关于口腔树脂基材料安全性问题的探讨
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摘要
口腔树脂基材料包括复合树脂充填材料、牙科用树脂水门汀、牙科用粘接剂和窝沟封闭剂等,本文基于口腔用树脂基材料安全性,从口腔用树脂基材料的组成及聚合引发体系、单体浸出及降解机理、树脂单体基本的毒理学信息以及口腔树脂基材料可引发的不良反应等方面综述了该类材料在临床使用过程中存在的风险,为口腔医师、患者、医疗器械产品制造者及监管部门对此类产品的安全性风险有正确地认知,指导此类产品在临床中的安全使用。
Dental resin-based materials include composite resin filling materials, dental resin cements, dental adhesives,fissure sealants and so on. Based on the safety of dental resin-based materials, this article reviews the risks of such materials during clinical use in the respects of composition and polymerization initiating system of resin-based materials, monomer leaching and degradation mechanism, basic toxicological information of resin monomer and adverse reactions possibly caused by dental resin-based materials, to make dentists, patients, medical device manufacturers and supervision departments have correct cognization on the risks of safety of such products, and guide the safe clinical use of such products.
Dental resin-based materials include composite resin filling materials, dental resin cements, dental adhesives,fissure sealants and so on. Based on the safety of dental resin-based materials, this article reviews the risks of such materials during clinical use in the respects of composition and polymerization initiating system of resin-based materials, monomer leaching and degradation mechanism, basic toxicological information of resin monomer and adverse reactions possibly caused by dental resin-based materials, to make dentists, patients, medical device manufacturers and supervision departments have correct cognization on the risks of safety of such products, and guide the safe clinical use of such products.
引文
[1]Buo nocore MG.A simple meth od of increasing th e adh esion of acrylic filling materials to enamel surfaces[J].J Dent Res,1955,34(6):849-853
[2]Bow en R L.Properties of a silica-reinforced polymer for dental restorations[J].J Am Dent Assoc,1963,66(1):57-64
[3]Malkiew icz K,Wych ow ański P,Olkow ska-Truch anow icz J,et al.Uncompleted polymerization and cytotox icity of dental restorative materials as potential h ealth risk factors[J].Ann Agric Environ Med,2017,24(4):618-623
[4]Reis AF,Vestph al M,AMARAL RC,et al.Efficiency of polymerization of bulk-fill composite resins:a systematic review[J].Braz Oral Res,2017,31:59-59
[5]Santerre JP,Sh ajii L,Leung BW.Relation of dental composite formulations to th eir degradation and th e release of h ydrolyzed polymeric-resin-derived products[J].Crit Rev Oral Biol Med,2001,12(2):136-151
[6]Meng J,Yang H,Cao M,et al.Correlating cytotox icity to elution beh aviors of composite resins in term of curing kinetic[J].Mater Sci Eng:C,2017,78:413-419
[7]Mich aud PL,MacKenzie A.Compatibility betw een dental adh esive systems and dual-polymerizing composite resins[J].J Prosth et Dent,2016,116(4):597-602
[8]Lagocka R,Mazurek-Mochol M,Jakubow ska K,et al.Analysis of Base Monomer Elution from 3 Flow able Bulk-Fill Composite Resins Using H igh Performance Liquid Ch romatograph y(H PLC)[J].Med Sci Monit,2018,24:4679-4690
[9]Polydorou O,Hammad M,K?nig A,et al.Release of monomers from different core build-up materials[J].Dent Mater,2009,25(9):1090-1095
[10]Miletic V,Santini A,Trkulja I.Quantification of monomer elution and carbon-carbon double bonds in dental adh esive systems using H PLC and micro-Raman spectroscopy[J].JDent,2009,37(3):177-184
[11]Lee JH,Yi SK,Kim SY,et al.Salivary bisph enol A levels and th eir association w ith composite resin restoration[J].Ch emosph ere,2017,172:46-51
[12]Ferracane JL,Berge H X,Condon JR.In vitro aging of dental composites in w ater-effect of degree of conversion,filler volume,and filler/matrix coupling[J].J Biomed Mater Res,1998,42(3):465-472
[13]Pelourde C,Bationo R,Boileau MJ,et al.Monomer release from orth odontic retentions:An in vitro study[J].Am J Orth od Dentofacial Orth op,2018,153(2):248-254
[14]Putzeys E,Cokic SM,Ch ong H,et al.Simultaneous analysis of bisph enol A based compounds and oth er monomers leaching from resin-based dental materials by UH PLC-MS/MS[J].J Sep Sci,2017,40(5):1063-1075
[15]?ys?d H,Ruyter IE,Sj?vik Kleven IJ.Release of formaldeh yde from dental composites[J].J Dent Res,1988,67(10):1289-1294
