Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
Status
Conditions
Treatments
Details and patient eligibility
About
The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 - 75 years of age
- Bone quality class III or IV, (according to Lekholm & Zarb16)
- Willing to give signed informed consent
Exclusion criteria
- Need for bone augmentation of the maxilla
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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