Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Healed rate
研究概览
简要总结
The purpose of this study is to compare the endodontic outcomes of Bio-MA and ProRoot MTA in pulpotomy, orthograde MTA apical barrier, root perforation repair, endodontic microsurgery.
详细描述
The patients were recruited at the Endodontic clinic, Faculty of Dentistry, Mahidol University, Thailand. Each treatment was provided following the standard protocol. The calcium silicate based material (Bio-MA or ProRoot MTA) was randomly selected and used in the treatment. The patients were periodically recalled at 6 to 12 months. The outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as ''healed/healing" or ''disease.''
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
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery
排除标准
- •Teeth with un-restorable condition
- •Teeth with crack or fracture
- •Teeth with external or internal root resorption
- •Teeth with chronic periodontitis with marginal bone loss more than 5 mm
结局指标
主要结局
Healed rate
时间窗: At least 1 year recall
No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.
Healing rate
时间窗: At least 1 year recall
No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.
Disease rate
时间窗: At least 1 year recall
Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage.
次要结局
未报告次要终点