Al-Mosalmy Tarek Ali, El-Far Heba Maged, Gomaa Madiha Mahmoud, Morsy Dina Ahmed
Cairo University, Faculty of Dentistry, Department of Endodontics, Cairo, Egypt.
Misr International University, Faculty of Dentistry, Obour City, Egypt.
BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.
TruNatomy instruments promises a more conservative alternative to conventionally used instruments. They are claimed by the manufacture to decrease the amount of debris extrusion as well as the torque generated during instrumentation, potentially resulting in lower post-operative discomfort and a safer more convenient experience for the patient and clinician.
To compare the effect of canal shaping using TruNatomy (TN) rotary system to RaCe (RC) rotary system on post-operative pain in necrotic maxillary bi-rooted premolars, while simultaneously inspecting the real-time dynamic forces produced during instrumentation.
In this parallel group superiority trial, following power calculation, 40 patients diagnosed with pulp necrosis in asymptomatic bi-rooted maxillary premolars were recruited and randomly allocated into two equal groups (n = 20) according to the instrumentation system used. Treatment was completed in a one visit for all cases. Pain levels were recorded immediately before RCT and at 6,12,24,48, 72 h, and 1-week post RCT using mVAS. The number of analgesics taken if any was also recorded. Operative torque generated during root canal preparation as well as the time taken for the instrument to reach the working length were simultaneously recorded during instrumentation. Outcome data was statistically analyzed using Shapiro Wilk test, independent t test, Mann-Whitney U, Chi square, Fisher exact tests, spearman's correlation coefficient. Significance level (α) was set at 0.05.
There was no statistically significant difference between pain scores in the test groups at all time points measured (P > .05). No significant different was also recorded in terms of number of analgesics taken (P > .05). Mean torque, average peak torque and maximum torque values showed no statistically significant difference as well, however the instrumentation time was significantly shorter for the TN Group (P < .05). A moderate significant positive correlation was found between the instrumentation time and generated operative torque.
TN and RC rotary instruments resulted in similar and acceptable levels of post-operative pain in cases of asymptomatic necrotic teeth. However, TN rotary system combined torque and instrumentation time values suggest an overall higher cutting efficiency and potentially a better safety profile as compared to RC rotary system.
ClinicalTrials.gov identifier: NCT04616469; registration date (10/08/2020).
TruNatomy器械有望成为传统使用器械的一种更为保守的替代方案。制造商宣称，它们可减少碎屑挤出量以及器械操作过程中产生的扭矩，这可能会降低术后不适，并为患者和临床医生带来更安全、更便捷的体验。
比较使用TruNatomy（TN）旋转系统和RaCe（RC）旋转系统对坏死性上颌双根前磨牙进行根管预备后对术后疼痛的影响，同时检查器械操作过程中产生的实时动态力。
在这项平行组优效性试验中，经过功效计算，招募了40例被诊断为无症状双根上颌前磨牙牙髓坏死的患者，并根据所使用的器械系统将其随机分为两组，每组20例。所有病例均在一次就诊中完成治疗。在根管治疗前、治疗后6、12、24、48、72小时以及1周时，使用mVAS记录疼痛水平。还记录了服用止痛药的数量（如有）。在根管预备过程中同时记录产生的操作扭矩以及器械到达工作长度所需的时间。使用Shapiro Wilk检验、独立t检验、Mann-Whitney U检验、卡方检验、Fisher精确检验、Spearman相关系数对结果数据进行统计分析。显著性水平（α）设定为0.05。
在所有测量的时间点，测试组的疼痛评分之间均无统计学显著差异（P＞0.05）。在服用止痛药的数量方面也未记录到显著差异（P＞0.05）。平均扭矩、平均峰值扭矩和最大扭矩值也均无统计学显著差异，然而TN组的器械操作时间明显更短（P＜0.05）。器械操作时间与产生的操作扭矩之间存在中度显著正相关。
对于无症状坏死牙病例，TN和RC旋转器械导致的术后疼痛水平相似且可接受。然而，TN旋转系统的扭矩和器械操作时间值表明，与RC旋转系统相比，其总体切割效率更高，潜在安全性更好。
ClinicalTrials.gov标识符：NCT04616469；注册日期（2020年8月10日）。
