年来新兴的口腔修复材料之一，且在医学领域的应用日益广泛。二氧化锆全瓷材料具有出色的视觉效果，良好的生物相容性和耐腐蚀性，以及足够的强度等诸多优点，常用于制作瓷冠桥、瓷贴面、瓷嵌体等高端修复体。同时与之配套的粘结材料和技术也已日臻完善，经专用粘结剂处理后获得的高粘结力能使二氧化锆全瓷修复体与牙体组织几乎融为一体，微渗漏极小，远期效果稳定。二氧化锆全瓷改善了传统陶瓷的脆性、低抗张强度和高收缩率的缺点，抗弯强度达到400MPa，断裂韧性2.75MPam1/2。
与传统金属钉修复相比，二氧化锆全瓷桩/钉有较高的强度、硬度、抗疲劳性、美观性和良好的生物相容性，能很好地解决金属钉带来的腐蚀、变色和过敏等问题；并且对核磁共振无干扰；对X线阻射性好，便于复查定位。同时二氧化锆全瓷桩钉相比较纤维桩具有更高的强度、更佳的粘结性和更好的生物相容性。
目前市场上几乎没有专门生产二氧化锆全瓷桩/钉的厂家，如何精准高效地制备符合临床需求的二氧化锆全瓷桩/钉，成为提高牙体微创修复成功的关键。
发明内容
本发明的目的是针对临床上牙体大面积缺损充填物易脱落，使用传统金属钉或纤维桩加强固位存在种种缺陷等问题，发明设计一种充填固位大面积牙体缺损(含切角缺损)用二氧化锆全瓷桩/钉制备方法。
本发明的技术方案是：
新型牙科修复用二氧化锆全瓷桩/钉制备方法，所述的二氧化锆全瓷桩/钉的头部为圆锥体，中段为圆柱体，尾部为扁平形长方体，所述的二氧化锆全瓷桩/钉的制备方法包括如下步骤：
1)以二氧化锆粉和聚乙烯醇缩丁醛PVB作为用于桩/钉生产的粉料，按比例配制、混合、干燥、造粒，聚乙烯醇缩丁醛PVB的添加量以能让二氧化锆粉粘结即可；
2)制备固定尺寸的桩钉成型模具；
3)按预定尺寸压制形成统一规格的锆棒，考虑到二氧化锆瓷块烧结过程中的收缩率，将瓷块尺寸作相对应的放大；正常收缩率在23％左右。
4)在二氧化锆结晶炉中将锆棒烧结成型；
5)无心磨床精密机械加工所需直径的二氧化锆棒材；
6)空心磨床加工桩/钉头部所需锥度；
7)平面磨床完成尾部结构，呈扁平状；
8)对成型的二氧化锆桩/钉进行表面喷砂，增加表面粗糙度；
9)体视镜下检测桩/钉表面裂纹，去除次品，消毒封装。
优选地，
所述的表面喷砂清洗处理是指在设定压强下用微米级砂粒喷砂至少5s，后用无水乙醇超声分别清洗桩/钉表面至少1min。
更优选地，
所述的表面喷砂清洗处理是指在0.25MPa压强下用50μm Al203砂粒喷砂10s，后用无水乙醇超声分别清洗桩/钉表面3min。
所述的新型牙科修复用二氧化锆全瓷桩/钉用于替代金属钉或玻璃纤维桩固位大面积牙体缺损或切角缺损。
本发明的有益效果：
1、本发明二氧化锆全瓷桩/钉制备方法是经过基础和临床多次实验得到的更加优化的制备方法，将锆粉等原料预制成为锆棒，再完成烧结结晶、机械加工、表面处理等一系列程序，精准高效，从选料、结晶、机械加工等各方面对二氧化锆全瓷桩/钉的材质、强度、外形进行控制，保证制作出符合临床需要的二氧化锆全瓷桩/钉。
2、二氧化锆全瓷桩/钉的设计是在对现有桩钉外形研究分析后，进行了改良优化，进行表面处理，使临床操作更方便，粘结效果更出众，最大化地发挥二氧化锆材料的优点，并且可以根据需要制作加工个性化的全瓷桩/钉，以适应临床上复杂多变的实际缺损情况，便于全面推广应用。
3、本发明二氧化锆全瓷桩/钉固位充填术在牙体大面积缺损的治疗中，是一种微创的修复方法，相比较冠修复等方法可以最大限度地减少牙体组织损伤、少磨牙、保留更多的健康牙体组织，很好地满足了牙体微创治疗的需求，操作简便而经济，减少了患者就诊次数，节约了患者治疗成本。
4、本发明研发的二氧化锆全瓷桩/钉在牙体大面积缺损充填中，既能提供接近金属钉的强度和固位力，又能避免金属钉带来的牙本质微裂及易被腐蚀染色等问题；同时相比较纤维桩具有更大的强度、更佳的粘结性和更好的生物相容性。将二氧化锆全瓷桩钉用来修复大面积龋齿缺损，避免了大面积牙体缺损冠修复后的一系列问题，避免了活髓牙因充填体固位不足而进行不必要的根管治疗，应用前景广阔。
