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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.
This study aims to conduct a randomized controlled clinical trial to evaluate the 3-24months efficacy (including radiographic reduction of periapical radiolucency, postoperative pain, etc.) of the two materials in patients with chronic apical periodontitis. The objective is to provide evidence-based support for the optimization and clinical selection of domestically produced materials, thereby promoting the precise application of bioceramic sealers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iRoot SP | Active Comparator | iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment. |
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| nRoot SP | Experimental | nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iRoot SP | Device | use iRoot SP in root canal treatment |
| |
| nRoot SP |
| Measure | Description | Time Frame |
|---|---|---|
| therapeutic effect | 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. | 3,6,12,24months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical manifestation | Four distinct clinical assessments to be evaluated at 3, 6, 12, and 24 months postoperatively: tooth mobility, assessed clinically using a standard grading scale (Miller index. Grade I: Mobility with a buccolingual displacement of ≤1 mm; Grade II: Mobility with a buccolingual displacement of 1-2 mm, possibly accompanied by slight mesiodistal mobility; Grade III: Mobility with a buccolingual or mesiodistal displacement exceeding 2 mm, or the presence of vertical mobility.) ; periodontal probing depth, measured at designated sites(mesiobuccal, midbuccal, distobuccal mesiolingual, midlingual, distolingual).) around the tooth with a periodontal probe and recorded in millimeters; percussion pain, evaluated by vertical and horizontal tapping and documented either as a binary presence/absence; the presence of a sinus tract, determined through visual inspection and verification with a gutta-percha point if necessary and recorded as a binary outcome. Each parameter will be analyzed independent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tu Yan | Contact | +8615858224066 | tuyan1984@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tu Yan | School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2025 | Jan 28, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2025 | Jan 28, 2026 | ICF_001.pdf |
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| Device |
use nRoot SP in root canal treatment |
|
| 3,6,12,24months |
| Imaging findings | Change in the size of the periapical radiolucent area. Specifically, after acquiring the image, the DICOM format image will be imported into 3D slicer, the maximum diameter of the apical low-density shadow will be measured using the ruler function, the range of the apical low-density shadow will be divided using the segment editor module, and the volume of the periapical shadow will be calculated using the segment statistics module | 3,6,12,24months |