NCT03655990

A Full-Arch Implant- Supported Prosthesis in the Upper and/or Lower Jaw-USA

A Prospective, Single-Centre, Post-Market Study to Evaluate the Use of Polyetheretherketone (PEEK) Full-Arch Implant-Supported Prostheses in the Edentulous Jaw

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Juvora Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study follows subjects who have agreed with their dentist that their failing teeth or missing teeth all need replacing. This study follows their standard routine care with some additional assessments. The dental treatment option that replaces a whole arch or both arches (upper and lower jaws) of the mouth is call "Teeth in a Day" and information on the use of the JUVORA™ Dental Disc during this treatment is what is being collected as part of this study along with subjects follow-up care.

Detailed description

Over the last decade full-arch metal implant-supported prosthetics have been used as a replacement for missing teeth in edentulous (toothless) patients. The standard has been a titanium metal base. Due to its potential shock-absorbing properties and patients' demands for metal-free restorations, there is rising enthusiasm surrounding the use of High Performance Polymers (HPPs) such as the polyaryletherketone (PAEKs) as metal alternatives for such cases. The JUVORA™ Dental Disc is made from PEEK-OPTIMA™ polymer (Invibio Biomaterial Solutions) which allows efficient fabrication of reliable non-metal dentures by using CAD/CAM technology to manufacture precise, custom-fit prostheses. The JUVORA™ Dental Disc is indicated for the manufacture of: full-arch implant-supported dentures and implant bars; full and partial removable dentures and overdentures; crowns and 3-unit bridges. This study aims to evaluate the short- and long-term clinical performance and patient satisfaction of the JUVORA™ full-arch implant-supported prostheses. Two subjects will be included in a run-in phase and 10 subjects will be included in the main study. The subjects will be followed-up at 6 weeks, 6 months, 12 months and for as long as willing yearly after the implant of the definitive prosthesis (artificial teeth).

Conditions

• Missing Teeth

Interventions

Type	Name	Description
DEVICE	Treatment with the JUVORA™ Dental Disc	treatment with the JUVORA™ Dental Disc

Timeline

• Start date: 2018-08-07
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2018-09-04
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States