收稿日期: 2021-08-17
网络出版日期: 2024-12-18
版权
A randomized controlled trial of iRoot BP Plus used as pulp capping agent in the complex fracture of young permanent tooth
Received date: 2021-08-17
Online published: 2024-12-18
Copyright
目的: 观察牙根发育情况,评价iRoot BP Plus与氢氧化钙用于年轻恒牙外伤露髓后部分牙髓切断治疗3年的临床随机对照实验效果。方法: 选取符合入组条件的外伤冠折露髓的年轻恒牙104颗,随机分为2组, 每组52颗,分别应用iRoot BP Plus(iRoot)和氢氧化钙(calcium hydroxide,CH)作为盖髓剂进行部分牙髓切断术治疗。术后1、3、6、12、18、24、30、36个月复查,通过临床及影像学检查观察牙根发育情况,评价临床疗效。结果: CH组和iRoot组最终分别有44颗牙(失访8颗,失访率15.4%)和45颗牙(7颗失访,失访率13.5%)纳入本研究,采用符合方案分析方法的成功率分别为80%和87%,采用意向治疗方案分析方法的成功率分别为67%和75%,两组间差异均无统计学意义(非劣效界值为-10%,疗效差异的95%CI为-8%~22%)。牙髓切断治疗牙的牙根继续发育,根管壁厚度与健康同名对照牙相比差异无统计学意义。iRoot组近冠1/3根管壁厚度比CH组略薄[(1.82±0.21) mm vs. (1.91±0.20) mm,P=0.047]。结论: iRoot BP Plus用于年轻恒牙外伤露髓后牙髓切断治疗可以有效保存活髓,且促进了牙根的继续发育。
杨颖婷 , 李若竹 , 窦桂丽 , 雷玥 , 夏斌 . iRoot BP Plus用于年轻恒牙外伤部分牙髓切断治疗的临床随机对照研究[J]. 北京大学学报(医学版), 2024 , 56(6) : 1083 -1088 . DOI: 10.19723/j.issn.1671-167X.2024.06.022
Objective: To investigate the clinical and radiographic outcomes of 3 years after partial pulpotomy with iRoot BP Plus in immature permanent teeth with complex crown fracture and to provide refe-rence for the clinical application. Methods: The study was prospectively designed and 104 immature permanent teeth with complex crown fracture were randomly allocated into two groups (n=52). The experiment group received iRoot BP Plus as the pulp capping agent while the control group received calcium hydroxide as the pulp capping agent. After partial pulpotomy, all teeth were clinically and radiographically assessed at the end of 1, 3, 6, 12, 18, 24, 30, and 36 months. The success rate in the two groups was evaluated to see if there was significant difference. The root canal wall thickness in the treated teeth was compared both between the groups and within the groups with those of the corresponding healthy teeth on the opposite side, in the same patient. Results: Excluding those lost to follow-up, there were 44 teeth in calcium hydroxide group (8 teeth accounting for 15.4% were lost to follow up) and 45 teeth in iRoot BP Plus group (7 teeth accounting for 13.5% were lost to follow up) in the end. There was no intergroup difference in the success rate between calcium hydroxide group and iRoot BP Plus group (per-protocol analysis: 80% vs. 87%; intent-to-treat analysis: 67% vs. 75%). The non-inferiority margin was -10%. The 95% confidence interval of the difference in success rate was -8% to 22%. There was no significant difference in root development between the experimental teeth and contralateral control teeth. The thickness of upper 1/3 root canal in the iRoot BP Plus group was thinner than that in the CH group [(1.82±0.21) mm vs. (1.91±0.20) mm, P=0.047]. Conclusion: iRoot BP Plus used in pulpotomy can effectively preserve the living pulp and promote the development of root in the young permanent teeth with complex crown fracture.
