可吸收与不可吸收口腔修复膜在牙种植中引导骨再生临床疗效的Meta分析
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摘要
目的系统评价可吸收与不可吸收口腔修复膜在牙种植中引导骨再生的临床疗效。方法计算机检索PubMed、EMbase、The Cochrane Library、Web of Science、VIP、CNKI和WanFang Data数据库,搜集有关可吸收和不可吸收口腔修复膜在牙种植中引导骨再生临床疗效的随机对照试验(RCT),检索时限均从建库至2019年2月20日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入22个RCT,包括1 995例患者。Meta分析结果显示:可吸收膜组在修复情况[RR=1.21,95%CI(1.17,1.26),P<0.000 01]、骨厚度[MD=0.40,95%CI(0.36,0.43),P<0.000 01]、植骨厚度[MD=0.40,95%CI(0.35,0.46),P<0.000 01]、患者满意度[RR=1.19,95%CI(1.04,1.36),P=0.009]、组织学水平上的骨结合[MD=4.82,95%CI(0.14,9.50),P=0.04]和矿化组织总量[MD=3.73,95%CI(0.32,7.14),P=0.03]等方面均优于不可吸收膜组,且不良反应发生率更低[RR=0.28,95%CI(0.20,0.39),P<0.000 01]、术前至术后6个月骨缺损宽度变化更小[MD=-0.62,95%CI(-0.93,-0.31),P<0.000 01]。但两组在组织学水平上非矿化组织总量[MD=-2.48,95%CI(-5.81,0.85),P=0.14]的差异无统计学意义。结论当前证据表明,可吸收口腔修复膜具有较好的修复效果,有助于成骨并减少不良反应的发生,具有良好的安全性和有效性。受纳入研究数量和质量限制,上述结论尚需开展更多高质量研究予以验证。
Objectives To systematically review the efficacy of resorbable membrane and non-resorbable membrane in dental implant to guide bone regeneration. Methods PubMed, EMbase, The Cochrane Library, Web of Science, VIP, CNKI and WanFang Data databases were electronically searched to collect randomized controlled trials(RCTs) of the efficacy of resorbable membrane and non-resorbable membrane in dental implant to guide bone regeneration from inception to February 20 th, 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 22 RCTs involving 1 995 patients were included. The results of meta-analysis showed that: the resorbable membrane group was superior to non-resorbable membrane group in terms of repair success(RR=1.21, 95%CI 1.17 to1.26, P<0.000 01), the bone thickness(MD=0.40, 95%CI 0.36 to 0.43, P<0.000 01), bone graft thickness(MD=0.40, 95%CI0.35 to 0.46, P<0.000 01), patient satisfaction(RR=1.19, 95%CI 1.04 to 1.36, P=0.009), histological evaluation in bone contact(MD=4.82, 95%CI 0.14 to 9.50, P=0.04) and the total mineralized tissue(MD=3.73, 95%CI 0.32 to 7.14, P=0.03).They also had lower adverse reaction rate(RR=0.28, 95%CI 0.20 to 0.39, P<0.000 01) and changes of bone defect width from preoperative to 6 months postoperatively(MD=-0.62, 95%CI-0.93 to-0.31, P<0.000 01) with statistically significant differences. However, there was no significant difference in histological evaluation of non-mineralized tissue(MD=-2.48, 95%CI-5.81 to 0.85, P=0.14) between two groups. Conclusions Current evidence shows that the resorbable membrane has better repairing effects, for which helps to promote the development of bone and bone graft,reduce the incidence of adverse reactions, which has good safety and effectiveness. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusion.
Objectives To systematically review the efficacy of resorbable membrane and non-resorbable membrane in dental implant to guide bone regeneration. Methods PubMed, EMbase, The Cochrane Library, Web of Science, VIP, CNKI and WanFang Data databases were electronically searched to collect randomized controlled trials(RCTs) of the efficacy of resorbable membrane and non-resorbable membrane in dental implant to guide bone regeneration from inception to February 20 th, 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 22 RCTs involving 1 995 patients were included. The results of meta-analysis showed that: the resorbable membrane group was superior to non-resorbable membrane group in terms of repair success(RR=1.21, 95%CI 1.17 to1.26, P<0.000 01), the bone thickness(MD=0.40, 95%CI 0.36 to 0.43, P<0.000 01), bone graft thickness(MD=0.40, 95%CI0.35 to 0.46, P<0.000 01), patient satisfaction(RR=1.19, 95%CI 1.04 to 1.36, P=0.009), histological evaluation in bone contact(MD=4.82, 95%CI 0.14 to 9.50, P=0.04) and the total mineralized tissue(MD=3.73, 95%CI 0.32 to 7.14, P=0.03).They also had lower adverse reaction rate(RR=0.28, 95%CI 0.20 to 0.39, P<0.000 01) and changes of bone defect width from preoperative to 6 months postoperatively(MD=-0.62, 95%CI-0.93 to-0.31, P<0.000 01) with statistically significant differences. However, there was no significant difference in histological evaluation of non-mineralized tissue(MD=-2.48, 95%CI-5.81 to 0.85, P=0.14) between two groups. Conclusions Current evidence shows that the resorbable membrane has better repairing effects, for which helps to promote the development of bone and bone graft,reduce the incidence of adverse reactions, which has good safety and effectiveness. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusion.
