Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study
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
- 142
- 试验地点
- 12
- 主要终点
- Clinical and radiological performance impact of the endodontic treatment at 5 years.
研究概览
简要总结
The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.
Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, > 18 years of age at the time of inclusion in the study.
- •Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
- •All roots of the investigational teeth were treated with BioRootTM RCS.
- •Having a documented retro-alveolar radiography immediately after root canal obturation.
- •Patient affiliated or beneficiary of a social security system.
- •Patient has signed his/her informed consent form.
排除标准
- •History of malignant tumors in the 5 years prior to the root canal treatment.
- •Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
- •Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
- •The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
- •Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).
结局指标
主要结局
Clinical and radiological performance impact of the endodontic treatment at 5 years.
时间窗: At 5 years post treatment
The "success" and "failure" of the 5-year clinical and radiological performance impact of the endodontic treatment.
次要结局
- The post-obturation adverse device effects.(At baseline visit, 5 and 10 years post treatment)
- Clinical and radiological performance impact of the endodontic treatment at 10 years.(At 10 years post treatment)
- Evaluation of the need of treatment or retreatment at 5 and 10 years.(At 5 and 10 Years post treatment)
- Assessment of the "tooth functional retention" at 5 and 10 years.(At 5 and 10 Years post treatment)
- The technical characteristics of the sealer BioRootTM RCS at 5 and 10 years after Root Canal Treatment.(At 5 and 10 Years post treatment)
- The ease of use and insertion of BioRootTM RCS in the canal.(At 5 years post treatment)
- The Investigator overall satisfaction of the experience with BioRootTM RCS.(At 5 and 10 Years post treatment)