采用本发明的二氧化锆全瓷桩/钉，使用双固化树脂水门汀RelyX Unicem或流动树脂粘结植入牙本质中，联合树脂修复牙体大面积缺损尤其是前牙切角缺损。经临床观察发现：采用二氧化锆全瓷桩/钉固位充填与直接树脂充填组相比，实验组(二氧化锆全瓷桩/钉固位充填)修复成功率(93.1％)远高于对照组(57.1％)。
经实验室微拉伸实验和剪切实验研究表明(表1)：二氧化锆全瓷桩/钉显著提升牙本质-树脂界面的粘结强度，可接近或达到金属钉的粘结强度水平。
表1各组牙本质-树脂界面粘结强度值(MPa，Mean±SD)
采用三维有限元分析方法，通过建立二氧化锆全瓷桩/钉修复模拟上颌切牙大面积龋齿模型，分析不同的修复方式(玻璃纤维桩+树脂充填与二氧化锆全瓷桩钉+树脂充填)对上颌切牙牙体组织应力分布的影响，结果表明二氧化锆全瓷桩/钉系统较玻璃纤维桩修复更适用于上颌切牙，前者的咬合应力集中在根尖1/3，而后者的咬合应力集中在牙颈部薄弱区域。
附图说明
图1a是一种二氧化锆全瓷钉结构的侧视图；(图中数字单位为mm)
图1b是一种二氧化锆全瓷钉结构的主视图；(图中数字单位为mm)
图2a是一种二氧化锆全瓷桩结构的侧视图；(图中数字单位为mm)
图2b是一种二氧化锆全瓷桩结构的主视图；(图中数字单位为mm)
图3a是另一种二氧化锆全瓷桩结构的侧视图；(图中数字单位为mm)
图3b是另一种二氧化锆全瓷桩结构的主视图；(图中数字单位为mm)
图4是本发明的二氧化锆全瓷钉修补前牙缺损过程示意图；
图5是本发明的二氧化锆全瓷桩修补前牙大面积缺损临床操作实物图。
具体实施方式
下面结合附图和实施例对本发明作进一步的说明。
实施例1
本实施例的牙科修复用二氧化锆全瓷桩/钉制备方法，包括以下步骤：
1)以二氧化锆粉和聚乙烯醇缩丁醛PVB作为用于桩/钉生产的粉料，按比例配制、混合、干燥、造粒，聚乙烯醇缩丁醛PVB的添加量以能让二氧化锆粉粘结即可；
2)制备固定尺寸的桩钉成型模具；
3)按预定尺寸压制形成统一规格的锆棒，考虑到二氧化锆瓷块烧结过程中的收缩率，将瓷块尺寸作相对应的放大；正常收缩率在23％左右。
4)在二氧化锆结晶炉中将锆棒烧结成型；
5)无心磨床精密机械加工所需直径的二氧化锆棒材；
6)空心磨床加工桩/钉头部所需锥度；
7)平面磨床完成尾部结构，呈扁平状；
8)对成型的二氧化锆桩/钉进行表面喷砂，增加表面粗糙度；
9)体视镜下检测桩/钉表面裂纹，去除次品，消毒封装。
所述的表面喷砂清洗处理是指在0.25MPa压强下用50μm Al203砂粒喷砂10s，后用无水乙醇超声分别清洗桩/钉表面3min。
具体实施时的表面喷砂清洗处理所用压力、砂粒类别和粒径以及表面预处理时的参数可根据发明内容部分标定的范围或实际情况加以选择。
制备的二氧化锆全瓷桩/钉：尾部设计为近似扁平形的长方体，便于牙科镊子夹持，中段为圆柱体，头部为圆椎体，可以减少桩道预备时的牙体切割量，降低牙折的概率，同时也便于放入备好的牙体桩(钉)道。因为二氧化锆的强度足够高，无须较粗的直径。最后通过喷砂表面处理初步获得较好的机械结合力。
本发明的二氧化锆全瓷桩/钉可广泛用于替代金属钉或玻璃纤维桩固位大面积牙体缺损或切角缺损。
用本发明的方法制造的二氧化锆全瓷桩/钉为近似长圆锥形，常用标准尺寸有三种(如图1～3所示)，也可根据需要设计成其它尺寸。
图1a和图1b为一种二氧化锆全瓷钉，二氧化锆全瓷钉总长度12mm。尾部为长3mm的扁平形长方体，中段为长6mm、直径0.6mm的圆柱体，头部为长2mm、锥度5度的圆锥体，圆锥体尖端直径0.37mm。置于牙本质钉道内，主要应用于冠部缺损尤其是前牙切角缺损的固位修复。
图2a和图2b为一种二氧化锆全瓷桩，二氧化锆全瓷桩总长度14mm。尾部为长3mm的扁平形长方体，中段为长5mm、直径1.1mm的圆柱体，头部为长5mm、锥度5度的圆锥体，圆锥体尖端直径0.68mm。置于根管桩道内，主要用于根管直径较细且较短的牙齿(如后磨牙)。
