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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03655990
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
PCG Clinical Services
Information provided by (Responsible Party):
Juvora Ltd.

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.

Condition or disease Intervention/treatment
Missing Teeth Device: Treatment with the JUVORA™ Dental Disc

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).

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Group/Cohort Intervention/treatment
Treatment with the JUVORA™ Dental Disc
Subjects receive the device as per normal standard practice, there are no other treatment arms for this prospective study.
Device: Treatment with the JUVORA™ Dental Disc
treatment with the JUVORA™ Dental Disc




Primary Outcome Measures :
  1. Survival of the Prosthetic [ Time Frame: 12 months ]
    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")


Secondary Outcome Measures :
  1. Patient quality of life assessment using a patient questionnaire. [ Time Frame: 6 weeks 6 & 12 months ]
    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.

  2. Oral and dental:Patients will be assessed for a history of Bruxism (grinding of the teeth). [ Time Frame: 6 weeks 6 &12 months ]
    If patients have suffered with Bruxism they will be asked if they have been wearing their night guard during their dental treatment.

  3. Oral and dental: Patients will be checked for occlusion. [ Time Frame: 6 weeks &12 months ]

    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)

  4. Survival of the implant in the patients mouth. [ Time Frame: 12 months ]
    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).

  5. Success of the implant in the patients mouth. [ Time Frame: 12 months ]
    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.

  6. Success of the implant in the patients mouth according to marginal bone resorption. [ Time Frame: 12 months ]
    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.

  7. Success of the implant in the patients mouth according to the presence of Peri-implantitis. [ Time Frame: 12 months ]
    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)

  8. Success of the implant in the patients mouth according to modified plaque index (mPI). [ Time Frame: 12 months ]

    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

  9. Success of the implant in the patients mouth according to Modified Bleeding Index (mBI). [ Time Frame: 12 months ]

    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

  10. Success of the implant in the patients mouth according to the probing depth. [ Time Frame: 12 months ]
    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).

  11. Success of the implant in the patients mouth according to Soft Tissue Reactions. [ Time Frame: 12 months ]
    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.

  12. Success of the implant in the patients mouth according to Mechanical Complications. [ Time Frame: 12 months ]
    Complications related to the implant include implant fracture, abutment/screw fracture and loosening will be reported.

  13. Success of the prosthesis assessed according to specific criteria and in accordance with the ITI Treatment Guide Volume 8. [ Time Frame: 12 months ]

    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).


  14. 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. [ Time Frame: 6 weeks 6 & 12 months ]

    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


  15. Patient adverse events related to the dental surgery and treatment only will be collected. [ Time Frame: 6 weeks 6 & 12 months ]

    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.


  16. If the patient has to have any additional dental procedures and or treatments will be collected. [ Time Frame: 6 weeks 6 & 12 months ]

    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



Other Outcome Measures:
  1. Technical Satisfaction not related to the patient [ Time Frame: between 4 - 6 months prior to fixture in the patients mouth. ]

    Data collected during the Laboratory processing of the JUVORA™ Dental Disc into the prosthesis.

    Infrastructure manufacturing issues? Framework integrity issues? Veneer adhesion issues?




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655990


Contacts
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Contact: Bea Acton 001 210.491.0015 drlemke@oralsurgerytx.com

Locations
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United States, Texas
Dr Robert Lemke Recruiting
San Antonio, Texas, United States, 78216
Contact: Robert Dr Lemke         
Sponsors and Collaborators
Juvora Ltd.
PCG Clinical Services
Investigators
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Study Director: Juvora Juvora Ltd.

Additional Information:
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Responsible Party: Juvora Ltd.
ClinicalTrials.gov Identifier: NCT03655990    
Other Study ID Numbers: JUV17-08
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Juvora Ltd.:
Dentures Implant
Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities