CN1343109A - 牙齿增白带的形状 - Google Patents

牙齿增白带的形状 Download PDF

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CN1343109A
CN1343109A CN00804993A CN00804993A CN1343109A CN 1343109 A CN1343109 A CN 1343109A CN 00804993 A CN00804993 A CN 00804993A CN 00804993 A CN00804993 A CN 00804993A CN 1343109 A CN1343109 A CN 1343109A
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P·A·萨奇尔
L·R·普罗克特
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61C19/00—Dental auxiliary appliances
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
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Abstract

本发明涉及一种牙齿增白带,它具有适合于使用者牙齿的形状。使用者每人都有四颗前齿、两颗犬齿和另外的后齿例如臼齿。每颗齿都有前表面、尖端和背面。该带子具有的形状是使带子基本覆盖使用者的至少四颗前齿和两颗犬齿的前表面。其他牙齿的前表面也可以被覆盖。然后,牙齿增白带可从齿尖端向后翻折到四颗前齿中的一颗或多颗的背面上。但是,该带子并不覆盖两颗犬齿的齿尖。该带子可以是任何可使犬齿露出的形状。可能的形状包括有或没有台阶形侧边或凹槽的大致梯形,也包括有凹槽、台阶形侧边或凹进部位的长方形。

Description

牙齿增白带的形状
发明的领域
本发明涉及一种牙齿增白释放体系用带的改进形状。该体系包括一条带子和牙齿增白物质。
发明的背景
在目前的生活文化中，牙齿增白变得很普遍。越来越多的消费者寻求达到牙齿增白的最佳方法。普遍的是牙医进行专业牙齿漂白。通常，有两类专业牙齿漂白：在牙医诊所内或牙医诊所外。在诊所内的漂白通常要去诊断数次，使用橡皮障保护顾客牙龈受到漂白剂侵害。诊所外的漂白通常是使用在牙医诊所内制成的适于顾客牙齿用的装置如托盘。该装置是重复使用的，因此，必须足够坚固，能耐重复使用、清洗、填充、安装和磨损。顾客一般是在非社会交往期间，使用该装置。
目前，有一些非专业的办法可供希望增白牙齿的人们使用，是使用药店可买到的商品。该商品是成套供应的，包括一类用具和漂白凝胶的容器。显然，需要降低该办法的成本。该类“一个尺寸适合所有”的用具的主要缺陷，是用具内壁与牙齿之间的空隙比专业用的用具大。因此，为了保证漂白凝胶与牙齿表面的紧密接触，就需要用更多的漂白凝胶。此外，配合较差就意味着较多漂白凝胶流失到牙龈上、口腔内，最终被食入。买到的成套用具，一种在诊所外有专业指导的办法，需要使用者清洗和重复使用该用具。由于这类用具并不适合于单个使用者，它们甚至在口腔内比诊所内对人现装的用具大，因此，它们在很大程度上限制了人们的社会交往。
1996年11月19日授予Fontenot的美国专利№5575654揭示了解决买到的成套用具的部分问题的一种尝试。Fontenot揭示了适于宽范围尺寸齿弓用的预包装可模制牙用具。使用时，从包装内取出牙用具，将其排列成与齿缘平行，并沿牙周组织方向推到牙齿上，直至它覆盖牙表面。
1994年5月10日授予Curtis等人的美国专利№5310563揭示了另一种解决方法。Curtis等人揭示了一种贴着牙齿挤压而形成的类似灰泥的材料。它通过与底切表面的机械啮合作用和摩擦作用固定在位。该组合物内部有活性物质。
