Abstract：
OBJECTIVE: To assess the clinical and radiographic outcome of partial pulpotomy by comparing MTA Angelus and Total Fill BC, as pulpotomy agents, in mature teeth with deep caries and symptoms indicative of irreversible pulpitis.
METHODS: The study was designed as a parallel-two arm, double-blind, randomized superiority clinical trial registered at www.
RESULTS: gov (NCT04870398). Symptomatic mature permanent teeth with deep caries fulfilling the inclusion criteria were randomly treated using either MTA Angelus or Total Fill BC. A partial pulpotomy was performed and following complete haemostasis, the capping material was placed over the remaining pulp tissue and a postoperative periapical radiograph was taken. Clinical and radiographic follow-up evaluation was performed for a median time of 2 years, whereas levels of pain intensity were evaluated preoperatively and for 7 days after intervention using Visual Analogue Scale. For the primary outcome (failure/success of treatment), the Kaplan-Meier survival curves for the capping materials were plotted and a log-rank test for equality of survivor functions was applied. A multivariable random effects Cox Regression model was also applied. For the secondary outcome (postoperatively reported pain), a multivariable mixed effects ordinal logistic regression was structured.
RESULTS: One hundred and thirty-seven teeth in 123 patients underwent partial pulpotomy using randomly either MTA Angelus (N = 74) or Total Fill BC (n = 63). The percentage failure for MTA Angelus and Total Fill BC was 10.8% (8/74) and 17.5% (11/63), respectively, but the difference was not statistically significant [adjusted HR: 1.83; 95% confidence interval (CI): 0.68, 4.91; p = .23]. Weak evidence was found that secondary caries involvement may impose a 3.54 times greater hazard for treatment failure (adjusted HR: 3.54; 95% CI: 1.00, 12.51; p = .05). For each passing minute of procedural bleeding control, there was also a 57% higher hazard for treatment failure (adjusted HR: 1.57; 95% CI: 0.99, 2.48; p = .05). The odds for higher postoperative pain were 4.73 times greater for the Total Fill BC compared to MTA Angelus (adjusted OR: 4.73; 95% CI: 2.31, 9.66; p < .001).
CONCLUSIONS: Both materials exhibited similar and favourable outcome rates after partial pulpotomy in teeth with deep caries and symptoms of irreversible pulpitis. Total Fill BC was associated with a higher level of postoperative pain intensities.
METHODS: The study was designed as a parallel-two arm, double-blind, randomized superiority clinical trial registered at www.
RESULTS: gov (NCT04870398). Symptomatic mature permanent teeth with deep caries fulfilling the inclusion criteria were randomly treated using either MTA Angelus or Total Fill BC. A partial pulpotomy was performed and following complete haemostasis, the capping material was placed over the remaining pulp tissue and a postoperative periapical radiograph was taken. Clinical and radiographic follow-up evaluation was performed for a median time of 2 years, whereas levels of pain intensity were evaluated preoperatively and for 7 days after intervention using Visual Analogue Scale. For the primary outcome (failure/success of treatment), the Kaplan-Meier survival curves for the capping materials were plotted and a log-rank test for equality of survivor functions was applied. A multivariable random effects Cox Regression model was also applied. For the secondary outcome (postoperatively reported pain), a multivariable mixed effects ordinal logistic regression was structured.
RESULTS: One hundred and thirty-seven teeth in 123 patients underwent partial pulpotomy using randomly either MTA Angelus (N = 74) or Total Fill BC (n = 63). The percentage failure for MTA Angelus and Total Fill BC was 10.8% (8/74) and 17.5% (11/63), respectively, but the difference was not statistically significant [adjusted HR: 1.83; 95% confidence interval (CI): 0.68, 4.91; p = .23]. Weak evidence was found that secondary caries involvement may impose a 3.54 times greater hazard for treatment failure (adjusted HR: 3.54; 95% CI: 1.00, 12.51; p = .05). For each passing minute of procedural bleeding control, there was also a 57% higher hazard for treatment failure (adjusted HR: 1.57; 95% CI: 0.99, 2.48; p = .05). The odds for higher postoperative pain were 4.73 times greater for the Total Fill BC compared to MTA Angelus (adjusted OR: 4.73; 95% CI: 2.31, 9.66; p < .001).
