RecruitingNot ApplicableNCT07388901
In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers
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
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
Enrollment
160 participants
Start Date
May 27, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria9
- 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 Criteria8
- 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.
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Interventions
DEVICEiRoot SP
use iRoot SP in root canal treatment
DEVICEnRoot SP
use nRoot SP in root canal treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07388901