图3a和图3b为另一种二氧化锆全瓷桩，二氧化锆全瓷桩总长度16mm。尾部为长3mm的扁平形长方体，中段为长6mm、直径1.3mm的圆柱体，头部为长6mm、锥度5度的圆锥体，圆锥体尖端直径0.8mm。置于根管桩道内，主要用于根管直径较粗且较长的牙齿(如前牙)。
本发明的全瓷钉使用方法示意图如图4所示：
先使用配套的扩孔钻沿牙体长轴方向预备钉道，将二氧化锆根据前述实施例制备好的全瓷钉用双固化树脂水门汀RelyX Unicem或流动树脂粘结植入牙本质中，联合树脂修复牙体大面积缺损特别是前牙切角缺损。
具体操作步骤如下：
1、患牙常规去腐，预备标准洞形，将洞缘釉质磨成与洞壁成60°角的斜面，宽度1.0～2.0mm。
2、活髓牙洞壁近髓侧用玻璃离子垫底(洞深者行光敏氢氧化钙护髓)，死髓牙根管口直接行玻璃离子垫底。
3、在窝洞轴角区龈壁釉牙本质交界处内侧0.5mm处，用金属自攻自断螺纹钉配套扩孔钻沿牙体长轴方向预备钉道，深度2mm、直径0.65mm。
4、根据牙体及窝洞外形用金刚砂车针调磨固位钉使之长度合适，钉末端距患牙切端约1～2mm。
5、洞壁按SingleBond说明书要求进行酸蚀、粘结，自粘型树脂水门汀(RelyXUnicem，3M ESPE)进行固位钉粘结植入。
6、Z350纳米树脂充填修复，调磨抛光。
本发明的全瓷桩使用方法实物图如图5所示：
二氧化锆全瓷桩的实施方式与全瓷钉类似，用于无髓牙根管治疗后，桩道预备在根管内。具体方法如下：
1、根管治疗后大面积缺损的牙齿，使用专用扩孔钻按预先确定的深度预备根管、去除牙胶。
2、试戴二氧化锆全瓷桩，桩的直径与预备后的根管直径吻合并完全就位。
3、洞壁按SingleBond说明书要求进行酸蚀、粘结，将双固化树脂水门汀RelyXUnicem或流动树脂导入根管内，将二氧化锆全瓷桩缓慢就位。
4、光固化灯光照使树脂充分固化。
5、均匀切割多余长度的二氧化锆全瓷桩。
6、完成树脂核的成形与牙体的最终修复形态。
以上所述仅为本发明的实施例，并非因此限制本发明的专利范围，凡是利用本发明说明书及附图内容所作的等效结构或等效流程变换，或直接或间接运用在其他相关的技术领域，均同理包括在本发明的专利保护范围内。
本发明未涉及部分均与现有技术相同或可采用现有技术加以实现。
Claims (4)
1.新型牙科修复用二氧化锆全瓷桩/钉制备方法，其特征在于，所述的二氧化锆全瓷桩/钉的头部为圆锥体，中段为圆柱体，尾部为扁平形长方体，所述的二氧化锆全瓷桩/钉的制备方法包括如下步骤：
1）以二氧化锆粉和聚乙烯醇缩丁醛PVB作为用于桩/钉生产的粉料，按比例配制、混合、干燥、造粒，聚乙烯醇缩丁醛PVB的添加量以能让二氧化锆粉粘结即可；
2）制备固定尺寸的桩钉成型模具；
3）按预定尺寸压制形成统一规格的锆棒，考虑到二氧化锆瓷块烧结过程中的收缩率，将瓷块尺寸作相对应的放大；
4）在二氧化锆结晶炉中将锆棒烧结成型；
5）无心磨床精密机械加工所需直径的二氧化锆棒材；
6）空心磨床加工桩/钉头部所需锥度；
7）平面磨床完成尾部结构，呈扁平状；
8）对成型的二氧化锆桩/钉进行表面喷砂，增加表面粗糙度；
9）体视镜下检测桩/钉表面裂纹，去除次品，消毒封装。
2.根据权利要求1所述的方法，其特征在于，所述的表面喷砂清洗处理是指在设定压强下用微米级砂粒喷砂至少5s，后用无水乙醇超声分别清洗桩/钉表面至少1min。
3.根据权利要求2所述的方法，其特征在于，所述的表面喷砂清洗处理是指在0.25MPa压强下用50µm Al203砂粒喷砂10s，后用无水乙醇超声分别清洗桩/钉表面3min。
4.如权利要求1所述的新型牙科修复用二氧化锆全瓷桩/钉用于替代金属钉或玻璃纤维桩固位大面积牙体缺损或切角缺损。
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