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

NCT05614635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2023-04-24

No results posted yet for this study

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

Conditions

  • Dental Malocclusion
  • Edentulous Mouth
  • Dental Misalignment

Interventions

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.

Sponsors & Collaborators

  • Septodont

    lead INDUSTRY

Principal Investigators

  • Stephanie INDUNI, MD · Cabinet dentaire

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2023-03-07
Completion
2023-03-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614635 on ClinicalTrials.gov