[iRoot BP Plus作为年轻恒牙复杂骨折盖髓剂的随机对照试验]
[A randomized controlled trial of iRoot BP Plus used as pulp capping agent in the complex fracture of young permanent tooth].
作者信息
Yang Yingting, Li Ruozhu, Dou Guili, Lei Yue, Xia Bin
机构信息
Third Clinical Division, Peking University School and Hospital of Stomatology & National Center for Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices, Beijing 100191, China.
Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing 100081, China.
出版信息
Beijing Da Xue Xue Bao Yi Xue Ban. 2024 Dec 18;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 (=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% . 87%; intent-to-treat analysis: 67% . 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 . (1.91±0.20) mm, =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.
目的
探讨iRoot BP Plus用于复杂冠折年轻恒牙部分活髓切断术3年后的临床及影像学疗效，为临床应用提供参考。
方法
本研究为前瞻性设计，将104颗复杂冠折的年轻恒牙随机分为两组（每组52颗）。试验组采用iRoot BP Plus作为盖髓剂，对照组采用氢氧化钙作为盖髓剂。部分活髓切断术后，在1、3、6、12、18、24、30和36个月时对所有牙齿进行临床和影像学评估。评估两组的成功率，观察是否存在显著差异。将治疗牙齿的根管壁厚度在两组之间以及组内与同一患者对侧相应健康牙齿的根管壁厚度进行比较。
结果
排除失访病例后，最终氢氧化钙组有44颗牙齿（8颗失访，占15.4%），iRoot BP Plus组有45颗牙齿（7颗失访，占13.5%）。氢氧化钙组和iRoot BP Plus组之间的成功率无组间差异（符合方案分析：80% 对87%；意向性分析：67% 对75%）。非劣效界值为-10%。成功率差异的95%置信区间为-8%至22%。试验牙齿与对侧对照牙齿的牙根发育无显著差异。iRoot BP Plus组上1/3根管的厚度比氢氧化钙组薄[（1.82±0.21）mm 对（1.91±0.20）mm，P=0.047]。
结论
iRoot BP Plus用于活髓切断术可有效保存年轻恒牙复杂冠折时的牙髓活力并促进牙根发育。
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