CONCLUSIONS: Both materials exhibited similar and favourable outcome rates after partial pulpotomy in teeth with deep caries and symptoms of irreversible pulpitis. Total Fill BC was associated with a higher level of postoperative pain intensities.
摘要：
目的：通过比较MTAAngelus和TotalFillBC来评估部分牙髓切除术的临床和影像学结果，作为牙髓切除剂，在具有深龋齿和指示不可逆牙髓炎的症状的成熟牙齿中。
方法：本研究设计为平行双臂，双盲,在www注册的随机优势临床试验（RCT）。
结果：gov(NCT04870398)。使用MTAAngelus或TotalFillBC随机治疗符合纳入标准的有症状的具有深龋齿的成熟恒牙。进行部分牙髓切除术，并在完全止血后，将封盖材料放置在剩余的牙髓组织上，并进行术后根尖周X线照片。临床和影像学随访评估的中位时间为2年，而术前和干预后7天使用视觉模拟量表（VAS）评估疼痛强度水平。对于主要结果，（治疗失败/成功），绘制了封盖材料的Kaplan-Meier存活曲线，并应用了幸存者函数相等性的对数秩检验。还应用了多变量随机效应Cox回归模型。对于次要结果，（术后报告疼痛），构建了多变量混合效应序数logistic回归.
结果：123例患者随机使用MTAAngelus（N=74）进行部分牙髓切除术，或总填充BC(n=63)。MTAAngelus和TotalFillBC的失败百分比分别为10.8％（8/74）和17.5％（11/63），但差异无统计学意义(校正后HR:1.83;95CI:0.68,4.91;p=0.23).微弱的证据表明，继发性龋齿受累可能会导致治疗失败的危险增加3.54倍（调整后的HR：3.54；95CI：1.00，12.51；p=0.05）。程序出血控制的每一分钟,治疗失败的风险也增加了57%(校正后HR:1.57;95CI:0.99,2.48;p=0.05).与MTAAngelus相比，TotalFillBC术后疼痛较高的几率为4.73倍（调整后OR：4.73；95CI：2.31，9.66；p<0.001）。
结论：两种材料在深龋和不可逆牙髓炎症状的牙齿部分切除后表现出相似和良好的转归率。总充盈BC与较高的术后疼痛强度相关。
方法：本研究设计为平行双臂，双盲,在www注册的随机优势临床试验（RCT）。
结果：gov(NCT04870398)。使用MTAAngelus或TotalFillBC随机治疗符合纳入标准的有症状的具有深龋齿的成熟恒牙。进行部分牙髓切除术，并在完全止血后，将封盖材料放置在剩余的牙髓组织上，并进行术后根尖周X线照片。临床和影像学随访评估的中位时间为2年，而术前和干预后7天使用视觉模拟量表（VAS）评估疼痛强度水平。对于主要结果，（治疗失败/成功），绘制了封盖材料的Kaplan-Meier存活曲线，并应用了幸存者函数相等性的对数秩检验。还应用了多变量随机效应Cox回归模型。对于次要结果，（术后报告疼痛），构建了多变量混合效应序数logistic回归.
结果：123例患者随机使用MTAAngelus（N=74）进行部分牙髓切除术，或总填充BC(n=63)。MTAAngelus和TotalFillBC的失败百分比分别为10.8％（8/74）和17.5％（11/63），但差异无统计学意义(校正后HR:1.83;95CI:0.68,4.91;p=0.23).微弱的证据表明，继发性龋齿受累可能会导致治疗失败的危险增加3.54倍（调整后的HR：3.54；95CI：1.00，12.51；p=0.05）。程序出血控制的每一分钟,治疗失败的风险也增加了57%(校正后HR:1.57;95CI:0.99,2.48;p=0.05).与MTAAngelus相比，TotalFillBC术后疼痛较高的几率为4.73倍（调整后OR：4.73；95CI：2.31，9.66；p<0.001）。
结论：两种材料在深龋和不可逆牙髓炎症状的牙齿部分切除后表现出相似和良好的转归率。总充盈BC与较高的术后疼痛强度相关。
