Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
研究概览
简要总结
Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.
详细描述
36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of apexification treatment of an anterior immature tooth
- •Patients aged 6 to 18
- •Enlightened agreement of the patient and his/her legal representatives
- •Prerequisite medical examination
排除标准
- •General disease
- •immunosuppression of whatever origin (AIDS, drugs, …)
- •severe asthma
- •chronical disease requiring treatment
- •eating disorders (anorexia, bulimia, malnutrition, …) Oral disease
- •periodontal disease
- •Administration of corticoids in a period of 3 months preceding the inclusion
- •Patient with no social security cover
研究组 & 干预措施
Calcium hydroxide
干预措施: Calcium hydroxide (Drug)
MTA
干预措施: Mineral Trioxide Aggregate (Drug)
结局指标
主要结局
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months
时间窗: 30 days
次要结局
- Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months(12 months)