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

Juvora Ltd.

Status: Terminated

Conditions: Missing Teeth

Treatments: Device: Treatment with the JUVORA™ Dental Disc

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03655990

JUV17-08

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18 years or older in need of a full-arch implant supported rehabilitation in a single jaw (mandibular or maxillary) or both edentulous jaws (mandibular and maxillary).
• Subjects with adequate bone quality and quantity to allow the placement of a minimum of four Neodent implants into the arch area.
• Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion criteria

Female subjects who are pregnant or lactating.

• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects with insufficient bone volume or quality in the edentulous jaw.
• Subjects on any chemotherapeutic or bisphosphonate medications.
• Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than 2 years.
• Subjects who smoke more than 10 cigarettes per day.
• Subjects who are currently enrolled in another clinical study.

Trial design

10 participants in 1 patient group

Treatment with the JUVORA™ Dental Disc

Description:

Subjects receive the device as per normal standard practice, there are no other treatment arms for this prospective study.

Treatment:

Device: Treatment with the JUVORA™ Dental Disc