NCT07388901

In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers

Randomized Controlled Trial of iRoot SP (Injectable Root Canal Sealer Paste) and nRoot SP (ENPUNUO Root Canal Sealer Paste) in Patients With Chronic Apical Periodontitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The Dental Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial was conducted to compare the treatment efficacy of iRoot SP and nRoot SP Root Canal Sealer Materials in patients with chronic apical periodontitis.

Detailed description

This study aims to conduct a randomized controlled clinical trial to evaluate the 3-24months efficacy (including radiographic reduction of periapical radiolucency, postoperative pain, etc.) of the two materials in patients with chronic apical periodontitis. The objective is to provide evidence-based support for the optimization and clinical selection of domestically produced materials, thereby promoting the precise application of bioceramic sealers.

Conditions

• Chronic Apical Periodontitis

Interventions

Type	Name	Description
DEVICE	iRoot SP	use iRoot SP in root canal treatment
DEVICE	nRoot SP	use nRoot SP in root canal treatment

Timeline

• Start date: 2025-05-27
• Primary completion: 2027-01-30
• Completion: 2027-06-30
• First posted: 2026-02-05
• Last updated: 2026-04-15

Locations

1 site across 1 country: China