NCT05614635已完成不适用
Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Septodont
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.
研究概览
简要总结
The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation. The target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults.
Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of participating patients during and after the study
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient fulfilling all the following criteria is eligible for the clinical investigation:
- •Male or female patient ≥ 5 years of age.
- •Indication of dental impressions for the fabrication of prosthesis such as mouth guards and trays, total or partial dentures, and fixed prosthesis (crowns, bridges, dental veneers).
- •Total or partially edentulous patient or patient with disocclusion or patient with misalignment.
- •Patient affiliated or beneficiary of a social security system.
- •Written informed consent must be obtained before any study-related assessment is performed.
排除标准
- •The presence of any of the following exclusion criteria will lead to the exclusion of the patient:
- •Inability to comply with study procedures.
- •Patient opposing the processing of their data.
结局指标
主要结局
Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.
时间窗: Immediately after the procedure.
Dentist's opinion through a questionnaire completed by the dentist
次要结局
- Rate of adverse events(During and immediately after the procedure.)
- Setting time of Plastalgin and Plastalgin Fast(During the procedure.)
- Rate of device-related adverse event(During and immediately after the procedure.)
- Number of impressions needed per patient(Immediately after the procedure.)
研究者
研究点 (1)
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