Efficacy and Safety of Treatment with Root ZX3 Alone in Symptomatic Irreversible Pulpitis

JRCT ID: jRCTs072240124

Registered date:07/03/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Symptomatic Irreversible Pulpitis
• Date of first enrollment: 07/03/2025
• Target sample size: 10
• Study type: Interventional
• Intervention(s): After infiltration anesthesia, a hole is drilled into the pulp cavity using a rotary cutting instrument for one target tooth with acute suppurative pulpitis. The tip of the Root ZX3 tip electrode is then brought into contact with the pulp, and the footswitch for high-frequency waves (530 kHz) is pressed to perform the procedure. The drilled hole is then sealed with hydraulic cement.

Outcome(s)

• Primary Outcome: Rate of resolution of spontaneous pain on evaluation date

Secondary Outcome

Resolution rate of spontaneous pain on postoperative days 1, 2, 3, and 7 (questionnaire survey)
Occlusal pain (VAS value) (questionnaire survey)
Incidence of pain during file insertion
Pain induced by percussion (VAS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with symptomatic irreversible pulpitis requiring pulp extraction
(2) Patients whose tooth to be extracted is a permanent tooth
(3) Patients with spontaneous pain
(4) Patients with a positive electric pulp examination
(5) Patients over 18 years old at the time of consent
(6) Patients who can perform VAS evaluation by themselves
(7) Patients with no bone permeation image at the root apex on radiographs
(8) Patients who do not have periodontal pockets with a PD of 4 mm or more in the affected tooth
(9) Patients without bifurcation lesions in the affected teeth.
(10) Patients with alveolar bone resorption of the affected tooth within 1/3.
(11) Patients whose consent has been obtained from the patient

Exclude criteria

(1) Patients with a pacemaker or implantable cardioverter-defibrillator.
(2) Patients with two or more teeth with symptomatic irreversible pulpitis.
(3) Patients who are participating in clinical trials or other clinical studies.

Related Information

• Primary Sponsor: Matsuura Takashi
• Source(s) of Monetary Support: Morita