Jaw, EdentulousNCT00748397
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
A study testing Fixture MicroThread (Micro-Macro) in people with Jaw, Edentulous, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 countries.
Trial summary
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Fixture MicroThread (Micro-Macro)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 1999to Dec 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Sufficient amount of bone to give good support for implants of at least 9 mm length.
- Willing to give signed informed consent
Who cannot join
- Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Unable or unwilling to return for follow-up visits
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Louisiana State University Medical Center, School of Dentistry
New Orleans, Louisiana, 70119-2799
Germany1 site
Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität
Heidelberg
Spain1 site
Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia
Madrid, 28040
About this study
Official title: An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.
Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.
- Conditions
- Jaw, Edentulous
- Being tested
- Fixture MicroThread (Micro-Macro)
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixture MicroThread (Micro-Macro)Device
Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Fixture MicroThread (Micro-Macro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Measured: Continuously during 5,5 years after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJan 1999
- Primary completionDec 2007
Why it stopped: Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bo Sunzel, Dr, Principal investigator, Käkkirurgiska kliniken, Universitetssjukhuset MAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748397
- Sponsor's protocol ID
- YA-MMF-0002
- Status last verified
- Sep 2008
- First submitted
- 5 Sep 2008
- Last updated
- 8 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro
- ClinicalTrials.gov ID
- NCT00748397
- Acronym / sponsor ID
- YA-MMF-0002
- Conditions
- Jaw, Edentulous
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Dec 2007 (actual)
- First posted
- 8 Sep 2008 (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.
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.
Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Fixture MicroThread (Micro-Macro) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years of age
- Sufficient amount of bone to give good support for implants of at least 9 mm length.
- Willing to give signed informed consent
Key exclusion criteria (3 listed)
- Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Unable or unwilling to return for follow-up visits
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 |
|---|---|---|
| Fixture MicroThread (Micro-Macro)Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm. | Device | A |
Primary outcome
Implant survival
Time frame: Continuously during 5,5 years after implant placement
Results and safety
The study was stopped early (reason given: Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2008.
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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.
Bo Sunzel, Dr principal investigator
Käkkirurgiska kliniken, Universitetssjukhuset MAS
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixture MicroThread (Micro-Macro) in people with Jaw, Edentulous, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 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 3 inclusion and 3 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 8 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, Spain, Sweden. 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: Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.). 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?
Implant survival (time frame: Continuously during 5,5 years after implant placement). 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 8 Sep 2008.