引文
1赵铱民.口腔修复学.北京:人民卫生出版社,2012:371-398.
2Wessing B,Urban I,Montero E,et al.A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites:interim results of a bone augmentation procedure.Clin Oral Implants Res,2017,28(11):e218-e226.
3谢苗苗,赵保东,王维英,等.口腔修复膜材料在牙种植中引导骨再生的效应.中国组织工程研究与临床康复,2010,14(16):2911-2915.
4薛媛,但年华,刘新华.口腔修复膜的研究进展及其应用.生物医学工程与临床,2016,20(1):101-107.
5邱建.膜引导组织再生术的研究进展及口腔修复膜应用.中国卫生产业,2018,15(21):191-192.
6Kinaia BM,Steiger J,Neely AL,et al.Treatment of Class II molar furcation involvement:meta-analyses of reentry results.JPeriodontol,2011,82(3):413-428.
7Higgins JPT,Green S.Cochrane handbook for systematic reviews of interventions(version 5.1.0).The Cochrane Collaboration,2011.Available at:http://www.cochrane-handbook.org.
8于淼.口腔修复膜在牙种植中引导骨再生的临床效果研究.中国医药指南,2015,13(9):71-72.
9何丽明,郭强,何永文.口腔修复膜材料在牙种植中引导骨再生的临床效果.昆明医科大学学报,2017,38(3):31-34.
10何添荣,林毅.口腔修复膜材料在牙种植中引导骨再生的应用效果分析.中外医学研究,2015,(25):28-29.
11侯玉一,侯玉泽.口腔修复膜材料在牙种植中引导骨再生的效应分析.现代诊断与治疗,2017,28(11):2038-2039.
12刘茂富.海奥口腔修复膜引导骨再生对牙种植患者的疗效及安全性分析.中国口腔种植学杂志,2017,22(1):19-21.
13单显峰,陈程.探究口腔修复膜材料在牙种植中引导骨再生的临床效果.航空航天医学杂志,2017,28(2):146-148.
14吕丽莉,孙红.口腔修复膜材料在牙种植中引导骨再生的作用研究.中国医疗美容,2016,6(6):52-54.
15吴喆,王涛.口腔修复膜材料在牙种植中引导骨再生中的应用.中国医学创新,2015,12(2):22-24.
16周春峰,管玉新,张天峰,等.口腔修复膜材料在牙种植中引导骨再生的效应.全科口腔医学电子杂志,2015,2(9):102-103.
17孙欢,吴杨,赵吉宏.口腔修复膜材料在牙种植中引导骨再生的效应研究.西部医学,2016,28(5):666-669.
18张华,孟志勇,武东辉,等.口腔修复膜材料在牙种植中引导骨再生效应分析.中国口腔种植学杂志,2016,21(3):113-115.
19张飞.口腔修复膜在牙种植引导骨再生中的效应研究.中国继续医学教育,2017,9(8):112-113.
20温灵,区韵婵,翟炜东,等.海奥口腔修复膜与钛膜对牙种植引导骨再生患者骨厚度及修复成功率的影响.临床医学,2016,36(2):102-103.
21王杏松.口腔修复膜材料在牙种植中引导骨再生中的应用分析.中国医药指南,2014,12(4):172-173.
22王璐,许凤.口腔修复膜材料在牙种植中引导骨再生的效应分析.中国医疗器械信息,2018,24(3):146-148.
23赵爱萍.口腔修复膜材料在牙种植中引导骨再生的临床效果观察.中国医药指南,2016,14(5):95-96.
24郭艳杰,王志滨,王文玲.牙种植中口腔修复膜引导骨再生的临床观察.基层医学论坛,2018,22(22):3063-3065.
25靳高杰.牙种植中引导骨再生中口腔修复膜材料的效果观察.中国医药指南,2017,15(15):132-133.
26Carpio L,Loza J,Lynch S,et al.Guided bone regeneration around endosseous implants with anorganic bovine bone mineral.A randomized controlled trial comparing bioabsorbable versus non-resorbable barriers.J Periodontol,2000,71(11):1743-1749.