[16]?ilo G.Biodegradation of dental composites/glass-ionomer cements[J].Adv Dent Res,1992,6(1):50-54
[17]陈秀春,张志民,张雅琪,等.复合树脂类牙科材料细胞毒性研究[J].中国实用口腔科杂志,2017,10(2):117-121
[18]Sch w eikl H,Sch malz G,Rackebrandt K.Mutagenic activity of resin components in mammalian cells[J].J Dent Res,1997,76:2946-2946
[19]Vom Scral F.Getting to th e truth:w h at w e know and don't know about th e h azards of endocrine disrupting ch emicals[J].Pesticides and You,1997,17:9-16
[20]Nagel SC,vom Saal FS,Th ayer KA,et al.Relative binding affinity-serum modified access(RBA-SMA)assay predicts th e relative in vivo bioactivity of th e x enoestrogens bisph enol A and octylph enol[J].Environ H ealth Perspect,1997,105(1):70-76
[21]Xue J,Kannan P,Kumosani TA,et al.Resin-based dental sealants as a source of h uman ex posure to bisph enol analogues,bisph enol A diglycidyl eth er,and its derivatives[J].Environ Res,2018,162:35-40
[22]Ah san A,Ash ley M.H ypersensitivity to dental composites and resin-bonding agents[J].Dent Update,2016,43(9):836-842
[23]Joh ns DA,H emaraj S,Varoli RK.Allergic contact stomatitis from bisph enol-a-glycidyl dimeth acrylate during application of composite restorations:A case report[J].Indian J Dent Res,2014,25(2):266-268
[24]Bioc?ina-Luk enda D,Gr egurek-Novak T,Cekic′-Arambaóin A.Denture stomatitis associated w ith allergic reaction to teeth prosth eses[J].J Eur Acad Dermatol Venereol,2004,18(2):227-229
[25]Syed M,Ch opra R,Sach dev V.Allergic reactions to dental materials-a systematic review[J].J Clin Diagn Res,2015,9(10):ZE04-ZE09
[26]Hensten-Pettersen A,Jacobsen N.Biocompatibility of restorative materials[J].Oper Dent,2001,26:229-236
[27]Blomgren J,Ax ell T,Sandah l O,et al.Adverse reactions in th e oral mucosa associated w ith anterior composite restorations[J].J Oral Path ol Med,1996,25(6):311-313
[28]Carmich ael AJ,Gibson JJ,Walls AW.Allergic contact dermatitis to bisph enol-A-glycidyldimeth acrylate(BIS-GMA)dental resin associated w ith sensitivity to epox y resin[J].Br Dent J,1997,183(8):297-298
[29]Tinkelman DG,Tinkelman CL.An unusual etiology of urticaria[J].Pediatrics,1979,63(2):339-339
[30]Goon ATJ,Isaksson M,Zimerson E,et al.Contact allergy to(meth)acrylates in th e dental series in south ern Sw eden:simultaneous positive patch test reaction patterns and possible screening allergens[J].Contact Dermatitis,2006,55(4):219-226
[31]Jacobsen N,H ensten-Pettersen A.Occupational h ealth problems and adverse patient reactions in orth odontics[J].Eur JOrth od,1989,11(3):254-264
[32]H ensten-Pettersen A,Jacobsen N.Th e role of biomaterials as occupational h azards in dentistry[J].Int Dent J,1990,40(3):159-166
[33]L?nnroth E C,Sh ah navaz H.Adverse h ealth reactions in skin,eyes,and respiratory tract among dental personnel in Sw eden[J].Sw ed Dent J,1998,22(1-2):33-45
[34]Nakamura M,Osh ima H,H ash imoto Y.Monomer permeability of disposable dental gloves[J].J Prosth et Dent,2003,90(1):81-85
[35]ISO 10993-1 Biological evaluation of medical devices-Part 1:Evaluation and testing w ith in a risk management process[S],2018
[2]Bow en R L.Properties of a silica-reinforced polymer for dental restorations[J].J Am Dent Assoc,1963,66(1):57-64
[3]Malkiew icz K,Wych ow ański P,Olkow ska-Truch anow icz J,et al.Uncompleted polymerization and cytotox icity of dental restorative materials as potential h ealth risk factors[J].Ann Agric Environ Med,2017,24(4):618-623
[4]Reis AF,Vestph al M,AMARAL RC,et al.Efficiency of polymerization of bulk-fill composite resins:a systematic review[J].Braz Oral Res,2017,31:59-59
[5]Santerre JP,Sh ajii L,Leung BW.Relation of dental composite formulations to th eir degradation and th e release of h ydrolyzed polymeric-resin-derived products[J].Crit Rev Oral Biol Med,2001,12(2):136-151
[6]Meng J,Yang H,Cao M,et al.Correlating cytotox icity to elution beh aviors of composite resins in term of curing kinetic[J].Mater Sci Eng:C,2017,78:413-419
[7]Mich aud PL,MacKenzie A.Compatibility betw een dental adh esive systems and dual-polymerizing composite resins[J].J Prosth et Dent,2016,116(4):597-602
[8]Lagocka R,Mazurek-Mochol M,Jakubow ska K,et al.Analysis of Base Monomer Elution from 3 Flow able Bulk-Fill Composite Resins Using H igh Performance Liquid Ch romatograph y(H PLC)[J].Med Sci Monit,2018,24:4679-4690
