Clinical Evaluation of a New Printable Denture Base Material: A Prospective Single-arm Study

Ivoclar Vivadent AG1 site in 1 country22 target enrollmentJuly 2024

ConditionsEdentulous Mouth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Edentulous Mouth
Sponsor: Ivoclar Vivadent AG
Enrollment: 22
Locations: 1
Primary Endpoint: rate of failures leading to replacement of denture
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.

Registry

clinicaltrials.gov

Start Date

July 2024

End Date

December 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ivoclar Vivadent AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18 to 84 years
•informed consent signed and understood by the subject
•full edentulous patients
•a digital design of the dentures is already existing.
•ability to visit the clinic in person until the baseline recall

Exclusion Criteria

•patient does not wear the dentures regularly
•mental health status does not allow reliable feedback
•patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
•patients with severe systemic diseases
•poor oral / denture hygiene
•pregnancy