NCT05614635

Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression

Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dental Malocclusion
• Edentulous Mouth
• Dental Misalignment

Interventions

Type	Name	Description
DEVICE	Plastalgin and Plastalgin Fast	Plastalgin and Plastalgin Fast are potassium alginate-based powders designed for dental impression. The powder is mixed with water to obtain an impression material paste, used to imprint the teeth and mouth of the patient. The product is available under two presentations: Plastalgin and Plastalgin Fast. Plastalgin Fast has a shorter mixing time.

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2022-11-14
• Last updated: 2023-04-24

Locations

2 sites across 1 country: France