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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Apical Periodontitis
• Intervention / Treatment: Device: iRoot SP; Device: nRoot SP

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tu Yan; Phone Number: +8615858224066; Email: tuyan1984@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
      • Contact: Tu Yan; Phone Number: +8615858224066; Email: tuyan1984@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iRoot SP; iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.	Device: iRoot SP; use iRoot SP in root canal treatment
Experimental: nRoot SP; nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.	Device: nRoot SP; use nRoot SP in root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical manifestation	Four distinct clinical assessments to be evaluated at 3, 6, 12, and 24 months postoperatively: tooth mobility, assessed clinically using a standard grading scale (Miller index. Grade I: Mobility with a buccolingual displacement of ≤1 mm; Grade II: Mobility with a buccolingual displacement of 1-2 mm, possibly accompanied by slight mesiodistal mobility; Grade III: Mobility with a buccolingual or mesiodistal displacement exceeding 2 mm, or the presence of vertical mobility.) ; periodontal probing depth, measured at designated sites(mesiobuccal, midbuccal, distobuccal mesiolingual, midlingual, distolingual).) around the tooth with a periodontal probe and recorded in millimeters; percussion pain, evaluated by vertical and horizontal tapping and documented either as a binary presence/absence; the presence of a sinus tract, determined through visual inspection and verification with a gutta-percha point if necessary and recorded as a binary outcome. Each parameter will be analyzed independent	3,6,12,24months
Imaging findings	Change in the size of the periapical radiolucent area. Specifically, after acquiring the image, the DICOM format image will be imported into 3D slicer, the maximum diameter of the apical low-density shadow will be measured using the ruler function, the range of the apical low-density shadow will be divided using the segment editor module, and the volume of the periapical shadow will be calculated using the segment statistics module	3,6,12,24months

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Tu Yan, School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No