牙周再生片的开发及性能研究
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摘要
近年来综合了细胞生物学、工程学、材料学和临床医学等领域的组织工程日益受到了人们的关注。纺织与它也有了新的融合。本论文研究对象是牙周引导组织再生技术(GTR)及牙周引导组织再生阻挡片。“牙周再生片”是一种发展的引导性组织再生器具，一般由可降解的生物材料制成，是一种能令齿骨膜再生的最新概念。目前的国内外研究主要针对不同材料牙周再生片的体内、体外降解性能和生物相容性的研究而缺乏对其物理机械性能和相关的编织工艺参数的分析，对牙周再生片降解性能的研究也没有涉及降解过程中其力学性能的变化趋势。材料、编织工艺和表面涂层浓度的改变对牙周再生片的力学性能和降解性能会产生一定的影响，目前的国内外研究尚缺乏对这方面的探讨。
本课题研究不同材料、纱线粗细、编织密度和涂层对牙周再生片力学性能的影响，探讨较优的工艺参数组合，初步研究不同材料在体外模拟降解过程中的强力衰减速度和质量损耗周期。
通过选用两种不同的可生物降解材料(PGA、PGLA)，在纬平针组织的基础上，分别改变牙周再生片的骨架织物密度、涂层浓度等工艺参数，运用正交试验方法，探讨该牙周再生片的撕裂强力、拉伸断裂强力和初始模量，最终找出较优的工艺条件和参数。
在正交试验的基础上进行两种不同原料牙周再生片的体外模拟降解试验。通过对两种牙周再生片强力、初始模量和质量的损耗率测定以及降解过程中表面形态的观察分析两种牙周片的结构特点和降解特性，找出更适用于生产牙周再生片的原料。
通过本课题的研究，开辟牙周再生片新的研究方向，用正交试验法优选牙周再生片的工艺参数发现，内层骨架织物的原料、编织密度和表面涂层浓度对牙周片的力学性能均有高度显著的影响，且原料与编织密度之间的交互作用对牙周片的性能也有较大的影响。PGA和PGLA牙周再生片的降解都是通过酯键的水解来实现，是一个化学降解的过程。材
料强力和初始模量的衰减比质量的损耗快得多，PGA牙周再生片强力和
初始模量下降速度比较均匀，而PGLA牙周再生片强力和初始模量下降
过程中有速度的突变点。
由正交试验优选出力学性能较优的4号试样，其工艺条件为内层骨架
纬平组织采用14texPGLA紧密编织，表面覆质量百分比浓度为3.5%的甲
壳胺浆液。PGLA和PGA牙周再生片的体外降解试验结果显示:PGA牙
周片的强力和初始模量衰减较PGLA牙周片快，但是质量保持的时间稍
长。从外观上，PGLA牙周片降解过程中的形态保持比PGA牙周片好。
Nowadays, people pay more and more attention on tissue engineering, which combines cell biology, engineering, material science and clinical medicine, etc. Textile also has new development on it. This paper mainly discusses Guided Tissue Regeneration (GTR) and "GTR Barrier". "GTR Barrier" is a kind of apparatus that can guide the regeneration of tissue, which is made of biodegradable material. At present, most researches on it are focusing on its degradation properties in vivo and in vitro, but they don't relate to the change of the physical properties during the degradation. In addition, few researches are on how materials and techniques influence the physical properties and degradation properties of GTR Barrier, so this paper will do some work on it.
In this paper, the influences of materials, yarn thickness, knitting density and coating on physical properties of GTR Barrier were studied. In addition, some elementary researches were taken on several degradation properties such as strength attenuation and mass loss of different materials in vitro.
Two biodegradable materials (PGLA, PGA) were selected to knit single jersey fabrics with different density as skeletons of GTR Barriers. Orthogonal test was used to select optimum parameters of material, knitting density and coating by testing splitting strength, tensile strength and initial modulus of GTR Barriers. Through the test, the comparatively better technical parameters could be found.
