[A randomized controlled trial of iRoot BP Plus used as pulp capping agent in the complex fracture of young permanent tooth].

Q3 Medicine

北京大学学报（医学版） Pub Date : 2024-12-18

Yingting Yang, Ruozhu Li, Guili Dou, Yue Lei, Bin Xia

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引用次数: 0

Abstract

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.

本刊更多论文

[iRoot BP Plus作为牙髓封盖剂治疗年轻恒牙复杂骨折的随机对照试验]。

目的：探讨iRoot BP Plus在复杂冠折的未成熟恒牙部分切髓术后3年的临床及影像学结果，为临床应用提供参考。方法：采用前瞻性设计，将104颗复杂冠折的未成熟恒牙随机分为两组（n=52）。实验组采用iRoot BP Plus盖髓剂，对照组采用氢氧化钙盖髓剂。髓体部分切开术后，于1、3、6、12、18、24、30、36个月末对所有牙齿进行临床和影像学评估。观察两组患者的成功率有无显著差异。将治疗牙的根管壁厚度与组间及组内同一患者对应侧健康牙的根管壁厚度进行比较。结果：排除丢失随访者，氢氧化钙组44颗牙（丢失随访8颗牙，占15.4%），iRoot BP Plus组45颗牙（丢失随访7颗牙，占13.5%）。氢氧化钙组和iRoot BP Plus组的成功率无组间差异(按方案分析：80% vs 87%；意向治疗分析：67% vs. 75%)。非劣效性边际为-10%。成功率差异的95%置信区间为-8% ~ 22%。实验牙与对侧对照牙的牙根发育无显著差异。iRoot BP Plus组上1/3根管厚度较CH组薄[(1.82±0.21)mm比（1.91±0.20）mm， P=0.047]。结论：iRoot BP Plus应用于复杂冠折的年轻恒牙切髓术中，能有效保存活牙髓，促进牙根发育。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

北京大学学报（医学版） Medicine-Medicine (all)

CiteScore

0.80

自引率

0.00%

发文量

9815

期刊介绍： Beijing Da Xue Xue Bao Yi Xue Ban / Journal of Peking University (Health Sciences), established in 1959, is a national academic journal sponsored by Peking University, and its former name is Journal of Beijing Medical University. The coverage of the Journal includes basic medical sciences, clinical medicine, oral medicine, surgery, public health and epidemiology, pharmacology and pharmacy. Over the last few years, the Journal has published articles and reports covering major topics in the different special issues (e.g. research on disease genome, theory of drug withdrawal, mechanism and prevention of cardiovascular and cerebrovascular diseases, stomatology, orthopaedic, public health, urology and reproductive medicine). All the topics involve latest advances in medical sciences, hot topics in specific specialties, and prevention and treatment of major diseases. The Journal has been indexed and abstracted by PubMed Central (PMC), MEDLINE/PubMed, EBSCO, Embase, Scopus, Chemical Abstracts (CA), Western Pacific Region Index Medicus (WPR), JSTChina, and almost all the Chinese sciences and technical index systems, including Chinese Science and Technology Paper Citation Database (CSTPCD), Chinese Science Citation Database (CSCD), China BioMedical Bibliographic Database (CBM), CMCI, Chinese Biological Abstracts, China National Academic Magazine Data-Base (CNKI), Wanfang Data (ChinaInfo), etc.