Study the Feasibility of Preparing an Autologous Advanced Therapy Medicinal Product for the Dental Pulp Regeneration in the Patient With Irreversible Pulp Inflammation or Dental Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion
研究概览
简要总结
Current endodontic treatment are based essentially on the ouster of parenchyma in case of trauma or irreversible pulp inflammation. These situations typically affect immature teeth in subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to discontinuation of root development and apical closure. The challenge for the clinician in the management of such situations is then preserving a pulp vitality. But current practices consist in a filling of the endo-canal system with an inert or semi-inert material. In this case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is the study the feasibility of preparing an autologous combined advanced therapy medicinal product (ATMP) for dental pulp regeneration in the patient with irreversible pulp inflammation or dental trauma.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 8 to 15 years, with at least one tooth affected by a carious process,
- •Patients aged from 8 to 15 years with major trauma preventing the maintenance of the tooth in the arch
- •Patients aged from 16 to 20 years requiring avulsion germs wisdom teeth,
- •Ability to carry out the extraction of pulp chamber content
- •Signature of informed consent (from the patient and his guardian)
- •Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study,
- •Patient with French social insurance.
排除标准
- •Lack of ability to collect the dental pulp,
- •Presence of necrosis in pulp complex or the possibility of preserving the pulp through appropriate techniques,
- •Legal incapacity or limited legal capacity
- •Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator,
- •Patient without health insurance,
- •The patient is in the period of exclusion of another study,
- •Patients with congenital pathology of dental pulp (amelogenesis and dentinogenesis imperfect)
- •Patient with intrapulpal calcification or violations of pulp obliteration
- •Teeth having external or internal inflammatory resorption
- •Teeth diagnosed with pulp necrosis process
- •Teeth undergoing fragmentation for their avulsion
- •Time of pulp air exposition > 2 hours (risk of bacterial contamination)
结局指标
主要结局
Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion
时间窗: 1 day
次要结局
未报告次要终点