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

NCT05614635 | Completed

• 2 other identifiers: PLAS 2022-022022-A00882-41
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 2

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

Conditions

Dental Malocclusion; Edentulous Mouth; Dental Misalignment

Keywords

Fabrication of prosthesis; Alginate Dental Impression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of impressions needed per patient

  Immediately after the procedure.

• Setting time of Plastalgin and Plastalgin Fast

  During the procedure.

• Rate of adverse events

  During and immediately after the procedure.

• Rate of device-related adverse event

  During and immediately after the procedure.

Interventions

Plastalgin and Plastalgin Fast DEVICE

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.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Septodont: lead

Study Sites (2)

Cabinet dentaire

Montigny-le-Bretonneux, 78180, France

Location

Cabinet dentaire

Paris, 75011, France

Location

MeSH Terms

Conditions

Malocclusion; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Study Officials

• Stephanie INDUNI, MD

  Cabinet dentaire

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 14, 2022
• Study Start: October 12, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (2)