In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers

The Dental Hospital of Zhejiang University School of Medicine160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Chronic Apical Periodontitis

Interventions

iRoot SPDEVICE

use iRoot SP in root canal treatment

nRoot SPDEVICE

use nRoot SP in root canal treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3,6,12,24months

Secondary Outcomes

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

Time frame: 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

Central Contacts

Tu Yan

CONTACT

+8615858224066 tuyan1984@zju.edu.cn

Data from ClinicalTrials.gov

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