On the base of orthogonal test, two kinds of GTR Barriers of different materials were picked out to take degradation experiment in vitro. ' Comparing the ratio of strength attenuation and mass loss of these GTR Barriers and their appearance change in course of degradation to analyze their structure characters and degradation properties. Through the comparison, appropriate material used in GTR Barrier could be selected.
Through the .researches, finding a new study direction on GTR Barrier. The result of orthogonal test shows the material, knitting density of skeleton
fabric and coating can remarkably influence the mechanical properties of GTR Barrier. In addition, the interaction between material and knitting density can also influence the result. The degradation courses of PGA and PGLA GTR Barriers in vitro are chemical degradation processes, which achieved by hydrolysis of ester bond. The attenuation of tensile strength is faster than mass loss. The degradation velocity of PGA film is uniform, but when it comes to PGLA film, there is a break point in attenuation of tensile strength and initial modulus during the degradation.
In orthogonal test, the better GTR Barrier is 4# sample, which skeleton fabric is tightly knitted with 14tex PGLA, coated with 3.5% chitosan. The in vitro degradation experiment of PGA film and PGLA film shows that the attenuation of tensile strength and initial modulus of PGLA barrier is slower than that of PGA barrier, but its mass loss period is shorter. Judging from the appearance change during degradation, PGLA barrier has a better appearance retention than PGA barrier.
本课题研究不同材料、纱线粗细、编织密度和涂层对牙周再生片力学性能的影响，探讨较优的工艺参数组合，初步研究不同材料在体外模拟降解过程中的强力衰减速度和质量损耗周期。
通过选用两种不同的可生物降解材料(PGA、PGLA)，在纬平针组织的基础上，分别改变牙周再生片的骨架织物密度、涂层浓度等工艺参数，运用正交试验方法，探讨该牙周再生片的撕裂强力、拉伸断裂强力和初始模量，最终找出较优的工艺条件和参数。
在正交试验的基础上进行两种不同原料牙周再生片的体外模拟降解试验。通过对两种牙周再生片强力、初始模量和质量的损耗率测定以及降解过程中表面形态的观察分析两种牙周片的结构特点和降解特性，找出更适用于生产牙周再生片的原料。
通过本课题的研究，开辟牙周再生片新的研究方向，用正交试验法优选牙周再生片的工艺参数发现，内层骨架织物的原料、编织密度和表面涂层浓度对牙周片的力学性能均有高度显著的影响，且原料与编织密度之间的交互作用对牙周片的性能也有较大的影响。PGA和PGLA牙周再生片的降解都是通过酯键的水解来实现，是一个化学降解的过程。材
料强力和初始模量的衰减比质量的损耗快得多，PGA牙周再生片强力和
初始模量下降速度比较均匀，而PGLA牙周再生片强力和初始模量下降
过程中有速度的突变点。
由正交试验优选出力学性能较优的4号试样，其工艺条件为内层骨架
纬平组织采用14texPGLA紧密编织，表面覆质量百分比浓度为3.5%的甲
壳胺浆液。PGLA和PGA牙周再生片的体外降解试验结果显示:PGA牙
周片的强力和初始模量衰减较PGLA牙周片快，但是质量保持的时间稍
长。从外观上，PGLA牙周片降解过程中的形态保持比PGA牙周片好。
Nowadays, people pay more and more attention on tissue engineering, which combines cell biology, engineering, material science and clinical medicine, etc. Textile also has new development on it. This paper mainly discusses Guided Tissue Regeneration (GTR) and "GTR Barrier". "GTR Barrier" is a kind of apparatus that can guide the regeneration of tissue, which is made of biodegradable material. At present, most researches on it are focusing on its degradation properties in vivo and in vitro, but they don't relate to the change of the physical properties during the degradation. In addition, few researches are on how materials and techniques influence the physical properties and degradation properties of GTR Barrier, so this paper will do some work on it.
In this paper, the influences of materials, yarn thickness, knitting density and coating on physical properties of GTR Barrier were studied. In addition, some elementary researches were taken on several degradation properties such as strength attenuation and mass loss of different materials in vitro.
