Trials Sponsors Conditions Drugs Pricing

Conditions

Dental Malocclusion Dental Misalignment Edentulous Mouth

Keywords

Fabrication of prosthesisAlginate 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 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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age5 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

Septodont
Industrylead

Study Sites (2)

Cabinet dentaire

Montigny-le-Bretonneux, 78180, France

Cabinet dentaire

Paris, 75011, France

MeSH Terms

Conditions

MalocclusionMouth, Edentulous

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMouth Diseases

Study Officials

Stephanie INDUNI, MD
Cabinet dentaire
STUDY DIRECTOR

Enrollment

59 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations