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下颌磨牙牙髓坏死患者应用 1.3%次氯酸钠与 5.25%次氯酸钠根管冲洗后的术后疼痛:一项随机双盲临床试验。

Postoperative pain following endodontic irrigation using 1.3% versus 5.25% sodium hypochlorite in mandibular molars with necrotic pulps: a randomized double-blind clinical trial.

机构信息

Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.

出版信息

Int Endod J. 2020 Feb;53(2):154-166. doi: 10.1111/iej.13222. Epub 2019 Oct 23.

Abstract

AIM

This randomized, prospective, double-blind, clinical trial assessed the effect of 1.3% and 5.25% sodium hypochlorite (NaOCl) as irrigants on post-endodontic pain and medication intake following root canal treatment of mandibular molars with nonvital pulps.

METHODOLOGY

Three hundred and eight patients, each with one symptomatic or asymptomatic molar, were randomly assigned, using the permuted-block method, into two equal groups according to NaOCl concentration: 1.3% or 5.25% (n = 154). For both groups, syringe irrigation was performed using a 27-gauge needle advanced into the canal to a depth of 3 mm from the working length; 3 mL were used between every two consecutive instruments. All root canal treatments were carried out in two visits, with no intracanal medication, by trained postgraduate students. The canals were prepared using the ProTaper Universal rotary system during the first visit. In the second visit 7 days later, the same irrigant per group was used and the canal walls were reprepared with the final instrument before filling the canal using the modified single-cone technique with an epoxy resin-based sealer. Patients assessed their postoperative pain using a 0-10 numerical rating scale immediately after instrumentation, 3, 24, 48 h and 7 days after the first visit and immediately following root canal filling. The incidence of rescue medication intake (Sham or analgesic) was also recorded; patients received a sham capsule to be used first, but, if pain persisted, an analgesic was prescribed. Outcome data were analysed using Mann-Whitney U-test, Friedman's test, Wilcoxon's rank test and chi-square (χ ) test. Relative risk reduction (RRR) and its 95% confidence interval (CI) were calculated for binary data.

RESULTS

The incidence and intensity of postoperative pain were significantly lower with 1.3% NaOCl than 5.25% NaOCl at all time-points (P < 0.05). Postoperative pain intensity exceeded preoperative pain at 3 and 24 h with 5.25% NaOCl only (P < 0.05). The RRR in pain incidence was 38% (95% CI: 17%, 54%) immediately after instrumentation, 41% (95% CI: 31%, 49%) at 3 h, 42% (95% CI: 32%, 51%) at 24 h, 59% (95% CI: 45%, 69%) at 48 h, 62% (95% CI: 27%, 80%) at 7 days and 81% (95% CI: 68%, 89%) after root filling. RRR was 38% (95% CI: 1%, 61%) for sham intake and 69% (95% CI: 37%, 85%) for analgesic intake.

CONCLUSIONS

Using 1.3% NaOCl was associated with less intense and less frequent post-endodontic pain than 5.25% NaOCl in mandibular molars with nonvital pulps treated in two visits. The incidence of pain was reduced by up to 60% within the week post-instrumentation and 80% after root canal filling and the rescue analgesic intake by about 70% on using 1.3% NaOCl compared to 5.25% NaOCl.

摘要

目的

本随机、前瞻性、双盲、临床试验评估了 1.3%和 5.25%次氯酸钠(NaOCl)作为冲洗液对下颌磨牙非活力牙髓根管治疗后术后疼痛和药物摄入的影响。

方法

308 名患者,每个患者均有一颗有症状或无症状的磨牙,采用随机区组法,根据 NaOCl 浓度随机分为两组,每组 154 名:1.3%或 5.25%(n=154)。对于两组,均使用 27 号注射器针头,从工作长度向根管内推进 3mm 深度进行冲洗;每两根连续器械之间使用 3mL。所有根管治疗均在两次就诊中进行,不使用根管内药物,由经过培训的研究生进行。第一次就诊时使用 ProTaper Universal 旋转系统进行根管预备;7 天后的第二次就诊中,每组使用相同的冲洗液,并在使用环氧树脂基密封剂的改良单锥技术进行根管充填前,用最终器械重新预备根管壁。患者在器械处理后立即、处理后 3、24、48 小时和 7 天以及根管充填后即刻使用 0-10 数字评分量表评估术后疼痛。还记录了止痛药物(假或镇痛)摄入的发生率;患者首先使用假胶囊,如果疼痛持续,则开具镇痛药。使用 Mann-Whitney U 检验、Friedman 检验、Wilcoxon 秩和检验和卡方(χ )检验分析结局数据。对于二项数据,计算相对风险降低(RRR)及其 95%置信区间(CI)。

结果

在所有时间点,1.3%NaOCl 的术后疼痛发生率和强度均明显低于 5.25%NaOCl(P<0.05)。5.25%NaOCl 在 3 和 24 小时时术后疼痛强度超过术前疼痛(P<0.05)。器械处理后即刻疼痛发生率的 RRR 为 38%(95%CI:17%,54%),3 小时时为 41%(95%CI:31%,49%),24 小时时为 42%(95%CI:32%,51%),48 小时时为 59%(95%CI:45%,69%),7 天时为 62%(95%CI:27%,80%),根管充填后为 81%(95%CI:68%,89%)。假药物摄入的 RRR 为 38%(95%CI:1%,61%),镇痛药物摄入的 RRR 为 69%(95%CI:37%,85%)。

结论

在两次就诊中治疗下颌磨牙非活力牙髓时,使用 1.3%NaOCl 与使用 5.25%NaOCl 相比,术后疼痛程度较轻,疼痛发生频率较低。在器械处理后的一周内,疼痛发生率降低了 60%,在根管充填后,疼痛发生率降低了 80%,使用 1.3%NaOCl 时止痛药物的摄入减少了约 70%,而使用 5.25%NaOCl 时止痛药物的摄入减少了约 70%。

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