27Friedmann A,Strietzel FP,Maretzki B,et al.Histological assessment of augmented jaw bone utilizing a new collagen barrier membrane compared to a standard barrier membrane to protect a granular bone substitute material.Clin Oral Implants Res,2002,13(6):587-594.
28Naenni N,Schneider D,Jung RE,et al.Randomized clinical study assessing two membranes for guided bone regeneration of peri-implant bone defects:clinical and histological outcomes at 6 months.Clin Oral Implants Res,2017,28(10):1309-1317.
29Schneider D,Jung RE.A randomized controlled clinical multicenter trial comparing the clinical and histological performance of a new,modified polylactide-coglycolide acid membrane to an expanded polytetrauorethylene membrane in guided bone regeneration procedures.Clin Oral Impl Res,2014,25:150-158.
30Chiapasco M,Zaniboni M.Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations:a systematic review.Clin Oral Implants Res,2009,20(Suppl 4):113-123.
31Ronda M,Rebaudi A,Torelli L,et al.Expanded vs.dense polytetrafluoroethylene membranes in vertical ridge augmentation around dental implants:a prospective randomized controlled clinical trial.Clin Oral Implants Res,2014,25(7):859-866.
32Schwarz F,Hegewald A,Sahm N,et al.Long-term follow-up of simultaneous guided bone regeneration using native and cross-linked collagen membranes over 6 years.Clin Oral Implants Res, 2014,25(9):1010-1015.
33Schwarz F,SahmN,BeckerJ.Impact of the outcome of guided bone regeneration in dehiscence-type defects on the long-term stability of per implant health:clinical observations at 4 years.Clin Oral Implants Res,2012,23(2):191-196.
34Meijndert L,Raghoebar GM,Meijer HJ,et al.Clinical and radiographic characteristics of single-tooth replacements preceded by local ridge augmentation:a prospective randomized clinical trial.Clin Oral Implants Res,2008,19(12):1295-1303.
35Schwarz F,Schmucker A,Becker J.Long-term outcomes of simultaneous guided bone regeneration using native and cross-linked collagen membranes after 8 years.Clin Oral Implants Res,2017,28(7):779-784.
36Jung RE,H?lg GA,Thoma DS,et al.A randomized,controlled clinical trial to evaluate a new membrane for guided bone regeneration around dental implants.Clin Oral Implants Res,2009,20(2):162-168.
37Barboza EP,Stutz B,Ferreira VF,et al.Guided bone regeneration using nonexpanded polytetrafluoroethylene membranes in preparation for dental implant placements-a report of 420 cases.Implant Dent,2010,19(1):2-7.
38Friedmann A,Gissel K,Soudan M,et al.Randomized controlled trial on lateral augmentation using two collagen membranes:morphometric results on mineralized tissue compound.J Clin Periodontol,2011,38(7):677-685.
2Wessing B,Urban I,Montero E,et al.A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites:interim results of a bone augmentation procedure.Clin Oral Implants Res,2017,28(11):e218-e226.
3谢苗苗,赵保东,王维英,等.口腔修复膜材料在牙种植中引导骨再生的效应.中国组织工程研究与临床康复,2010,14(16):2911-2915.
4薛媛,但年华,刘新华.口腔修复膜的研究进展及其应用.生物医学工程与临床,2016,20(1):101-107.
5邱建.膜引导组织再生术的研究进展及口腔修复膜应用.中国卫生产业,2018,15(21):191-192.
6Kinaia BM,Steiger J,Neely AL,et al.Treatment of Class II molar furcation involvement:meta-analyses of reentry results.JPeriodontol,2011,82(3):413-428.
7Higgins JPT,Green S.Cochrane handbook for systematic reviews of interventions(version 5.1.0).The Cochrane Collaboration,2011.Available at:http://www.cochrane-handbook.org.
8于淼.口腔修复膜在牙种植中引导骨再生的临床效果研究.中国医药指南,2015,13(9):71-72.
9何丽明,郭强,何永文.口腔修复膜材料在牙种植中引导骨再生的临床效果.昆明医科大学学报,2017,38(3):31-34.
10何添荣,林毅.口腔修复膜材料在牙种植中引导骨再生的应用效果分析.中外医学研究,2015,(25):28-29.
11侯玉一,侯玉泽.口腔修复膜材料在牙种植中引导骨再生的效应分析.现代诊断与治疗,2017,28(11):2038-2039.
12刘茂富.海奥口腔修复膜引导骨再生对牙种植患者的疗效及安全性分析.中国口腔种植学杂志,2017,22(1):19-21.
13单显峰,陈程.探究口腔修复膜材料在牙种植中引导骨再生的临床效果.航空航天医学杂志,2017,28(2):146-148.
14吕丽莉,孙红.口腔修复膜材料在牙种植中引导骨再生的作用研究.中国医疗美容,2016,6(6):52-54.