1995年6月20日授予Sintov等人的美国专利№5425953揭示了其他方法。Sintov等人揭示了漂白牙齿用的一种液态聚合物组合物。该液态聚合物组合物在施加到牙齿上之后形成膜。揭示在口腔内使用膜的其他文献包括1987年12月15日授予Schiraldi等人的美国专利№4713243和1958年5月20日授予Saffir的美国专利№2835628。
通常假设，每个使用者或病人都有四颗前齿、两颗犬齿，另有后齿例如臼齿。这个情况适用于使用者的上牙和下牙。上牙和下牙的四颗前齿和犬齿的形状通常相同，上牙通常较大。每颗牙齿都有前表面、背面和齿尖。牙齿的前表面被认为是人们看得见的并面向嘴唇。牙齿的背面别人通常是看不到的，除非嘴张得很大。齿尖定义为是离牙龈最远的牙部分。齿尖还可以分为冠、峰、点或顶端。四颗前齿齿尖的形状与犬齿或后齿不同。四颗前齿的形状通常是平坦形状的，使牙齿增白带能容易地从齿尖部位翻处折过来。犬齿齿类通常成为一个顶点即锥形。这种形状不适合于使增白带在齿尖部位翻折过来或包起来。使用覆盖犬齿齿类的带子的使用者会发现，增白带不容易贴合于齿类，因此随着时间的延长难以留在原位。另外，使用者也不容易将带子放到犬齿上。增白带也会在犬齿齿尖端部位破裂。通常，带子也不宜在臼齿上翻折过来或包住臼齿。臼齿齿尖的形状通常是正方形，使增白带不容易在牙齿上翻折过来。但是，根据带子形状的调节，在臼齿齿尖上翻折过来也是合适的。
所需要的是可买到的低成本牙齿增白带，它应具有良好的形状，与相应的牙齿表面紧贴接触，而且在日常活动中可留在原位。另外，也需要这样的牙齿增白带形状，它不要求使用者进行费事的放置操作来保证良好的接触。此外，还需要容纳活性物质的部位体积不大，使得戴用者在社会交谈期间使用该体系，而不妨碍戴用者的外貌和说话。
在美国专利申请№09/040000和美国专利№5879691中，揭示了一种牙齿增白体系。该体系含有柔性材料带和牙齿增白物质。带子的形状可以是任何具有圆角的形状。上述两个专利资料的内容集中在带子的特性例如弯曲刚度上，所述体系包括带子、悬帘，带子与牙齿增白物质之间应具有使带子固定在位的相互作用。现在，本发明发现，牙齿增白带的形状也很重要。牙齿增白带的良好形状可使牙齿增白带和增白物质与牙齿更好地粘合。本发明对其形状进行心里，可使牙齿增白带留在使用者牙齿上更长时间而不滑动。另外，本发明牙齿增白带新的形状也可使它不显眼。
发明的概述
本发明涉及一种牙齿增白带材料，它具有适合于使用者牙齿的形状。每个使用者都有四颗前齿、两颗犬齿，另有后齿例如臼齿。每颗牙齿都有前表面、背面和齿尖。带子具有这样的形状，能使带子基本上覆盖使用者的至少四颗前齿和两颗犬齿的前表面，也能覆盖其他牙齿的前表面。然后，牙齿增白带又能从齿尖处向后翻折到四颗前齿中的一颗或多颗的背面。但是，该带子不应覆盖两颗犬齿的齿尖。该带子可以是任何使犬齿露出的形状。可能的形状包括具有或没有台阶形侧边或凹槽的大致梯形，也包括具有凹槽、台阶形侧边或凹进部位的长方形。
发明的详细说明
虽然本文末尾是具体指出并清晰地要求本发明权利范围的权利要求书，但是可以认为，从下述优选实施方式的描述中，结合附图，可更好地理解本发明，附图中相同的编号表示相同的部分，其中：
图1是牙齿增白带的平面图，它的形状大致为梯形；
图2是牙齿增白带的平面图，它的形状大致为具有台阶形侧边的梯形；
图3是牙齿增白带的平面图，它的形状大致为具有台阶形侧边的长方形；
图4是牙齿增白带的平面图，它的形状大致为具有凹槽侧边的长方形；
图5是牙齿增白带的平面图，它的形状为具有两条缝的长方形；
图6是牙齿增白带的平面图，它的形状为具有两个十字缝的长方形；
图7是牙齿增白带的平面图，它的形状为具有两个孔的长方形；
图8是使用者六颗前齿的剖面图；
图9是放在使用者六颗前齿上的牙齿增白带在翻折到使用者牙齿背面之前的剖面图。
发明的详细说明
本文中使用的缩写“cm”，指厘米。本文中使用的“mm”指毫米。
