Dental Malocclusion, Dental Misalignment, Edentulous Mouth
Conditions
Keywords
Fabrication of prosthesis, Alginate Dental Impression
Brief 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
Interventions
DEVICEPlastalgin 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.
Sponsors
Septodont
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* The presence of any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast. | Immediately after the procedure. | Dentist's opinion through a questionnaire completed by the dentist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of impressions needed per patient | Immediately after the procedure. | Number of impressions needed per patient to make a quality impression. |
| Setting time of Plastalgin and Plastalgin Fast | During the procedure. | Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast |
| Rate of adverse events | During and immediately after the procedure. | Cumulative number of adverse events and serious adverse events |
| Rate of device-related adverse event | During and immediately after the procedure. | Cumulative number of adverse events and serious adverse events related to Plastalgin or Plastalgin Fast |
Countries
France
Outcome results
None listed