Department of Stomatology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue North, Guangzhou, 510515, China.
Trials. 2021 Jul 6;22(1):436. doi: 10.1186/s13063-021-05401-7.
Dental pulp necrosis, a common health problem, is traditionally treated with root canal therapy; however, it fails in restoring the vitality of damaged pulp. Most studies regarding regenerative endodontic therapy (RET) are limited to the treatment of immature necrotic teeth. Given that injectable platelet-rich fibrin (i-PRF) has shown great potential in regenerative medicine as a novel platelet concentration, this study is designed to explore whether i-PRF can serve as a biological scaffold, extending the indications for RET and improving the clinical feasibility of RET in mature permanent teeth with pulp necrosis.
This is a randomised, double-blind, controlled, multicentre clinical trial designed to evaluate the clinical feasibility of RET for mature permanent teeth with pulp necrosis and to compare the efficacy of i-PRF and blood clots as scaffolds in RET. A total of 346 patients will be recruited from three centres and randomised at an allocation ratio of 1:1 to receive RET with either a blood clot or i-PRF. The changes in subjective symptoms, clinical examinations, and imaging examinations will be tracked longitudinally for a period of 24 months. The primary outcome is the success rate of RET after 24 months. The secondary outcome is the change in pulp vitality measured via thermal and electric pulp tests. In addition, the incidence of adverse events such as discolouration, reinfection, and root resorption will be recorded for a safety evaluation.
This study will evaluate the clinical feasibility of RET in mature permanent teeth with pulp necrosis, providing information regarding the efficacy, benefits, and safety of RET with i-PRF. These results may contribute to changes in the treatment of pulp necrosis in mature permanent teeth and reveal the potential of i-PRF as a novel biological scaffold for RET.
ClinicalTrials.gov NCT04313010 . Registered on 19 March 2020.
牙髓坏死是一种常见的健康问题，传统上采用根管治疗；然而，这种方法无法恢复受损牙髓的活力。大多数关于再生性根管治疗（RET）的研究都局限于治疗未成熟的坏死牙。鉴于富含血小板的纤维蛋白（i-PRF）作为一种新型血小板浓缩物在再生医学中显示出巨大潜力，本研究旨在探讨 i-PRF 是否可以作为生物支架，扩大 RET 的适应证，并提高成熟恒牙牙髓坏死的 RET 的临床可行性。
这是一项随机、双盲、对照、多中心临床试验，旨在评估 RET 治疗成熟恒牙牙髓坏死的临床可行性，并比较 i-PRF 和血凝块作为 RET 支架的疗效。将从三个中心招募 346 名患者，按 1:1 的分配比例随机分为接受血凝块或 i-PRF 治疗的 RET 组。将对主观症状、临床检查和影像学检查的变化进行纵向跟踪，时间为 24 个月。主要结局是 24 个月后 RET 的成功率。次要结局是牙髓活力的变化，通过牙髓冷热测试和电活力测试来测量。此外，还将记录不良事件的发生率，如变色、再感染和根吸收，以进行安全性评估。
本研究将评估 RET 在成熟恒牙牙髓坏死中的临床可行性，提供关于 i-PRF 治疗 RET 的疗效、益处和安全性的信息。这些结果可能会改变成熟恒牙牙髓坏死的治疗方法，并揭示 i-PRF 作为 RET 新型生物支架的潜力。
ClinicalTrials.gov NCT04313010。注册于 2020 年 3 月 19 日。