现在，参看附图，特别是参看附图1。图1示出了本发明第一个优选实施方式，它一般示为10。实施方式10表示一个形状大致为梯形的牙齿增白带。实施方式10具有第一侧边11和第二侧边12，第三侧边13和第四侧边14。第一侧边11和第二侧边12是自第四侧边14至第三侧边13形成一个角度的直边。第三侧边13是凹的，比第四侧边14短。第四侧边14是露的，它放置在使用者下前齿的前表面底边附近。另外，如果戴用在使用者上牙上，第四侧边14就可以达到沿着使用者上前齿的前表面的上部分。实施方式10的折叠线15从第一侧边11延伸至第二侧边12。折叠线15可以更接近第三侧边13或第四侧边14。折叠线15由使用者牙齿的尺寸和牙齿增白带在使用者牙齿上的放置情况决定。带10沿着折叠线15折叠后，第三侧边13将位于使用者牙齿的背面。
如图2中实施方式20所示，牙齿增白带的形状可以大致为带台阶形侧边的梯形。实施方式20具有第一侧边21，第二侧边22，第三侧边23和第四侧边24。第三侧边23是凹的，比第四侧边24短。第四侧边24是露的。第一侧边21和第二侧边22都是台阶形侧边。折叠线25从第一侧边21台阶的角26延伸到第二侧边22台阶的角27。实施方式20也可以描述为两个大致的梯形形状，其中一个梯形位于另一个梯形的上面。上面的梯形由第三侧边23、第二侧边22自其角27向上至第三侧边23的部分、折叠线25和第一侧边21自其角26向上至第三侧边23的部分构成。下面的梯形由折叠线25、第二侧边22自其角27向下至第四侧边24的部分、第四侧边24和第一侧边21自其角26向下至第四侧边24的部分构成。
图3示出了本发明的另一个实施方式30，牙齿增白带的形状可以大致为带台阶形侧边的长方形。实施方式30具有第一侧边31，第二侧边32，第三侧边33和第四侧边34。第一侧边31和第二侧边32都是台阶形侧边。折叠线35从第一侧边31台阶的角36延伸到第二侧边32台阶的角37。实施方式30也可以描述为两个大致的长方形形状，其中一个长方形位于另一个形的上面。上面的长方形由第三侧边33、第二侧边32自其角37向上至第三侧边33的部分、折叠线35和第一侧边31自其角36向上至第三侧边33的部分构成。上面的长方形也可以描述为适于覆盖在使用者牙齿背面的口袋盖。下面的长方形由折叠线35、第二侧边32自其角37向下至第四侧边34的部分、第四侧边34和第一侧边31自其角36向下至第四侧边34的部分构成。
使用增白带时，将带的折叠线放在使用者牙齿的齿尖部位，使带折过来覆在牙齿的前表面和背面上。所述带子要这样放置，使使用者的两颗犬齿恰好在角36和37的外面。第四侧边34置于使用者下前齿前表面的底边附近。另外，如果戴用在使用者的上牙上，第四侧边34就可以在使用者上前齿前表面的上部分放置。第三侧边33在使用者齿的背面上。
图4详细示出了形状大致为带凹槽侧边的长方形的牙齿增白带。实施方式40具有第一侧边41、第二侧边42、第三侧边43和第四侧边44。第三侧边43和第四侧边44两者都大致为直边，长度相等。第一侧边41和第二侧边42分别具有凹槽46和47，有了凹槽在带子放置到使用者牙齿上时，犬齿齿尖就不会被覆盖。折叠线45从第一侧边41的凹槽46延伸至第二侧边42的凹槽47。凹槽46和47具有如图所示的V形。凹槽可以是任何使犬齿齿尖不会被包住的形状，包括长方形、半圆形等。
实施方式50、60和70分别如图5、6和7所示。实施方式50、60和70的牙齿增白带的形状大致为具有圆角的长方形。每个实施方式都含有两个牙齿增白带放在使用者牙齿上时使两颗犬齿露出的凹进部位。图5示出了凹进部位是直缝56和57的情形。直缝56和57从增白带的外边延伸至内部的某个位置。折叠线55在直缝56和57之间。图6示出了缝66和67，它们是十字缝。十字缝66和67位于增白带是60范围之内。折叠线65从十字缝66延伸至十字缝67。图7的实施方式70示出了带子内的孔76和77。孔76和77可以是任何足以使犬齿齿尖露出的尺寸。折叠线75在孔76和77之间延伸。
图8示出了使用者的六颗前面下齿相应的俯视图81和前视图82。俯视图81示出了六颗前面牙齿所见的通常弓形。两颗犬齿83和84位于四颗前齿85的两边。图中未显示后齿，例如臼齿，它们位于每颗犬齿的旁边。前视图82示出了四颗前齿85和犬齿83和84的通常形状，包括齿尖。
