Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported RestorationNCT02178891
Extra Short Implants Brånemark System® RP Ø4.5x4.5 mm Implants
A study testing extra short implant in people with Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration, run by Nobel Biocare at 2 sites in Germany.
Trial summary
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
- What is being tested?
- extra short implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2010to Aug 2019
- 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
- The subject should be at least 18 years of age and have passed secession of growth
- The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant
- Obtained informed consent from the subject
- The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
- The subject should have a severely resorbed posterior mandible and/ or maxilla.
- Implants are only to be placed in healed sites, defined as a site with minimum 6 months of healing following tooth extraction
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- At least 6 mm residual bone width, between 4-7 mm residual bone height in the maxilla and between 6-9 mm residual bone height in the mandible
- At implant installation the implant should be stable; final tightening torque of the implant about 25 Ncm or higher, preferably not exceeding 45 Ncm
- The subject should be healthy and compliant with good oral hygiene
- Favorable and stable occlusal relationship
Who cannot join
- The subject is not able to give her/his informed consent of participating
- Health conditions, which do not permit the surgical treatment
- Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history
- Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation
- Alcohol or drug abuse as noted in subject records or in subject history.
- Heavy smoking (>10 cigarettes/day)
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- Intake of medication containing bisphosphonates
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- Severe bruxism or other destructive habits
- Immediate insertion (i.e. placement of the implant immediately after extraction)
- Bone augmentation procedures before or at implant installation is not allowed
- Deviation from stated drilling protocol, utilizing osteotomes, is not allowed
- Lack of opposing dentition
- Single crown restorations are not to be performed in the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universtätsmedizin Mainz
Mainz, Rhl-Palat., 55131
Universitätsmedizin Mainz
Mainz, 55131
About this study
Official title: A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.
- Conditions
- Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
- Being tested
- extra short implant
- Keywords
- short implants, Nobel Biocare, partially edentulous, maxilla or mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra short implantDevice
| Study group | Role | What they receive |
|---|---|---|
| short implants | Other | Not described Receives: Device: extra short implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone level changes
Measured: yearly, up to 5 years
Secondary outcomes (1)
cumulative survival and success rates
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 posted1 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported RestorationStudies 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
- 144 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
- NCT02178891
- Sponsor's protocol ID
- T-163
- Status last verified
- Jun 2014
- First submitted
- 27 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
- ClinicalTrials.gov ID
- NCT02178891
- Acronym / sponsor ID
- T-163
- Conditions
- Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration
- Keywords
- short implants, Nobel Biocare, partially edentulous, maxilla or mandible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 1 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.
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| short implants | Other | Device: extra short implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject should be at least 18 years of age and have passed secession of growth
- The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant
- Obtained informed consent from the subject
- The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
- The subject should have a severely resorbed posterior mandible and/ or maxilla.
Key exclusion criteria (14 listed)
- The subject is not able to give her/his informed consent of participating
- Health conditions, which do not permit the surgical treatment
- Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history
- Any disorders in the planned implant area such as previous tumours, 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 |
|---|---|---|
| extra short implant | Device | short implants |
Primary outcome
marginal bone level changes
Time frame: yearly, up to 5 years
1 secondary outcome
cumulative survival and success rates
Time frame: yearly, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra short implant in people with Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration, run by Nobel Biocare at 2 sites 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
marginal bone level changes (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 1 Jul 2014.