Clinical trial NCT03655990: A Full-Arch Implant- Supported Prosthesis in the Upper and/or Lower Jaw-USA
Official title: A Prospective, Single-Centre, Post-Market Study to Evaluate the Use of Polyetheretherketone (PEEK) Full-Arch Implant-Supported Prostheses in the Edentulous Jaw
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Missing Teeth
Keywords: Dentures Implant
Lead sponsor: Juvora Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PCG Clinical Services
First posted: 2018-09-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated to receive a full-arch implant-supported prosthesis in a single jaw (mandibular or maxillary) or full-arch implant-supported prosthesis in both jaws (mandibular and maxillary).

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Survival of the Prosthetic
timeFrame: 12 months
Secondary outcomes:
measure: Patient quality of life assessment using a patient questionnaire.
timeFrame: 6 weeks 6 & 12 months
measure: Oral and dental:Patients will be assessed for a history of Bruxism (grinding of the teeth).
timeFrame: 6 weeks 6 &12 months
measure: Oral and dental: Patients will be checked for occlusion.
timeFrame: 6 weeks &12 months
measure: Survival of the implant in the patients mouth.
timeFrame: 12 months
measure: Success of the implant in the patients mouth.
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to marginal bone resorption.
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to the presence of Peri-implantitis.
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to modified plaque index (mPI).
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to Modified Bleeding Index (mBI).
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to the probing depth.
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to Soft Tissue Reactions.
timeFrame: 12 months
measure: Success of the implant in the patients mouth according to Mechanical Complications.
timeFrame: 12 months
measure: Success of the prosthesis assessed according to specific criteria and in accordance with the ITI Treatment Guide Volume 8.
timeFrame: 12 months
measure: Device Deficiencies reported for the JUVORA™ Dental Disc/prosthesis only: Inadequacy of medical device with respect to identity, quality, durability, reliability, safety and performance and includes malfunctions, user errors and inadequate labelling.
timeFrame: 6 weeks 6 & 12 months
measure: Patient adverse events related to the dental surgery and treatment only will be collected.
timeFrame: 6 weeks 6 & 12 months
measure: If the patient has to have any additional dental procedures and or treatments will be collected.
timeFrame: 6 weeks 6 & 12 months
Other outcomes:
measure: Technical Satisfaction not related to the patient
timeFrame: between 4 - 6 months prior to fixture in the patients mouth.
Locations:
city: San Antonio
country: United States
facility: Dr Robert Lemke
state: Texas
Study officials:
affiliation: Juvora Ltd.
name: Juvora
role: STUDY_DIRECTOR
References: