Dental MalocclusionNCT05614635
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
An observational study of Dental Malocclusion and Edentulous Mouth, run by Septodont at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- What is being tested?
- Plastalgin and Plastalgin Fast
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Oct 2022to 7 Mar 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cabinet dentaire
Montigny-le-Bretonneux, 78180
Cabinet dentaire
Paris, 75011
About this study
Official title: 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
- Conditions
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- Being tested
- Plastalgin and Plastalgin Fast
- Keywords
- Fabrication of prosthesis, Alginate Dental Impression
- Medical subject headings
- Malocclusion, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastalgin and Plastalgin FastDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.
Dentist's opinion through a questionnaire completed by the dentist
Measured: Immediately after the procedure.
Secondary outcomes (4)
Number of impressions needed per patient
Number of impressions needed per patient to make a quality impression.
Measured: 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
Measured: During the procedure.
Rate of adverse events
Cumulative number of adverse events and serious adverse events
Measured: 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
Measured: During and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start12 Oct 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie INDUNI, MD, Study director, Cabinet dentaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614635
- Sponsor's protocol ID
- PLAS 2022-02
- Other IDs
- 2022-A00882-41
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression
- ClinicalTrials.gov ID
- NCT05614635
- Acronym / sponsor ID
- PLAS 2022-02
- Conditions
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- Keywords
- Fabrication of prosthesis, Alginate Dental Impression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plastalgin and Plastalgin FastPlastalgin 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. | Device | – |
Primary outcome
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
4 secondary outcomes
Number of impressions needed per patient
Time frame: Immediately after the procedure.
Setting time of Plastalgin and Plastalgin Fast
Time frame: During the procedure.
Rate of adverse events
Time frame: During and immediately after the procedure.
Rate of device-related adverse event
Time frame: During and immediately after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie INDUNI, MD study director
Cabinet dentaire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Malocclusion and Edentulous Mouth, run by Septodont at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast. (time frame: Immediately after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.