Revitalization of Immature Permanent Teeth With or Without Apical Periodontitis Post Trauma: a European Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- radiographic root area (RRA)
研究概览
简要总结
This study aims to assess the hypothesis that revitalization of teeth without (a)symptomatic apical periodontitis have a more favourable outcome in terms of further root development, periapical bone healing, maintaining/regaining pulp sensitivity and survival, than teeth with (a)symptomatic apical periodontitis.
详细描述
- Trial objectives
This study aims to investigate the effectiveness of revitalization procedures, in terms of maintaining or restoring periapical health, further root development and regaining of pulp sensitivity, in immature permanent teeth with (group 1) or without (group 2) (a)symptomatic apical periodontitis . 2. Primary endpoints RRA at 1 year post revitalization. 3 Secondary endpoints Maintained or restored periapical health (evaluated within each group separately due to expected baseline inequivalency between groups) 1 year post revitalization.
4 Other endpoints
- RRA 2 and 3 years post revitalization
- Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately)
- Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups)
- Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms).
5 Trial Design Open, prospective cohort, multicenter Blinded: radiographic assessment and statistical analysis; operators and patients cannot be blinded, due to practically not feasible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Provision of Informed Consent
- •Female and male patients
- •Age range: 6-18 years
- •"Healthy": ASA I and II
- •Permanent immature tooth (Cvek stage of root maturation ≤ 2) requiring revitalization
- •Etiological factor: (a)symptomatic apical periodontitis post dental trauma or irreversible pulpitis post dental trauma
排除标准
- •Unlikely to be able to comply with the study procedures, as judged by the investigator
- •Patients older than 18 years and younger than 6
- •Deciduous teeth
- •Cvek root maturation stage > 2: permanent immature tooth that can be treated by conventional root canal treatment or apexification
- •Known or suspected current malignancy
- •History of chemotherapy within 5 years prior to study
- •History of radiation in the head and neck region
- •History of other metabolic bone diseases
- •Bleeding disorders
- •Involvement in the planning and conduct of the study
结局指标
主要结局
radiographic root area (RRA)
时间窗: 1 year
RRA post revitalization
次要结局
- periapical health(1 year)