Harikrishnan Nikhil, Nesamani Ravi Kumar, Sherin S Aysha, Sanjeev Kavitha, Sekar Mahalaxmi
Dept of Conservative Dentistry and Endodontics, Yenopoya Dental College, University Road, Yenopoya University Campus, Deralakatte, Karnataka, India.
Dept of Conservative Dentistry and Endodontics, SRM Dental College, Bharathi Salai, Ramapuram, Chennai, India.
J Transl Med. 2025 Jul 9;23(1):760. doi: 10.1186/s12967-025-06579-z.
The objective of this prospective, triple-blind, randomized clinical controlled trial is to investigate and compare the expressions of interleukin-6 (IL-6), interleukin-10 (IL-10), and matrix metalloproteinase-9 (MMP-9) in the periapical tissues of teeth with symptomatic apical periodontitis following the placement of calcium hydroxide (Ca(OH)₂) and simvastatin as intracanal medicaments (ICM). Additionally, the study aims to evaluate pre-treatment and interappointment pain levels. This research could lead to improved treatment protocols for symptomatic apical periodontitis, enhancing patient comfort and outcomes.
The study adhered to CONSORT guidelines. A total of 34 patients aged 14 to 60 years with single-rooted teeth diagnosed with pulp necrosis and symptomatic apical periodontitis underwent root canal procedures. They were randomly divided into two groups based on the ICM used: Group I received Ca(OH)₂, while Group II received simvastatin. Tissue fluid samples were collected at three time points (T0, T1, T2) using paper points inserted into the periapical tissues immediately after access opening, after cleaning and shaping, and 7 days after ICM placement. The samples were stored at - 20 °C for analysis. Pain levels were recorded using the Heft Parker Visual Analogue Scale (HP-VAS) at various intervals. All samples underwent enzyme-linked immunosorbent assay (ELISA) to estimate IL-6, IL-10, and MMP-9 levels in pg/ml. Statistical analysis included the Mann-Whitney U test and Quade nonparametric ANCOVA for inter-group comparisons, while intra-group comparisons were performed using the Friedman test.
Statistically significant differences were observed in IL-6 and MMP-9 levels within groups but not in IL-10 across time points (p < 0.05). In intergroup comparisons at T2, simvastatin showed significantly lower expressions of IL-6 and MMP-9 compared to Ca(OH)₂ (p < 0.05). IL-10 levels increased in both groups without significant differences. Pain scores were significantly lower following simvastatin treatment compared to Ca(OH)₂ (p < 0.05).
The expression of these biomarkers indicates that simvastatin is effective in reducing inflammation and pain in teeth with pulpal necrosis and symptomatic apical periodontitis when used as an intracanal medicament compared to Ca(OH)₂.
Clinical Trial Registry of India CTRI/2022/08/044749; Registered 18 August 2022 https://drive.google.com/file/d/17JXArM3qoqvTMiUa9ITMTQTGLEvsxpW_/view?usp=sharing.
这项前瞻性、三盲、随机临床对照试验的目的是研究和比较在有症状的根尖周炎患牙的根尖周组织中，使用氢氧化钙（Ca(OH)₂）和辛伐他汀作为根管内药物（ICM）后白细胞介素-6（IL-6）、白细胞介素-10（IL-10）和基质金属蛋白酶-9（MMP-9）的表达情况。此外，该研究旨在评估治疗前和复诊间的疼痛水平。这项研究可能会改进有症状根尖周炎的治疗方案，提高患者舒适度和治疗效果。
该研究遵循CONSORT指南。共有34例年龄在14至60岁之间、诊断为牙髓坏死和有症状根尖周炎的单根牙患者接受了根管治疗。根据所使用的根管内药物，他们被随机分为两组：第一组接受Ca(OH)₂，第二组接受辛伐他汀。在三个时间点（T0、T1、T2）使用纸尖收集组织液样本，分别在开髓后立即、清理成形后以及根管内药物放置7天后插入根尖周组织。样本储存在-20°C用于分析。使用Heft Parker视觉模拟量表（HP-VAS）在不同时间间隔记录疼痛水平。所有样本均进行酶联免疫吸附测定（ELISA）以估计pg/ml水平的IL-6、IL-10和MMP-9水平。统计分析包括用于组间比较的Mann-Whitney U检验和Quade非参数协方差分析，而组内比较使用Friedman检验。
在各时间点，组内IL-6和MMP-9水平存在统计学显著差异，但IL-10无差异（p < 0.05）。在T2的组间比较中，与Ca(OH)₂相比，辛伐他汀显示出IL-6和MMP-9的表达显著更低（p < 0.05）。两组的IL-10水平均升高，但无显著差异。与Ca(OH)₂相比，辛伐他汀治疗后的疼痛评分显著更低（p < 0.05）。
这些生物标志物的表达表明，与Ca(OH)₂相比，辛伐他汀作为根管内药物用于牙髓坏死和有症状根尖周炎的患牙时，在减轻炎症和疼痛方面是有效的。
印度临床试验注册中心CTRI/2022/08/044749；2022年8月18日注册https://drive.google.com/file/d/17JXArM3qoqvTMiUa9ITMTQTGLEvsxpW_/view?usp=sharing。
