Assessment of Tooth Retention 10 Years After Root Canal Treatment With Endomethasone N: 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
- 179
- 试验地点
- 5
- 主要终点
- Assessment of tooth functional retention
研究概览
简要总结
The aim of root canal treatment, or endodontic treatment, is to treat pulpal or periapical diseases and thus transform a pathological tooth into a healthy, asymptomatic and functional entity on the dental arch. The diagnosis of pulp pathology is based on the symptomatology described by the patient, on data from the clinical examination and tests performed as well as the radiographic examinations.
Different families of root canal sealers are used in endodontics: cements based on zinc oxide-eugenol (ZOE), resin-based materials, and calcium silicate-based cements. They provide a stable and hermetic sealing. The Septodont laboratory has developed and manufactured endomethasone N, a zinc oxide-eugenol root canal sealer.
The aim of this retro-prospective PMCF study is to collect long term clinical and safety data on root canal obturation after treatment or retreatment by Endomethasone N.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 Endomethasone N, in a context of an endodontic treatment, or retreatment, before 01-Mar-2016
- •Having a documented patient follow-up visit (clinical examination and radiographic examination) at least 5 years after the endodontic treatment or retreatment with Endomethasone N
- •Patient affiliated or beneficiary of a social security system
- •Patient informed about the study and who confirm their non-opposition in participating in the study
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 Endomethasone N
- •Patient who had endodontic treatment with Endomethasone N obturation on a wisdom tooth
- •Patient whose tooth has suspected perforation during endodontic treatment
- •Patient suffering from active non-stabilized periodontitis, untreated during endodontic treatment
- •Patients participating in an interventional clinical trial at the time of root canal treatment
结局指标
主要结局
Assessment of tooth functional retention
时间窗: 10 years
Rate of tooth functional retention after Root Canal Treatment with Endomethasone N
次要结局
- Assessment of the tooth functional retention after Root Canal Treatment with Endomethasone N according to initial treatment or retreatment(5 and 10 years)
- Assessment of the periapical healing(5 and 10 years)
- The Investigator overall satisfaction of the experience with Endomethasone N(5 and 10 years)
- Assessment of tooth functional retention(5 years)
- The technical characteristics of the sealer Endomethasone N(5 and 10 years)
- The ease of use and insertion of Endomethasone N in the canal(5 and 10 years)
- The immediate and long-term post-obturation adverse device effects(Immediately after root canal filling, and at long-term (i.e. 5 and 10 years))