METHODS: This was a single-centre study conducted as a follow-up to a short-term parallel-arm randomised controlled noninferiority trial in which root canal treatment was performed on teeth using either rotary or manual instrumentation. Patients were monitored at post 6-month, 1-year, 4-year, and 5-year review periods by blinded evaluators. Treatment outcome was categorised as favourable, uncertain, and unfavourable (employing European Society of Endodontology categorisation based on strict clinical and radiographic criteria), and 5-year tooth survival was determined by assessing whether tooth was in situ in the oral cavity or extracted. The Kaplan-Meier method and log rank test evaluated tooth survival. P value <.05 was considered statistically significant.
RESULTS: Ninety of 120 treated teeth were assessed in 37 men and 40 women with mean age of 30.6 ± 10.99 years. Treatment outcome was significantly more favourable in the rotary group compared to the manual group at post 6-month (P = .021) and 1-year (P = .043) review periods. The differences in favourable outcome (P = .498) and tooth survival (P = .296) between the 2 groups were, however, not significant at the 5-year review period.
CONCLUSIONS: The rotary instrumentation technique was shown to be more effective in resolving clinical symptoms and promoting periapical healing after the post 6-month and 1-year review compared to the manual instrumentation technique; however, both groups had similar favourable outcomes and survival rates after an extended 5-year review period.
方法:这是一项单中心研究,作为一项短期平行臂随机对照非劣效性试验的后续研究,其中使用旋转或手动器械对牙齿进行根管治疗。在6个月后对患者进行了监测,1年,4年,和盲目评估者的5年审查期。治疗结果被归类为有利的,不确定,和不利(采用基于严格的临床和放射学标准的欧洲牙髓学会分类),通过评估牙齿是否在口腔中原位或拔除来确定5年牙齿存活率。Kaplan-Meier方法和对数秩检验评估牙齿存活率。P值<0.05被认为具有统计学意义。
结果:在37名男性和40名女性(平均年龄为30.6±10.99岁)的120颗治疗牙齿中评估了90颗。在6个月(P=.021)和1年(P=.043)的审查期内,旋转组的治疗结果明显优于手动组。两组之间的有利结果(P=0.498)和牙齿存活率(P=0.296)的差异是,然而,在5年审查期间并不重要。
结论:与手动仪器技术相比,旋转仪器技术在6个月和1年后的复查后在解决临床症状和促进根尖周愈合方面更有效;但是,经过延长的5年回顾期后,两组均有相似的有利结局和生存率.