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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-03-07

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

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Detailed Description

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Conditions

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Dental Malocclusion Edentulous Mouth Dental Misalignment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.