A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Absence of infection and inflammation.
研究概览
简要总结
Both methods tested in this study disinfect the non-vital root canals and induce blood clot formation inside the root canal. One method places calcium hydroxide inside the root canal after disinfection and the blood clot is induced four weeks later.
The other method performs disinfection and induction of blood clot in one appointment. The investigators hypothesize that both methods will obtain the same success rate in eliminating infection, increase in root length and canal walls thickness.
详细描述
Collagen is placed on top of the blood clot, followed by white MTA. Glass ionomer is used to seal the access to the canal, which will be replaced by a permanent restoration 3 months later.
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
- None
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy or having a mild systemic disease (ASA Physical Status 1 or 2), with no contraindications to the treatment.
- •Cooperative.
- •Clinical diagnosis of pulp necrosis based on cold test, electric pulp test as well as an identified cause of pulp necrosis such as caries, deep restorations, dental anomalies, history of trauma, associated with radiographic and/or clinic signs of periapical lesion.
- •Open apex with a diameter of at least 1mm. For teeth with more than one apical foramen, at least one foramen needs to be 1mm wide.
- •Tooth is restorable and periodontally stable.
排除标准
- •Pregnancy.
- •Evidence of pathological external or internal root resorption, root fracture or ankylosis.
结局指标
主要结局
Absence of infection and inflammation.
时间窗: 12 and 24 months after the induction of blood clot
clinic evaluation to determine the status of periodontal tissues
次要结局
- Changes in root length and canal wall width(Baseline and 24 months after the induction of blood clot)
研究者
Tatiana Botero
Clinical Associate Professor
University of Michigan