图9示出了如图8所示的使用者六颗前面下齿前视图82上有图2实施方式20所示牙齿增白带的情况。此图中实施方式20的增白带沿着牙齿放置，但是尚没有在牙齿上翻折过来。如图所示，第四侧边24沿着四颗前齿85和两颗犬齿83和84的底部放置。折叠线25与四颗前齿85的齿尖齐平，而让犬齿83和84的齿尖露出。犬齿83和84在台阶角26和27的位置露出。随后，第三侧边23向下翻折到四颗前齿85的背面上。
牙齿增白带
牙齿增白带可以称为牙齿增白带材料、带材料或带子。牙齿增白带具有适合于使用者牙齿的形状。优选的是带子基本覆盖使用者至少四颗前齿和两颗犬齿的前表面。这些牙齿是多数使用者经常可见的牙齿。带子可以覆盖其余牙齿的前表面，例如两颗犬齿旁边的牙齿。如果别人看得见这些牙齿，那么这也是要求的。这实际上意味着至少前面牙齿表面的一半被覆盖。牙齿增白带可以覆盖全部前面牙齿的表面，也可以覆盖与牙齿相邻的牙龈部分。通常，牙齿增白带在牙齿表面与牙龈相交的部位开始覆盖。
牙齿增白带可以在齿尖上翻折到四颗前齿中的一颗或多颗的背面，但不覆盖两颗犬齿的齿尖。带子的形状要使犬齿齿尖不被覆盖。在齿尖上翻折起来，是指带子在齿尖上覆盖，包住牙齿的前表面、齿尖直到牙齿的背面。根据带子的尺寸情况，带子可以覆盖牙齿的整个背面包括相邻的牙龈，或者仅覆盖牙齿背面的一部分。
牙齿增白带的形状对能够覆盖犬齿前表面而不覆盖其齿尖很关键。带子的形状可以是任何能达到这种效果的形状。牙齿增白带的形状可以具有多种形状。这种带子的形状可以大致为梯形。大致梯形的术语用来指共有四条边的任何形状，其中两条边通常平行或以同样方式弓起来。当一条边露出，相对边凹进部位时就产生这种结果。弓形会有助于减少带子的聚挤现象，使带子在牙齿表面上包得平整。另外两边通常不平行。带子的形状可以是大致的长方形。这通常用来指具有四条边的形状，其中每两条边都近似平行。平行用来广泛地包括弓形、非直线和通常非垂直的情形。另外，带了的形状可以是任何形状，例如圆形或椭圆形。带了也可以是具有许多边的形状。带了的形状不需对称。
带了的任何面或边缘都可以是带凹槽的、台阶形的或弓形的。凹槽指凹入或某种类型的曲线。台阶指边不直，可以包含一个或多个台阶。带子上也可以有缝、十字缝、孔、洞或使犬齿能穿过带子露出或避开被其覆盖的任何合适构型。通常，所述凹进部位应当有2cm可让犬齿露出。
每个带上都有个折叠线。折叠线定义为当带子在齿尖上折起来或包住时牙齿齿尖与带子接触的带子部分。该线可以从一条边上的一个凹进部位、台阶或凹槽的部位延伸达到相对边上的另一个凹进部位、台阶或凹槽部位。例如，在台阶角或凹槽的部位。折叠线通常从带子的一边延伸至另一个平行边，并且沿着带子的较长部分。折叠线自身可以根据带子的尺寸和形状进行调整。对于梯形带，根据带子在使用者牙齿上的定位决定折叠线。对于设计成适合于使用者下牙的带，折叠线的长度通常长至约4cm。对折叠线的最短长度没有要求，只要带子的一部分在四颗前齿的至少一颗的齿尖上能够折叠。通常折叠线长度约为0.1cm-4cm，优选约为0.5-3.5cm，更优选约为1-3.2cm，最优选约为2-3.1cm。对于使用者的上牙，折叠线最长达约4.3cm，通常约为0.1-4.3cm，优选约为0.5-4cm，更优选约为1-3.5cm，最优选约为2-3.4cm。
带子的形状优选具有圆角的任何形状。“圆角”定义为没有任何锐角和尖端。可贴合的带子优选具有这样的尺寸，即适合于要漂白的牙齿列的每颗牙。带子的尺寸决定于很多因素，包括要漂白的牙齿数目、牙齿尺寸和戴用者的个人爱好。通常，带子的长度约为2-12cm，优选约为3-9cm，更优选约为4-6cm。如果带子的侧边上有台阶，或是梯形，那么带子的长边通常约为3-12cm，优选约为3.1-10cm，更优选约为3.5-8cm，最优选约为4-6cm，短边约为0.1-12cm，优选约为0.5-8cm，更优选约为1-5cm，最优选约为1.5-3cm。带子的宽度也决定于许多因素，包括带子是否完全包住牙齿，覆盖牙齿的前表面和背面的部分还是全部。在通常的用途中，带子的宽度约为0.5-4cm，优选约为1-2cm。
