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

The Dental Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Chronic Apical Periodontitis

Treatments: Device: iRoot SP; Device: nRoot SP

Study type: Interventional

Funder types: Other

Identifiers

NCT07388901

2025-064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Diagnosis of apical periodontitis conforming to the diagnostic criteria in Endodontics.
• The affected tooth is deemed restorable upon evaluation, with non-vital pulp requiring extirpation.
• The affected tooth is a single tooth with a fully developed apical foramen.
• No root resorption and no significant morphological variation of the root canal.
• The affected tooth is undergoing primary root canal treatment.
• Periapical radiolucency with a diameter of 1-5 mm and no peripheral sclerotic border observed on preoperative radiographs.
• Patient is in normal mental state, conscious, and capable of normal communication.
• Patient has provided informed consent.

Exclusion criteria

• Patients with alveolar bone loss exceeding one-third of the root length.
• Affected teeth with root fracture, root canal obstruction, calcification, or root surface caries.
• Patients with severe systemic diseases (e.g., osteoporosis, mental disorders, hepatic or renal insufficiency).
• Patients who have taken analgesics, immunosuppressants, or antibiotics within one week prior to enrollment.
• Patients with concurrent periapical cysts, oral tumors, or other oral diseases.
• Pregnant or lactating patients.
• Patients with dental phobia, severe gag reflex, limited mouth opening, or poor compliance.
• Patients with a known allergy to the root canal sealer materials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

160 participants in 2 patient groups

iRoot SP

Active Comparator group

Description:

iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.

Treatment:

Device: iRoot SP

nRoot SP

Experimental group

Description:

nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.

Treatment:

Device: nRoot SP