Centro "Activa Biosilicate Technology™" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile.
Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile.
J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.
A randomized controlled phase I/II clinical trial was designed to evaluate the safety and efficacy of encapsulated human umbilical cord mesenchymal stem cells in a plasma-derived biomaterial for regenerative endodontic procedures (REPs) in mature permanent teeth with apical lesions. The trial included 36 patients with mature incisors, canines, or mandibular premolars showing pulp necrosis and apical periodontitis. Patients were randomly and equally allocated between experimental (REP) or conventional root canal treatment (ENDO) groups. On the first visit, cavity access and mechanical preparation of the root canal were performed. Calcium hydroxide medication was used, and the cavity was sealed. Three weeks later, patients were treated following their assigned protocol of ENDO or REP. Clinical follow-up examinations were performed at 6 and 12 mo. Categorical variables were evaluated by Fisher's exact test. Quantitative variables were compared using the Mann-Whitney test. The evolution over time of the percentage of perfusion units and the dimensions of lesion and cortical compromise were explored. After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups. Interestingly, in the REP group, the perfusion unit percentage measured by laser Doppler flowmetry revealed an increase from 60.6% to 78.1% between baseline and 12-mo follow-up. Sensitivity tests revealed an increase of the positive pulp response in the REP group at 12-mo follow-up (from 6% to 56% on the cold test, from 0% to 28% on the hot test, and from 17% to 50% on the electrical test). We present the first clinical safety and efficacy evidence of the endodontic use of allogenic umbilical cord mesenchymal stem cells encapsulated in a plasma-derived biomaterial. The innovative approach, based on biological principles that promote dentin-pulp regeneration, presents a promising alternative for the treatment of periapical pathology (ClinicalTrials.gov NCT03102879).
一项随机对照的 I/II 期临床试验旨在评估包封的人脐带间充质干细胞在用于再生性牙髓治疗（REP）的血浆衍生生物材料中的安全性和有效性，用于成熟恒牙的根尖病变。该试验纳入了 36 名具有牙髓坏死和根尖周炎的成熟切牙、尖牙或下颌前磨牙患者。患者被随机分为实验组（REP）和传统根管治疗组（ENDO）。首次就诊时，进行牙体腔暴露和根管机械预备，使用氢氧化钙药物，并封闭牙体腔。3 周后，根据 ENDO 或 REP 方案对患者进行治疗。分别在 6 个月和 12 个月时进行临床随访检查。采用 Fisher 确切概率法评估分类变量。采用 Mann-Whitney 检验比较定量变量。探讨灌注单位百分比以及病变和皮质骨损伤程度的时间演变。在 12 个月的随访后，两组均未报告不良事件，患者的临床疗效均为 100%。有趣的是，在 REP 组中，激光多普勒血流仪测量的灌注单位百分比从基线时的 60.6%增加到 12 个月时的 78.1%。敏感性试验显示，REP 组在 12 个月随访时冷测试的阳性牙髓反应增加（从 6%增加到 56%，热测试从 0%增加到 28%，电测试从 17%增加到 50%）。我们首次提供了使用包封在血浆衍生生物材料中的同种异体脐带间充质干细胞进行牙髓治疗的临床安全性和有效性证据。该创新性方法基于促进牙本质牙髓再生的生物学原理，为治疗根尖周病变提供了一种有前途的替代方案（ClinicalTrials.gov NCT03102879）。
