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NCT Number: NCT07388901

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

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.

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Key information

Conditions

Chronic Apical Periodontitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Tu Yan

CONTACT

[email protected]

+8615858224066

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iRoot SP

Device

use iRoot SP in root canal treatment

nRoot SP

Device

use nRoot SP in root canal treatment

Primary outcomes

  1. therapeutic effect

    Time frame: 3,6,12,24months

    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.

Secondary outcomes

  1. clinical manifestation

    Time frame: 3,6,12,24months

    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

  2. Imaging findings

    Time frame: 3,6,12,24months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Tu Yan

CONTACT

[email protected]

+8615858224066

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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