NCT02064517终止2 期
Randomized Comparative Test Multicentric, Forward-looking Single-blind, Between a Reference Technique and an Innovative Technic.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Followed in 24 months
研究概览
简要总结
Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium) allows to obtain a better forecast of preservation of the tooth without complication than the conventional technique with the creation of an apicale barrier in the MTA in 24 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting one or monoradicular immature definitive several teeth ( open apex) with a pulpar necrosis,
- •6-year-old patients in 17 years the parents(relatives) of which agree to give a lit(enlightened) written consent or patients of more than 18 years old.
排除标准
- •general order: any pathology or treatment(processing) dissuading a treatment(processing) endodontic (patients at risk of infectious endocarditis) or pulling(entailing) an immunosuppression (diabetes, HIV, immunosuppresseurs treatments(processings) post-transplant, long-term corticoids, chemotherapies), allergy known about the used, antecedent products of cervico-facial radiotherapy, presenting subject of the communications problems, the pregnancy and the feeding.
- •local order: generalized periodontal disease or superior located(localized) periodontal pocket in 3mm, crack or fracture(split) radiculaire, radiculaire reduction of the necrosed immature tooth
研究组 & 干预措施
Conventional technique
Placebo Comparator
Apical MTA barrier
干预措施: MTA (Device)
Revascularisation pulpaire
Experimental
hydroxide of calcium
干预措施: Hydroxide of calcium (Device)
结局指标
主要结局
Followed in 24 months
时间窗: 24 months
Clinical and radiological follow-up in 24 months
次要结局
- Obtaining of a closure apicale and of an increase of length and thickness of radiculaires walls(3-6 months)
- Clinical and radiographic success(3-6 months)
- Appearance of complications (dyschromie dental)(3-6 months)
- Return of the pulpaire sensibility(3-6 months)
研究者
研究点 (6)
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