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

Septodont

Status: Completed

Conditions: Dental Misalignment; Dental Malocclusion; Edentulous Mouth

Treatments: Device: Plastalgin and Plastalgin Fast

Study type: Observational

Funder types: Industry

Identifiers

NCT05614635

2022-A00882-41 (Other Identifier)

PLAS 2022-02

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.