Objective: To evaluate the efficacy of iRoot BP Plus, a novel bioceramic material, and mineral trioxide aggregate (MTA) by comparing the clinical and radiographic results of pulpotomy in human primary molars, and to find out the influence factor.
Methods: Children who had at least one primary molar diagnosed as pulpitis, and received pulpotomy in the Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology from January, 2017 to December, 2018 were searched by the selection criteria in the Electronic Medical Record Database of Peking University School and Hospital of Stomatology. The molars with the pulp capping agents were iRoot BP Plus or MTA were included, and the molars with other pulp capping agents were excluded. Molars using iRoot BP Plus were selected into the experimental group (iRoot BP Plus group). Molars using MTA were selected into the control group (MTA group) using propensity score matching model (1 ∶ 1), considering the gender, age, tooth position, the title of clinician, pulp status, restoration and length of follow-up as the potential influence factor. Basic information, the relevant medical records including symptoms, clinical and radiographic examination before and after operation, intraoperative information and follow up examination records were collected. The success rates were compared and the influence factors were analyzed respectively.
Results: The study included 132 children, 178 molars (89 molars from each group) and the mean follow-up time was (462±99) days by December, 2019. In the iRoot BP Plus group, 9 molars failed whilst 6 molars failed in MTA group. The success rate was 89.9% and 93.3%, respectively, showing no significant difference between the two groups. Through Cox proportional risk model analysis, the success rate of iRoot BP Plus was significantly lower when the pulp status was poor, while other factors including age, tooth position, title of clinician and restoration were not found to be associated with the clinical outcome.
Conclusion: Pulpotomy of human primary molars with iRoot BP Plus has the same effectiveness with MTA. The pulp status is the main factor that influences the outcome of iRoot BP Plus. Further studies with larger sample sizes and longer follow-up terms are needed.
目的: 对新型生物陶瓷材料iRoot BP Plus和三氧化矿物凝聚体(mineral trioxide aggregate, MTA)作为盖髓剂应用于乳磨牙牙髓切断术的疗效进行评价，比较两者成功率，并分析影响因素。
方法: 通过检索北京大学口腔医院电子病历数据库，筛选2017年1月至2018年12月期间于北京大学口腔医院儿童口腔科门诊就诊、有乳磨牙诊断为慢性牙髓炎、行牙髓切断术的患儿，选择符合纳入标准且盖髓剂为iRoot BP Plus或MTA的患牙，盖髓剂为iRoot BP Plus的患牙全部纳入实验组(iRoot BP Plus组)，使用倾向评分匹配法选择性别、年龄、牙位、医生级别、牙髓状态、冠部修复方式和随访时长作为协变量进行1 ∶ 1匹配盖髓剂为MTA的患牙纳入对照组(MTA组)。收集各组患牙治疗前自觉症状、临床检查、影像学表现、治疗情况、随访情况，比较两组治疗成功率，并分别分析影响因素。
结果: 共纳入132例患儿，178颗患牙，每组各89颗，平均随访时间(462±99) d，截止至2019年12月，iRoot BP Plus组和MTA组成功率分别为89.9%、93.3%，iRoot BP Plus组成功率稍低于MTA组，差异无统计学意义。通过Cox比例风险模型进行分析发现，牙髓状态的好坏显著影响iRoot BP Plus组的治疗成功率，而年龄、牙位、医生级别、冠部修复方式对成功率均无显著影响。
结论: iRoot BP Plus作为盖髓剂应用于乳磨牙牙髓切断术可以取得与MTA相似的治疗效果，牙髓状态是影响治疗效果的主要因素，其远期疗效及影响因素仍需进行更大样本、更长随访时间的研究。
Keywords: Novel bioceramic material; Pulpitis; Pulpotomy.