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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00882-41 | Other Identifier | BRC Identification number |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plastalgin and Plastalgin Fast | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast. | Dentist's opinion through a questionnaire completed by the dentist | Immediately after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of impressions needed per patient | Number of impressions needed per patient to make a quality impression. | Immediately after the procedure. |
| Setting time of Plastalgin and Plastalgin Fast |
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Inclusion Criteria:
Exclusion Criteria:
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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.
Minors are eligible to participate in the study. Other vulnerable patients can be included in the study as there is no additional risk for this population.
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie INDUNI, MD | Cabinet dentaire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire | Montigny-le-Bretonneux | 78180 | France | |||
| Cabinet dentaire |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
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Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast
| During the procedure. |
| Rate of adverse events | Cumulative number of adverse events and serious adverse events | 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 | During and immediately after the procedure. |
| Paris |
| 75011 |
| France |