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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- therapeutic effect
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
iRoot SP
iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.
干预措施: iRoot SP (Device)
nRoot SP
nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.
干预措施: nRoot SP (Device)
结局指标
主要结局
therapeutic effect
时间窗: 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.
次要结局
- clinical manifestation(3,6,12,24months)
- Imaging findings(3,6,12,24months)