Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
NCT ID: NCT00748670
Last Updated: 2008-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
23 participants
INTERVENTIONAL
1999-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Bone quality class III or IV, (according to Lekholm \& Zarb16)
* Willing to give signed informed consent
Exclusion Criteria
* Tobacco smoking more than 5 cigarettes/day
* 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
* Bruxism or other parafunctional activity
18 Years
75 Years
ALL
No
Sponsors
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Dentsply Sirona Implants and Consumables
INDUSTRY
Responsible Party
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Astra Tech AB
Principal Investigators
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Clark Stanford, D.D.S., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Locations
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University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Iowa City, Iowa, United States
Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken
Gävle, , Sweden
Odontologiska kliniken, Länssjukhuset
Halmstad, , Sweden
Countries
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Other Identifiers
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YA-MMF-0003
Identifier Type: -
Identifier Source: org_study_id