iRoot SP versus nRoot SP root canal sealers for chronic apical periodontitis
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
This trial will test whether iRoot SP or nRoot SP root canal sealers produce better healing and less post-procedure pain in adults with chronic apical periodontitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07388901 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with chronic apical periodontitis affecting a single, restorable non‑vital tooth with a fully formed apex, no significant root anomalies, and a 1–5 mm periapical radiolucency are ideal candidates.
Not a fit: Patients with advanced alveolar bone loss (> one‑third of the root length), root fracture, canal obstruction or calcification, severe systemic disease, or non-restorable teeth are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could help dentists choose the sealer that gives better healing and less pain and support broader use of effective domestic bioceramic materials.
How similar studies have performed: Previous laboratory and some clinical studies of bioceramic sealers such as iRoot SP have shown favorable sealing and healing properties, but direct long‑term randomized head‑to‑head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.