[9]Polydorou O,Hammad M,K?nig A,et al.Release of monomers from different core build-up materials[J].Dent Mater,2009,25(9):1090-1095
[10]Miletic V,Santini A,Trkulja I.Quantification of monomer elution and carbon-carbon double bonds in dental adh esive systems using H PLC and micro-Raman spectroscopy[J].JDent,2009,37(3):177-184
[11]Lee JH,Yi SK,Kim SY,et al.Salivary bisph enol A levels and th eir association w ith composite resin restoration[J].Ch emosph ere,2017,172:46-51
[12]Ferracane JL,Berge H X,Condon JR.In vitro aging of dental composites in w ater-effect of degree of conversion,filler volume,and filler/matrix coupling[J].J Biomed Mater Res,1998,42(3):465-472
[13]Pelourde C,Bationo R,Boileau MJ,et al.Monomer release from orth odontic retentions:An in vitro study[J].Am J Orth od Dentofacial Orth op,2018,153(2):248-254
[14]Putzeys E,Cokic SM,Ch ong H,et al.Simultaneous analysis of bisph enol A based compounds and oth er monomers leaching from resin-based dental materials by UH PLC-MS/MS[J].J Sep Sci,2017,40(5):1063-1075
[15]?ys?d H,Ruyter IE,Sj?vik Kleven IJ.Release of formaldeh yde from dental composites[J].J Dent Res,1988,67(10):1289-1294
[16]?ilo G.Biodegradation of dental composites/glass-ionomer cements[J].Adv Dent Res,1992,6(1):50-54
[17]陈秀春,张志民,张雅琪,等.复合树脂类牙科材料细胞毒性研究[J].中国实用口腔科杂志,2017,10(2):117-121
[18]Sch w eikl H,Sch malz G,Rackebrandt K.Mutagenic activity of resin components in mammalian cells[J].J Dent Res,1997,76:2946-2946
[19]Vom Scral F.Getting to th e truth:w h at w e know and don't know about th e h azards of endocrine disrupting ch emicals[J].Pesticides and You,1997,17:9-16
[20]Nagel SC,vom Saal FS,Th ayer KA,et al.Relative binding affinity-serum modified access(RBA-SMA)assay predicts th e relative in vivo bioactivity of th e x enoestrogens bisph enol A and octylph enol[J].Environ H ealth Perspect,1997,105(1):70-76
[21]Xue J,Kannan P,Kumosani TA,et al.Resin-based dental sealants as a source of h uman ex posure to bisph enol analogues,bisph enol A diglycidyl eth er,and its derivatives[J].Environ Res,2018,162:35-40
[22]Ah san A,Ash ley M.H ypersensitivity to dental composites and resin-bonding agents[J].Dent Update,2016,43(9):836-842
[23]Joh ns DA,H emaraj S,Varoli RK.Allergic contact stomatitis from bisph enol-a-glycidyl dimeth acrylate during application of composite restorations:A case report[J].Indian J Dent Res,2014,25(2):266-268
[24]Bioc?ina-Luk enda D,Gr egurek-Novak T,Cekic′-Arambaóin A.Denture stomatitis associated w ith allergic reaction to teeth prosth eses[J].J Eur Acad Dermatol Venereol,2004,18(2):227-229
[25]Syed M,Ch opra R,Sach dev V.Allergic reactions to dental materials-a systematic review[J].J Clin Diagn Res,2015,9(10):ZE04-ZE09
[26]Hensten-Pettersen A,Jacobsen N.Biocompatibility of restorative materials[J].Oper Dent,2001,26:229-236
[27]Blomgren J,Ax ell T,Sandah l O,et al.Adverse reactions in th e oral mucosa associated w ith anterior composite restorations[J].J Oral Path ol Med,1996,25(6):311-313
[28]Carmich ael AJ,Gibson JJ,Walls AW.Allergic contact dermatitis to bisph enol-A-glycidyldimeth acrylate(BIS-GMA)dental resin associated w ith sensitivity to epox y resin[J].Br Dent J,1997,183(8):297-298
[29]Tinkelman DG,Tinkelman CL.An unusual etiology of urticaria[J].Pediatrics,1979,63(2):339-339
[30]Goon ATJ,Isaksson M,Zimerson E,et al.Contact allergy to(meth)acrylates in th e dental series in south ern Sw eden:simultaneous positive patch test reaction patterns and possible screening allergens[J].Contact Dermatitis,2006,55(4):219-226
[31]Jacobsen N,H ensten-Pettersen A.Occupational h ealth problems and adverse patient reactions in orth odontics[J].Eur JOrth od,1989,11(3):254-264
[32]H ensten-Pettersen A,Jacobsen N.Th e role of biomaterials as occupational h azards in dentistry[J].Int Dent J,1990,40(3):159-166
[33]L?nnroth E C,Sh ah navaz H.Adverse h ealth reactions in skin,eyes,and respiratory tract among dental personnel in Sw eden[J].Sw ed Dent J,1998,22(1-2):33-45
[34]Nakamura M,Osh ima H,H ash imoto Y.Monomer permeability of disposable dental gloves[J].J Prosth et Dent,2003,90(1):81-85
[35]ISO 10993-1 Biological evaluation of medical devices-Part 1:Evaluation and testing w ith in a risk management process[S],2018