根管治療用機器Root ZX3による症候性不可逆性歯髄炎の安全性と有効性：単一施設、非盲検、単群臨床試験プロトコル

Background Root ZX3, a high-frequency dental generator introduced in 2021, utilizes high-frequency current (HFC) within the root canal to coagulate and incinerate pulp tissue in seconds. Despite its clinical potential, evidence regarding its specific application for symptomatic irreversible pulpitis (SIP) remains scarce. This study aims to evaluate the safety and clinical effectiveness of Root ZX3 for the management of SIP in a dedicated clinical trial. Specifically, the primary objective is to assess the immediate relief of spontaneous pain (primary endpoint) and the incidence of adverse events following HFC application. Methods In this single-center, single-arm trial, we will include 10 permanent teeth diagnosed with SIP. Following infiltration anesthesia and dental dam isolation, an access cavity will be prepared to allow the Root ZX3 tip electrode to contact the pulp tissue. After the HFC application, the cavity will be sealed with a temporary restoration. Our primary endpoint is the resolution of spontaneous pain on postoperative day 0, defined as the proportion of participants achieving complete relief. Discussion SIP-related emergencies often disrupt clinical workflows due to their unscheduled nature. The treatment time is a critical bottleneck in these scenarios. By employing Root ZX3, clinicians may manage SIP more efficiently without increasing chair time or affecting other patients. If this protocol proves effective and safe, Root ZX3 will offer a valuable technical alternative for the immediate management of acute pulpitis. Conclusion This clinical trial will provide the first systematic evaluation of the Root ZX3's HFC application for managing SIP. By leveraging its ability to rapidly coagulate pulp tissue in anatomically complex areas, this approach aims to streamline the emergency endodontic workflow without compromising patient safety or treatment precision. Although this exploratory study is limited by its single-center design and small cohort, the results are expected to provide a critical foundation for optimizing pain-relief protocols. Ultimately, demonstrating the effectiveness of Root ZX3 could establish it as a valuable, time-efficient option for the immediate relief of acute pulpal pain in busy clinical settings.