iRoot BP Plus 和 iRoot SP 联合用于根管显微镜下根尖封闭术的效果：一项随机对照试验。
The outcome of combined use of iRoot BP Plus and iRoot SP for root-end filling in endodontic microsurgery: a randomized controlled trial.
机构信息
Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Department of Stomatology, The First People's Hospital of Liangshan Yi Autonomous Prefecture, Xichang, China.
出版信息
Clin Oral Investig. 2024 Mar 2;28(3):188. doi: 10.1007/s00784-024-05569-7.
OBJECTIVES
Root-end filling is important for the clinical outcome of endodontic microsurgery. Our previous study showed that combined application of iRoot BP Plus Root Repair Material (BP-RRM) and iRoot SP Injectable Root Canal Sealer (SP-RCS) in root-end filling exhibited better apical sealing as compared to the application of BP-RRM alone. The aim of this randomized controlled clinical trial was to evaluate the effect of the combined use of BP-RRM and SP-RCS on the prognosis of teeth with refractory periapical diseases after endodontic microsurgery.
MATERIALS AND METHODS
240 teeth with refractory periapical diseases scheduled for endodontic microsurgery were randomly divided into BP-RRM/SP-RCS group (n = 120) and BP-RRM group (n = 120). The patients were followed up at 3 months, 6 months, and 12 months after endodontic microsurgery. Pre- and post-operative clinical and radiographic examinations were performed to evaluate the treatment outcome. The 1-year success rate of endodontic microsurgery in BP-RRM/SP-RCS and BP-RRM groups was compared by Chi-square test. Factors that might impact the prognosis were further analyzed using Chi-square test or Fisher's exact test.
RESULTS
A total of 221 teeth completed the 12-month follow-up. The 1-year success rates of the BP-RRM/SP-RCS and BP-RRM groups were 94.5% (104/110) and 92.8% (103/111), respectively. The combined use of BP-RRM and SP-RCS achieved a clinical outcome comparable to BP-RRM alone (P = 0.784). Tooth type (P = 0.002), through-and-through/apico-marginal lesion (P = 0.049), periodontal status (P < 0.0001), and Kim's lesion classification (P < 0.0001) were critical factors associated with the 1-year success of endodontic microsurgery.
CONCLUSIONS
The combined use of BP-RRM and SP-RCS is a practicable method for root-end filling in endodontic microsurgery with a satisfactory 1-year clinical outcome.
CLINICAL RELEVANCE
The combined application of BP-RRM and SP-RCS in EMS is an effective root-end filling method with a satisfactory 1-year clinical outcome.
TRIAL REGISTRATION
This study was registered in the Chinese Clinical Trial Registry (ChiCTR2100052174).
目的
根尖封闭对于根管显微手术的临床效果至关重要。我们之前的研究表明，与单独应用 iRoot BP Plus 根管修复材料（BP-RRM）相比，iRoot SP 可注射根管封闭剂（SP-RCS）联合应用于根尖封闭可获得更好的根尖封闭效果。本随机对照临床试验旨在评估 BP-RRM 和 SP-RCS 联合应用对根管显微手术后难治性根尖病变牙齿预后的影响。
材料和方法
将 240 颗难治性根尖病变的患牙随机分为 BP-RRM/SP-RCS 组（n=120）和 BP-RRM 组（n=120）。在根管显微手术后的 3、6 和 12 个月进行随访。进行术前和术后临床及影像学检查以评估治疗效果。采用卡方检验比较 BP-RRM/SP-RCS 组和 BP-RRM 组根管显微手术后 1 年的成功率。采用卡方检验或 Fisher 确切概率法进一步分析可能影响预后的因素。
结果
共有 221 颗牙完成了 12 个月的随访。BP-RRM/SP-RCS 组和 BP-RRM 组的 1 年成功率分别为 94.5%（104/110）和 92.8%（103/111）。BP-RRM 和 SP-RCS 的联合应用可获得与 BP-RRM 单独应用相当的临床效果（P=0.784）。牙型（P=0.002）、贯穿性/根尖边缘病变（P=0.049）、牙周状况（P<0.0001）和 Kim 病变分类（P<0.0001）是与根管显微手术 1 年成功率相关的关键因素。
结论
BP-RRM 和 SP-RCS 的联合应用是根管显微手术中一种可行的根尖封闭方法，具有满意的 1 年临床效果。
临床相关性
BP-RRM 和 SP-RCS 在 EMS 中的联合应用是一种有效的根尖封闭方法，具有满意的 1 年临床效果。
试验注册
本研究在中国临床试验注册中心（ChiCTR2100052174）注册。
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