iRoot SP versus nRoot SP root canal sealers for chronic apical periodontitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled clinical trial will compare iRoot SP and nRoot SP bioceramic root canal sealers in adults with chronic apical periodontitis. Eligible patients with a single, restorable non‑vital tooth and a 1–5 mm periapical radiolucency will be randomly assigned to receive one of the two sealers during primary root canal treatment. Outcomes include radiographic reduction of periapical radiolucency and postoperative pain measured over 3 to 24 months with standardized clinical and radiographic follow-up. The trial is conducted at the Affiliated Stomatology Hospital of Zhejiang University School of Medicine in Hangzhou.

Why it matters

Who can join: the full rules

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.

Where it's running

• School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Tu Yan — School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
• Study coordinator: Tu Yan
• Email: tuyan1984@zju.edu.cn
• Phone: +8615858224066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sonic versus passive ultrasonic irrigation for chronic root canal infection

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• Different root canal sealers and salivary oxidative stress in chronic apical periodontitis.

  This test will compare two types of root canal sealers to see if they change saliva oxidative stress markers in adults with chronic apical periodontitis.

  Recruiting Ordu University · Ordu, Ordu- Altınordu · NCT07059481

• Activation techniques in antimicrobial photodynamic therapy for retreatment of apical periodontitis

  This trial tests whether different methods of agitating methylene blue during antimicrobial photodynamic therapy can improve healing and reduce infection in teeth that prior root canals had treated for asymptomatic apical periodontitis.

  Recruiting Karadeniz Technical University · Trabzon, Ortahisar · NCT07921277

• Conventional and nano-metronidazole irrigation with or without ultrasonic activation for necrotic single-rooted teeth with apical periodontitis

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• Post-operative Pain and Healing After Root Canal Re-Treatment Using Laser-Activated Irrigation vs Sonic or No Activation

  This study tests whether laser-activated irrigation or sonic activation helps reduce post-operative pain and improve healing after re-treating a tooth with persistent apical inflammation, compared to conventional needle irrigation.

  Recruiting at 2 sites University Ghent · Antwerp and 1 other locations · NCT07883486

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.