1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 主要终点
- Radiographical assessments
研究概览
简要总结
The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the arms.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects were required to:
- •have a mature tooth with closed apices;
- •have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
- •be prepared to appear for follow-up and
- •sign informed consent form.
排除标准
- •Subjects with:
- •moderate or severe marginal periodontitis;
- •internal or external root resorption in periapical radiograph;
- •active systemic disease;
- •physical or mental disability,
- •pregnant or lactating
研究组 & 干预措施
AH Plus sealer
AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
干预措施: Root canal sealer (Procedure)
iRoot SP sealer
iRoot SP sealer was used as root canal sealer in root canal obturation.
干预措施: Root canal sealer (Procedure)
结局指标
主要结局
Radiographical assessments
时间窗: 1 year after root canal therapy
The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
次要结局
- Clinical assessments(1 year after root canal therapy)
- Postoperative Pain Evaluation(1 week after root canal therapy)
研究者
Hui Chen
Professor
The Dental Hospital of Zhejiang University School of Medicine