# The Safety and Effectiveness of Root ZX3 for Symptomatic Irreversible Pulpitis: A Protocol for a Single-Center, Open-Label, Single-Arm Clinical Trial

## TL;DR

This study will test a new dental device, Root ZX3, to quickly and safely relieve pain from a severe tooth condition called symptomatic irreversible pulpitis.

## Contribution

This is the first clinical trial to evaluate the safety and effectiveness of Root ZX3 for treating symptomatic irreversible pulpitis.

## Key findings

- The study will assess immediate pain relief and adverse events after using Root ZX3.
- Results may establish Root ZX3 as a time-efficient option for managing acute pulpal pain.
- The trial could provide a foundation for optimizing emergency dental treatment protocols.

## Abstract

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.