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OpenTrials
Completed

NCT Number: NCT05614635

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

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Key information

Conditions

Dental Malocclusion Dental Misalignment Edentulous Mouth Malocclusion Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet dentaire, Montigny-le-Bretonneux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.

    Time frame: Immediately after the procedure.

    Dentist's opinion through a questionnaire completed by the dentist

Secondary outcomes

  1. Number of impressions needed per patient

    Time frame: Immediately after the procedure.

    Number of impressions needed per patient to make a quality impression.

  2. Setting time of Plastalgin and Plastalgin Fast

    Time frame: During the procedure.

    Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast

  3. Rate of adverse events

    Time frame: During and immediately after the procedure.

    Cumulative number of adverse events and serious adverse events

  4. Rate of device-related adverse event

    Time frame: During and immediately after the procedure.

    Cumulative number of adverse events and serious adverse events related to Plastalgin or Plastalgin Fast

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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