15吴喆,王涛.口腔修复膜材料在牙种植中引导骨再生中的应用.中国医学创新,2015,12(2):22-24.
16周春峰,管玉新,张天峰,等.口腔修复膜材料在牙种植中引导骨再生的效应.全科口腔医学电子杂志,2015,2(9):102-103.
17孙欢,吴杨,赵吉宏.口腔修复膜材料在牙种植中引导骨再生的效应研究.西部医学,2016,28(5):666-669.
18张华,孟志勇,武东辉,等.口腔修复膜材料在牙种植中引导骨再生效应分析.中国口腔种植学杂志,2016,21(3):113-115.
19张飞.口腔修复膜在牙种植引导骨再生中的效应研究.中国继续医学教育,2017,9(8):112-113.
20温灵,区韵婵,翟炜东,等.海奥口腔修复膜与钛膜对牙种植引导骨再生患者骨厚度及修复成功率的影响.临床医学,2016,36(2):102-103.
21王杏松.口腔修复膜材料在牙种植中引导骨再生中的应用分析.中国医药指南,2014,12(4):172-173.
22王璐,许凤.口腔修复膜材料在牙种植中引导骨再生的效应分析.中国医疗器械信息,2018,24(3):146-148.
23赵爱萍.口腔修复膜材料在牙种植中引导骨再生的临床效果观察.中国医药指南,2016,14(5):95-96.
24郭艳杰,王志滨,王文玲.牙种植中口腔修复膜引导骨再生的临床观察.基层医学论坛,2018,22(22):3063-3065.
25靳高杰.牙种植中引导骨再生中口腔修复膜材料的效果观察.中国医药指南,2017,15(15):132-133.
26Carpio L,Loza J,Lynch S,et al.Guided bone regeneration around endosseous implants with anorganic bovine bone mineral.A randomized controlled trial comparing bioabsorbable versus non-resorbable barriers.J Periodontol,2000,71(11):1743-1749.
27Friedmann A,Strietzel FP,Maretzki B,et al.Histological assessment of augmented jaw bone utilizing a new collagen barrier membrane compared to a standard barrier membrane to protect a granular bone substitute material.Clin Oral Implants Res,2002,13(6):587-594.
28Naenni N,Schneider D,Jung RE,et al.Randomized clinical study assessing two membranes for guided bone regeneration of peri-implant bone defects:clinical and histological outcomes at 6 months.Clin Oral Implants Res,2017,28(10):1309-1317.
29Schneider D,Jung RE.A randomized controlled clinical multicenter trial comparing the clinical and histological performance of a new,modified polylactide-coglycolide acid membrane to an expanded polytetrauorethylene membrane in guided bone regeneration procedures.Clin Oral Impl Res,2014,25:150-158.
30Chiapasco M,Zaniboni M.Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations:a systematic review.Clin Oral Implants Res,2009,20(Suppl 4):113-123.
31Ronda M,Rebaudi A,Torelli L,et al.Expanded vs.dense polytetrafluoroethylene membranes in vertical ridge augmentation around dental implants:a prospective randomized controlled clinical trial.Clin Oral Implants Res,2014,25(7):859-866.
32Schwarz F,Hegewald A,Sahm N,et al.Long-term follow-up of simultaneous guided bone regeneration using native and cross-linked collagen membranes over 6 years.Clin Oral Implants Res, 2014,25(9):1010-1015.
33Schwarz F,SahmN,BeckerJ.Impact of the outcome of guided bone regeneration in dehiscence-type defects on the long-term stability of per implant health:clinical observations at 4 years.Clin Oral Implants Res,2012,23(2):191-196.
34Meijndert L,Raghoebar GM,Meijer HJ,et al.Clinical and radiographic characteristics of single-tooth replacements preceded by local ridge augmentation:a prospective randomized clinical trial.Clin Oral Implants Res,2008,19(12):1295-1303.
35Schwarz F,Schmucker A,Becker J.Long-term outcomes of simultaneous guided bone regeneration using native and cross-linked collagen membranes after 8 years.Clin Oral Implants Res,2017,28(7):779-784.
36Jung RE,H?lg GA,Thoma DS,et al.A randomized,controlled clinical trial to evaluate a new membrane for guided bone regeneration around dental implants.Clin Oral Implants Res,2009,20(2):162-168.
37Barboza EP,Stutz B,Ferreira VF,et al.Guided bone regeneration using nonexpanded polytetrafluoroethylene membranes in preparation for dental implant placements-a report of 420 cases.Implant Dent,2010,19(1):2-7.
38Friedmann A,Gissel K,Soudan M,et al.Randomized controlled trial on lateral augmentation using two collagen membranes:morphometric results on mineralized tissue compound.J Clin Periodontol,2011,38(7):677-685.