目的: 评价两种硅酸钙类材料——生物陶瓷材料iRoot和三氧化矿物凝聚体(mineral trioxide aggregate, MTA)在成熟恒牙牙髓切断治疗中的应用效果。方法: 选择2017 年 11月至2019 年9 月在北京大学口腔医院综合科就诊患者,对龋源性露髓的成熟恒前磨牙、磨牙行牙髓切断术,随机分组,使用iRoot(iRoot组,n=22)和MTA(MTA组,n=21)作为盖髓剂,并分别于术后3、6、12个月通过临床检查(温度测试和电活力测试)及影像学检查评价临床疗效。对患者、评价者采用盲法,但由于两种盖髓剂性状有明显差异,因此对实施治疗者(接诊医师)未能采用盲法。结果: 两组患者的性别、平均年龄、牙列及牙位分布差异均无统计学意义(P>0.05)。术后12个月随访时失访7例(iRoot组4例,MTA组3例)。两组各有1例在3个月复查时出现一过性敏感,而在6个月复查时牙髓活力正常。iRoot组有1例在12个月复查时出现一过性敏感。两组12个月随访时的成功率均为100%,治愈率分别为94.4%(iRoot组)及100%(MTA组), 差异无统计学意义(P>0.05)。iRoot组无病例发生明显的牙冠变色,而MTA组有3例患牙出现明显牙冠变色。结论: 12个月观察期内, iRoot用于成熟恒牙活髓保存治疗取得与MTA相似的令人满意的临床效果;iRoot不易造成治疗后牙齿变色且操作便利,因此拥有更好的临床应用前景。

Objective: To evaluate the clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot and mineral trioxide aggregate (MTA). Methods: Pulpotomy was performed on mature permanent premolars and molars with carious exposures at the Department of General Dentistry of Peking University School and Hospital of Stomatology,from November 2017 to September 2019. The patients were randomly divided into 2 groups, Group iRoot (n=22) and Group MTA (n=21). In Group iRoot, bioceramic putty repairmen iRoot was used as pulp capping agent, while in Group MTA, mineral trioxide aggregate was used as pulp capping agent. All the patients had signed informed consent forms. The clinical efficacy was evaluated by clinical examinations (temperature and electrical activity test) and imaging examinations 3, 6, and 12 months after surgery. Blinding was used for the patients and evaluators, but due to the obvious differences in the properties of the two pulp capping agents, the blinding method was not used for the treatment provider (the attending physician). Results: There was no significant difference in gender, average age, dentition and tooth position distribution between the two groups (P>0.05). In the study, 7 cases were lost to follow-up 12 months after operation (4 cases in Group iRoot, and 3 cases in Group MTA). One case in each of the two groups had transient sensitivity at the end of the 3-month follow-up, and the pulp vitality was normal at the end of the 6-month follow-up. One case in Group iRoot showed sensitivity at the end of the 12-month follow-up. The success rates of the two groups at the end of 12-month follow-up were 100%, and the cure rates were 94.4% (Group iRoot) and 100% (Group MTA), respectively, and the difference was not statistically significant (P>0.05). No cases in Group iRoot had obvious crown discoloration, while 3 cases in Group MTA had. Conclusion: The clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot were similar with MTA. Bioceramic putty repairmen iRoot is an acceptable material when used in pulpotomy of mature permanent teeth. Because it is not easy to cause tooth discoloration after treatment and is convenient to operate, bioceramic putty repairmen iRoot has a better clinical application prospect.