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
Study Type
OBSERVATIONAL
Enrollment
59
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.
Cabinet dentaire
Montigny-le-Bretonneux, France
Cabinet dentaire
Paris, France
Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.
Dentist's opinion through a questionnaire completed by the dentist
Time frame: Immediately after the procedure.
Number of impressions needed per patient
Number of impressions needed per patient to make a quality impression.
Time frame: Immediately after the procedure.
Setting time of Plastalgin and Plastalgin Fast
Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast
Time frame: During the procedure.
Rate of adverse events
Cumulative number of adverse events and serious adverse events
Time frame: During and immediately after the procedure.
Rate of device-related adverse event
Cumulative number of adverse events and serious adverse events related to Plastalgin or Plastalgin Fast
Time frame: During and immediately after the procedure.
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