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

Completed

• Conditions: Dental Malocclusion; Edentulous Mouth; Dental Misalignment

• Registration Number: NCT05614635
• Lead Sponsor: Septodont

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-11-05
• Study First Posted: 2022-11-14
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.	Immediately after the procedure.	Dentist's opinion through a questionnaire completed by the dentist

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events	During and immediately after the procedure.	Cumulative number of adverse events and serious adverse events
Setting time of Plastalgin and Plastalgin Fast	During the procedure.	Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast
Rate of device-related adverse event	During and immediately after the procedure.	Cumulative number of adverse events and serious adverse events related to Plastalgin or Plastalgin Fast
Number of impressions needed per patient	Immediately after the procedure.	Number of impressions needed per patient to make a quality impression.

Trial Locations

Locations (1)

Cabinet dentaire; 🇫🇷 Paris, France