带了是起保护隔离的作用，能基本防止唾液接触牙齿增白物质，并防止戴用者的口唇、舌头和其他软组织从牙齿表面浸出和/或磨蚀牙齿增白物质。为了使牙齿增白物质在牙齿表面上长期(从数分钟至数小时)起作用，这种浸出和/或磨蚀应防止到最少很重要。在本文中，“起作用”术语定义为产生所要求的变化。例如，如果所述物质是牙齿增白剂，那么它会将有颜色的物体漂白，导致增白的效果。
所述带子的材料可以是例如聚合物、天然和合成的织物、非织造织物、箔、纸、橡胶及其混合物。所述带子可以是单层或一层以上的叠层。带子材料通常基本上不透水。该材料可以是满足所要求的弯曲刚度，并与牙齿增白活性物质例如过氧化物相容的任何类型聚合物。该材料可以是单种聚合物或聚合物的混合物。合适的聚合物包括而不局限于聚乙烯、聚乙基乙烯基乙酸酯、聚乙基乙烯基醇、聚酯例如杜邦生产的Mylar、氟塑料例如杜邦生产的Teflon及其混合物。该材料优选聚乙烯。带子的厚度通常小于约1mm，优选小于约0.05mm，更优选约为0.001-0.03mm厚。聚乙烯材料带子的厚度优选低于约0.1mm，更优选约为0.005-0.02mm。
带子上可以有一些浅坑。当增白物质涂到带子的要涂布该物质的面上时，较多的物质就会填充这些浅凹坑，形成该物质的容器。另外，浅坑有助于对此释放体系提供一种织构。带子上优选具有呈点阵分布的浅坑。通常，浅坑约0.4mm宽，0.1mm深。当带子上有浅坑，因此增白物质以不同厚度施加到带子上时，此释放体系的总厚度通常小于约1mm，优选小于约0.5mm。
弯曲刚度是一种，随带子厚度、宽度和材料弹性模量的综合而变化的材料性能。其测试方法是测量聚烯烃带子的刚度的方法。它是使用装在水平梁一端的应变仪来，测定样品的抗弯性能的。梁的另一端压在样品带上，迫使带子的一部分进入置放样品带的水平平台上的一个垂直凹槽内。用线接到应变仪上的微安计以偏移力(克)进行过校准。直接从微安计读出样品的刚度，以每厘米样品带宽度的克数表示。在本发明中，带子材料的弯曲刚度小于约5g/cm，是在购自宾夕法尼亚州费城的Thwing-Albert Instrument Co.的#211-300型Handle-O-Meter上，根据ASTM D2923-95测试方法测量的。带子材料的弯曲刚度优选小于约4g/cm，更优选小于约3g/cm，最优选约为0.1-1g/cm。带子材料的弯曲刚度优选基本上是恒定的，在正常使用期内不会明显变化。例如，为使带子达到上述指定范围内的低弯曲刚度，带子材料不需水化。
这种较低的刚度能使带材料只要施加很小的力就能披盖在牙齿的表面轮廓上，即与戴用者口腔的曲率一致，并保持相邻牙齿的间隙，因为带子材料内几乎没有残余应力能使它回复到原来的基本平面形状。随着时间的延长，带子的柔性可使带子材料接触相邻的软组织，不会有物理刺激作用。带子不需什么压力就可贴合到牙齿上。
带子在许多相邻牙齿上由增白物质提供的粘合力固定在位。这种物质的粘度和通常的粘性使带子藉粘合力粘合到许多相邻牙齿上，在口腔进行谈话、饮食等运动期间，在口唇、舌和其他软组织对带子产生摩擦时，带子基本上不会滑动。但是，这种对牙齿的粘合力要足够低，可使戴用者用一个手指或指甲就可将带子剥离下来而容易地取下释放体系。不需使用仪器、化学溶剂或过度用力就可容易地从牙齿表面取下释放体系。化学溶剂包括通常用于口腔护理产品中的任何有机溶剂，例如醇和其他安全性溶剂例如水，它们能够用来稀释胶凝剂。过度用力是指用人的手指或软的东西例如棉球、药签或网垫进行任何类型的用力摩擦作用。
对于宽1.5cm的(约17g/cm)带子只需要约1-50g的剥离力。剥离力优选约为5-40g，更优选约为10-30g。对于消费者自己使用的情形，剥离力应低为宜。由于凝胶物质的非侵蚀性，低剥离力是可能的。只有当带子的弯曲刚度低时，增白物质对带子的粘合力也才能够低。为了防止带子回复其平面状态并从许多牙齿的表面轮廓上脱落，较硬带子的粘合力与带子刚度相比必须较大。
带子可以用本行业内已知的几种制膜方法制成。聚乙烯为材料的带子优选用吹塑方法或浇注方法制成。不会影响带子材料弯曲刚度的其它方法例如挤压也是可行的。此外，增白物质也可以在制带过程中加到带子上。增白物质可以是带子上的一个叠层。
