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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Chronic Apical Periodontitis

NCT07388901

The Dental Hospital of Zhejiang University School of Medicine

15 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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