EdentulousNCT02186912
All-On-4® Treatment Concept
A study testing Nobel Active, Nobel Procera IBO in people with Edentulous, run by Nobel Biocare at 1 site in Germany.
Trial summary
Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- Nobel Active, Nobel Procera IBO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Dec 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
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 in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
- Alcohol or drug abuse as noted in subject records or in subject history Smoking of >10 cigarettes/day
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- Pathologic occlusion, e.g. severe bruxism or other destructive habits
Show all 13Show fewer
- 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.
- Bone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement.
- Bis-phosphonate therapy
- Implant insertion torque is <35 Ncm or >70 Ncm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge
Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.
- Conditions
- Edentulous
- Being tested
- Nobel Active, Nobel Procera IBO
- Keywords
- edentulous, Nobel Active, Nobel Procera, IBO, CAD/CAM
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nobel Active, Nobel Procera IBODevice
Also called Nobel Active implants, Implant bar
| Study group | Role | What they receive |
|---|---|---|
| mandible | Experimental | Nobel Active Nobel Procera IBO Receives: Device: Nobel Active, Nobel Procera IBO |
| maxilla | Experimental | Nobel Active Nobel Procera IBO Receives: Device: Nobel Active, Nobel Procera IBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone level change around tilted and straight implants
Measured: yearly up to 5 years
Secondary outcomes (1)
cumulative survival rate (CSR)
Measured: yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: The study stopped as the performance of the study showed insufficient patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulousStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT02186912
- Sponsor's protocol ID
- T-185
- Status last verified
- Apr 2016
- First submitted
- 8 Jul 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge
- ClinicalTrials.gov ID
- NCT02186912
- Acronym / sponsor ID
- T-185
- Conditions
- Edentulous
- Keywords
- edentulous, Nobel Active, Nobel Procera, IBO, CAD/CAM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped as the performance of the study showed insufficient patient recruitment.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2014 (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.
Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandible | Experimental | Device: Nobel Active, Nobel Procera IBONobel Active Nobel Procera IBO |
| maxilla | Experimental | Device: Nobel Active, Nobel Procera IBONobel Active Nobel Procera IBO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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 in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
- Alcohol or drug abuse as noted in subject records or in subject history Smoking of >10 cigarettes/day
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
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 |
|---|---|---|
| Nobel Active, Nobel Procera IBOAlso: Nobel Active implants, Implant bar | Device | mandible, maxilla |
Primary outcome
bone level change around tilted and straight implants
Time frame: yearly up to 5 years
1 secondary outcome
cumulative survival rate (CSR)
Time frame: yearly up to 5 years
Results and safety
The study was stopped early (reason given: The study stopped as the performance of the study showed insufficient patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nobel Active, Nobel Procera IBO in people with Edentulous, run by Nobel Biocare at 1 site in Germany.
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 0 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: stopped early, as of the sponsor's last update on 5 Apr 2016. 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 Germany. 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: The study stopped as the performance of the study showed insufficient patient 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?
bone level change around tilted and straight implants (time frame: yearly up to 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 5 Apr 2016.