牙齿增白物质
牙齿增白物质是能够对与它接触的表面外观和/或结构影响或产生所要求变化的组合物、化合物或混合物。所述外观和结构变化的例子包括但不局限于增白、污斑漂白、污斑去除和牙垢去除。所用的活性作用优选是牙齿表面的增白。
牙齿增白物质可以涂布到带子上，即由使用者施加到带子上，也可以由使用者先施加到牙齿上，接着，在已涂布了增白物质的牙齿上施加上带子。所述物质在带子或牙齿上的施加量决定于带子的尺寸和容量、活性物质的浓度和所要求的效果。通常需要的是少于约1g物质，优选使用约0.05-0.5g，更优选约0.1-0.4g。每平方厘米材料上的物质量少于约0.2g/cm2，优选约0.005-0.1g/cm2，更优选约0.01-0.04g/cm2。
本发明增白物质的形式可以是粘性液体、糊料、凝胶、溶液或其他可提供足够粘合力的合适形式。所述物质的形式优选是凝胶。所述物质在低剪切速率下(低于1/秒)的粘度约为200-1,000,000厘泊。粘度优选约为100,000-800,000厘泊，更优选约为400,000-600,000厘泊。
适合于增白的活性物质包括任何能安全地用于口腔，提供漂白或去除污斑的物质。适合于增白的活性物质选自过氧化物、亚氯酸金属盐、过硼酸盐、过碳酸盐、过氧酸及其混合物。合适的过氧化物化合物包括过氧化氢、过氧化钙、过氧化脲及其混合物。最优选过氧化脲。合适的亚氯酸金属盐包括亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠和亚氯酸钾。其他的增白活性物质可以是次氯酸盐和二氧化氯。优选的亚氯酸盐是亚氯酸钠。
牙齿增白活性物质的含量约为物质总量的0.01-40％(重量)。如果某种过氧化物化合物选作活性物质，那么该过氧化物化合物应当提供物质总量的约0.1-20％(重量)、优选约0.5-10％(重量)、最优选约1-7％(重量)的过氧化氢等效量。为了释放该过氧化氢等效量，过氧化物化合物例如过氧化脲的含量通常约为物质总量的0.1-30％(重量)，优选约3-20％(重量)。
所述活性物质通常存在于水凝胶中。该凝胶是由本行业内已知的胶凝剂形成的高粘度基体。这些胶凝剂在口腔中使用是安全的，不容易溶解于唾液中，而且不与加入的口腔护理化合物反应或使该化合物失去效用。胶凝剂通常是可膨胀的聚合物。此外，用这些胶凝剂形成的凝胶可提供足够的粘合力使带子结合到口腔的目标区。形成凝胶组合物的胶凝剂含量约为物质总量的0.1-15％(重量)，优选约为1-10％(重量)，更优选约为2-8％(重量)，最优选约为4-7％(重量)。
用于本发明的合适胶凝剂包括羧基聚亚甲基、羧甲基纤维素、羧丙基纤维素、泊洛沙姆、角叉菜胶、V胶(Veegum)、羧乙烯基聚合物和天然胶例如刺梧桐树胶、黄原胶、胍尔豆胶、阿拉伯胶、黄蓍胶及其混合物。用于本发明的优选胶凝剂是以商品名“Carbopol”购自B.F.Goodrich Company的羧基聚亚甲基。尤其优选的Carbopols包括Carbopol 934、940、941、956及其混合物。尤其优选Carbopol 956。羧基聚亚甲基是具有活性羧基的微酸性乙烯基聚合物。据供货商称，各种羧基聚亚甲基树脂在水中的正常浓度低于约2％。但是发现，制备具有上述范围内绝对浓度的超饱和羧基聚亚甲基组合物，可以制成合适的口腔用高粘度凝胶组合物。
浓的羧基聚亚甲基凝胶除了高粘度外，还应具有许多重要的特性。除了需要提供高粘度外，口腔用凝胶组合物中的羧基聚亚甲基应足量，使得需要大量的唾液或水才能将其粘度降低至组合物被稀释并被唾液冲洗掉。浓的羧基聚亚甲基组合物也应具有可将带子留存并包封在它所附着的口腔目标部位的表面上，尤其是牙齿表面上的独特的粘性。但是，应当注意避免羧基聚亚甲基过多，以致难以塞入或取出带子。
本文所揭示的凝胶组合物中也含有水。本发明中使用的水应当优选是去离子水，而且不含有机杂质。水约占物质总量的0.1-95％(重量)，优选约5-90％(重量)，最优选约10-80％(重量)。该水含量包括加入的游离水和随其他材料引入的水之和。
