NCT07388901 In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers
| NCT ID | NCT07388901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine |
| Condition | Chronic Apical Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-05-27 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Tu Yan
PRINCIPAL INVESTIGATOR
School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT07388901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Apical Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07388901 currently recruiting?
Yes, NCT07388901 is actively recruiting participants. Contact the research team at tuyan1984@zju.edu.cn for enrollment information.
Where is the NCT07388901 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07388901 clinical trial?
NCT07388901 is sponsored by The Dental Hospital of Zhejiang University School of Medicine. The principal investigator is Tu Yan at School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine. The trial plans to enroll 160 participants.