Clinical Trials in China / NCT07388901
Recruiting
Not applicable
In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers
NCT07388901 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Apical Periodontitis
Investigational drug(s) / intervention(s)
iRoot SPnRoot SP
iRoot SP: use iRoot SP in root canal treatment
nRoot SP: use nRoot SP in root canal treatment
Study 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
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.
Primary outcome measure(s)
- therapeutic effect — 3,6,12,24months
Markedly Effective: Post-treatment X-ray examination shows complete resolution of the periapical radiolucency. The patient's chewing function is largely restored, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort have disappeared. Effective: Post-treatment X-ray examination shows significant reduction in the size of the radiolucency. The patient may experience mild percussion pain or discomfort. Chewing function is largely normal, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show improvement. Ineffective: Post-treatment X-ray examination shows no reduction or even enlargement of the radiolucency. The patient reports significant percussion pain. Symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show no improvement.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
More The Dental Hospital of Zhejiang University School of Medicine trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07388901 on ClinicalTrials.gov ↗ ← All trials in China