Missing TeethNCT03655990
A Full-Arch Implant- Supported Prosthesis in the Upper and/or Lower Jaw-USA
An observational study of Missing Teeth, run by Juvora Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Treatment with the JUVORA™ Dental Disc
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Treatment with the JUVORA™ Dental Disc
- Keywords
- Dentures Implant
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with the JUVORA™ Dental DiscDevice
treatment with the JUVORA™ Dental Disc
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Treatment with the JUVORA™ Dental Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 12 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 12 months
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.
Measured: 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.
Measured: 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)
Measured: 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
- = plaque only recognized by running a probe across the smooth marginal surface of the implant
- = plaque can be seen by the naked eye
- = abundance of soft matter
Measured: 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
- = isolated bleeding spots visible
- = blood forms a confluent red line on mucosal margin
- = heavy or profuse bleeding
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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:
- 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
- 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
Measured: 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.
Measured: 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
Measured: 6 weeks 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start7 Aug 2018
- Primary completion3 May 2022
- Study completion3 May 2022
Why it stopped: Impact of COVID-19 on Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juvora Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PCG Clinical Services
- Responsible party
- Sponsor
- Investigators
- Juvora, Study director, Juvora Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655990
- Sponsor's protocol ID
- JUV17-08
- Status last verified
- Mar 2022
- First submitted
- 8 Aug 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03655990
- Acronym / sponsor ID
- JUV17-08
- Conditions
- Missing Teeth
- Keywords
- Dentures Implant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Impact of COVID-19 on Recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Juvora Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PCG Clinical Services
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the JUVORA™ Dental Disc | – | Device: Treatment with the JUVORA™ Dental DiscSubjects receive the device as per normal standard practice, there are no other treatment arms for this prospective study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with the JUVORA™ Dental Disctreatment with the JUVORA™ Dental Disc | Device | Treatment with the JUVORA™ Dental Disc |
Primary outcome
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")
16 secondary outcomes
Patient quality of life assessment using a patient questionnaire.
Time frame: 6 weeks 6 & 12 months
Oral and dental:Patients will be assessed for a history of Bruxism (grinding of the teeth).
Time frame: 6 weeks 6 &12 months
Oral and dental: Patients will be checked for occlusion.
Time frame: 6 weeks &12 months
Survival of the implant in the patients mouth.
Time frame: 12 months
Success of the implant in the patients mouth.
Time frame: 12 months
Success of the implant in the patients mouth according to marginal bone resorption.
Time frame: 12 months
Success of the implant in the patients mouth according to the presence of Peri-implantitis.
Time frame: 12 months
Success of the implant in the patients mouth according to modified plaque index (mPI).
Time frame: 12 months
Success of the implant in the patients mouth according to Modified Bleeding Index (mBI).
Time frame: 12 months
Success of the implant in the patients mouth according to the probing depth.
Time frame: 12 months
Success of the implant in the patients mouth according to Soft Tissue Reactions.
Time frame: 12 months
Success of the implant in the patients mouth according to Mechanical Complications.
Time frame: 12 months
Success of the prosthesis assessed according to specific criteria and in accordance with the ITI Treatment Guide Volume 8.
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.
Time frame: 6 weeks 6 & 12 months
Patient adverse events related to the dental surgery and treatment only will be collected.
Time frame: 6 weeks 6 & 12 months
If the patient has to have any additional dental procedures and or treatments will be collected.
Time frame: 6 weeks 6 & 12 months
Results and safety
The study was stopped early (reason given: Impact of COVID-19 on Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Study location web site for enquiriesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juvora study director
Juvora Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missing Teeth, run by Juvora Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impact of COVID-19 on Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the Prosthetic (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.