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

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

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion; Edentulous Mouth; Dental Misalignment
• Intervention / Treatment: Device: Plastalgin and Plastalgin Fast

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Montigny-le-Bretonneux, France, 78180
    • Cabinet dentaire
  • Paris, France, 75011
    • Cabinet dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Minors are eligible to participate in the study. Other vulnerable patients can be included in the study as there is no additional risk for this population.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Septodont
• Investigators: Study Director: Stephanie INDUNI, MD, Cabinet dentaire

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 5, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fabrication of prosthesis; Alginate Dental Impression
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Malocclusion; Mouth, Edentulous
• Other Study ID Numbers: PLAS 2022-02; 2022-A00882-41 (Other Identifier: BRC Identification number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No