Two biodegradable materials (PGLA, PGA) were selected to knit single jersey fabrics with different density as skeletons of GTR Barriers. Orthogonal test was used to select optimum parameters of material, knitting density and coating by testing splitting strength, tensile strength and initial modulus of GTR Barriers. Through the test, the comparatively better technical parameters could be found.
On the base of orthogonal test, two kinds of GTR Barriers of different materials were picked out to take degradation experiment in vitro. ' Comparing the ratio of strength attenuation and mass loss of these GTR Barriers and their appearance change in course of degradation to analyze their structure characters and degradation properties. Through the comparison, appropriate material used in GTR Barrier could be selected.
Through the .researches, finding a new study direction on GTR Barrier. The result of orthogonal test shows the material, knitting density of skeleton
fabric and coating can remarkably influence the mechanical properties of GTR Barrier. In addition, the interaction between material and knitting density can also influence the result. The degradation courses of PGA and PGLA GTR Barriers in vitro are chemical degradation processes, which achieved by hydrolysis of ester bond. The attenuation of tensile strength is faster than mass loss. The degradation velocity of PGA film is uniform, but when it comes to PGLA film, there is a break point in attenuation of tensile strength and initial modulus during the degradation.
In orthogonal test, the better GTR Barrier is 4# sample, which skeleton fabric is tightly knitted with 14tex PGLA, coated with 3.5% chitosan. The in vitro degradation experiment of PGA film and PGLA film shows that the attenuation of tensile strength and initial modulus of PGLA barrier is slower than that of PGA barrier, but its mass loss period is shorter. Judging from the appearance change during degradation, PGLA barrier has a better appearance retention than PGA barrier.
引文
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[3]孙勇．组织工程在病损组织替代中的应用．国外医学生物医学工程分册．1999，22(1)：31-36．
[4]王勤涛，吴织芬．牙周引导组织再生技术的理论基础和临床应用．实用口腔医学杂志．2001，17(1)：77-79．
[5]Nyman S, Lindhe J, Karring T, et al. New attachment following surgical treament of human periodontal disease. J Clin Periodontol. 1982, (9).. 290.
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[7]中华人民共和国进口医疗器械注册证(牙周再生片)．
[8]Varunee Kerdvongbundit, BSC, DDs, GradDipClinsc, et al. A clinical comparison of the new attachment obtained by guided tissue regeneration and coronally positioned flap techniques in the management of human molar furca tion defects. Australia Dental Journal. 1999, 44(1): 31-39.
[9]Gabriele Pecora, MD, DDS, et al. Barrier Membrance Techniques in Endodontic Micmsurgery. Microscopes in Endodontics. 1997, 41 (3): 1-16.
[10]Igihaut J, Aukhil I, Simpson D.M. et al. Progenitor cell kinetics during guided tissue regeneration in experimental periodontal wound. J Periodontal Res 1998, 23: 107.
[11]P.Robert, J.Mauduit, R.M. Frank et al. Biocompatibility and resorbability of a polylactic acid membrane for periodontal guided tissue regeneration. Biomaterials. 1993, 14(5): 353-358.
[12]王梅编．聚合物(医用)腐蚀和降解机理．国外医学生物医学工程分册．1997，20(3)：177-183．
[13]何伟．上海第二医科大学口腔医学院94级硕士学位论文．
[14]李超伦．可吸收材料体外降解实验和评价．口腔材料器械杂志．1998，7(3)：149-151．
[15]Flandroy P, Grandfils Ch, Daenen B, Snaps F, Heinen E et al. In vivo behavior of Poly(D,L)-lactide microspheres designed for hemoembolization. J Controlled Release. 1997, 47: 153-170.
[16]Ali SAM, Doherty PJ, Williams DF. Molecular biointeractions of biomedicals polymers with extracellular exudates and inflammatory cell and their effects on the biocompatibility, in vivo. Biomaterials. 1994, 15: 779-785.
[17]Tokiwa Y, Suzuki T. Hydrolysis of polyesters by lipases. Nature 1977, 270: 76-78.
[18]几丁质体内外生物降解性和安全性的研究(技术资料)．上海第二医科大学附属第九人民医院上海生物材料研究测试中心．2001．
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