也可以加入pH调节剂，以便优化凝胶的贮放稳定性，并使所述物质对于口腔组织安全。这些pH调节剂或缓冲剂能够是适于调节所述物质pH值的任何材料。合适的材料包括碳酸氢钠、磷酸钠、氢氧化钠、氢氧化铵、锡酸钠、三乙醇胺、柠檬酸、盐酸、柠檬酸钠及其混合物、pH调节剂以足量加入，目的是将凝胶组合物的pH值调节至约4.5-11，优选约5-8.5，更优选约5.5-7。pH调节剂的含量通常约为物质总量的0.01-15％(重量)，优选约为0.05-5％(重量)。
虽然上述凝胶可提供足够的粘合性，但是配方中也可以含有其他的胶凝剂，以帮助活性物质成分粘合到口腔内的组织上。合适的胶凝剂包括具有有限水溶性的聚合物和没有水溶性的聚合物两种。当唾液与所述组合物混合时，这些聚合物可在口腔软和硬组织两者上沉积成薄膜。合适的具有有限水溶性的粘合剂包括：羟乙基或羟丙基纤维素。没有水溶性的粘合剂包括：乙基纤维素和絮凝剂树脂。另一种适用于所述组合物的可能的粘合剂是分子量约为50,000-300,000的聚乙烯基吡咯烷酮。再一种适用于所述组合物的可能粘合剂是Gantrez与半合成的可溶于水聚合物羧甲基纤维素的混合物。
也可以向增白物质内加入另外的载体材料。载体材料可以是湿润剂。合适的湿润剂包括甘油、山梨糖醇、聚乙二醇、丙二醇和其他可食用多元醇。通常，湿润剂的含量约为物质总量的10-95％(重量)，优选约为20-80％(重量)，更优选约为50-70％(重量)。除了本发明凝胶的上述材料，也能够向增白物质内加入许多其他组分。其他的组分包括而不局限于香味剂、甜味剂、木糖醇、遮光剂、着色剂和鳌合剂例如乙二胺四乙酸。这些其他组分也能够用来代替上述那些化合物。
剥离衬
剥离衬可以由对增白物质的亲合性小于增白物质自身和其对带子的亲合性的任何材料形成。剥离衬优选是一种硬材料例如聚乙烯、纸、聚酯或其他材料的片材，其上面随后用非粘性类型材料涂布。所述剥离衬材料可以用蜡、硅氧烷、聚酯例如Teflon、含氟聚合物或其他非粘性类型材料涂布。优选的剥离衬是3M生产的Scotchpak。剥离衬可以切成与带子基本相等的尺寸和形状，也可以切成比带子大，以便能将带子从剥离衬上分离取下。剥离衬可以用带子挠曲时会裂开的脆性材料形成，也可以是片的材料或者是有刻痕的材料。另外，所述剥离衬也可以是两个重叠的片，例如一般的粘性带绷类型的结构。在Kirk-Othmer Encyclopedia of Chemical Technology，第四版，第21卷，第207-218页中可找到适用作剥离剂的材料的进一步说明，其内容参考结合于此。
实施例
带子优选是一片厚0.009mm的聚乙烯膜。该膜上面优选具有一个阵列的浅坑，一般宽0.4mm，深0.1mm。带子的弯曲刚度约为0.6g/cm，是在购自宾夕法尼亚州费城的Thwing-Albert Instrument Co.的#211-300型Handle-O-Meter上，根据ASTM D2923-95测试方法测得的。
牙齿增白物质的一个例子是如下所述的凝胶：混合70％甘油、5％羧基聚亚甲基、10％过氧化脲和15％用氢氧化钠将pH值调节至6.5的水。混合直至均匀。
牙齿增白凝胶的另一些实施例如下所述：
在约84％水中混入8％羧基聚亚甲基，加入4％氢氧化钠和足量碳酸氢钠，使pH值达到约10。溶入3.75％亚氯酸钠，并混合直至均匀。
混合60％甘油、4.5％羧基聚亚甲基和5％过氧化氢。加入氢氧化钠(50％溶液)直至pH值调节到所要求的值，然后，加入余量水。混合直至均匀。
混合56％甘油、6％羧基聚亚甲基、10％过氧化脲和24％水。加入4％氢氧化钠(50％溶液)调节pH值。混合直至均匀。
混合68％甘油、6％羧基聚亚甲基、22％过氧化脲和4％氢氧化钠(50％溶液)。混合直至均匀。
混合25％甘油、69.7％水、2％黄原胶、3％羧甲基纤维素和0.3％过氧化脲。混合直至均匀。
混合24％泊洛沙姆、20％甘油、46％聚乙二醇和10％过氧化脲。混合直至均匀。
可买到的牙齿增白物质例如Opalescence和Nu-Pro Gold也可与本发明的释放体系一同使用。
