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

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

NCT05614635•Septodont

View on ClinicalTrials.gov

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

Eligibility

Age

5 - No limit years

Sex

ALL

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

•Inability to comply with study procedures.
•Patient opposing the processing of their data.

Locations (2)

Cabinet dentaire

Montigny-le-Bretonneux, France

Cabinet dentaire

Paris, France

Key Dates

Start Date

October 12, 2022

Primary Completion Date

March 7, 2023

Completion Date

March 7, 2023

Last Updated

April 24, 2023

Enrollment

ACTUAL participants

Conditions

Dental MalocclusionEdentulous MouthDental Misalignment

Interventions

Plastalgin and Plastalgin Fast

DEVICE

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

NCT06315348

Dental MalocclusionMaxillary Deficiency

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ACTIVE_NOT_RECRUITINGNA

Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants

NCT05768295

Surgical OperationEdentulous Jaw+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants

Accuracy of Photogrammetric Three-Dimensional Facial Models Reconstruction Compared With Direct Anthropometry

Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics

Zirconia Bars for Mandibular Implant Overdentures

3D Printing for the Fabrication of Mandibular Implant Overdentures