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

Juvora Ltd.10 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Missing Teeth

Interventions

Treatment with the JUVORA™ Dental DiscDEVICE

treatment with the JUVORA™ Dental Disc

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr Robert Lemke

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Survival of the Prosthetic

Survival will be evaluated using the ITI Treatment Guide Volume 8 - Survival is defined as "is the prosthesis present in the mouth at the time of assessment ("presence or absence")

Time frame: 12 months

Secondary Outcomes

Patient quality of life assessment using a patient questionnaire.

Overall health-related QOL questionnaires - (Oral Health Impact Profile) OHIP - 14 measures peoples perceptions of the social impact of Oral Disorders on their well-being. Fourteen questions with 5 possible answers: Never, Hardly Ever,Occasionally, Fairly Often, Very Often. Questions are related to whether subjects have had problems with their teeth, mouth or dentures.

Time frame: 6 weeks 6 & 12 months

Oral and dental:Patients will be assessed for a history of Bruxism (grinding of the teeth).

If patients have suffered with Bruxism they will be asked if they have been wearing their night guard during their dental treatment.

Time frame: 6 weeks 6 &12 months

Oral and dental: Patients will be checked for occlusion.

This is a way of checking when the teeth are clenched how many generalized number of contacts there are between the two arches (i.e., how many teeth are in contact between the upper and lower jaw arches) * Amount of cantilever from the most distal implant for the left side will be recorded in (mm) * Amount of cantilever from the most distal implant for the right side will be recorded in (mm)

Time frame: 6 weeks &12 months

Survival of the implant in the patients mouth.

Survival will be evaluated in accordance with the ITI Treatment Guide Volume 8. Survival is defined as 'is the implant present in the mouth at the time of the assessment' (presence or absence).

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Success of the implant in the patients mouth.

Success will be evaluated in accordance with the ITI Treatment Guide Volume 8. Implants will be deemed to be successful if they are present:without implant fracture, without radiolucency changes from pre-treatment condition, without mobility, without pain, infection (suppuration, abscess and/or fistula), or paresthesia and without bone loss \> 2mm.

Time frame: 12 months

Success of the implant in the patients mouth according to marginal bone resorption.

Success will be evaluated according to the marginal bone resorption (bone loss). Evaluated using a conventional digital panorex xray and measured. The measurements will be performed on the mesial and distal aspects of the implant platform and the lowest value will be recorded.

Time frame: 12 months

Success of the implant in the patients mouth according to the presence of Peri-implantitis.

Success will be evaluated according to the presence of Peri-implantitis (presence of inflamed mucosa with positive bleeding on probing and or suppuration ≥5mm and cumulative bone loss of ≥ 2mm and/or ≥3 threads of implant)

Time frame: 12 months

Success of the implant in the patients mouth according to modified plaque index (mPI).

Success will be evaluated according to the Modified Plaque Index (mPI) will be evaluated by inserting a periodontal plastic probe 1 mm into the peri-implant sulcus running a circular movement all around the implant and measured in a scale between 0 to 3: 0 = no detection of plaque 1. = plaque only recognized by running a probe across the smooth marginal surface of the implant 2. = plaque can be seen by the naked eye 3. = abundance of soft matter

Time frame: 12 months

Success of the implant in the patients mouth according to Modified Bleeding Index (mBI).

Success will be evaluated according to the Modified Bleeding Index (mBI) evaluated by inserting a periodontal plastic probe 1 mm into the peri-implant sulcus running a circular movement all around the implant and measured in a scale between 0 to 3: 0 = no bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant 1. = isolated bleeding spots visible 2. = blood forms a confluent red line on mucosal margin 3. = heavy or profuse bleeding

Time frame: 12 months

Success of the implant in the patients mouth according to the probing depth.

Success will be evaluated according to the Probing Depth. The depth of the peri-implant sulcus will be determined by measuring the distance from the mucosal margin to the base of the sulcus using a calibrated periodontal probe using minimal force (\< 0.3M).

Time frame: 12 months

Success of the implant in the patients mouth according to Soft Tissue Reactions.

Success will be evaluated according to Soft Tissue Reactions. The presence or absence of oral mucosal disorders not related to peri-implant infection (e.g., reporting of allergic reactions, lichen planus) will be recorded.

Time frame: 12 months

Success of the implant in the patients mouth according to Mechanical Complications.

Complications related to the implant include implant fracture, abutment/screw fracture and loosening will be reported.

Time frame: 12 months

Success of the prosthesis assessed according to specific criteria and in accordance with the ITI Treatment Guide Volume 8.

Success will be evaluated in accordance with the ITI Treatment Guide Volume 8. JUVORA™ prosthesis will be deemed to be successful if they are present: * without complications (fracture of the veneering material, framework fracture and loss of retention of the prosthesis) * with adequate 'in-mouth comfort': using a grading system between 0 (poor) and 10 (excellent). * with adequate function (chewing): Function is defined as the chewing ability of the patient to chew different food types (meat, fruit, vegetables, salad) using a grading system between 0 (poor) and 10 (excellent). * with adequate aesthetics: Aesthetic examination including surface luster and staining, colour stability, translucency, and anatomic form. Also Attachment Performance: Attachment performance will involve examination and recording of any issues related to attachment performance (presence or absence).

Time frame: 12 months

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.

Device Deficiency data collected: 1. Date deficiency occurred, if it could have led to a medical occurrence: if either a suitable action had not been taken or if intervention had not been made or if circumstances had been less fortunate 2. If could have led to a Serious Adverse Device Effect (SADE)? Which is a serious adverse event according to one of the criteria below and device related: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity (including a medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function or permanent impairment to a body structure or a body function) Is a congenital anomaly/birth defect

Time frame: 6 weeks 6 & 12 months

Patient adverse events related to the dental surgery and treatment only will be collected.

Information collected will be as follows: date and time of onset whether it is mild, moderate or severe. the frequency and the action taken. If it is related to the device and if so, is it anticipated or serious and when or if it is resolved.

Time frame: 6 weeks 6 & 12 months

If the patient has to have any additional dental procedures and or treatments will be collected.

The reason for the additional dental procedure treatments will be collected along with the date and broken down under the following reasons: Failed Implant Severe Bone Loss Loss of Attached Tissue

Time frame: 6 weeks 6 & 12 months