使用方法
在使用本发明增白释放体系的过程中，是将带子由使用者施加到牙齿上。已用牙齿增白物质涂布带子的朝向牙齿的一面上，所述牙齿增白物质应处于这样的粘性状态，它不仅能提供活性物质，而且在牙齿表面与带子之间提供粘性，使带子固定在位很长时间。另外，使用者也可以在将带子施加到牙齿之前，将牙齿增白物质施加到牙齿或带子上。用轻微的压力和/或由戴用者轻轻地齿间吸气，就可容易地将带子贴合到牙齿上。带子又可容易地由戴用者剥掉取出。优选地，每次后来的增白处理都使用新鲜的带子。
施加本发明的增白释放体系之前，不需对牙齿表面进行预处理。例如施加释放体系之前，戴用者可以或者不进行刷牙或漱口。施加带子之前，牙齿表面不需干燥，也无需用唾液或水进行过分湿润。
带子和增白物质优选是基本透明的，目的是戴用时几乎看不出。此释放体系很薄，使得戴用者口腔内较高的温度可通过带子材料将热量传导给一般较冷的牙齿，从而提高活性材料扩散到牙齿表面的速率。
戴用者优选每天将本发明的释放体系施加在牙齿上保持约5-120分钟，优选约30-60分钟。通常，每天这样做一次，共约7-28天。每天戴用的时间和天数决定于几个因素，包括所要求的漂白量、戴用者的牙齿、以及是否要求起始漂白或维持漂白。进行了漂白后，可达到1-4色标提高的增白效果，由德国BadSackingen的VITA Zahnfabrik产品，VITA LUMINVacuumFarbskala Shade Guide测得的。
当戴用者从牙齿上取下带子后，会有物质的残留物留在表面上。该残留物并不多，因为牙齿增白物质对带子和其自身两者都有亲合性。如果有残留物质，刷牙或漱口就可容易地清除之。
虽然说明和描述了本发明的一些具体实施方式，但是本行业内的普通技术人员会明白，在不脱离本发明的精神和范围情形下，可以对本发明进行各种改变和变化，所附的权利要求书覆盖所有处于本发明范围内的这些变化。

Claims (11)

1.一种牙齿增白带材料，它具有适合于使用者牙齿的形状，所述使用者的每颗牙齿都有前表面、背面和齿尖，每个使用者都有四颗前齿、两颗犬齿，另有后齿，所述带子的形状能使带子基本上覆盖使用者的至少四颗前齿和两颗犬齿的前表面，并可以在齿尖部位翻折到四颗前齿中的一颗或多颗的背面，而不覆盖两颗犬齿的齿尖。
2.如权利要求1所述的牙齿增白带，其中所述的带子具有第一、第二、第三和第四边，所述第一和第二边是相对边，所述第三和第四边是相对边，所述的第三边比第四边短。
3.如权利要求2所述的牙齿增白带，其中所述的第三边是凹的，第四边是凸的。
4.如权利要求2所述的牙齿增白带，其中所述的第一和第二边具有台阶。
5.如权利要求1所述的牙齿增白带，其中所述的第一和第二边具有使第三边比第四边短的凹进部位。
6.如权利要求1所述的牙齿增白带，其中所述的带子具有至少两个防止带子覆盖两颗犬齿齿尖的凹进部位。
7.如权利要求1所述的牙齿增白带，其中所述的带子具有至少两个孔或缝，优选是十字缝，以便防止带子覆盖两颗犬齿的齿尖。
8.如权利要求1所述的牙齿增白带，其中所述的带子上有自第一边至第二边的折叠线，使得当带子放到使用者上牙和下牙上时，该折叠线的位置对应于牙齿的齿尖，当使用者将带子施加到下牙上时，所述折叠线的长度达到0.1-4cm，当使用者将带子施加到上牙上时，达到4.3cm。
9.如权利要求1所述的牙齿增白带，其中所述的带子包含柔性材料，优选用这样的聚乙烯膜，它的额定厚度小于0.1mm，具有足够的柔性能形成弯曲形状，当放到牙齿上时，容易贴合牙齿表面，并填入牙齿缝隙，而不会永久性变形。
10.如权利要求1所述的牙齿增白带，其中所述的带子在戴上时，别人基本不会觉察到。
11.如权利要求1所述的牙齿增白带，其中所述的带子在其要涂布一种物质的面上具有一些浅坑，所述浅坑中含有所述物质。
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US7122199B2 (en) 2006-10-17
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