Clinical trial NCT05614635: Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
Official title: Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Malocclusion
Edentulous Mouth
Dental Misalignment
Keywords: Fabrication of prosthesis
Alginate Dental Impression
Lead sponsor: Septodont
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 59
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.
timeFrame: Immediately after the procedure.
Secondary outcomes:
measure: Number of impressions needed per patient
timeFrame: Immediately after the procedure.
measure: Setting time of Plastalgin and Plastalgin Fast
timeFrame: During the procedure.
measure: Rate of adverse events
timeFrame: During and immediately after the procedure.
measure: Rate of device-related adverse event
timeFrame: During and immediately after the procedure.
Other outcomes:
Locations:
city: Montigny-le-Bretonneux
country: France
facility: Cabinet dentaire
city: Paris
country: France
facility: Cabinet dentaire
Study officials:
affiliation: Cabinet dentaire
name: Stephanie INDUNI, MD
role: STUDY_DIRECTOR
References: