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

NCT07388901 | Recruiting

• 1 other identifier: 2025-064
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• therapeutic effect

  Markedly Effective: Post-treatment X-ray examination shows complete resolution of the periapical radiolucency. The patient's chewing function is largely restored, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort have disappeared. Effective: Post-treatment X-ray examination shows significant reduction in the size of the radiolucency. The patient may experience mild percussion pain or discomfort. Chewing function is largely normal, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show improvement. Ineffective: Post-treatment X-ray examination shows no reduction or even enlargement of the radiolucency. The patient reports significant percussion pain. Symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show no improvement.

  3,6,12,24months

Secondary Outcomes (2)

• clinical manifestation

  3,6,12,24months

• Imaging findings

  3,6,12,24months

Study Arms (2)

iRoot SP

ACTIVE COMPARATOR

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

Device: iRoot SP

nRoot SP

EXPERIMENTAL

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

Device: nRoot SP

Interventions

iRoot SP DEVICE

use iRoot SP in root canal treatment

iRoot SP

nRoot SP DEVICE

use nRoot SP in root canal treatment

nRoot SP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Tu Yan

  School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tu Yan

CONTACT

+8615858224066; tuyan1984@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 5, 2026
• Study Start: May 27, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)