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

Study Overview
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Brief Summary
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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

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

Conditions
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Dental Malocclusion, Edentulous Mouth, Dental Misalignment

Intervention / Treatment
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* Device: Plastalgin and Plastalgin Fast


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria will lead to the exclusion of the patient: Inability to comply with study procedures. Patient opposing the processing of their data.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fabrication of prosthesis, Alginate Dental Impression