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

Edentulous Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614635
• Other study ID #: PLAS 2022-02
• Secondary ID: 2022-A00882-41
• Status: Completed
• Start date: October 12, 2022
• Est. completion date: March 7, 2023

Study information

• Verified date: April 2023
• Source: Septodont
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Malocclusion
• Edentulous Mouth
• Malocclusion
• Mouth, Edentulous

Intervention

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.

Locations

Country	Name	City	State
France	Cabinet dentaire	Montigny-le-Bretonneux
France	Cabinet dentaire	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Septodont

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of impressions needed per patient	Number of impressions needed per patient to make a quality impression.	Immediately after the procedure.
Secondary	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.
Secondary	Rate of adverse events	Cumulative number of adverse events and serious adverse events	During and immediately after the procedure.
Secondary	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.