| 1 | Bourguignon C , Cohenca N , Lauridsen E , et al.International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 1. Fractures and luxations[J].Dent Traumatol,2020,36(4):314-330. |
| 2 | Guideline on pulp therapy for primary and immature permanent teeth[J]. Pediatr Dent, 2016, 38 (6): 280-288 |
| 3 | 秦满.儿童口腔科诊疗指南与护理常规[M].北京: 人民卫生出版社,2015:62. |
| 4 | Schwendicke F , Brouwer F , Schwendicke A , et al.Different materials for direct pulp capping: Systematic review and meta-analysis and trial sequential analysis[J].Clin Oral Investig,2016,20(6):1121-1132. |
| 5 | Wang G , Wang C , Qin M .Pulp prognosis following conservative pulp treatment in teeth with complicated crown fractures: A retrospective study[J].Dent Traumatol,2017,33(4):255-260. |
| 6 | Nowicka A , Wilk G , Lipski M , et al.Tomographic evaluation of reparative dentin formation after direct pulp capping with Ca(OH)2, MTA, biodentine, and dentin bonding system in human teeth[J].J Endod,2015,41(8):1234-1240. |
| 7 | Mohammadi Z , Dummer PM .Properties and applications of cal-cium hydroxide in endodontics and dental traumatology[J].Int Endod J,2011,44(8):697-730. |
| 8 | 王敏永, 刘鹤, 李盛林, 等.三氧化矿物凝聚体对乳、恒牙牙髓细胞增殖和分化影响的比较[J].华西口腔医学杂志,2015,(1):75-79. |
| 9 | Marconyak LJ , Kirkpatrick TC , Roberts HW , et al.A comparison of coronal tooth discoloration elicited by various endodontic reparative materials[J].J Endod,2016,42(3):470-473. |
| 10 | Leal F , De-Deus G , Brandao C , et al.Similar sealability between bioceramic putty ready-to-use repair cement and white MTA[J].Braz Dent J,2013,24(4):362-366. |
| 11 | Lovato KF , Sedgley CM .Antibacterial activity of EndoSequence root repair material and ProRoot MTA against clinical isolates of enterococcus faecalis[J].J Endod,2011,37(11):1542-1546. |
| 12 | Jiang Y , Zheng Q , Zhou X , et al.A comparative study on root canal repair materials: A cytocompatibility assessment in L929 and MG63 cells[J].Sci World J,2014,2014,463826. |
| 13 | Shokouhinejad N , Nekoofar MH , Razmi H , et al.Bioactivity of EndoSequence root repair material and bioaggregate[J].Int Endod J,2012,45(12):1127-1134. |
| 14 | 李羽弘, 韦曦.iRoot BP和iRoot BP Plus应用于牙髓治疗的研究现状[J].中华口腔医学研究杂志(电子版),2016,10(3):208-211. |
| 15 | Rao Q , Kuang J , Mao CX , et al.Comparison of iRoot BP Plus and calcium hydroxide as pulpotomy materials in permanent incisors with complicated crown fractures: A retrospective study[J].J Endod,2020,46(3):352-357. |
| 16 | Zheng Y , Wang XY , Wang YM , et al.Dentin regeneration using deciduous pulp stem/progenitor cells[J].J Dent Res,2012,91(7):676-682. |
| 17 | Azimi S , Fazlyab M , Sadri D , et al.Comparison of pulp response to mineral trioxide aggregate and a bioceramic paste in partial pulpotomy of sound human premolars: A randomized controlled trial[J].Int Endod J,2014,47(9):873-881. |
| 18 | Liu S , Wang S , Dong Y .Evaluation of a bioceramic as a pulp capping agent in vitro and in vivo[J].J Endod,2015,41(5):652-657. |
| 19 | Oncel TZ , Torun D , Demirkaya K , et al.Effects of "iRoot BP" and "white mineral trioxide aggregate" on cell viability and the expression of genes associated with mineralization[J].Int Endod J,2015,48(10):986-993. |
| 20 | 梅雪, 谢俐萍, 金幼虹, 等.iRoot BP Plus直接盖髓后比格犬牙髓的反应性变化[J].口腔医学研究,2016,32(12):1234-1239. |
| 21 | Swarup SJ , Rao A , Boaz K , et al.Pulpal response to nano hydroxyapatite, mineral trioxide aggregate and calcium hydroxide when used as a direct pulp capping agent an in vivo study[J].J Clin Pediatr Dent,2014,38(3):201-206. |
| 22 | 陈宁宁, 张洋, 汪育苗, 等.生物陶瓷材料iRoot BP Plus对小型猪修复性牙本质形成影响的实验研究[J].北京口腔医学,2017,25(6):313-316. |
| 23 | Okamoto M , Takahashi Y , Komichi S , et al.Novel evaluation method of dentin repair by direct pulp capping using highresolution micro-computed tomography[J].Clin Oral Investig,2018,22(8):2879-2887. |
| 24 | Yang YT , Xia B , Xu Z , et al.The effect of partial pulpotomy with iRoot BP Plus in traumatized immature permanent teeth: A randomized prospective controlled trial[J].Dent Traumatol,2020,36(5):518-525. |
| 25 | 秦满.儿童恒牙外伤后牙髓预后评估及其影响因素[J].中国实用口腔科杂志,2012,5(9):517-520. |
| 26 | Kallel I , Douki N , Amaidi S , et al.The incidence of complications of dental trauma and associated factors: A retrospective study[J].Int J Dent,2020,2020,2868174. |
| 27 | 王岐麟, 黄山娟, 陈洁, 等.年轻上颌切牙冠折露髓的预后及影响因素回顾分析[J].华西口腔医学杂志,2011,29(6):622-625. |
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