Edentulous or Failing Dentition MandibleNCT02940353
The TREFOIL Concept 5 Year Clinical Investigation
A study testing TREFOIL concept in people with Edentulous or Failing Dentition Mandible, run by Nobel Biocare at 5 sites in 5 countries.
Trial summary
Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous or Failing Dentition Mandible
- What is being tested?
- TREFOIL concept
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2016to Jun 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obtained informed consent from the subject.
- The subject is at least 18 years of age (passed cessation of growth) and not older than 80 years.
- The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
- The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based) or soft tissue born denture.
- The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- The subject is compliant with good oral hygiene.
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- The subject has an edentulous mandible or failing mandibular dentition providing sufficient bone in the interforaminal where a fixed restoration on three (3) implants is regarded as an appropriate treatment solution.
- The subject has an osseous architecture enough to receive three implants with a length of at least 11.5 mm and a diameter of 5 mm in the interforaminal (e.g. jaw volume B, C or D; inter foramina distance at least 20 mm; buccal/lingual width at least 6-7 mm, vertical height after leveling bone sufficient to receive an implant of at least 11.5 mm length).
- The subject has a jaw curvature that fits to the prefabricated framework design.
- Implants will be placed in healed or extraction sites (clinical stability has to be ensured).
- The implant sites are free from infection and extraction remnants.
- The subjects as well as the implant sites fulfill the criteria for early loading.
- Smokers that have reduced their consumption may be included after a certain test phase (e.g. test phase for reduction from 2 to 1 packages of cigarettes should be at least 6 months).
- Class II inter-jaw relation patients are not an exclusion criteria per se. Based on the individual judgment of the clinician those patients may be treated.
- Subject inclusion criteria at time of surgery
- After bone leveling sufficient mandible bone volume in the interforaminal present for three (3) implants with a length of at least 11.5 mm and a diameter of 5 mm.
- After bone leveling the jaw curvature does fit to the prefabricated framework.
- The implant sites are free from infection and extraction remnants.
- The subject as well as the implant sites fulfill the criteria for early loading.
Who cannot join
- The subject is not able to give her/his informed consent of participating.
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation.
- Alcohol or drug abuse as noted in subject records or in subject history.
- Smoking of more than 1 package of cigarettes per day (> 20 cigarettes or equivalent).
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- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
- Bisphosphonate therapy - based on individual judgment of the clinician (if intravenously administered or too high oral doses recently before surgery and during follow-up period).
- Pathologic occlusion, e.g. severe bruxism or other destructive habits.
- Lack of opposing dentition or unstable occlusion.
- Ongoing infections, endodontic or periodontal problems in opposing teeth or implants.
- Subject shows an unacceptable oral hygiene.
- Subject has allergic or adverse reactions to the restorative material.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Dr. Higuchi &Skinner
Spokane, Washington, 99216-1077
About this study
Official title: The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework
Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).
- Conditions
- Edentulous or Failing Dentition Mandible
- Being tested
- TREFOIL concept
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREFOIL conceptDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Trefoil concept | Other | Treatment Receives: Device: TREFOIL concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative survival rates for the implants
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous or Failing Dentition MandibleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940353
- Sponsor's protocol ID
- T-188
- Status last verified
- Sep 2022
- First submitted
- 19 Oct 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework
- ClinicalTrials.gov ID
- NCT02940353
- Acronym / sponsor ID
- T-188
- Conditions
- Edentulous or Failing Dentition Mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Trefoil concept | Other | Device: TREFOIL conceptTreatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Obtained informed consent from the subject.
- The subject is at least 18 years of age (passed cessation of growth) and not older than 80 years.
- The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
- The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based) or soft tissue born denture.
- The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
Key exclusion criteria (13 listed)
- The subject is not able to give her/his informed consent of participating.
- Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation.
- Alcohol or drug abuse as noted in subject records or in subject history.
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 |
|---|---|---|
| TREFOIL concept | Device | Treatment with Trefoil concept |
Primary outcome
Cumulative survival rates for the implants
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREFOIL concept in people with Edentulous or Failing Dentition Mandible, run by Nobel Biocare at 5 sites in 5 countries.
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 19 inclusion and 13 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Chile, Italy, Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative survival rates for the implants (time frame: 5 years). 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 22 Mar 2023.