Observational Clinical Trial, Prospective and Multicenter, Measuring the Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Septodont
- 入组人数
- 145
- 试验地点
- 12
- 主要终点
- Clinical and radiographic success of treatment
研究概览
简要总结
In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:
- Repair of root or furcation perforations.
- Repair of root resorptions (internal and external).
- Root-end filling in endodontic surgery (retrograde filling).
- Apexification (tooth with open apex).
- Revitalization procedure by means of revascularization.
Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, adult or child with permanent study tooth (immature or mature)
- •Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
- •Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
- •Availability of baseline radiographic image of the study tooth
- •Patient affiliated to national health insurance
- •Patient informed about the study and who confirms his/her consent to participate to the study
排除标准
- •Patient treated with anti-cancer therapy in the 5 years prior to the treatment
- •Uncontrolled systemic disease 1 month prior to the treatment
- •Development of a cancer or a systemic disease just after the treatment
- •Participation to an interventional clinical trial at the time of the treatment
结局指标
主要结局
Clinical and radiographic success of treatment
时间窗: At 10 years post-treatment
The proportion of patients with successfull treatment at 10 years post-surgery will be determined on clinical and radiographic success evidences for each endodontic indication of Biodentine™: * In root end-filling * In root resorption repair (internal, external) * In root and furcation perforation repair * In apexification * In revitalization procedure by means of revascularization
次要结局
- Number of Adverse Events (AE) and device deficiencies(From treatment onset to 10 years post-treatment)